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Atrial Fibrillation Pipeline Shows Robust Development with 15+ Novel Therapies from Leading Pharmaceutical Companies

Monoclonal Antibody
  • DelveInsight's 2025 pipeline report reveals over 12 active companies developing 15+ novel atrial fibrillation therapies, with promising candidates including Abelacimab, Etripamil, and THRV-1268 advancing through clinical trials.
  • Major pharmaceutical players including Novartis, Bayer, Bristol-Myers Squibb, and Johnson & Johnson are actively evaluating new treatments to address the growing market driven by aging populations and rising AF prevalence.
  • Recent regulatory milestones include Thryv Therapeutics receiving FDA IND clearance for THRV-1268 and Bayer initiating Phase I trials for BAY 3670549, demonstrating accelerating development momentum.
  • The pipeline features diverse therapeutic approaches including Factor XI inhibitors, multi-ion channel blockers, and calcium channel antagonists, targeting various aspects of AF management from acute episodes to long-term stroke prevention.

NextCure's Anti-Siglec-15 Antibody NC605 Shows Promise for Osteogenesis Imperfecta Treatment in Preclinical Study

Monoclonal AntibodyRare Disease
  • NextCure's NC605, a novel anti-Siglec-15 antibody, demonstrated improved bone microarchitecture and reduced fracture incidence in preclinical studies of osteogenesis imperfecta mice.
  • The treatment showed superior bone quality outcomes compared to current anti-resorptive therapies by both inhibiting bone loss and producing new bone with increased quality and density.
  • NC605 represents a potential breakthrough for osteogenesis imperfecta patients, as there is currently no FDA-approved standard of care for this rare brittle bone disease.
  • NextCure is seeking financial support to advance NC605 toward an Investigational New Drug submission within 12 to 18 months.

Incyte Reports Strong Q2 2025 Results with Jakafi Growth and New Drug Approvals

Drug ApprovalMonoclonal AntibodyOncology
  • Incyte reported strong second quarter 2025 financial results with Jakafi net revenues of $764 million, representing 8% year-over-year growth driven by increased demand across all indications.
  • The company achieved two significant regulatory milestones with FDA approvals of Zynyz for squamous cell anal carcinoma and Monjuvi for follicular lymphoma, expanding treatment options for cancer patients.
  • Niktimvo, launched in Q1 2025, demonstrated continued strong commercial uptake with $13.6 million in sales, while Opzelura revenues grew 35% to $164 million driven by increased patient demand in both atopic dermatitis and vitiligo.
  • The company raised its 2025 revenue guidance for Jakafi and other oncology products, reflecting strong first-half performance and successful product launches.

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

NCT06388564RecruitingPhase 2
Incyte Corporation
Posted 10/11/2024

MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

NCT06132256RecruitingPhase 2
Syndax Pharmaceuticals
Posted 12/11/2023

A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

NCT06585774RecruitingPhase 3
Incyte Corporation
Posted 1/21/2025

Kling Bio Partners with Sanofi to Develop Next-Generation Antiviral Antibodies Using Proprietary B Cell Platform

Monoclonal Antibody
  • Kling Bio has entered into a collaboration and license option agreement with Sanofi to discover neutralizing antibodies against a clinically relevant human viral pathogen using its Kling-Select platform.
  • The Kling-Select platform leverages patient-derived B cells to rapidly identify novel antibodies and conserved viral epitopes, with validated candidates already developed against RSV, COVID-19, and influenza.
  • The partnership aims to develop next-generation antiviral therapeutics and inform more efficacious vaccine design by combining Kling Bio's antibody discovery expertise with Sanofi's vaccine development leadership.
  • The collaboration highlights the potential of B cell immortalization technology to address global health challenges through the discovery of first-in-class, human-derived antibodies.

Long-Acting Anti-TSLP Antibody HBM9378/WIN378 Enters Global Phase 2 Trial for Asthma Treatment

Monoclonal Antibody
  • Windward Bio has initiated the global Phase 2 POLARIS trial evaluating HBM9378/WIN378, a long-acting anti-TSLP monoclonal antibody for asthma treatment, with initial data expected in mid-2026.
  • The fully human antibody targets thymic stromal lymphopoietin (TSLP) and has been engineered for extended half-life with potential twice-yearly dosing, addressing the need for more effective long-acting treatments.
  • HBM9378/WIN378 demonstrated extended half-life, low antidrug antibody incidence, and good safety profile in Phase 1 trials, with additional COPD clinical programs planned for 2026.
  • The therapy represents a collaborative effort between Harbour BioMed and Kelun-Biotech, with Windward Bio holding exclusive global licensing rights outside Greater China and select Asian countries.

