Beyond Biotech - the podcast from Labiotech

1:33  Labiotech news3:31  Daiichi Sankyo/AstraZenecaThe companies Daiichi Sankyo and AstraZeneca have worked together for several years.This week’s podcast is sponsored by Daiichi Sankyo and AstraZeneca.On this week’s podcast, we have a conversation with Markus Kosch, the head of Oncology Europe and Canada for Daiichi Sankyo, and Greg Rossi, Senior Vice President, Oncology, Europe and Canada, from AstraZeneca, who are joining forces to bring new oncology medicines into clinical practice. In March 2019, AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialize health technologies worldwide. Their collaboration is designed to leverage strengths and combine efforts to improve patient care.

4:26  Labiotech news6:36  Medidata21:43 Bill & Melinda Gates Research InstituteThis week’s podcast is sponsored by Jubilant Biosys.May 20 is International Clinical Trials Day.ECRIN,  the European Clinical Research Infrastructure Network, is a not-for-profit organization that supports the conduct of multinational clinical trials in Europe. Based in Paris, France, the organization launched International Clinical Trials Day (ICTD) in 2005 to commemorate the day when James Lind started his clinical trial on scurvy in 1747, on May 20.ECRIN is hosting an event, both in-person and online, on Monday, May 23, called Decentralised Clinical Trials: challenges and opportunities. While the physical event in Warsaw, Poland, is full, online registration can be found here.International Clinical Trials Day is also supported and promoted by a range of charities, companies and organizations, such as the 13,000-member Association of Clinical Research Professionals (ACRP), which is the only non-profit organization solely dedicated to representing, supporting, and advocating for clinical research professionals.To celebrate the day, we have two interviews about the importance of the event and clinical trials in general. We have conversations with Dr. Michael Dunne, head of development and chief medical officer of the Bill & Melinda Gates Medical Research Institute, and Kelly McKee, vice president, decentralized clinical trials (DCT) and patient registries at Medidata.

This week’s podcast is sponsored by Quantoom.International MPS Awareness DayMay is the big month when it comes to awareness - there are almost 100 awareness months, weeks, and days being marked.Some of these are well known conditions. Others, however, are less prominent.International MPS (mucopolysaccharidosis) Awareness Day takes place on May 15.According to the National MPS Society in the U.S., mucopolysaccharidosis (MPS) and mucolipidosis (ML) are genetic lysosomal storage diseases (LSD) caused by the body’s inability to produce specific enzymes. The missing or insufficient enzyme prevents cells from recycling waste, resulting in the storage of materials in cells throughout the body. As the disease progresses, there is widespread damage throughout the body, including the heart, bones, joints, respiratory system and central nervous system, leading to a shortened lifespan.There are 12 different forms of MPS.For example, MPS I includes Hurler Syndrome, Scheie Syndrome and Hurler-Scheie Syndrome, while MPS II covers Hunter Syndrome.Hurler Syndrome takes its name from Gertrude Hurler, the doctor who described a boy and girl with the condition in 1919. In 1962, Dr. Scheie, a consultant ophthalmologist, wrote about patients who were more mildly affected. Individuals who do not fit the severe or mild ends of the disease were said to have Hurler/Scheie. The specific disease names have been replaced with the designations attenuated (diminished severity) and severe MPS I. MPS I has a wide range of symptoms that vary in severity and can be managed and treated with enzyme replacement therapies. There is no cure for MPS I. Mucopolysaccharides are chains of sugar molecules used to build connective tissues in the body. MPS I patients are missing the enzyme alpha-L-iduronidase, which is essential in breaking down the mucopolysaccharides dermatan sulfate and heparan sulfate. These materials remain stored in the body’s cells, causing progressive damage. Babies may show little sign of the disease, but as cells sustain damage, symptoms start to appear.To talk about the disease, treatments, research, and the future prognosis for those with MPS, is Dr Matthew Ellinwood, chief scientific officer at the National MPS Society.

3:32  Labiotech news5:33  Lupus interviewThis week’s podcast is sponsored by Lonza.May is Lupus Awareness Month, and to talk about lupus with us this week on the podcast are Katherine Tran, senior global market development & marketing manager of the proteomics division at SCIEX, and Allan Stensballe, associate professor, Department of Health Science and Technology and associate professor, The Faculty of Medicine, at Aalborg Universitet in Denmark.Each May, The Lupus Foundation of America gathers the lupus community to make lupus visible.Lupus is a chronic autoimmune disease where the immune system can’t tell the difference between healthy tissues and foreign invaders. This can result in inflammation, pain, and damage to any organ system in the body. Common symptoms include extreme fatigue, debilitating joint pain, skin rashes, and swelling. While lupus can affect anyone, people with lupus overwhelmingly consist of women and disproportionately impacts certain racial and ethnic backgrounds, including Black/African-American, Hispanic/Latino, Asian-American and Pacific Islander.Due to the mysterious and elusive nature of this disease, many of the symptoms of lupus aren’t always visible, and can often result in years of misdiagnosis and inadequate treatment. And, because many of its symptoms and impact aren’t always seen, it can lead to those living with lupus to feel misunderstood and isolated.

2:13  Labiotech news5:17  bit.bioThis week’s podcast is sponsored by Scientist.com.The mainstream news in the past couple of months has picked up on artificial intelligence (AI). Not so much its uses, more the potential for conflict and fears over AI developing too quickly, or ‘taking over humanity.’Debates have sprung up around deepfakes, ChatGPT, and other AI technologies, and there are concerns over how new technology will impact our everyday lives. The debate covers ethics, regulations, law, education; in fact AI and the future seem intertwined. AI has been around for some time, it’s just increased sophistication has brought it more into the spotlight. There are many positives to AI, not least in the life sciences. We now have the potential to analyze far more data, and there is real potential for identification of new drugs and drug targets being found through new technology. Of course, AI has other applications in science, such as climate change and sustainability, and in food technology.  AI and machine learning were just some of the topics Labiotech discussed with Mark Kotter, CEO of U.K. biotech bit.bio.bit.bio is a synthetic biology company providing human cells for research, drug discovery and cell therapy. The company applies a patented safe harbor gene-targeting approach to inducibly express transcription factor combinations that reprogram human induced pluripotent stem cells (iPSCs) into highly defined and mature human cell types. The company is currently building a clinical pipeline and marketing a range of cells and disease models for research and drug discovery under its ioCells brand. This includes nerve cells, immune cells and muscle cells. The company was spun out of the University of Cambridge in 2016, and has since raised $150 million capital from Arch Ventures, Foresite Capital, Milky Way, Charles River Laboratories, National Resilience, Tencent, and Puhua Capital among others.

2:05  Labiotech news3:32  MEET2WIN9:38 Lund Spring Symposium19:31 MerckThis week, we’re talking about the upcoming Lund Spring Symposium with Claes Wahlestedt, Leonard M. Miller professor and director of the Center for Therapeutic Innovation (CTI) and associate dean for therapeutic innovation at the University of Miami Miller School of Medicine;  about Meet2Win with Lucia Robert, CEO of MATWIN which stages the event; and then an interview with two people, Andrew Clutterbuck, associate director MSAT EMEA and Mark Peacock,  director, technical applications, from Merck.This week’s podcast is sponsored by Merck.Merck is a science and technology company, operates across life science, healthcare and electronics. The company provides products and services that accelerate drug development and manufacturing as well as discovering ways to treat the most challenging diseases to enable the intelligence of devices. Merck holds the global rights to the Merck name and brand. The only exceptions are the U.S. and Canada, where the business sectors of Merck operate as MilliporeSigma in life science.Lund Spring SymposiumA new event, which will include presentations by Nobel laureates, is set to showcase the best of pharmacology.The Lund Spring Symposium, which takes place from May 24 to 26 at the Palaestra et Odeum in Lund, Sweden, aims to raise the profile of pharmacology as a cross-functional discipline in the 21st Century and to provide a forum to facilitate collaborations across academia and industry.MEET2WINThe 8th annual MEET2WIN event takes place in Bordeaux, France, from May 11 to 12. The MEET2WIN convention, staged by MATWIN (Maturation & Accelerating Translation With Industry) brings together nearly 300 European players specifically involved in translational research and innovation in oncology (researchers, clinicians, entrepreneurs, biotechs, pharmaceutical groups, investors, support structures, etc.) looking to expand their network of contacts and optimize their collaboration around the fight against cancer.More than 1,000 companies and organizations attend the event, with more than 5,000 meetings scheduled. 

