Latest news with #Biohaven
Yahoo
10-06-2025
- Business
- Yahoo
Bexorg Announces Research Collaboration with Biohaven Leveraging Its Novel AI-Driven Whole-Brain Discovery Platform to Enhance CNS Drug Development
NEW HAVEN, Conn., June 10, 2025 (GLOBE NEWSWIRE) -- Bexorg, Inc., a pioneering techbio company working to decode the human brain and advance new therapies for central nervous system (CNS) disorders, today announced a multi-program research collaboration with Biohaven Ltd. (NYSE: BHVN) to identify, de-risk, and advance next-generation therapies for CNS disorders. As part of the collaboration, Bexorg's novel whole-brain discovery platform will be used to demonstrate target engagement in relevant cell types and tissues and generate novel biomarkers, pharmacokinetic and pharmacodynamic relationships, and other mechanistic data to support two preclinical development programs at Biohaven. Bexorg's whole-brain discovery platform is the only technology capable of perfusing isolated, cadaver human and pig brains with custom-made artificial blood, thereby restoring metabolic and molecular activity for prolonged periods. Bexorg's founders developed the whole-brain perfusion technology at Yale University. Using it, the company can extract high-resolution transcriptomic, proteomic, and metabolic insights in disease-relevant states. With this information, Bexorg is building the largest and most physiologically relevant datasets in human neurodegeneration to enable machine learning and artificial intelligence (AI)-centered CNS drug discovery and development. This breakthrough aims to provide unparalleled insights into human brain molecular activity and advances in the understanding of CNS disorders. 'Our technology enables preclinical testing of almost any therapeutic in metabolically active whole human brains, whether diseased or non-diseased, providing a significant advantage over any other preclinical model in neuroscience,' said Zvonimir Vrselja, MD, PhD, CEO and Co-founder at Bexorg. 'Our ability to collect longitudinal data from our whole-brain discovery platform allows us to validate new targets and biomarkers and understand the pharmacokinetic and pharmacodynamic profiles and potential safety and effectiveness of drugs before going into the clinic. We are thrilled to team up with Biohaven to help advance two preclinical programs and potentially unlock a faster, more precise path to new CNS therapies.' 'The lack of robust translational preclinical models that adequately capture the complexity of human brain structure and function, including the architecture and dynamics of neural networks comprised of billions of neurons and glial cells and the trillions of connections that exist between them, and account for physiological gradients of drug exposure throughout the brain associated with distinct profiles of drug transport across the blood-brain barrier, has, until now, severely handicapped CNS drug discovery and development,' said Bruce D. Car, DVM, PhD, DACVP, Chief Scientific Officer at Biohaven. 'Bexorg's novel platform effectively overcomes the myriad deficiencies inherent in this translational gap, permitting unprecedented and detailed insights into the CNS pharmacology, dosimetry, and potential efficacy of drug candidates before advancing to costly and time-consuming clinical trials.' As part of the collaboration, Bexorg aims to deliver insights from systemic delivery of Biohaven's therapeutics, including analysis of pharmacokinetics, pharmacodynamics, and mechanism of action. Data generated from the platform may also potentially point to the responsiveness of patient subpopulations and identify novel biomarkers to inform clinical trials. Financial terms of the collaboration were not disclosed. About BiohavenBiohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. Biohaven is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and nonclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for OCD and SCA (spinocerebellar ataxia); myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; antibody recruiting bispecific molecules and antibody drug conjugates for cancer. For more information, visit About BexorgBexorg is a privately held techbio company with the first-ever full-stack tech platform to support central nervous system (CNS) drug discovery and development in the human brain in a way that has not been possible before. Bexorg is building a drug discovery artificial intelligence (AI) loop based on its proprietary wet-lab platform, BrainEx, which enables restoration of molecular activity in postmortem human brains to generate high-fidelity, clinically predictive data, model drug response, and create a foundation model for CNS discovery. The company is generating large volumes of human brain data to train predictive models across diseases. Bexorg is building an AI engine, XO Digital, which learns from each experiment, creating a closed-loop system of in-silico prediction and wet-lab validation. With this fully integrated