Former Poseida CEO Kristin Yarema Named to Lead Ikena-Inmagene Merger as Companies Advance Anti-OX40 Therapy

Monoclonal Antibody
  • Ikena Oncology and Inmagene Biopharmaceuticals have appointed former Poseida Therapeutics CEO Kristin Yarema to lead the merged company ImageneBio following their anticipated July 2025 closing.
  • The merger includes a concurrent $75 million private placement and will focus on advancing IMG-007, an anti-OX40 monoclonal antibody that recently completed Phase 2a trials in atopic dermatitis and alopecia areata.
  • IMG-007 demonstrated sustained clinical activity with a 34.7-day half-life in subcutaneous formulation, supporting potential for infrequent dosing in immunological and inflammatory diseases.

A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

NCT07037901RecruitingPhase 2
Inmagene LLC
Posted 6/17/2025

Bio Usawa and ServareGMP Partner to Establish Monoclonal Antibody Manufacturing in Africa

Monoclonal Antibody
  • Bio Usawa Biotechnology and ServareGMP announced a strategic partnership to build advanced monoclonal antibody manufacturing capabilities in Africa, addressing critical healthcare access gaps in low- and middle-income countries.
  • The collaboration focuses on four core pillars: local biomanufacturing infrastructure, workforce development, process innovation for cost reduction, and emergency response capabilities for pandemics and health crises.
  • The partnership aims to fundamentally restructure how biotherapeutics are developed, produced, and delivered in LMICs by investing in local talent, infrastructure, and innovation to ensure equitable access to life-saving therapies.

Stanford Researchers Develop Radiation-Free Stem Cell Transplant Protocol for Fanconi Anemia Patients

Monoclonal AntibodyRare Disease
  • Stanford Medicine researchers successfully conducted stem cell transplants in three Fanconi anemia patients using the anti-CD117 antibody briquilimab, eliminating the need for toxic radiation or busulfan chemotherapy.
  • All three pediatric patients achieved nearly 100% donor cell engraftment after two years, far exceeding the initial 1% target, with no graft rejection or major complications.
  • The innovative protocol addresses donor shortage by allowing transplants from half-matched donors like parents through alpha/beta T-cell depletion techniques.
  • Researchers are now conducting phase 2 trials and exploring applications for other genetic diseases including Diamond-Blackfan anemia and elderly cancer patients.

Eyam Health and MMV Partner to Develop $1 Malaria Prevention Shot Using AI-Designed Monoclonal Antibodies

Monoclonal Antibody
  • Eyam Health and Medicines for Malaria Venture announce a strategic partnership to develop next-generation monoclonal antibody-based malaria therapies costing less than $1 per dose.
  • The collaboration leverages Eyam's Jennerator AI platform to design biologics and the Gemini delivery system that can carry multiple antibodies without cold storage requirements.
  • A single long-acting injection could protect over 50 million young children and pregnant women for an entire 4-5 month rainy season during peak malaria transmission.
  • The nucleic acid-based Gemini platform eliminates expensive lipid nanoparticles and can be readily adapted for local African manufacturing to address pandemic preparedness.

CASI Pharmaceuticals Names David Cory CEO to Advance Anti-CD38 Antibody CID-103 Program

Monoclonal AntibodyLeadership Change
  • CASI Pharmaceuticals appointed industry veteran David Cory as CEO to lead the U.S. operations and focus on advancing CID-103, a potential best-in-class anti-CD38 monoclonal antibody.
  • CID-103 is currently dosing patients in a multi-center Phase 1/2 study for chronic immune thrombocytopenia (ITP) and has an IND application filed for renal allograft antibody-mediated rejection.
  • Cory brings over 30 years of biotech experience, having raised over $1 billion in capital markets and led multiple company exits totaling approximately $9 billion in acquisitions.
  • The leadership change positions CASI to concentrate resources on maximizing the therapeutic potential of CD38 targeting for organ transplant rejection and autoimmune diseases.

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