1:44  Labiotech news3:27  MolecureThis week, to coincide with World Sarcoidosis Day, April 13, we talk about sarcoidosis with Marcin Szumowski, CEO and president of the management board of Molecure. World Sarcoidosis DayAs part of Sarcoidosis Month, which is marked each April, World Sarcoidosis Day is on April 13. But what is sarcoidosis?The Foundation for Sarcoidosis Research explains that it is an inflammatory disease characterized by the formation of granulomas—or small clumps of inflammatory cells—in one or more organs of the body. When the immune system goes into overdrive and too many of these clumps form, they can interfere with an organ’s structure and function. When left unchecked, chronic inflammation can lead to fibrosis, or permanent scarring of organ tissue. Sarcoidosis affects the lungs in around 90% of cases, but it can affect almost any organ in the body. Despite advances in research, sarcoidosis is difficult to diagnose, and has limited treatment options. There is no known cure.In the U.S. alone, there are between 150,000 and 200,000 people with the condition, with around 1.2 million individuals with sarcoidosis worldwide.MolecureMolecure is a clinical stage biotechnology company that uses its medicinal chemistry and biology capabilities to discover and develop first-in-class small molecule drug candidates that directly modulate the function of underexplored protein and RNA targets to treat multiple incurable diseases.Molecure has generated a diverse pipeline of seven programs with the support of academic life science institutions globally, including Yale University, Rutgers University, the Flemish Institute for Biotechnology (VIB) in Ghent, the University of Michigan and the International Institute of Molecular and Cell Biology in Warsaw (IIMCB).Molecure’s most advanced in-house drug candidate is OATD-01, a first-in-class inhibitor of CHIT1 for the treatment of interstitial lung diseases, such as sarcoidosis and idiopathic pulmonary fibrosis, which is phase II ready. A phase II trial in patients with sarcoidosis is expected to start in the second half of 2023.Its second proprietary candidate is OATD-02, an oral, potent and selective first-in-class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer, which advanced to phase I clinical development in March 2023.Molecure’s headquarters and laboratories are located in Warsaw, Poland, with an additional laboratory facility in Łódź.

3:13  Nectin Therapeutics26:47 ImmunomeThis episode of the podcast is an in-depth look at antibody drug conjugates (ADCs). Our guests are Dr Pini Tsukerman, chief scientific officer of Nectin Therapeutics, and Matthew Robinson, chief technology officer of Immunome.This episode of the podcast is sponsored by PHTA.ImmunomeImmunome’s Discovery Engine leverages the information stored in memory B cells to guide the discovery of first-in-class antibody therapeutics directed at potentially novel targets in oncology and other areas. Immunome’s research has revealed - and continues to unveil - novel target classes, such as proteins ectopically expressed on the surface of cancer cells, which are uniquely tumor selective and potentially suitable for development as ADCs. The company talked about those applications recently at World ADC London and has also established an ADC and T Cell Redirection Advisory Board to prioritize selection of novel targets for ADC and TCR modalities. Immunome’s focus is on discovering and developing therapeutics in oncology internally and in collaboration with partners, including through a recently established strategic collaboration with AbbVie. Nectin TherapeuticsNectin Therapeutics is a clinical-trial biotechnology company developing new immuno-oncology therapies to address resistance towards existing cancer treatments. In addition to its collaboration with Merck (MSD) to trial KEYTRUDA (pembrolizumab) with Nectin’s novel anti-PVR antibody, NTX1088, Nectin is also working on developing three ADCs in its drug discovery pipeline. 

2:57 Labiotech.eu news4:17 PBD Biotech14:52 AAHI29:36 TB AllianceMarch 24 is World Tuberculosis Day. To mark the occasion, we have conversations with Christopher Fox, senior vice president, formulations, at the Access to Advanced Health Institute; TB Alliance CEO Mel Spigelman; and Jane Theaker, CEO of PBD Biotech.This episode of the podcast is sponsored by Samplix.World Tuberculosis DayTuberculosis is a leading infectious disease. According to the WHO, 10.6 million people became ill with the disease in 2021, and there were 1.6 million deaths from tuberculosis. The theme for World TB Day 2023 is Yes! We can end TB!It aims to inspire hope and encourage high-level leadership, increased investments, faster uptake of new WHO recommendations, adoption of innovations, accelerated action, and multisectoral collaboration to combat TB. TB AllianceTB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. Through innovative science and with partners around the globe, the organization aims to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from various global governments as well as the Bill & Melinda Gates Foundation, Cystic Fibrosis Foundation, the Global Health Innovative Technology Fund, and the United States Agency for International Development. Access to Advanced Health InstituteA potential new vaccine for tuberculosis has been developed by the Access to Advanced Health Institute in Seattle, a nonprofit biotech research institute.The results of a phase 1 clinical trial were published earlier this month in the journal Nature Communications.PBD BiotechPBD Biotech has developed a rapid screening blood test for identifying people with the disease as well as a subgroup with pre-clinical infection at higher risk of developing the disease.The company said this has the potential to revolutionize the management of TB. Biotech’s Actiphage blood test is sensitive and specific, and clinical studies at the Leicester Respiratory NIHR Biomedical Centre have shown it is able to diagnose patients with pulmonary TB and identify contacts with recent exposure that have very early stage infection and may be at higher risk of developing TB in the future. By enabling rapid screening of a population for TB, Actiphage offers a breakthrough in disease prevention and treatment. Further trials of Actiphage are currently running in the U.K., South Africa and Zambia.

1:27 Labiotech.eu news2:38 Allogenica12:06 Helex15:51 FreezeM19:55 MediSieveThe Hello Tomorrow Global Summit took place in Paris last week (March 8-10), and we feature interviews with four of the participants.Our guests this week are: FreezeM CEO and co-founder, Dr. Yuval Gilad; Allogenica CEO and co-founder Inna Menkova; George Frodsham, founder and CEO of MediSieve; and Poulami Chaudhuri, co-founder, and CEO of Helex Bio.Hello TomorrowThe 8th edition of the Hello Tomorrow Global Summit 2023 welcomed more than 3,000 people to the forefront of deep tech. There were hundreds of meetings, presentations and exhibitors in attendance, showcasing science in action - including many biotech and biopharma companies.The Grand Winner of the Hello Tomorrow Global Challenge 2023 was Sweetch Energy, but a biotech company came in third, Allogenica. Allogenica also won the Medical Biotech & Pharmaceuticals category.AllogenicaCreated in January 2022, Allogenica is a French-headquartered startup developing universal cell therapies to treat certain forms of blood cancer (leukemia, lymphoma). It recently completed its first fundraising of €500,000 ($530,000) in order to continue its development towards an approach to industrializing the process. The startup, led by Inna Menkova, and assisted by PULSALYS, aims to offer a ready-to-use, less expensive and safer treatment, in order to treat more patients with blood cancers.HelexHelex, based in India, is a biotech with a platform built on proprietary bioinformatics and AI powered systems to identify unique sequences on the gene. The pre-clinical stage biotech company unlocks epigenetics and 3D genome structures through data and machine learning to design high precision gene-editing systems.The company’s platform enables the design of appropriate gene editing apparatus. It prevents editing in unwanted tissues in cases of vector biodistribution through a Double Lock Safety system - tissue-specific vector modifications (first lock) combined with Hele-GUIDE tissue specific guide RNA (second lock) for greater safety. MediSieveMediSieve is a U.K.-based start-up that has developed magnetic blood filtration, a platform therapy that enables the physical removal of specific substances from the bloodstream of patients. It can be used as a direct treatment, to increase the safety and efficacy of other therapies, or to enable personalized medicine. The company is a spin-off from University College London.FreezeMFreezeM is an Israel-based company founded in 2018 that provides insect breeding and post-breeding solutions. FreezeM has developed cutting-edge biotechnology centered on black soldier fly (BSF) breeding, helping to increase alternative protein production capacity for livestock, while at the same time salvaging scarce global farmland, decreasing ocean exhaustion, and repurposing organic waste. The company is reducing costs by an estimated 30% and increasing protein production capacity and efficiency by 25%. Most recently, FreezeM has been selected to join the Google Startups for Sustainable Development Program, has been ranked by Dealflow as a company to watch in the industry and raised €6.3 million in European Innovation Council (EIC) funding.