platform, Bexorg is setting a new standard for CNS translational and discovery research. In collaboration with the National Institutes of Health (NIH), Bexorg's founders have been at the forefront of bioethics in postmortem brain molecular recovery research, and the company has an independent board comprised of bioethics leaders to ensure its operations maintain the highest standards. Bexorg is strategically partnering with leading neuroscience companies to integrate its platform into clinical development programs, as well as advancing in-house neurodegeneration assets. Visit us at and follow us on LinkedIn to learn more. Biohaven's Forward-looking StatementsThis news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including 'next generation', 'most', 'unparalleled', 'largest', significant', 'novel', 'unprecedented', and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable US regulatory requirements; the potential commercialization of Biohaven's product candidates; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. CONTACT: Bexorg Media Contact: Adam Silverstein SCIENT PR adam@ Biohaven Contacts: Investor Contact: Jennifer Porcelli Vice President, Investor Relations +1 (201) 248-0741 Media Contact: Mike Beyer Sam Brown Inc. mikebeyer@ +1 (312) 961-2502
Globe and Mail
04-06-2025
- Health
- Globe and Mail
Major Depressive Disorder Pipeline Appears Robust With 75+ Key Companies Actively Working in the Therapeutics Segment
DelveInsight's 'Major Depressive Disorder Pipeline Insight 2025' report provides comprehensive insights about 75+ companies and 75+ pipeline drugs in the Major Depressive Disorder pipeline landscape. It covers the Major Depressive Disorder pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Major Depressive Disorder pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Discover the latest drugs and treatment options in the Major Depressive Disorder Pipeline. Dive into DelveInsight's comprehensive report today! @ Major Depressive Disorder Pipeline Outlook Key Takeaways from the Major Depressive Disorder Pipeline Report In May 2025, Biohaven Therapeutics Ltd announced a study to determine the efficacy and safety of BHV-7000 in participants with Major Depressive Disorder (MDD). In May 2025, Neurocrine Biosciences conducted a study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression. In May 2025, Neumora Therapeutics, Inc. organized a study will evaluate the effects of NMRA-335140 (formerly BTRX-335140) on symptoms of depression in participants with Major Depressive Disorder (MDD). The study design consists of a Screening Period (up to 35 days), and a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo). At the completion of the 6-week Treatment Period, participants who complete the study, provide informed consent, and meet the eligibility criteria may enter an open-label extension study (NMRA-335140-501). In May 2025, Otsuka Pharmaceutical Development & Commercialization, Inc. announced a phase 2 study parallel-arm trial to assess the efficacy, safety, and tolerability of centanafadine once-daily (QD) extended-release (XR) capsules for the treatment of adult subjects diagnosed with Major Depressive Disorder (MDD). In May 2025, Janssen Research & Development LLC announced a study is to evaluate how well JNJ-89495120 works (anti-depressant effects) and how well it is tolerated as compared to placebo on reducing the symptoms of depression in participants with major depressive disorder (MDD). DelveInsight's Major Depressive Disorder pipeline report depicts a robust space with 75+ active players working to develop 75+ pipeline therapies for Major Depressive Disorder treatment. The leading Major Depressive Disorder Companies such as GH Research, Praxis Precision Medicines, AbbVie, Gedeon Richter, Intra-Cellular Therapies, Bristol-Myers Squibb, Relmada Therapeutics, SAGE Therapeutics, Janssen Research & Development, Minerva Neurosciences, Takeda, Neurocrine Biosciences, Pherin Pharmaceuticals and others. Promising Major Depressive Disorder Pipeline Therapies such as NMRA-335140 Aticaprant, NBI-1065845, CYB003, Azetukalner, GW679769, BHV-7000 and others. Stay ahead with the most recent pipeline outlook for Major Depressive Disorder. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Major Depressive Disorder Medication Major Depressive Disorder Emerging Drugs Profile SAGE-217: Sage Therapeutics SAGE-217 is an investigational, oral, novel medicine in development for depression. SAGE-217 is an investigational oral neuroactive steroid (NAS) GABAA receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the brain and central nervous system (CNS), and contributes significantly to regulating CNS function. Biogen and Sage Therapeutics have submitted a new drug application (NDA) to the FDA for zuranolone for the treatment of major depressive disorder (MDD). REL-1017: Relmada Therapeutics Inc. REL-1017, an NCE and novel NMDAR channel blocker with a preference for hyperactive channels associated with MDD. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for REL-1017 as an adjunctive treatment of MDD. REL-1017, has entered its Phase 3 registration program as an adjunctive treatment for MDD. Seltorexant: Minerva Sciences Seltorexant is an innovative selective orexin 2 receptor antagonist under development for the treatment of insomnia and related mood disorders. Insomnia is the repeated difficulty with sleep initiation, maintenance or quality that occurs despite adequate time and opportunity for sleep, resulting in daytime impairment. The clinical trials are being carried out for the treatment of major depressive disorder in phase III stage of development. SP-624: Sirtsei Pharmaceuticals, Inc. SP-624 is being studied in phase II stage of development for the treatment of major depressive disorder in comparison with placebo by Sirtsei Pharmaceuticals, Inc. SPL026: Small Pharma SPL026 (DMT), is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects. DMT is differentiated by its short psychedelic experience (< 30mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics. Small Pharma is advancing a pipeline of DMT-based therapies and is leading the world's first DMT clinical trial for depression, in collaboration with Imperial College London. PDC-1421: BioLite Inc. PDC-1421 (BLI-1005) is a Norepinephrine plasma membrane transport protein inhibitor being developed by BioLite Inc, for the treatment of major depressive disorder. The drug is currently in phase II stage of development. The Major Depressive Disorder Pipeline Report Provides Insights into The report provides detailed insights about companies that are developing therapies for the treatment of Major Depressive Disorder with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Major Depressive Disorder Medication. Major Depressive Disorder Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Major Depressive Disorder Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Major Depressive Disorder market Explore groundbreaking therapies and clinical trials in the Major Depressive Disorder Medication. Access DelveInsight's detailed report now! @ New Major Depressive Disorder Drugs Major Depressive Disorder Companies GH Research, Praxis Precision Medicines, AbbVie, Gedeon Richter, Intra-Cellular Therapies, Bristol-Myers Squibb, Relmada Therapeutics, SAGE Therapeutics, Janssen Research & Development, Minerva Neurosciences, Takeda, Neurocrine Biosciences, Pherin Pharmaceuticals and others. Major Depressive Disorder pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Subcutaneous Intravenous Intramuscular Major Depressive Disorder Products have been categorized under various Molecule types such as Bispecific Antibody Peptides Small molecule Gene therapy Unveil the future of Major Depressive Disorder Medication. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ Major Depressive Disorder Market Drivers and Barriers Scope of the Major Depressive Disorder Pipeline Report Coverage- Global Major Depressive Disorder Companies- GH Research, Praxis Precision Medicines, AbbVie, Gedeon Richter, Intra-Cellular Therapies, Bristol-Myers Squibb, Relmada Therapeutics, SAGE Therapeutics, Janssen Research & Development, Minerva Neurosciences, Takeda, Neurocrine Biosciences, Pherin Pharmaceuticals and others. Major Depressive Disorder Pipeline Therapies- NMRA-335140 Aticaprant, NBI-1065845, CYB003, Azetukalner, GW679769, BHV-7000 and others. Major Depressive Disorder Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Major Depressive Disorder Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Get the latest on Major Depressive Disorder Medication and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Major Depressive Disorder Companies, Key Products and Unmet Needs Table of Content Introduction Executive Summary Major Depressive Disorder: Overview Pipeline Therapeutics Therapeutic Assessment Major Depressive Disorder – DelveInsight's Analytical Perspective Late Stage Products (Preregistration) SAGE-217: Sage Therapeutics Drug profiles in the detailed report….. Mid Stage Products (Phase II) SP-624: Sirtsei Pharmaceuticals, Inc. Drug profiles in the detailed report….. Early Stage Products (Phase I/II) SPL026: Small Pharma Drug profiles in the detailed report….. Preclinical Stage Products Drug Name: Company name Drug profiles in the detailed report….. Inactive Products Major Depressive Disorder Key Companies Major Depressive Disorder Key Products Major Depressive Disorder- Unmet Needs Major Depressive Disorder- Market Drivers and Barriers Major Depressive Disorder- Future Perspectives and Conclusion Major Depressive Disorder Analyst Views Major Depressive Disorder Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
Yahoo
28-05-2025
- Business
- Yahoo
In Your Neighborhood: Kathryn Hauser at MADE Leadership Series event at Yale Innovation Summit
