Beyond Biotech - the podcast from Labiotech

In this episode, Christian Schwarz, CEO and co-founder of Numaferm, shares insights on pepteins, an underdeveloped class of molecules with high biological activity. They discuss the challenges of manufacturing pepteins, their potential applications in various industries, and the unique biochemical production platform developed by Numaferm. The podcast also explores the use of peptides and nanobodies in drug development and the role of artificial intelligence in protein and peptide development. Additionally, they touch upon global market presence, regulatory issues, and sustainability changes.

2:02 Labiotech.eu news2:51 MinervaX To recognize International Group B Strep Awareness Month in July, we had a conversation with MinervaX CEO, Per Fischer. MinervaX is a privately-held Danish biotechnology company developing a novel prophylactic vaccine against Group B streptococcus (GBS), with two phase II clinical trials ongoing in pregnant women and a phase I clinical trial ongoing in older adults. Due to the global burden and no current mechanism for preventing this invasive GBS disease available. There is an urgent need for a vaccine to prevent GBS which has a well-recognized morbidity and mortality rate. MinervaX’s GBS vaccine has been granted Fast Track regulatory status by the US Food and Drug Administration. The process is designed to facilitate the development of investigational treatments that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions.  This follows the European Medicines Agency’s decision to award Priority Medicine (PRIME) status to the vaccine.

2;00  Labiotech news3:36  BaseLaunchIn today's episode, we have a conversation with Stephan Emmerth, director business development and operations at biotech startup incubator BaseLaunch, and Sai Reddy, an entrepreneur well versed in the highs and lows of the biotech startup journey. The discussion includes BaseLaunch’s approach to empowering early-stage biotech entrepreneurs with not just financing, but also the necessary tools for success, from team-building to IP licensing. Emmerth and Reddy offer their perspectives on the realities of building a biotech startup, the perfect time to transition from a lab to a new venture uncover the significance of choosing the right team making this episode a must-listen for anyone looking to navigate the biotech landscape successfully. 

1:54  Labiotech news3:48  NodTheraThis week, we’re talking about inflammasome inhibitors with Alan Watt, CEO of NodThera.The company recently announced it is the first to show a reduction in neuroinflammation with an inflammasome inhibitor.​​NodThera announced positive initial data from four subjects in the elderly volunteer stage of its phase Ib/IIa study evaluating the effects of its lead candidate NT-0796 on inflammatory and disease-specific biomarkers in the blood and cerebrospinal fluid (CSF).NodThera is a clinical-stage biotech developing brain-penetrant NLRP3 inflammasome inhibitors to treat chronic inflammatory diseases.Initial data from the ongoing study confirm earlier findings from the completed first-in-human and preclinical studies with NT-0796 showing excellent pharmacokinetics with a novel capsule formulation.Subjects in the study were cannulated and CSF-sampled on day one (pre-dose) and day seven following daily NT-0796 dosing. CSF drug levels were confirmed as consistent with previous observations and a range of inflammatory CSF biomarkers demonstrated meaningful reductions.Neurofilament light chain (NfL), exclusively synthesized in the central nervous system (CNS), decreased by approximately 25% over seven days in the most inflamed subject and by 13% on average. NfL is now recognised by the U.S. Food and Drug Administration (FDA) as a key biomarker of neuroaxonal damage and neurodegeneration.

1:24  Labiotech news3:45  TolerogenixXTolerogenixX GmbH, a biopharmaceutical company developing personalized cellular therapies aimed at achieving sustained immune tolerance to combat organ rejection and autoimmune diseases, has announced that its phase IIb study in renal transplant patients has received the green light to initiate the B arm of the study. MIC treatment is a personalized cell therapy approach modulating the immune system via a novel mode of action to achieve a specific and sustained immune tolerance. It can not only be applied to transplant recipients, but also to patients with autoimmune diseases such as systemic lupus erythematosus and multiple sclerosis. TolerogenixX has already reported positive results from the one- and three-year follow-up of 10 transplant recipients of its TOL-1 phase I trial initiated at Heidelberg University Hospital. All patients who had received MIC infusions prior to kidney transplantation in the TOL-1 clinical trial had a favorable clinical course three years after surgery. 

Pejvack Motlagh, CMO at Mablink Bioscience, discusses antibody-drug conjugates. He talks about his background, the switch to Mablink, and the future of ADCs in cancer therapy. The podcast also explores advancements in ADCs, challenges in their development, and potential applications beyond cancer.