 1:19 Labiotech.eu news2:32 Biomedical Research & Bio-Products12:15 Model N21:39 Institute of Clinical MedicineThis week our guests are Marit Inngjerdingen from the Institute of Clinical Medicine in Norway; Kyle Forcier, senior director of life sciences product marketing at Model N; and Dr. Andreas Roetzer, head of R&D for vaccines at Biomedical Research & Bio-Products.The next breakthrough in cancer treatment?In our body, we have an innate immune system and an immune system that is developed throughout life. Part of the innate immune system consists of so-called NK (natural killer) cells. This is a type of immune cell that specializes in killing cancer cells. These cells may be of great importance for cancer treatment in the future. NK cells kill cancer cells with the help of small “killer torpedoes,” or vesicles, that the NK cells secrete. Vesicles are small bubbles with a fatty wall of lipids and a space filled with toxic proteins. Researchers at the Institute of Clinical Medicine in Norway have recently discovered new things about these killer vesicles.“We have discovered that we can separate the killer torpedoes from other types of vesicles so that they form a kind of arsenal of weapons. Our research also shows that this type of vesicle is probably stored in a separate room inside the NK cell,” Miriam Aarsund Larsen said.Model N publishes revenue reportModel N, Inc. recently announced the results of its fifth annual State of Revenue Report. The report captures detailed data intended to help life sciences and high-tech industry executives grappling with how to grow company revenue and market share. Most executives named inflation as a significant headwind, with 84% calling it the single biggest impact on innovation.“Our findings show three main themes: Innovation collides with current market realities, innovation directly impacts revenue management, and the use of technology for revenue management is expanding,” said Suresh Kannan, chief product officer, Model N. “As organizations continue to navigate the current economic climate, the quality and reliability of technology solutions are more important than ever. These insights help us understand how to empower our customers to create and bring life-changing products to market.”Phase 2 study of breakthrough vaccine against toxic shock syndrome successfully completedThe first vaccine to potentially prevent Staphylococcal-induced toxic shock syndrome (TSS) has successfully completed a phase 2 study. TSS is a life-threatening condition caused by toxins that can lead to multiple organ failure and death.Nosocomial pathogen Methicillin-resistant Staphylococcus aureus (MRSA) bacteria are resistant to widely used antibiotics. Infections with MRSA are harder to treat and therapies are more expensive as the length of hospital stays is significantly prolonged. If the treatment does not lead to rapid clearance of the bacterial pathogen, dangerous symptoms such as septic or toxic shock can occur – a potentially life-threatening condition.Researchers at Biomedical Research & Bio-Products AG, under the direction of Martha Eibl, in cooperation with MedUni Vienna’s Department of Clinical Pharmacology, conducted the study. The promising results showed the TSST-1 vaccine is safe and effective, with immunization lasting for at least two years. 

1:41 Labiotech.eu news3:41 Cellular Origins20:17 Bio-Europe SpringTwo of the interviews on the podcast today are related to Bio-Europe Spring. There are conversations with Rosie Bernard, senior director, production and content strategy for EBD Group EU, with an overview of the event, and also Jordan Stillman, project manager, partnering services at EBD Group.  We also have a chat with Cellular Origins' CEO Edwin Stone. Cellular OriginsCellular Origins is a TTP spin-out, created to enable scalable, cost-effective and efficient manufacture of cell and gene therapies. Cellular Origins’ proprietary technology addresses the current barriers associated with the manufacture of advanced therapies that are in late-stage development, enabling commercial manufacturing without process change. By providing a solution for automated sterile fluidic interconnection that has the flexibility to adapt and link current and future bioprocess equipment, Cellular Origins hopes to enable full automation of current cell therapy manufacturing and future innovation of new processes.Bio-Europe SpringBio-Europe Spring takes place March 20-22 in Basel, Switzerland. There is a virtual component for those unable to make the event, or who still have leftover meetings to schedule, and the online portion takes place from March 28 to 30.The event, at the Messe Basel, is an opportunity to engage in face-to-face meetings with representatives of hundreds of companies from around the world. The partneringONE tool allows meetings to be set up, and to find information on companies and attendees.As well as networking, there are exhibitors, receptions, and a variety of presentations. There is also a startup spotlight section. This year, the keynote presentations are being given by Roche and Novartis.Currently, there are more than 3,200 attendees expected to be in Basel and 18,000 meetings are being requested weekly. More than 1,600 companies will be represented, from more than 50 countries.Bio-Europe Spring sees companies from a variety of sectors, including products, services, and technologies. 

0:58 Labiotech.eu news2:37 Replay23:45 Azafaros39:39 GRO BiosciencesAs February 28 is Rare Disease Day, we have three guests on the podcast today all relevant to rare diseases. And they are Dan Mandell, CEO and co-founder of GRO Biosciences; Stefano Portolano, chief executive officer, Azafaros; and from Replay, Adrian Woolfson, executive chairman, president, and co-founder, and Lachlan MacKinnon, CEO and co-founder.Rare Disease DayTaking place on February 28 each year, the event raises awareness and looks to generate change for the 300 million people worldwide living with a rare disease, as well as their families and carers.This year, the day will be marked by more than 600 events in 106 countries.Replay and The University of Texas MD Anderson Cancer Center create SyenaReplay, a genome writing company reprogramming biology by writing and delivering big DNA, and The University of Texas MD Anderson Cancer Center, have launched Syena, a new oncology-focused product company pioneering T-cell receptor (TCR) natural killer (NK) cell therapies (TCR-NKs).Building on the intellectual property and technology from MD Anderson and Replay, Syena has the potential to create the next generation of cell therapy.AzafarosAzafaros is a clinical stage company founded in 2018 with a deep understanding of rare genetic disease mechanisms, and a compound library from Leiden University. Its aim is to build a pipeline of disease-modifying therapeutics to offer patients and their families new treatment options. The company’s lead clinical-staged program is AZ-3102, a small molecule, orally available, brain penetrant azasugar, with the potential to treat GM1 gangliosidosis and GM2 gangliosidosis (Tay-Sachs and Sandhoff diseases) and Niemann-Pick disease type C (NP-C). This week, the company announced it has been granted two Rare Pediatric Disease Designations (RPDD) by the United States Food and Drug Administration (FDA) for the treatment of GM1 and GM2 gangliosidoses, Orphan Medicinal Product Designation (OMPD) by the European Medicines Agency (EMA) for the treatment of GM2 gangliosidosis, and an Innovation Passport by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of GM1 and GM2 gangliosidoses.GRO BiosciencesGRO Biosciences is leveraging groundbreaking science to expand the amino acid alphabet and deliver on protein therapeutics. The U.S. company is transforming treatments for increasingly prevalent chronic medical conditions including autoimmune and metabolic diseases to improve the lives of patients. GRObio is applying its platform to advance partnered and collaborative programs, as well as its own pipeline of protein therapeutics bearing unique NSAA (non-standard amino acid) chemistries. The company’s NSAA therapeutics feature previously unattainable capabilities including unprecedented duration of action and precise regulation of the immune system.

1:25 Labiotech.eu news3:02 GPCR Therapeutics22:16 eClinical Solutions31:04 Orbsen TherapeuticsThis week, our guests are Katrina Rice, chief delivery officer, biometrics services at eClinical Solutions; Pina Cardarelli, president and CSO of GPCR Therapeutics; and Larry A Couture, CEO of Orbsen Therapeutics.GPCR Therapeutics launches multiple myeloma trial GPCR Therapeutics, Inc., a drug discovery company targeting G Protein Coupled Receptors (GPCR) pairs, recently started its phase 2 trial in the U.S. for its lead small molecule asset, GPC-100.  GPC-100 targets CXCR4, one of the most prevalent chemokine GPCRs overexpressed in more than 23 cancers.This randomized, open-label phase 2 study assesses the efficacy of GPC-100 and propranolol, with and without granulocyte colony-stimulating factor (G-CSF) for the mobilization of stem cells in patients with multiple myeloma undergoing autologous stem cell transplant. Survey looks at biotech challengeseClinical Solutions, a provider of digital clinical software and biometrics services, has published a survey detailing insights from 60 biopharmaceutical clinical operations and biometrics professionals on the most pressing trends, challenges, and opportunities that are shaping the clinical data landscape. Some key takeaways include: 64% of respondents are leveraging 6 or more external data sources; harnessing automation is the top overarching industry priority for more than one-third (36%) of respondents; and speed (30%) and quality (30%) are reported as the largest pain points for electronic data capture (EDC) database build.Orbsen TherapeuticsOrbsen Therapeutics is an Irish-headquartered company working in stromal cell immunotherapy. The company has leveraged its proprietary technology platform, which is based on highly purified stromal stem cells, to establish a specific portfolio of early-stage product candidates. Orbsen's allogeneic or 'off-the-shelf' cell product candidates target significantly advanced stages of diseases where there are high unmet medical needs, including moderate-severe acute respiratory distress syndrome (ARDS), autoimmune disease and Stage 3 DKD.