NEW HAVEN, Conn. (WTNH) — News 8's Kathryn Hauser emceed the second MADE Leadership series on Wednesday in New Haven. The series was held at the Yale Innovation Summit and featured discussions on the state of innovation in Connecticut. The panel was moderated by the state's Chief Innovation Officer and Department Of Economic and Community Development Commissioner Dan O'Keefe. Also on the panel were CEOs of Biohaven, BioCT and QuantumCT. 'For me, innovation is not just disrupting, but it's actually solving big patient problems and healthcare problems, said Biohaven CEO Dr. Vlad Coric. The Yale Innovation Summit is a two-day event that features exhibits, discussions and dynamic experiences. 'What I love about Connecticut, is we all band together to really lure the companies,' said BioCT CEO Jodie Gillion. 'We can get together with Yale, with the state, with Connecticut innovations and all different groups and really put on a good show.' The next MADE Leadership Series event will take place in October in Fairfield County. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
28-05-2025
- Business
- Yahoo
Biohaven Highlights Innovation and Advancement Across MoDE and TRAP Degrader Platform at R&D Day, Announcing Positive TRAP Degrader Data Achieving > 80% Sustained Reductions in Galactose-Deficient IgA1 (Gd-IgA1) with Potential First-in-Class BHV-1400 for IgA Nephropathy (IgAN)
Optimized subcutaneous (SC) administration of BHV-1400 achieved rapid, deep, selective, and sustained lowering of Gd-IgA1, differentiating Biohaven's leading TRAP degrader for IgAN from the complement and BLyS/APRIL inhibitor competition. Up to 81% reduction of Gd-IgA1 was observed, with reductions from baseline sustained for weeks after a single SC dose administration. BHV-1400 brings precision immunology to the treatment landscape of IgAN as it was rationally designed to selectively remove galactose-deficient IgA1 (Gd-IgA1), the pathogenic antibody driver of the disease while sparing healthy antibodies IgA, IgG, IgE, and IgM. Preservation of immunoglobulins, the complement system, and cell-mediated and humoral immunity offers key differentiation against immunosuppressive BLyS/APRIL inhibitors, complement inhibitors, and budesonide. Based upon the rapid and deep reductions of Gd-IgA1 observed with subcutaneous BHV-1400, Biohaven plans to study BHV-1400 in patients with IgAN, initiating a pivotal trial in 2026 using urine protein-creatinine ratio (UPCR) as a surrogate endpoint for accelerated approval. Optimized SC administration of BHV-1300 has continued to demonstrate rapid, deep, and sustained lowering of total IgG in Phase 1 studies. Recently generated clinical data shows that BHV-1300 achieved rapid, deep, and sustained lowering of total IgG, with reductions up to 87%. Median maximum reductions of 83% were observed within 18 days of the first subcutaneous dose. The range of IgG reductions possible with varying dosing paradigms of BHV-1300 allows for tunable dosing regimens tailored for acute and chronic disease management, with higher doses for acute disease management and lower, less frequent dosing for chronic disease management. Based upon the rapid and deep reductions of IgG and favorable tolerability profile observed with BHV-1300, Biohaven plans to study BHV-1300 in patients with Graves' Disease and initiate pivotal trials in 2H 2025. NEW HAVEN, Conn., May 28, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today highlighted the success of its first MoDE™ and TRAP™ degraders in achieving key target pharmacodynamic endpoints and announced plans to initiate pivotal trials in Graves' Disease and in IgA nephropathy in 2H 2025 and 1H 2026, respectively at Biohaven's 2025 R&D Day, held concurrently with the Yale Innovation Summit in New Haven, Connecticut. The presentation slides from Biohaven's R&D day for the TRAP and MoDE degraders and its other platforms will be available on the Events and Presentations page of the Biohaven website just prior to their presentations. BHV-1400, the Company's potential first-in-class galactose-deficient IgA1 (Gd-IgA1) TRAP degrader for the treatment of IgA nephropathy (IgAN) achieved deep, rapid, and sustained reductions in Gd-IgA1. In the Phase 1 study, a single dose of BHV-1400 was subcutaneously administered at a dose of 500 mg and achieved rapid, deep and sustained reductions in Gd-IgA1 of up to 81%, with a median reduction of 66% (Figure 1). Reductions occurred within hours of each dose, were progressive, and were sustained for weeks after a single dose administration. Effects were selective, with no significant reductions observed in other immunoglobulins: IgA, IgG, IgE, or IgM. Dr. Jonathan Barratt, the Mayer Professor of Renal Medicine at University of Leicester and leading expert in the treatment of IgAN, commented on the new Phase 1 data, "The reason I am excited about BHV-1400 is because it specifically targets the fundamental abnormality in IgA nephropathy while leaving the rest of the immune system untouched. It has the potential to take away the major driver for immune complex formation while leaving other antibodies completely unaffected, which means it has