Beyond Biotech - the podcast from Labiotech

On this week’s podcast, to recognize Blood Cancer Awareness Month, we have a conversation with Affimed's CMO, Andreas Harstrick, to talk about blood cancers, and what Affimed is doing to tackle blood cancers.One of the main challenges in treating blood cancers is the limited options for therapeutic intervention. Treatment relies primarily on chemotherapy, which is often associated with high toxicity and limited duration of response. Most other approaches to treating hematologic tumors target the adaptive immune system, neglecting the importance of innate immunity. However, harnessing the body’s first line of response could be an important gateway to treating these cancers, which could drastically lower side effects and overcome immune evasion by cancers, especially in refractory or relapsed patients. Approaches based on the innate immune system mainly utilize NK (natural killer) cells. Innate Pharma, Dragonfly Therapeutics, and Affimed are among the biotech companies directing NK cells to tumors with the help of bi- or multi-specific antibodies. Affimed has completed a phase 2 trial with its innate cell engager (ICE), AFM13. To address the fact that cancer patients often lack a functional immune system, Affimed has combined its ICE approach with PD-1 inhibitors or allogeneic cord blood-derived NK cells to further increase the potential success of its treatments. Initial results from an exploratory study together with MD Anderson have already provided encouraging data with relapsed or refractory patients that previously exhausted all treatment options showing a complete response rate of 71% when treated with AFM13 precomplexed with cord blood-derived NK cells.

On this week’s podcast, we have a conversation with Dr Jack Scannell, CEO of Etheros Pharmaceuticals Corp. Scannell recently co-authored a paper on the expenses related to clinical research and the factors that underly the translational failure of inhibitors of the insulin-like growth factor-1 receptor (IGF-1R) in oncology.Costs and Causes of Oncology Drug Attrition With the Example of Insulin-Like Growth Factor-1 Receptor Inhibitors, published in Jama Network Open, looked at 16 inhibitors of IGF-1R, in 183 clinical trials involving more than 12,000 patients. None of the agents received approval for clinical use in oncology practice and the trials were estimated to have had expenses of greater than $1.6 billion. Half of the published in vivo preclinical data analyzed showed less than a 50% inhibition of tumor growth by IGF-1R inhibitors.The authors stated that failed drug development in oncology incurs substantial expense. At an industry level, an estimated $50 billion to $60 billion is spent annually on failed oncology trials. Improved target validation and more appropriate preclinical models are required to reduce attrition, with more attention paid to decision-making before launching clinical trials. A more appropriate use of resources may better reduce cancer mortality, the authors argued.

Since its inception in 2012, World Lung Cancer Day has been observed every year on August 1 in order to raise awareness of lung cancer issues and magnify the need for more lung cancer research funding.Around a quarter of a million people in the US alone will be diagnosed with some form of lung cancer in 2023. And more than 125,000 people in the US will die from the disease. And another pretty awful stat is that one in 16 men and one in 17 women will be diagnosed with lung cancer, which kills three times as many people as breast cancer or prostate cancer. However, there are some positive trends. The number of new lung cancer diagnoses is declining steadily. Since 2006, the incidence rate decreased by 2.6% per year in men and 1.1% per year in women. Mortality rates are declining even faster, because of advances in treatment and early detection.This week’s guest is Prof. Iris Barshack, Head of the Pathology Institute at Sheba Medical Center, to talk about a new diagnostic tool for lung cancer.Sheba Medical Center’s new AI cancer diagnostics platform reduces diagnosis timeSheba Medical Center, Israel’s largest medical center, has announced the deployment of a new accelerated, AI-powered cancer diagnostics research platform to improve patient diagnosis,  treatment and outcomes. The platform enables the integration of AI technology developed by Sheba in addition to solutions created by innovative digital health startups.One of the first AI solutions to be deployed was developed by Imagene, an emerging leader in AI-based precision oncology, incorporating an algorithm to identify actionable biomarkers of non-small cell lung cancer. The algorithm is directly applied to a digitized image of a conventionally stained pathology slide and can then, within minutes, identify the presence of actionable biomarkers in the tumor, thus providing crucial information for diagnostic and therapeutic decisions. The solution essentially shortens diagnostic time from three weeks to minutes, enabling patients to begin treatment earlier. “We have reached another significant milestone in digital pathology with this ability to detect biomarkers by AI. The use of deep learning algorithms is changing the world of diagnosis, and in certain cases can drastically shorten the cost and time to treatment. I am excited to hear about the growing number of patients who were able to receive rapid diagnoses and treatment using our new service,” said Prof. Iris Barshack, Head of the Pathology Institute at Sheba Medical Center.This latest advancement in cancer diagnostics builds on the progress Sheba’s Pathology Institute has made in recent years. In 2019, the pathology lab at the hospital went fully digital, using computer screens for diagnosis instead of microscopes. Once the lab turned fully digital, the team worked with Imagene who developed a rapid AI-based molecular profiling algorithm to identify actionable biomarkers from the digital biopsy image alone.        “We are very proud to be part of this incredibly important initiative by Prof. Barshack to facilitate an accelerated program for rapid diagnosis of cancer patients,” said Dean Bitan, co-founder and CEO of Imagene. “It takes an innovative approach and openness to new and advanced technologies to drive cancer research and advanced cancer care. We believe this program will showcase the importance of rapid molecular profiling within the clinical workflow.” 

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.