1:10 Labiotech.eu news2:50 Innovation Agency Lithuania25:25 Astellas Pharma34:37 4basebioThis week, our guests are Romualda Stragienė, director at Innovation Agency Lithuania and Andrius Sliuzas, export key account manager of high tech industries at Innovation Agency Lithuania; 4basebio CEO Heikki Lanckriet; and Yoshitsugu Shitaka, chief scientific officer at Astellas.4basebio4basebio, a spinout of 2Invest AG in 2020, is a life sciences company engaged in the design, manufacture and supply of application-specific synthetic DNA or mRNA, as well as targeted non-viral vectors for the delivery of nucleic acid payloads, for use in cell and gene therapies and vaccines.As cell and gene therapies expand, there is an increasing demand for DNA as a therapeutic agent and in the manufacture of mRNA. Existing plasmid DNA supply is produced by way of biofermentation. Synthetic DNA, in contrast, is produced in a matter of weeks using an enzymatically-driven bench top process. 4basebio currently produces four types of DNA constructs, which also offer unique application-specific flexibility and benefits.4basebio is also developing non-viral delivery technology to overcome some of the challenges associated with commonly used viral vector and LNP (lipid nanoparticle) solutions.LithuaniaDespite its small population of fewer than 3 million people, the Baltic country Lithuania punches above its weight in the life sciences. A major outlet of the Thermo Fisher Scientific is based in its capital city, Vilnius, for example. And the Life Sciences Center at Vilnius University was added to the European Molecular Biology Laboratory network in 2020, opening the door to major EU investments into biotech research in the center. More than 400 companies are working in Lithuania’s growing life sciences sector, and the space is growing every year. Astellas PharmaAstellas Pharma Inc. is a Japanese-headquartered pharmaceutical company conducting business in more than 70 countries around the world. It utilizes its ‘Focus Area Approach,’ which is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs.The company recently committed to achieve net zero greenhouse gas emissions by 2050.SponsorInterested in sponsoring one or more episodes of the podcast? Learn more here!Leave a review on Apple podcastsReviews are hugely important because they help new people discover this podcast. If you enjoyed listening to this episode, we would love to hear your feedback!Connect with uslabiotech.euSubscribe to our newsletter

Sometimes, there’s an interview that’s just a bit long for the regular podcast. So we’re going to start an occasional series of podcasts where we look a bit more in depth at a condition, and what’s the current state of affairs in treatment. In this podcast, the first, we take a closer look at Alzheimer’s disease with a conversation about current drugs, clinical trials, and the pipeline.Our guest is Sharon L. Rogers, CEO of the biotech AmyriAD Therapeutics.SponsorInterested in sponsoring one or more episodes of the podcast? Learn more here!Leave a review on Apple podcastsReviews are hugely important because they help new people discover this podcast. If you enjoyed listening to this episode, we would love to hear your feedback!Connect with uslabiotech.euSubscribe to our newsletter

01:38 Labiotech.eu news03:18 OncoHost18:13 Enterome41:04 TrakCel55:51 Cancer Research Horizons/TurbineOur guests are Ofer Sharon, CEO of OncoHost; Matthew Lakelin, co-founder, TrakCel; Pierre Belichard, CEO of Enterome; and Tony Hickson, chief business officer for Cancer Research UK and Cancer Research Horizons and Daniel Veres, chief science officer and co-founder, Turbine.World Cancer DayFebruary 4 is World Cancer Day. This year, the theme is Close the Gap. For the podcast this week, we feature four interviews related to cancer.TrakCelTrakCel is a developer of integrated technologies to manage the international autologous and allogeneic cell, gene and immunotherapy supply chain. TrakCel's software platform has been developed in collaboration with, and increasingly adopted by leading companies in the cell, gene and immunotherapy industries. Its solutions deliver real-time control over the entire therapeutic supply chain, from sample collection through manufacturing to treatment delivery. Cancer Research Horizons and Turbine partneringCancer Research Horizons, the innovation engine at the core of the world’s largest private funder of cancer research, Cancer Research UK, is partnering with Turbine AI, a tech-enabled biotech leveraging its proprietary Simulated Cell platform to solve complex diseases.The partnership will utilize Turbine AI’s platform to identify target patient populations who could benefit from CDC7 inhibitor therapy with Cancer Research Horizons’ lead compound CRT’2199.CRT’2199 originates from Cancer Research Horizons’ Therapeutic Innovation. CDC7 is a protein that plays a vital role in the regulation of cell division in normal cells. However, dysregulation of CDC7 can lead to the formation of cancer cells, and overexpression of this protein is correlated with poor clinical prognosis in diverse cancers of significant unmet patient need.EnteromeEnterome is a French clinical stage company developing off-the-shelf, transformational cancer treatments targeting all tumor types. Phase 2 trials for its most advanced program EO2401 have shown promising efficacy in recurrent glioblastoma and adrenal malignancies and good safety in more than 130 patients.Enterome’s OncoMimics approach generates a long-lasting immune response from the patient’s own effector memory T-cells, overcoming the immune tolerance to self-antigens.OncoMimics is a pipeline of immunotherapies made of a specific combination of bacterial peptides, derived from bacteria present in the gut microbiome, that closely mimic either overexpressed tumor-associated antigens (TAAs) or lineage-specific markers in solid and liquid tumors, respectively. These provide faster, stronger and durable immune responses, have excellent immunogenicity and can counteract tumor heterogeneity.OncoHost launches PROphet NSCLC test in the US OncoHost, a precision diagnostics company centered on predictive biomarker development for improved patient care, has launched its PROphet non-small lung cancer (NSCLC) test in the U.S.PROphet NSCLC, guides first line treatment decisions for advanced unresectable non-small lung cancer patients. It provides clinicians with actionable clinical insights into optimal first line therapeutic choices, and a better understanding of their patients’ personalized cancer dynamics. Requiring just one pre-treatment blood test, PROphet scans approximately 7,000 proteins in a patient's blood plasma and delivers a report that predicts their clinical benefit from anti-PD-1/PD-L1 immunotherapy-based treatment plans.Subscribe to our newsletter

01:22 Labiotech.eu news03:03 Phacilitate/Advanced Therapies Week14:15 Orgenesis25:18 Terumo31:47 VIVEBiotech38:33 University of BirminghamPhacilitate’s Advanced Therapies Week took place last week in Miami Beach, Florida.This week, we speak with the organizers, as well as some of the companies in attendance.Our guests are Kim Barnes, EVP, Phacilitate; Kathie Schneider, director and global commercial lead at Terumo; Vered Caplan, CEO, Orgenesis; Ivan Wall, head of the Centre for Advanced Therapies Manufacturing Training, University of Birmingham; and Natalia Elizalde, business development director, VIVEBiotech.PhacilitatePhacilitate stages two major events each year, Advanced Therapies Week, which took place from January 17 to 20 in Miami Beach, Florida, and Advanced Therapies Europe 2023, which takes place in Estoril, Portugal on September 6 and 7.The company also provides market intelligence and hosts a variety of webinars.OrgenesisOrgenesis is a global biotech company working to unlock the full potential of cell and gene therapies in an affordable and accessible format at the point of care. Orgenesis identifies promising new therapies and leverages its POCare Platform to provide a rapid, globally harmonized pathway for the therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. Its POCare Network unites patients, doctors, industry partners, research institutes, and hospitals worldwide to achieve harmonized, regulated clinical development and production of therapies. TerumoTerumo is a global provider of medical technology. Based in Tokyo, it provides medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. University of BirminghamThe Centre for Advanced Therapies Manufacturing Training is a newly established National Training Centre based in Birmingham, U.K. It is one of several centers that form the Advanced Therapies Skills and Training Network, which is coordinated by the Cell and Gene Therapy Catapult. Its aim is to provide training to U.K. advanced therapy and vaccine manufacturers, to enable rapid and sustainable workforce growth.VIVEBiotechVIVEBiotech is a Spanish developer and manufacturer of lentiviral vectors working under both EMA and FDA standards. The lentiviral vectors produced by VIVEbiotech are used to treat a range of disorders, including hematological and solid cancers, and rare diseases.SponsorInterested in sponsoring one or more episodes of the podcast? Learn more here!Leave a review on Apple podcastsReviews are hugely important because they help new people discover this podcast. If you enjoyed listening to this episode, we would love to hear your feedback!Connect with uslabiotech.euSubscribe to our newsletter