efficacy with unrivaled safety." IgA nephropathy is the leading cause of glomerular disease globally and is commonly diagnosed in individuals in their second and third decades of life, with most individuals progressing to renal failure over the ensuing 10-15 years. As a disease of the immune system, IgA nephropathy frequently returns even after renal transplant. While the 2021 Kidney Disease Improving Global Outcomes (KDIGO) treatment guidelines recommended only standard chronic kidney disease treatments, the 2024 draft guidelines emphasize the importance of treating the underlying immune disease by removing aberrant forms of IgA. "Galactose deficient IgA1 is the fundamental abnormality in IgA nephropathy," Dr. Barratt explained, "It's a group of IgA molecules that have changes to the sugars on the IgA1 hinge region that fundamentally change the way this antibody behaves. It promotes immune complex formation and it's these immune complexes that cause glomerular injury and damage and promote loss of kidney function." BHV-1400's selective approach has the potential to offer an improved safety profile compared to broadly immunosuppressive agents. BHV-1400 has been safe and well-tolerated across the ongoing Phase 1 study. Most adverse events (AEs) were mild and self-resolving, there were no discontinuations due to AEs related to study drug, and there were no serious or severe AEs related to drug. There were no clinically significant increases in ALT, AST or bilirubin, no clinically significant reductions in albumin and no clinically significant increases in cholesterol relative to placebo over the 4-week dosing period. There were no clinically significant reductions in other immunoglobulins including IgG, IgA, IgE, or IgM relative to baseline. With regards to the applicability of Phase 1 data in healthy volunteers to patients with IgAN, Dr. Barratt added, "It's not that the Gd-IgA1 is subtly different, it's the same in both (healthy volunteers and patients with IgAN), but in patients, they just have an excess quantity. And so, what I believe is that because you're seeing a suppressed Gd-IgA1 in healthy subjects you are going to see the same in patients with IgA nephropathy, and indeed that's what some of the drugs targeting BAFF and APRIL have shown. They presented data in their healthy volunteer population that was precisely replicated when they went in to patients." BHV-1400 fundamentally differentiates from alternative approaches by virtue of its precision. While agents targeting the glucocorticoid receptors may have steroid-like side effects, those targeting complement require vaccination for encapsulated bacterial infections, and B-cell-directing therapies cause reductions in all isotypes of immunoglobulin, potentially increasing long-term infection risk. Based upon the rapid and deep reductions of Gd-IgA1 observed with SC dosing of BHV-1400, Biohaven plans to study BHV-1400 in patients with IgAN and initiate pivotal trials in 2026 using UPCR surrogate endpoint via the accelerated approval pathway. At its R&D Day, Biohaven also released new positive data from its completing Phase 1 study of its leading MoDE degrader, BHV-1300, that targets IgG for removal. In the Phase 1 multiple-dose study, SC administered BHV-1300 achieved IgG reductions up to 87%. Median maximum reductions of 83% were achieved within 18 days (Figure 2). Biohaven recently reported the 1000 mg weekly dose achieved rapid, deep and sustained reductions in total IgG of up to 84%, with a median reduction of 80% by Week 4 (Figure 2). Reductions at all doses occurred within hours of administration, were progressive, and effects were durable between dosing intervals. The range of IgG lowering enabled by different dose levels of BHV-1300 offers tunability and flexibility in dosing paradigm, with higher doses planned for management of acute conditions, and lower, less frequent dosing planned for the management of chronic disease. BHV-1300 has been safe and well-tolerated in subcutaneous doses up to 2000 mg with no clinically significant increases in ALT, AST, or bilirubin, no clinically significant reductions in albumin, and no clinically significant increases in cholesterol over the four-week dosing period relative to placebo. There were no clinically significant reductions in IgG3, IgA, IgE, or IgM relative to baseline. Most AEs were mild and self-resolving, and there were no serious or severe AEs. BHV-1300 is a potential first-in-class novel small molecule MoDE degrader in development for the treatment of IgG-mediated diseases, such as Graves' Disease. It is designed for self-administration via an easy-to-use and patient-friendly autoinjector. Biohaven plans to study BHV-1300 in patients with Graves' Disease and initiate a pivotal trial in 2H 2025. Tova Gardin, MD, MPP, Chief Translational Officer at Biohaven, commented, "Our lead MoDE and TRAP degraders, BHV-1300 and BHV-1400, deliver on the promise of ground-breaking chemistry, demonstrating unrivaled selectivity, and