2:38  Labiotech news4:23  APSFA20:59 University of MichiganJune is Antiphospholipid Syndrome (APS) Awareness Month. APS is a rare autoimmune disorder in which the body recognizes certain normal components of blood and/or cell membranes as foreign substances and produces antibodies against them. There are two known forms. APS may occur in people with systemic lupus erythematosus, other autoimmune disease, or in otherwise healthy individuals.APS is also referred to as APLS or APLA in the U.S., and formerly Hughes Syndrome or Sticky Blood in the U.K.On the podcast this week, we spoke with Tina Pohlman, who suffers from APS, and who is president of the APSFA, about the disease and the organization.The APS Foundation of America, Inc. (APSFA) was founded in 2005, and is the only U.S. nonprofit health agency dedicated to bringing national awareness to APS, a major cause of multiple miscarriages, thrombosis, young strokes and heart attacks. The APSFA’s Medical Advisory Team includes nationally & internationally recognized experts on Antiphospholipid Syndrome.We also had a conversation with APS researcher Dr Jason Knight, Marvin and Betty Danto Research Professor of Connective Tissue Research and Associate Professor, Division of Rheumatology at the University of Michigan.Current APS trialsThere are currently several clinical trials being undertaken with respect to APS. University Hospital, Clermont-Ferrand, France, is looking to assess the effect of injectable anticoagulants (unfractionated heparin (UFH), low molecular weight heparins (LMWH), fondaparinux, danaparoid, and argatroban) on lupus anticoagulant testing assays over broad anti-Xa activity ranges and to establish their potential for causing false-positive or false-negative results.David Ware Branch, from the University of Utah, is also undertaking a trial with results expected in 2024. The treatment trial is evaluating the addition of an anti-tumor necrosis factor-alpha drug,certolizumab, compared to the usual treatment (a heparin agent and low-dose aspirin) in pregnant women with APS and repeatedly positive tests for lupus anticoagulant (LAC) to determine if this regimen will improve pregnancy outcomes. All enrolled patients will receive certolizumab, and pregnancy outcomes will be compared to those of women with APS and repeatedly positive tests for LAC enrolled in a previous study by the investigators.Another study, in China, also with results anticipated in 2024, is being run by Zhang Lei. The study aims to evaluate the safety and efficacy of zanubrutinib in the treatment of APS with secondary thrombocytopenia in 10 patients.The University of Turin in Italy is sponsoring BLAST (belimumab antiphospholipid syndrome trial), which is expecting to see results in 2025. BLAST aims to evaluate the safety and tolerability of belimumab for up to 24 months in patients with persistent aPL positivity and clinical features attributable to aPL that are resistant to warfarin and/or heparin.

1:13  Labiotech news3:09  Lund Spring Symposium27:36 SapientSapientSapient is an end-to-end biomarker discovery organization dedicated to accelerating the mapping of circulating chemistries in humans through rapid, large-scale small molecule biomarker profiling. Its platform combines next-generation mass spectrometry technologies capable of assaying tens of thousands of small molecule biomarkers in human biosamples, advanced biocomputational learning, and a proprietary Human Biology Database with extensive data from several hundred thousand biosamples. Together these approaches enable rapid discovery and validation of circulating biomarkers of health, disease, and drug responsiveness at unprecedented speed and scale.We spoke with founder and CEO of Sapient, Mo Jain. Lund Spring SymposiumThe inaugural Lund Spring Symposium held in Lund, Sweden from May 24 to 26. It was an impressive forum where an exceptional set of international and national top researchers, entrepreneurs, and business leaders gathered around the subject of ‘Enabling Novel Therapeutic Principles,’ with examples of actual treatment breakthroughs, as well as novel modalities across therapeutic areas ranging from cancer, COVID-19 to neuroscience.Six researchers were awarded for their groundbreaking discoveries and outstanding achievements: Craig Crews Yale University; Brian Kobilka, Stanford University; Robert Langer, MIT; Jude Samulski, University of North Carolina; Sarah Tabrizi, University College London; and Drew Weissman, University of Pennsylvania.The symposium also featured two other Nobel Prize laureates, David Julius, from the University of California San Francisco, who gave a presentation, and Bengt Samuelsson, after whom one of the awards was named.The organizer, Lars Grundemar, Lund University and AGB Pharma, decided together with Mikael Dolsten, Lund University, and chief scientific officer, president R&D, Pfizer, and Claes Wahlestedt, Lund University and University of Miami Miller School of Medicine, to create the event featuring high-profile international and local researchers at a symposium in Lund 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.“This event was designed to reflect the importance of combining basic research with clinical applications and entrepreneurship in successful development of novel therapeutic principles,” Grundemar said. The symposium was intended for scientists and entrepreneurs to be an engaging and interactive forum to broaden the participants’ horizons of cutting-edge science.The Lund Spring Symposium will be held biannually, with the next event taking place in 2025.

This podcast discusses the ISCT annual meeting, focusing on the potential replacement of autologous cell therapy with allogeneic cell therapy and the role of exosomes in replacing mesenchymal stromal cells. They also explore the differences between autologous and allogeneic cell therapies, the use of AI and machine learning in cell and gene therapy, innovative platforms and products in the field, and the use of axosomes in mesenchymal stem cell therapy.

1:24  Labiotech news3:40  BC PlatformsA conversation about precision medicine with Tero Silvola, CEO at BC Platforms. We also discuss the acquisition of 4Pharma.The acquisition expands BCP’s global service offering for accelerating the translation of innovations into clinical practice. In addition, 4Pharma customers will benefit from additional services in the field of RWD through the BC Platform technology.4Pharma (HQ Turku, Finland and Lund, Sweden) was founded more than 20 years ago, and has collaborations with around 70 clients in the Nordics, Central Europe, and the U.S. The company has developed expertise in a range of therapeutic areas including oncology, neurology, ophthalmology, musculoskeletal, respiratory diseases, infectious diseases, and gynecology. The company provides medical research services in several areas: high-quality and cost-effective solutions for the management and delivery of clinical trial data, including real world data; medical writing; patient safety data collection, analysis, and reporting including data visualization; trial design & interpretation; health technology assessment; global regulatory submissions to the FDA (U.S.), EMA (Europe) and PMDA (Japan); and risk-based patient monitoring. With this acquisition BCP bolsters its capabilities in these areas for drug development and clinical research, which further diversifies its service portfolio for pharma and biotech clients.Tero Silvola, CEO at BC Platforms, said: “This exciting acquisition of the excellent 4Pharma brings impressive healthcare data intelligence expertise. It aligns with our vision to build a world leading analytics platform to enable the pharmaceutical industry’s advancement of precision medicine, improving the efficiency of drug development and patient outcomes. This expands our service offering to healthcare and lifesciences customers, as well as connecting data partners in a global, interoperable federated network. We combine omics and clinical data assets around the world, without compromising data privacy and security. This enables our customers to conduct novel research and discover fascinating new insights to advance healthcare which are fundamental to helping patients receive better treatments and care.”