02:29 Labiotech.eu news04:11 C2i Genomics22:31 Advanced Therapies Congress31:37 BioAlps47:29 Bionter54:06 JLLThe guests on our podcast this week are: Jessica Robinson, project director, Advanced Therapies Congress, Terrapinn: Tobias Werk, CEO, Bionter; Asaf Zviran, CEO and co-founder of C2i Genomics; and Magali Bischof, secretary general of BioAlps.We also have our weekly commentary from Travis McCready at global commercial real estate services company JLL.This week’s podcast is sponsored by Bionter, a Swiss-based premier supplier of analytical testing solutions to support Pharma companies to bring drugs faster and safer onto the market. Their first product is a fully automated particle testing device for parenteral drug applications that is cost-efficient and compliant with current regulations. If you want to know more, go to www.Bionter.com.C2i Genomics Announce Successful Evaluation of Whole Genome-Based Residual Disease Test Across Multiple Solid Cancer modelsC2i Genomics, a cancer intelligence company, recently announced an extension of a collaboration with AstraZeneca. The two companies have collaborated to evaluate the potential of whole-genome minimal residual disease (MRD) testing across solid cancers, with the goal of enhancing oncology treatment, supporting clinical trial recruitment, and monitoring. C2i genomics has completed AstraZeneca’s BeyondBio Innovation Hub’s program for Israeli start-ups. Using artificially generated samples to reproduce varying levels of circulating tumor DNA (ctDNA) expected to be found in tumors, this collaboration provided early evidence that the C2i assay can sensitively detect ctDNA (down to 0.002% allelic frequency). Building on this work, AstraZeneca will further evaluate and validate the C2i Genomics platform across a panel of patient-derived samples using their in-house sequencing capabilities and expertise.The non-invasive detection of circulating tumor DNA (ctDNA) from plasma has been shown to have clinical value for the detection of Minimal Residual Disease (MRD), the emergence of resistance, and the prediction of treatment response. New MRD technologies aim to provide greater cancer detection sensitivity by expanding methods beyond small, personalized panels. C2i Genomics’ MRD technology applies whole-genome sequencing and artificial intelligence to a small blood sample to provide ultra-sensitive cancer detection. This technology aims to eliminate the need to develop a patient-specific assay, enabling high-performance, personalized monitoring and rapid turnaround across multiple solid cancers with reduced operational complexity.Advanced Therapies CongressThe Advanced Therapies Congress is Europe’s largest cell and gene therapy conference and exhibition. Presented by Terrapinn, the event is for the leaders of the world’s ATMP developers and their most senior executives in charge of the latest tech and strategies driving the industry forward. The event takes place on March 14 and 15 at the ExCeL in London.BioAlpsBioAlps is the life sciences cluster covering western Switzerland.It comprises an ecosystem of research institutions, academic institutions, startup companies and large multinationals concentrated in a small,  geographic area.Its aim is to promote western Switzerland as a world class centre for life sciences and to foster growth by creating synergies between academia, entrepreneurs, investors, authorities and new businesses. It offers a networking and support opportunities through regional, national and international events, while promoting BioAlps on the global stage.Interested in sponsoring episodes of the podcast? Learn more here!

1:03 Labiotech.eu news2:34 Knowledge Gate10:59 Janssen Scientific AffairsThis week, our guests are Viktoriya Vasilenko, Knowledge Gate co-founder and CEO; and Avery Ince, vice president, medical affairs, cardiovascular & metabolism at Janssen Scientific Affairs.Study confirms benefit of XARELTO (rivaroxaban) for secondary prevention of venous thromboembolism in cancer patientsThe Janssen Pharmaceutical Companies of Johnson & Johnson has revealed observational data from eight years of clinical practice showing that the oral Factor Xa inhibitor XARELTO (rivaroxaban) is associated with comparable effectiveness and safety to the Factor Xa inhibitor apixaban for the treatment of cancer-associated thromboembolism (CAT) in a broad cohort of patients with various cancer types. Patients with CAT are at a higher risk of venous thromboembolism (VTE), which is the second-leading cause of death in people with cancer.Data from the observational study in cancer-associated thrombosis for rivaroxaban (OSCAR) found XARELTO showed non-inferiority for the composite outcome of recurrent VTE or any bleeding resulting in hospitalization for treatment of patients with CAT. Janssen said the study adds to the evidence for XARELTO, with more than 300,000 patients having been evaluated since its initial approval in the U.S. in 2011.VTE occurs when a blood clot forms in a vein, affecting between 300,000 to 600,000 Americans each year, commonly triggered by surgery, cancer, immobilization and hospitalization. VTE is a common cause of morbidity and mortality, and people with cancer are at a higher risk for developing VTE than people without cancer.Cancer is known to increase the risk of VTE, with cancer patients having a four to seven times increased risk of developing VTE. These patients also have a higher risk of recurrent VTE and of bleeding.Previous studies such as SELECT-D and CONKO-11 demonstrated that changing from a low molecular weight heparin (LMWH) to XARELTO was associated with a reduction in risk of recurrent thrombosis and improved patient satisfaction.Knowledge GateKnowledge Gate Group provides a key opinion leader online platform. Based in Copenhagen, Denmark, the company bridges the gap between businesses and life science experts. The artificial intelligence platform connects those looking to innovate with the key opinion leaders who can provide valuable insights. It covers a broad range of therapy area experts in the life sciences, and features automated management of all contractual, compliance and confidentiality requirements.SponsorInterested in sponsoring one or more episodes of the podcast? Learn more here!Leave a review on Apple podcastsReviews are hugely important because they help new people discover this podcast. If you enjoyed listening to this episode, we would love to hear your feedback!Connect with uslabiotech.euSubscribe to our newsletter

2:18 Labiotech.eu news3: 46 Mainz Biomed19:14 NewronThis week, we have two guests. We have conversations with Newron Pharmaceuticals' CEO, Stefan Weber, and Mainz Biomed CEO, Guido Bächler.Mainz Biomed Provides Year-End 2022 Corporate ReviewMainz Biomed N.V., a molecular genetics diagnostic company specializing in the early detection of cancer, announced its corporate summary for the fiscal year ended December 31, 2022.The company launched its U.S.-based eAArly DETECT study by enrolling the first patient; study focused on the performance of Mainz Biomed’s mRNA biomarkers in identifying advance adenomas (AA), a type of pre-cancerous polyp often attributed to colorectal cancer (CRC); on track to report results in 1H 2023.It also Initiated ReconAAsense, a U.S. pivotal clinical study with company’s CRC screening test, anticipating commencing patient enrollment in mid-2023.Mainz Biomed also ramped up international commercial activities for ColoAlert, the company’s highly efficacious and easy-to-use detection test for CRC, including five new lab partners in Germany and Italy.It also Initiated and commenced patient enrollment in ColoFuture, a European study evaluating the integration of a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert; potential to identify advanced adenomas, a type of pre-cancerous polyp often attributed to CRC; with results expected in 2023.“The past year has proven to be an extraordinary period of growth as we strengthened every aspect of the Company while expanding our international commercial footprint and executing our product development programs,” said Guido Baechler, CEO of Mainz Biomed. “We head into 2023 with a great deal of momentum, and on behalf of the management team and Board of Directors, I wish to extend gratitude to our shareholders for their support as we continue our journey to become a leading provider of cancer-focused early detection and disease prevention molecular diagnostics.”Newron announces interim results from treatment-resistant schizophrenia trialNewron Pharmaceuticals S.p.A. has announced what it says are “very compelling new results” from the first 100 enrolled patients to have reached the six-month timepoint in its international study of evenamide as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe treatment-resistant schizophrenia (TRS), who were not responding to their current antipsychotic medication. Eighty-five of the 100 patients completed the 30-week treatment period with evenamide. The results follow on from the company’s announcement on June 7, 2022, summarizing the data from an interim analysis of the first 100 patients to have finished six weeks of treatment in this study.Newron is an Italian-headquartered biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS).SponsorInterested in sponsoring one or more episodes of the podcast? Learn more here!Leave a review on Apple podcastsReviews are hugely important because they help new people discover this podcast. If you enjoyed listening to this episode, we would love to hear your feedback!Connect with uslabiotech.euSubscribe to our newsletter

