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Chugai and Gero Form $250M Partnership to Develop AI-Driven Antibody Therapies for Age-Related Diseases

AIMonoclonal AntibodyDrug Discovery
  • Chugai Pharmaceutical and Singapore-based Gero have entered into a joint research and license agreement to develop novel antibody therapies targeting age-related diseases using AI-driven drug discovery.
  • The collaboration combines Gero's physics-based machine learning platform for target identification with Chugai's proprietary antibody engineering technologies to create first-in-class therapeutics.
  • Under the agreement, Chugai will pay up to approximately $250 million in milestone payments plus royalties, while gaining exclusive worldwide rights to develop and commercialize antibodies for Gero-identified targets.
  • The partnership represents a strategic move by Chugai to accelerate innovation through open collaboration as part of its TOP I 2030 growth strategy focused on global first-class drug discovery.

BTK Inhibitors Show Promise for Progressive MS as Current Therapies Fall Short

Monoclonal Antibody
  • Current therapeutic options for progressive multiple sclerosis remain severely limited, with only ocrelizumab approved for primary progressive MS showing modest efficacy that diminishes after age 53-55.
  • Emerging BTK inhibitors represent a promising new therapeutic class that targets both B cells and myeloid cells while offering crucial CNS penetration to impact microglia underlying progressive MS inflammation.
  • The HERCULES trial demonstrated a 31% reduction in confirmed disability progression over 6 months with BTK inhibitors compared to placebo in patients with nonrelapsing secondary progressive MS.
  • Current phase 3 trials are testing distinct BTK inhibitors in primary progressive MS, with one comparing against placebo and another against ocrelizumab as the gold standard.

Novel Nasal Antibody Treatment Shows Promise for Hay Fever Prevention in Preclinical Study

Monoclonal Antibody
  • Scientists at Kazakh National Agrarian Research University have developed a monoclonal antibody that acts as a "molecular shield" when applied directly to the nose, successfully blocking hay fever symptoms in mice exposed to mugwort pollen.
  • The treatment represents the first time a monoclonal antibody designed to block a specific pollen allergen has been delivered intranasally, showing protection against allergy symptoms in both upper and lower airways.
  • The antibody works by neutralizing allergens on contact at the nasal lining, preventing IgE antibody activation and potentially reducing inflammation through multiple mechanisms.
  • Researchers plan to begin humanization of the antibody and could start clinical trials within two to three years, with market availability potentially five to seven years away.

Novartis' Cosentyx Fails to Meet Primary Endpoint in Phase III Giant Cell Arteritis Trial

Monoclonal Antibody
  • Novartis announced that its Phase III GCAptAIN study of Cosentyx (secukinumab) failed to achieve sustained remission at Week 52 in adults with newly diagnosed or relapsing giant cell arteritis.
  • The study evaluated Cosentyx combined with a 26-week steroid taper versus placebo with a 52-week steroid taper, but did not demonstrate statistically significant improvement in the primary endpoint.
  • Despite the disappointing results, Cosentyx showed numerically better outcomes for cumulative steroid dose and steroid-related toxicity, with safety profile consistent with its established record.
  • Giant cell arteritis is the most common systemic vasculitis in people over 50 and is considered a medical emergency due to risks of irreversible vision loss and life-threatening aortic aneurysms.

Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)

NCT04930094Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 10/6/2021

Otsuka Pharmaceutical Acquires Cantargia's CAN10 Antibody Program for $33 Million Upfront in Autoimmune Disease Deal

Monoclonal Antibody
  • Otsuka Pharmaceutical has acquired worldwide rights to Cantargia's CAN10, an IL-1RAP targeting monoclonal antibody in Phase 1 development for autoimmune diseases, for $33 million upfront.
  • The deal includes potential milestone payments up to $580 million plus double-digit tiered earn-out payments from global product sales, with transaction expected to close in Q3 2025.
  • CAN10 uniquely inhibits multiple IL-1 family cytokines (IL-1, IL-33, and IL-36) simultaneously by targeting IL-1RAP, potentially offering next-generation treatment for inflammatory and autoimmune conditions.
  • The acquisition expands Otsuka's autoimmune disease pipeline and leverages their antibody drug platform through subsidiary Visterra to accelerate development across multiple therapeutic pathways.

A Study to Investigate the Safety and Tolerability of CAN10 Antibody in Healthy Subjects and in Subjects With Plaque Psoriasis.