profound depletion of potentially disease-causing proteins. With the selectivity of the platform and the initial profile observed in Phase 1, we aim to bring precision immunology to patients with safe and effective treatments that target the core of disease biology. We are incredibly proud of our innovative, agile, and dynamic team that has catalyzed a first of its kind extracellular degrader technology from bench to the clinic. Driven by patient need and leading-edge, mechanistically precise science, Biohaven remains focused on delivering the promise of precision therapies to patients with immune-mediated disease." About BHV-1400BHV-1400 is a potential first-in-class Gd-IgA1 TRAP degrader, rationally designed to leverage the body's natural hepatic clearance mechanisms to selectively target and remove Gd-IgA1, the underlying cause of the IgA nephropathy and IgA vasculitis. BHV-1400 spares IgG, IgA, IgE, and IgM to preserve patient immune protection against bacteria, viruses and parasites. The results of the ongoing Phase 1 study confirm that BHV-1400 produces deep reductions in Gd-IgA1 within hours, is selective, sparing other immunoglobulins, is tunable, and is safe and well-tolerated. About BHV-1300BHV-1300 is a small molecule and potential first-in-class extracellular IgG degrader, rationally designed to leverage the body's natural hepatic clearance mechanisms to selectively target and remove IgG1, IgG2, and IgG4, the underlying cause of many immune-mediated diseases. BHV-1300 spares IgG3 to preserve patient immune protection against bacteria, viruses and parasites. The results of ongoing Phase 1 study confirm that BHV-1300 produces deep reductions in total IgG, is selective, sparing IgG3, is tunable, and is safe and well-tolerated. About BiohavenBiohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. Biohaven is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for OCD and SCA; myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; antibody recruiting bispecific molecules; and antibody drug conjugates for cancer. For more information, visit Forward-looking Statements This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "potential first-in-class", "potentially", "groundbreaking" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, including the studies of BHV-1300 and BHV-1400; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable US regulatory requirements; the potential commercialization of Biohaven's product candidates; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. MoDE and TRAP are trademarks of Biohaven Therapeutics Ltd. Investor Contact:Jennifer PorcelliVice President, Investor (201) 248-0741 Media Contact:Mike BeyerSam Brown (312) 961-2502 View original content to download multimedia: SOURCE Biohaven Ltd. Sign in to access your portfolio
Yahoo
28-05-2025
- Business
- Yahoo
Biohaven Presents Oncology Program Updates and Preliminary Clinical Data Showcasing Innovative Trop2 and FGFR3 Antibody Drug Conjugates (ADCs) Incorporating Novel TopoIx Payload with Potential to Treat a Wide Variety of Tumors
BHV-1510, a highly differentiated Trop2 ADC incorporating the proprietary TopoIx payload, demonstrates early clinical activity and favorable safety profile in Phase 1 study as a monotherapy and in combination with Regeneron's anti-PD-1 cemiplimab. Tumor reduction was observed in the first 6 out of 6 patients treated with BHV-1510 plus cemiplimab including confirmed partial responses First patient dosed with Biohaven's novel, first-in-class FGFR3 directed TopoIx ADC, BHV-1530 Promising progress in the clinic demonstrates potential of Biohaven's innovative, next-generation ADC platform and TopoIx payload, with additional collaboration programs with Merus and GeneQuantum advancing preclinically. NEW HAVEN, Conn., May 28, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today provided an update and preliminary clinical data from its oncology development programs at Biohaven's 2025 R&D Day, held concurrently with the Yale Innovation Summit in New Haven, Connecticut. The presentation slides from Biohaven's R&D day for Oncology and its other platforms will be available on the Events and Presentations page of the Biohaven website just prior to their presentations. Biohaven reported that its novel next-generation trophoblast cell surface antigen 2 (Trop2) directed antibody drug conjugate (ADC), BHV-1510, demonstrated encouraging preliminary clinical activity both as a monotherapy and in combination with Regeneron's anti-PD-1 antibody cemiplimab. Early clinical data is consistent with BHV-1510's preclinical profile showing high ADC stability, differentiated safety and efficacy, immunogenic cell death, and anti-PD-1 synergism. Monotherapy tumor reductions including partial responses have been seen in patients failing standard of care therapies. The combination of BHV-1510 and cemiplimab in the ongoing Phase 1 study shows encouraging anti-tumor activity, with tumor shrinkage in the first 6 out of 6 patients