1:37 Labiotech.eu news3:34 Cradle19:47 Rani TherapeuticsThis week, we have two guests. We have conversations with Talat Imran, CEO of Rani Therapeutics; and Stef van Grieken, CEO and co-founder of Cradle.Rani Therapeutics - aiming to remove the pain of needlesRani Therapeutics Holdings, Inc., a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, has announced topline results from part 2 (the repeat-dose portion) of the phase 1 study of RT-102, the RaniPill GO capsule containing a proprietary formulation of human parathyroid hormone (1-34) analog (PTH) being developed for the treatment of osteoporosis. The study achieved all of its endpoints, with repeat doses of RT-102 being generally well tolerated and delivering the drug with high reliability to participants via the RaniPill GO.With these data, in total, 185 RaniPill GO capsules have now been administered to more than 90 participants in clinical studies, in addition to over 1,700 RaniPill capsules administered to animals in preclinical studies. In the clinical studies, the RaniPill capsule has been well tolerated and delivered its drug payload with high reliability and with bioavailability comparable to or better than subcutaneous injection.“The repeat-dose data contribute to our growing body of preclinical and clinical data that we believe support the viability of the RaniPill platform to orally deliver biologics and drugs to treat chronic diseases,” said Talat Imran, CEO of Rani. “These data give us confidence to move forward with multiple programs in parallel, including our ustekinumab biosimilar and adalimumab biosimilar programs, and to expand manufacturing scale-up. We can see a future where millions of patients no longer carry the burden of regular injections.”Startup Cradle raises $5.4M to design protein machines and cell factories with AICradle, a Dutch startup, has received €5.5 million ($5.4 million) in seed funding to further help scientists design and program proteins to produce a wide variety of everyday products including milk and meat.Cradle uses synthetic biology, adapting the genes of microorganisms such as bacteria and fungi, to create ‘cell factories’ that use programmable proteins to make a number of products without farming animals, to plastics created without petrochemicals, materials for clothing or electronic components, or even personalized medicines.

2:19 Labiotech.eu news4:37 CellCentric12:21 MicrofluidX29:12 Potter ClarksonThis week, we have three guests. We have conversations with Antoine Espinet, CEO of MicrofluidX; Will West, CEO of CellCentric; and Sara Holland, patent attorney at Potter Clarkson.MicrofluidX raises £3.3M to develop advanced therapy manufacturing platformMicrofluidX (MFX), a U.K. based provider of next-generation bioreactors for cell research and manufacturing, today announces £3.3 million ($4 million) of secured investments, bringing the company’s total funding to date to £7 million ($8.5 million). MFX’s next generation platform, the Cyto Engine, addresses the need for an affordable, scalable cell culture platform to revolutionize research, facilitate large-scale manufacture, and enable widespread access to advanced therapies.  “Advanced therapy manufacturing is hindered by out of date, inadequate manufacturing technologies,” said Antoine Espinet, CEO of MFX. “Our aim to commoditize manufacturing for cell and gene therapies through automation, digitalization, and the adoption of machine learning is supported by our investors, who appreciate the incredible impact this could have on the cell and gene therapy sector, and ultimately patients around the world.”MFX said it is addressing the two large pain points faced by the advanced therapies industry, commercialization and clinical translation. By providing a scalable bioprocessing platform with complete integration of online process analytical tools and data analytics powered by machine learning, the company hopes the Cyto Engine will reduce the cost and time of advanced therapy development and help bring these life-saving treatments to patients. Potter Clarkson patent attorney, Sara HollandSara Holland is a former research scientist turned patent attorney in the U.K. After finishing her PhD in engineering artificial yeast chromosomes, Holland carried out seven years of postdoctoral research at the University of Nottingham. This gave her a good understanding of the challenges that scientists face when she moved over to Potter Clarkson, an IP law firm.In her work as a patent attorney she helps universities, technology transfer departments and SMEs protect their inventions, with a focus on synthetic biology.Holland also co-founded the Women in Synthetic Biology Network, a group that aims to support gender diversity and support women working in the field of synthetic biology.CellCentric presents early clinical data at ASH CellCentric, a clinical stage biotechnology company pioneering small molecule inhibition of p300/CBP to treat cancer, announced clinical data for the first time at the 64th American Society of Haematology (ASH) annual meeting in New Orleans. To date, 26 patients with relapsed/refractory multiple myeloma (RRMM) have been treated with inobrodib as monotherapy, including seven most recently at the recommended phase 2 dose and dose schedule (RP2D). Treatment has been generally well-tolerated with the majority of on-target toxicities being mild or moderate in severity. Among the patients treated at the RP2D, six out of seven patients had reduction or stabilization of serum free light chains. One patient saw an unconfirmed complete response (CR), which went on to become a durable confirmed very good partial response (VGPR); a second patient demonstrated a confirmed partial response (PR); and a third currently has an unconfirmed PR (by IMWG response criteria).  These three patients remain on treatment after more than eight months.

2:33 Labiotech.eu news5:03 Humacyte23:01 Transgene37:21 Center for Global Development54:32 JLLThis week, we have three interviews. One is from Bio-Europe, a chat with Transgene chief business officer, Steven Bloom, and we also have conversations with Humacyte CEO Laura Niklason, and with Anthony McDonnell, Senior Policy Analyst at the Center for Global Development, on the subject of antimicrobial resistance.We also have our weekly commentary from Travis McCready at JLL.HumacyteThe ongoing war in Ukraine continues to present significant challenges for frontline hospitals in treating the injured. As part of the humanitarian aid effort, U.S. biotech, Humacyte, has worked with the FDA and the Ukrainian Ministry of Health to send 30 investigational bioengineered blood vessels to help repair tissue injuries from bomb and gunshot wounds. Humacyte’s human acellular vessels, or HAVs, are off-the-shelf replacement vessels that help the body heal itself. They are currently being evaluated in multiple advanced-stage clinical trials in vascular trauma  repair, arteriovenous access for hemodialysis and peripheral arterial disease and so far, have been implanted in more than 500 patients to date.   The HAV is made by seeding vascular cells from a qualified cell bank onto a biocompatible, biodegradable polymer mesh in a bioreactor bag. Over weeks, the cells grow and create new tissue, forming a tube-shaped vessel structure while the polymer mesh degrades. The resulting bioengineered vessel is then decellularized to create the HAV: an extracellular matrix that retains the biomechanical properties of the vessel but is cleansed of cellular components that could induce an immune response. The HAV in the bioreactor bag can then be shipped, stored, and is immediately available when needed.  Reaction to European Union action on antimicrobial resistanceFourteen Member States wrote to the European Commission recently outlining why they think the EU’s proposed policies around antimicrobial resistance (AMR) are costly, inefficient, and will disrupt the market for generic drugs.Anthony McDonnell, senior policy analyst at the Center for Global Development, looked in detail at the EU’s proposals, why member states are revolting against it, and which policies the EU should actually implement to successfully combat AMR.He said that, for months it has been speculated that the EU may move toward transferable exclusivity vouchers (TEVs). The14 countries have made three counter proposals for how new antimicrobials can be encouraged. TransgeneTransgene is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Its programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.The company’s clinical-stage programs consist of two therapeutic vaccines (TG4001 for the treatment of HPV-positive cancers, and TG4050, the first individualized therapeutic vaccine based on the myvac platform) as well as two oncolytic viruses (TG6002 for the treatment of solid tumors, and BT-001, the first oncolytic virus based on the Invir.IO platform).With Transgene’s myvac platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. myvac  allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by AI capabilities provided by its partner NEC.With its proprietary platform Invir.IO, Transgene is designing a new generation of multifunctional oncolytic viruses. It has an ongoing collaboration with AstraZeneca.Subscribe to our newsletter