NCT06143371RecruitingPhase 1
Cantargia AB
Posted 8/21/2023

Invivyd Forms SPEAR Study Group to Investigate Monoclonal Antibody Therapy for Long COVID

Monoclonal Antibody
  • Invivyd has established the SPEAR Study Group with leading researchers to investigate monoclonal antibody therapy for Long COVID and Post-Vaccination Syndrome, following anecdotal reports of symptom relief with PEMGARDA.
  • The study group will conduct rigorous clinical trials to evaluate the safety and efficacy of anti-SARS-CoV-2 spike protein monoclonal antibodies in patients with persistent viral reservoirs or circulating spike protein.
  • Long COVID affects approximately 5% or more of Americans with no approved treatments currently available, representing a significant unmet medical need.
  • The initiative aims to generate data for potential registrational studies and regulatory pathways, with Invivyd planning FDA discussions on rapid approval pathways for COVID-19 monoclonal antibodies.

EPO and UPC Reach Opposite Conclusions on Amgen's PCSK9 Antibody Patent Validity

Monoclonal Antibody
  • The European Patent Office (EPO) Opposition Division upheld Amgen's PCSK9 antibody patent EP 3666797, finding it inventive, while the Unified Patent Court (UPC) Central Division revoked the same patent for lacking inventive step.
  • Both tribunals agreed on the starting point for assessment and that skilled persons would be motivated to develop PCSK9-blocking antibodies, but diverged on whether there was a "reasonable expectation of success" for therapeutic efficacy.
  • The EPO emphasized uncertainties about therapeutic effectiveness based on prior art, while the UPC concluded that antibody development challenges were routine and did not prevent obviousness.
  • This case highlights potential systematic differences between EPO and UPC approaches to inventive step assessment, particularly relevant for biotechnology patents where "obvious to try" versus "reasonable expectation of success" standards may vary.

Bio-Thera's BAT4406F Achieves Early Trial Success in Rare Neurological Disorder NMOSD

Monoclonal AntibodyRare Disease
  • Bio-Thera Solutions' BAT4406F, an ADCC-enhanced anti-CD20 monoclonal antibody, demonstrated statistically significant efficacy in treating neuromyelitis optica spectrum disorder (NMOSD) during interim analysis of its pivotal Phase II/III trial.
  • The Independent Data Monitoring Committee recommended early termination of the 45-site Chinese trial due to compelling efficacy results that met pre-defined superiority criteria.
  • Bio-Thera has closed patient enrollment ahead of schedule and will begin preparing regulatory approval submissions to China's NMPA for this rare autoimmune disease affecting optic nerves and spinal cord.
  • The breakthrough addresses a critical unmet medical need for NMOSD patients, who face devastating outcomes including permanent blindness, paralysis, and progressive disability with limited current treatment options.

A Clinical Trial of BAT4406F Injection in Patients with Neuromyelitis Optica Spectrum Disorders

NCT06044350RecruitingPhase 2
Bio-Thera Solutions
Posted 8/1/2023

A Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders

NCT04146285CompletedPhase 1
Bio-Thera Solutions
Posted 9/1/2020

Oruka Therapeutics Promotes Laura Sandler to COO as Company Advances Novel Psoriasis Pipeline

Monoclonal AntibodyLeadership Change
  • Oruka Therapeutics has promoted Laura Sandler to Chief Operating Officer, leveraging her 20+ years of biopharmaceutical experience including her role in advancing CRISPR's first approved therapy exa-cel.
  • The company is advancing two novel biologics, ORKA-001 and ORKA-002, designed to treat plaque psoriasis with dosing as infrequent as once or twice yearly.
  • Phase 1 dosing for ORKA-002, a half-life extended IL-17A/F antibody, began in May 2025 with interim data expected by year-end and Phase 2 trials planned for early 2026.
  • Oruka has secured $500 million in funding since 2024, providing substantial capital to advance its clinical programs without dilution concerns.

Celltrion Advances Pembrolizumab Biosimilar Development as Herceptin Copy Nears European Launch

Monoclonal AntibodyDrug ApprovalOncology
  • Celltrion has initiated development of a biosimilar version of Merck's pembrolizumab (Keytruda), starting work 10 years ahead of the drug's patent expiration in June 2028.
  • The company's trastuzumab biosimilar Herzuma has gained EU approval and is expected to be priced up to 50% cheaper than Roche's subcutaneous Herceptin.
  • Biosimilar competitors will primarily target the intravenous Herceptin market, representing less than $1 billion in total European sales as most patients have switched to the more convenient subcutaneous formulation.

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