treated, including confirmed partial responses and in patients with brain metastasis (Figure 1). The majority of patients treated with the combination had failed prior anti–PD-1/PD-L1 therapies. BHV-1510 showed a favorable pharmacokinetic (PK) profile, with very low levels of free payload. As monotherapy, the main toxicity observed thus far in the Phase 1 study has been stomatitis, an expected on-target Trop2 class toxicity that has been manageable. Importantly, there were no cases of payload-associated interstitial lung disease (ILD), and low rates of gastrointestinal (e.g., diarrhea) and hematologic toxicities observed. The combination with cemiplimab was well tolerated with no dose limiting toxicity to date in initial cohorts. Nushmia Khokhar, M.D., Chief Medical Officer of Oncology at Biohaven, commented, "The early clinical data with BHV-1510 dosed in patients who failed standard of care treatment are highly encouraging, particularly the observed potential synergy with anti-PD-1 therapy. These findings, combined with the promising efficacy and tolerability profile of our novel TopoIx payload and stable linker technology, support the potential of BHV-1510 to advance into earlier lines of therapy for challenging tumor types." Biohaven also announced the first patient has been dosed in the Phase 1 study of BHV-1530, a potential first-in-class fibroblast growth factor receptor 3 (FGFR3)-directed ADC which utilizes the proprietary Topolx payload. BHV-1530 has potential in indications of cancers driven by FGFR3 alterations and/or upregulated FGFR3 protein expression, including urothelial cancers and other solid tumors (Figure 2). FGFR3 is a clinically validated target in oncology, with one small molecule inhibitor (erdafitinib) approved. There are no FGFR3 ADCs beyond BHV-1530 advanced in clinical testing. Michael Song, M.D., Ph.D., Principal Investigator and leading medical oncologist and hematologist at NEXT Oncology with over 22 years of experience in cancer patient care and cancer research, stated, "We are excited to partner with Biohaven and dose the first patient on this important study. This is an exciting, validated target with potential to extend therapeutic benefit to several FGFR3 driven tumors." Biohaven is also advancing a portfolio of innovative technologies to modernize next-generation ADCs through strategic collaborations with Merus and GeneQuantum (Figure 3). The preclinical programs leverage Biohaven's differentiated ADC platform directed against undisclosed novel validated and emerging high-value targets, and incorporating the TopoIx payload that preclinically demonstrated immunogenic cell death and synergistic efficacy with PD-1/PD-L1 checkpoint inhibitors. Brian Lestini, M.D., Ph.D., President of Oncology at Biohaven, commented, 'We are excited to be in the clinic with two innovative ADCs and to share the early clinical experience with the first of our two programs, demonstrating the potential of our oncology portfolio to deliver a wide range of optimized, next-generation ADCs. The early clinical data from the Trop2 ADC, BHV-1510, shows the predicted profile and potential of the proprietary TopoIx payload as seen preclinically, and supports broad investigation of ADCs incorporating TopoIx and highly stable linker technologies. Similarly, initiation of the first-in-human study of BHV-1530, an FGFR3 directed ADC, demonstrates the versatility of our approach to generate novel drugs with the potential to address a wide variety of unmet needs in oncology. Together with our collaborations with Merus and GeneQuantum as well as licensed conjugation technology from Yale University, Biohaven's platform has the potential to generate multiple differentiated mono- and bispecific ADC therapies with greater potency and selectivity over currently available ADC approaches." About BiohavenBiohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. Biohaven is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for OCD and SCA; myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; antibody recruiting bispecific molecules; and antibody drug conjugates for cancer. For more information, visit Forward-looking StatementsThis news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing and amounts of funding under the NPA. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "anticipate" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, including the combination of BHV-1510 and cemiplimab in the ongoing Phase 1 study; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates and the expected timing thereof; the potential for Biohaven's product candidates to be successful therapies; and the effectiveness and safety of Biohaven's product candidates, including the safety profile of BHV-1510. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Investor Contact:Jennifer PorcelliVice President, Investor (201) 248-0741 Media Contact:Mike BeyerSam Brown (312) 961-2502 View original content to download multimedia: SOURCE Biohaven Ltd.