2:40 Labiotech.eu news4:58 SOTIO Biotech13:43 Eversana19:37 Carl Borrebaeck36:42 Concarlo TherapeuticsThis week, we have four interviews: Franjo Hanzl, vice president commercial development Europe at Eversana; Stacy Blain, founder and CEO of Concarlo Therapeutics; Jens Hennecke, chief business officer at SOTIO Biotech; and Carl Borrebaeck, chairman of the board of directors of Immunovia and professor at the Department of Immunotechnology at the University of Lund in Sweden.Concarlo TherapeuticsConcarlo Therapeutics is a U.S.-based preclinical-stage precision-medicine oncology company. It is developing a novel therapy for drug-resistant metastatic breast cancer as a first indication.Concarlo’s patented IpY, a novel therapeutic peptide, will be the first to hit two targets, both CDK4/6- driven cell proliferation and CDK2-driven drug resistance at the same time, and the first to target p27. It is a specific cellular pathway to kill cancer cells rather than just slowing their proliferation.The novel approach relies on the role of p27Kpi, a natural inhibitor, an  "on-off" switch that regulates the activities of the major cancer-related proteins, CDK6, CDK4, and CDK2. EversanaEversana is a provider of global services to the life sciences industry. Its integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including start-ups and established pharmaceutical companies, to advance life sciences solutions.Labiotech spoke with Franjo Hanzl, vice president commercial development Europe, at the Medicon Valley Alliance annual summit in Copenhagen, Denmark.Medicon VillageDuring NLS Days, Labiotech visited Medicon Village, in Lund, Sweden. While there, we had the opportunity to chat with Carl Borrebaeck. To say he’s involved in biotech would be an understatement. He is chairman of the board of directors of Immunovia and professor at the Department of Immunotechnology at the University of Lund in Sweden, as well as being director of Create Health. Borrebaeck, former vice president of the University of Lund, has been involved in many companies throughout his career, including Alligator Bio, SenzaGen and PainDrainer. He received the AKZONobel Science Award 2009, for contributions to cancer proteomics and antibody-based therapy, a Research! Sweden Award 2012 for his medical research of value for patients and health organizations, and the Royal Academy of Engineering Sciences Gold Medal 2012 for outstanding contributions to biomedical science. He was honored as the Biotech Builder of the Year in 2017.SOTIO BiotechSOTIO Biotech is a clinical stage immuno-oncology company owned by PPF Group based in Prague, Czechia. The company is building a pipeline of oncology programs by pursuing promising early-stage candidates through strategic licensing, M&A and in-house discovery efforts. SOTIO has been active in the clinic in 2022. The company initiated two clinical trials, the first was a phase 2 study for its lead IL-15 superagonist, SOT101. The initiation of the AURELIO-04 trial comes on the heels of positive phase 1/1b data, which showed 15 of 19 patients with advanced/metastatic solid tumors demonstrated clinical benefit with SOT101 in combination with pembrolizumab. The company also plans to enter the CAR-T space with the initiation of its BOXR trial in Q4 2022.  SOTIO is well funded into 2023 and plans to use those funds for posting more data across its already promising programs.We spoke with SOTIO Biotech at BIO-Europe.  

1:45 Labiotech.eu news4:02 PsychoGenics20:56 Destiny Pharma36:30 QureTech Bio54:41 AiCuris70:45 JLLThis week, we have three interviews on the theme of antimicrobial resistance (AMR), to mark World Antimicrobial Awareness Week. We spoke with Holger Zimmermann, CEO of anti-infectives company AiCuris; Neil Clark, CEO of Destiny Pharma, and Fredrik Almqvist, co-founder of QureTech Bio.We also have an interview with the chief scientific officer at PsychoGenics, Mark Varney. We also have our weekly contribution from global commercial real estate services company JLL, with Travis McCready. Next week, we will be moderating a webinar on the microbiome, hosted by our sister company IN-PART. You can register here.World Antimicrobial Awareness WeekAs a result of drug resistance, antibiotics and other antimicrobial medicines may become ineffective and infections become increasingly difficult or impossible to treat. A global action plan to tackle the growing problem of resistance to antibiotics and other antimicrobial medicines was endorsed at the 68th World Health Assembly in 2015. A key objective of the plan is to improve awareness and understanding of AMR through effective communication, education and training.World Antimicrobial Awareness Week is a global campaign to improve awareness and understanding of AMR. Emyria commences US preclinical program with PsychoGenicsEmyria Limited, a clinical stage biotech, is working with PsychoGenics, a specialist neuroscience preclinical drug discovery and contract research organization (CRO). Emyria and partner, the University of Western Australia, will start by screening five novel MDMA analogs from their proprietary library using PsychoGenics’ advanced drug discovery platform, SmartCube. SmartCube employs computer vision and artificial intelligence (AI) to extract and analyze behavioral and physiological data from mice. These data can help predict the clinical effects of new drug compounds by comparing the novel drug’s effects to reference drug libraries. The automated testing platform offers an effective approach to the discovery and development of the next generation of breakthrough treatments for neurological disorders and can significantly reduce the time and cost to reaching approved Investigational New Drug status. PsychoGenics and Emyria have agreed to work collaboratively (at their own costs) in the initial phase, before exploring drug discovery and commercialization partnership models. PsychoGenics’s specialist drug screening platforms have been used in shared-risk partnerships with major pharmaceutical companies, including Sunovion and Roche, resulting in the discovery of several novel compounds now in clinical trials or advanced preclinical development. A successful partnership with Emyria could accelerate the development of Emyria’s novel MDMA-inspired drug candidate library, built with the University of Western Australia, into new treatments for severe neuropsychiatric disorders. PsychoGenics has successfully identified novel treatment candidates for serious and complex neuropsychiatric disorders via its proprietary SmartCube platform as well as formed innovative partnerships with major Pharmaceutical companies.SponsorInterested in sponsoring one or more episodes of the podcast? Learn more here!Connect with uslabiotech.euSubscribe to our newsletter

1:32 Labiotech.eu news4:02 PacBio34:02 Sierra Space57:12 JLLThis week, we have two longer interviews. We have conversations with Neil Ward, VP of PacBio EMEA, and Marc Giulianotti, senior manager in space biomanufacturing at Sierra Space.We also have our weekly contribution from global commercial real estate services company JLL, with Travis McCready. Sierra Space and UC San Diego to develop first stem cell research institute in spaceSierra Space and University of California San Diego, one of the world’s top 15 research universities and a leader in microgravity research, have formed a new agreement with the goal of defining the future of human health care research in space.In a new memorandum of understanding between the two organizations, Sierra Space and UC San Diego will collaborate on Orbital Reef, the first commercial space station in low Earth orbit (LEO), to expand the university’s Integrated Space Stem Cell Orbital Research (ISSCOR) program, which is currently operational on the International Space Station (ISS). Together they will help define and shape the future of biotech and biopharma research and development in microgravity.PacBio launches Onso and Revio sequencing systemsPacBio recently announced beta testing of its Onso Sequencing System. The benchtop short-read DNA sequencing platform is expected to provide a new level of accuracy by utilizing PacBio’s sequencing by binding (SBB) technology.The Onso Sequencing System has been designed for compatibility with the rich ecosystem of products currently available for short-read sequencers and supports a diverse set of library preparation types, single cell analysis solutions, whole-genome sequencing and other targeted methods, such as amplicon and hybridization capture panels. It is anticipated to deliver 500 million reads per run and offer 200 and 300 cycle kits enabling paired and single end reads, at a list price of US $259,000 per system.The Revio long-read sequencing system will enable customers to scale their use of PacBio’s HiFi sequencing technology. Revio is designed to provide customers with the ability to sequence up to 1,300 human whole genomes per year at 30-fold coverage for less than $1,000 per genome. PacBio believes Revio will enable the use of HiFi sequencing for large studies in human genetics, cancer research, agricultural genomics, and more.Scientists have achieved many ‘firsts’ with HiFi sequencing on PacBio’s Sequel IIe sequencing system – the first complete telomere-to-telomere assembly of a human genome (Nurk 2022), the first haplotype-resolved methylomes in a rare disease cohort (Cheung 2022), the first population surveys of structural variation with long reads (All of Us Research Program), the first single-cell full isoform catalogs (Al'Khafaji 2021), and the first complete assembly of the highly complex oat genome (European Seed 2020). Revio uses the same HiFi chemistry – producing accurate native long reads with uniform coverage, extraordinary application performance for variant calling and assembly, and accurate DNA methylation detection – but at a much larger scale.SponsorInterested in sponsoring one or more episodes of the podcast? Learn more here!Leave a review on Apple podcastsReviews are hugely important because they help new people discover this podcast. If you enjoyed listening to this episode, we would love to hear your feedback!Connect with uslabiotech.euSubscribe to our newsletter

1:41 Labiotech.eu news4:17 Longevity Science Foundation23:07 HTID35:56 CanSinoBio54:47 JLLThis week, we have three interviews, and four guests. We chat with Pierre Corneille VP of the HTFC, which is responsible for HealthTech Innovation Days; Sergey Jakimov, co-founder and managing partner of LongeVC and the Longevity Science Foundation's CEO Lisa Ireland; and Pierre Morgon, executive vice president of CanSinoBIO. We also have our weekly contribution from global commercial real estate services company JLL, with Travis McCready. HealthTech Innovation Days brings European healthtech ecosystem togetherThe 4th edition of HealthTech Innovation Days (HTID), organized by HealthTech For Care, took place recently in Paris, France.The two-day event had the objective of finding financing and encouraging new industrial partnerships to accelerate the development and market access of new products and treatments for all patients. Around 1,600 formal and informal face-to-face and virtual meetings were organized this year, alongside 19 round table discussions. The event brought together more than 165 European health technology companies, 15 pharmaceutical and industrial companies and more than 300 international investors. 86 international experts gathered and animated 19 round tables. CanSinoBIO presents data on inhaled COVID vaccineCanSino Biologics Inc. presented clinical trial data for the recombinant COVID-19 vaccine (adenovirus type 5 vector) for inhalation (with the trade name Convidecia Air) at World Vaccine Congress (WVC) Europe recently in Barcelona, Spain. Jean-Denis Shu, vice president for medical affairs of CanSino Biologics showed Convidecia Air induces a strong and lasting immune response, with greater immunogenicity against the Omicron variant than recombinant protein or inactivated vaccines. International nonprofit Longevity Science Foundation expands to U.S. with new CEOThe Longevity Science Foundation (LSF), a global nonprofit organization providing research funding to establish a longer and healthier human lifespan, has recently expanded by launching operations in the U.S. and appointing a new president & CEO, Lisa E. Ireland. A group of physicians, investors, and other stakeholders founded the Longevity Science Foundation in 2021 to convene biotech founders, physicians, and research institutions in pursuit of lengthening the healthy human lifespan. The Foundation uses a blockchain-based voting platform to distribute grant funding to projects advancing longevity science, focusing on therapeutics, artificial intelligence, personalized medicine and predictive diagnostics. SponsorInterested in sponsoring one or more episodes of the podcast? Learn more here!Leave a review on Apple podcastsReviews are hugely important because they help new people discover this podcast. If you enjoyed listening to this episode, we would love to hear your feedback!Connect with uslabiotech.euSubscribe to our newsletter

5:33 e-therapeutics21:25 BioWin 32:46 CMT Research Foundation57:47 JLLThis week, we have three interviews, and four guests. We chatted with Keith Fargo, chief scientific officer at the CMT Research Foundation; François Colery, head of the Talent Now initiative and Sylvie Ponchaut, managing director, from BioWin; and e-therapeutics’ CEO, Ali Mortazavi. We also have our weekly contribution from global commercial real estate services company JLL, with Robert Coughlin, managing director and New England Life Science Practice Group lead. CMT Research Foundation supports SamsaraThe CMT Research Foundation (CMTRF), a non-profit focused solely on delivering treatments and cures for Charcot-Marie-Tooth disease, has invested in Samsara Therapeutics Inc.Samsara Therapeutics is a biotech company developing several novel, orally active autophagy enhancers and demonstrated they can rescue CMT1A neuropathy in mice in a dose-dependent manner.The partnership with Samsara Therapeutics is CMTRF’s largest investment to date and is dedicated toward a project to further optimize pipeline autophagy compounds that may eventually become a treatment option for CMT patients.  About Charcot-Marie-ToothCharcot-Marie-Tooth is a group of inherited, chronic peripheral neuropathies that result in nerve degradation. CMT patients suffer from progressive muscle atrophy of legs and arms causing walking, running and balance problems and abnormal hand and foot functioning. CMT affects one in 2,500 people (about the same prevalence as multiple sclerosis). At the moment, there is no treatment or cure for CMT.BioWin helping ease job issuesBioWin, the health cluster of Wallonia in Belgium, has a Talent Now program which aims to tackle the recruitment challenges in the biotech and medtech industry in Belgium. With the support of Walloon government and private companies (GSK, Janssen, Takeda, etc.), Talent Now is based on a study performed by BioWin that showed potential of close to 1,000 recruitments per year in biomanufacturing and R&D activities in Wallonia.The Talent Now public-private consortium will pave the way for a EU Biotech Campus, set to open in Gosselies in 2025.  e-therapeutics completes £13.5M fundraisee-therapeutics plc, a company integrating computational power and biological data to discover life-transforming RNAi medicines, recently announced a fundraise of £13.5 million before expenses by way of a subscription for new ordinary shares.The fundraise allows the company to generate value and accelerate the next stage of its growth, advancing its position in creating an entirely new template for drug discovery using computation to capture and model disease complexity, identify novel targets and design RNAi drugs against those targets that can be rapidly progressed to the clinic. The net proceeds of the Subscription will be used to facilitate initiatives to accelerate growth, with a focus on expanding the Company’s in-house pipeline of first-in-class RNAi candidates derived from ETX’s computational platform; further developing cell type-specific computational tools and datasets; and general working capital including additional headcount.SponsorInterested in sponsoring one or more episodes of the podcast? Learn more here!Leave a review on Apple podcastsReviews are hugely important because they help new people discover this podcast. If you enjoyed listening to this episode, we would love to hear your feedback!Connect with uslabiotech.euSubscribe to our newsletter

2:22 Labiotech.eu news4:53 TAU Systems21:54 Bone Health Technologies 33:26 Immutep44:36 JLLThis week, we have conversations with Marc Voigt, CEO of Immutep; Manuel Hegelich, CEO of TAU Systems; and ​​Laura Yecies, CEO of Bone Health Technologies. We also have our weekly chat with global commercial real estate services company JLL, with Travis McCready. FDA fast tracks Immutep non-small cell lung cancer candidateImmutep Limited says the United States Food and Drug Administration (FDA) has granted fast track designation to eftilagimod alpha (efti or IMP321) in combination with pembrolizumab for the treatment of first line non-small cell lung cancer (NSCLC).Efti is the company’s first-in-class soluble LAG-3 clinical stage candidate, which activates antigen presenting cells (APC) to engage both the innate and adaptive immune system to target solid tumors.The designation has been granted for the development of efti in combination with pembrolizumab in first line treatment of stage IIIB/IV NSCLC patients expressing PD-L1 tumor proportion score greater than or equal to 1%, not amenable to EGFR/ALK based therapy. The designation is based on the TACTI-002/KEYNOTE-798 phase II clinical data in first line NSCLC for PD-L1 all-comers.This represents the second fast track designation for efti, following the same designation in April 2021 for efti in combination with pembrolizumab in first line treatment of recurrent or metastatic head and neck squamous cell carcinoma. TAU Systems to build new generation of compact particle accelerators after $15M investmentTAU Systems has raised $15 million in seed investment to bring particle accelerators to a multitude of users by harnessing the latest laser technology to make electrons surf on three-dimensional plasma waves and accelerate them to ultra-high energies.The news is significant as, until now, high-energy particle accelerators have been limited to countries and governmental organizations. Due to their huge size and high cost, access for engineers and biotech professionals is severely limited. The laser-driven particle accelerators and X-ray free-electron lasers (XFEL) developed by TAU Systems will give access to a world of ultra-small objects evolving ultra-fast under ultra-powerful conditions – TAU's team calls it the Ultraverse.TAU Systems said it will offer beamtime, data acquisition and analysis as a full-service supplier as well as complete laser-driven accelerators and XFEL systems for sale, to, for example, pharma and biotech, battery and solar technology, and other material-science driven markets. Bone Health Technologies at ASBMR 2022The American Society for Bone and Mineral Research (ASBMR) annual meeting was held recently in Texas.The ASBMR is a professional, scientific and medical society established to bring together clinical and experimental scientists who are involved in the study of bone and mineral metabolism.One of the companies attending was Bone Health Technologies, a San Francisco-based company that applies science and medical expertise to create better health outcomes for women and men at risk of developing osteoporosis and the associated bone fractures.  The company has created OsteoBoost, the first vibration belt specifically designed to treat osteopenia and prevent osteoporosis.Initially created in the med-tech incubator TheraNova, Bone Health Technologies is poised to become the new standard of care in treating both osteoporosis and osteopenia (the precursor to osteoporosis). SponsorInter