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Abcentra Initiates Phase 2b FORTIFY Trial for Novel Anti-Inflammatory Cardiovascular Therapy Orticumab

Monoclonal Antibody
  • Abcentra LLC has dosed the first patient in its Phase 2b FORTIFY trial evaluating orticumab, a first-in-class monoclonal antibody targeting oxidized LDL for secondary prevention of cardiac events.
  • The multi-center, placebo-controlled trial will enroll 240 patients with a history of type 1 myocardial infarction and elevated coronary inflammation across 40 sites in the U.S., UK, and Europe.
  • Orticumab aims to reduce cardiovascular risk by inhibiting inflammation locally within atherosclerotic plaques, potentially offering a transformative approach beyond current LDL-lowering therapies.
  • The study will assess anti-inflammatory activity using coronary computed tomography angiography to measure Fat Attenuation Index scores over 24 weeks of treatment.

Focused Orticumab Research for Treating Inflammation in Coronary Arteries

NCT06927739Not Yet RecruitingPhase 2
Abcentra
Posted 6/15/2025

Lupin Partners with Sandoz to Commercialize Ranibizumab Biosimilar Across Multiple Global Markets

Monoclonal Antibody
  • Lupin Limited has entered into a strategic partnership with Sandoz Group AG to commercialize its biosimilar ranibizumab across the European Union, Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia.
  • Under the agreement, Sandoz will handle commercialization while Lupin maintains responsibility for manufacturing and regulatory submissions, with Sandoz holding exclusive marketing rights in most markets except France, Australia, Vietnam, and Malaysia.
  • The biosimilar ranibizumab targets multiple retinal conditions including neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion-related macular edema.
  • A separate agreement grants Sandoz sole commercialization rights for the biosimilar in Canada, expanding the partnership's global reach for this VEGF-A inhibitor therapy.

WuXi Biologics Launches WuXia293Stable Platform to Address Manufacturing Challenges for Complex Biologics

Monoclonal Antibody
  • WuXi Biologics has launched WuXia293Stable, a new HEK293-based cell line platform designed to overcome manufacturing challenges for difficult-to-express biologics that struggle with traditional CHO cell systems.
  • The platform achieves fed-batch titers up to 5.0 g/L for monoclonal antibodies while eliminating truncation issues that compromise product quality in complex molecules.
  • WuXia293Stable enables scalable manufacturing at 2000L for fed-batch and 1000L for perfusion processes, maintaining stable expression during long-term cell passages.
  • The launch expands WuXi Biologics' WuXia platform family, which has generated over 1000 cell lines for clinical and commercial manufacturing as of 2024.

Faron Secures Extended Patent Protection for Bexmarilimab Cancer Immunotherapy Through 2040

Monoclonal Antibody
  • Faron Pharmaceuticals received US Patent No. 12,371,486 covering treatment of Clever-1 positive cancers with bexmarilimab, extending patent protection from 2037 to February 2040.
  • The new patent specifically covers treating cancers with Clever-1 positive cells in the tumor microenvironment, including acute myeloid leukemia and myelodysplastic syndrome.
  • Bexmarilimab is currently being investigated in Phase I/II clinical trials as an immunotherapy that reprograms macrophages to enhance immune response against tumors.
  • The extended patent life provides additional commercial protection for the investigational anti-Clever-1 antibody, which targets immunosuppressive pathways in cancer treatment.

Skye Bioscience Reports Promising Preclinical Data for Nimacimab as Obesity Treatment Ahead of Phase 2a Results

Monoclonal Antibody
  • Skye Bioscience's nimacimab demonstrated superior weight loss durability compared to incretin therapies in preclinical studies, with only 7.4% weight regain versus 29.7% for tirzepatide after treatment cessation.
  • Combination therapy of nimacimab with suboptimal tirzepatide doses achieved 44% vehicle-adjusted weight loss, outperforming optimal tirzepatide monotherapy at 38.9%.
  • The company expects top-line data from its CBeyond Phase 2a obesity trial in late Q3/early Q4 2025, with extension study enrollment already initiated to potentially provide 52-week efficacy data.
  • Nimacimab's peripherally-restricted CB1 mechanism offers potential advantages over GLP-1 therapies by avoiding gastrointestinal side effects while providing broader metabolic benefits.

Study to Evaluate the Effect on Obesity of Once Weekly Nimacimab Injection and Once Weekly Nimacimab Injection Co-administered With Semaglutide Injection Versus Placebo

NCT06577090Active, Not RecruitingPhase 2
Skye Bioscience, Inc.
Posted 8/22/2024

Almirall and Absci Expand AI Drug Discovery Partnership with Second Dermatology Target

AIDrug DiscoveryMonoclonal Antibody
  • Almirall and Absci have expanded their AI drug discovery collaboration to include a second dermatology target following successful delivery of AI-designed antibody leads against a difficult-to-drug target.
  • The collaboration combines Absci's Integrated Drug Creation™ platform with Almirall's dermatology expertise to develop novel therapeutics for chronic and debilitating skin diseases.
  • Under the expanded partnership terms, Absci is eligible to receive up to approximately $650 million in milestone payments across both programs, plus royalties on potential product sales.
  • The partnership demonstrates the potential of AI de novo drug design to unlock novel biology where traditional drug discovery approaches have previously failed.

Chai Discovery Raises $70M Series A to Revolutionize Antibody Design with AI Platform Achieving 20% Hit Rate

AIDrug DiscoveryMonoclonal Antibody
  • Chai Discovery secured $70 million in Series A funding led by Menlo Ventures, bringing total funding to $100 million to advance AI-driven drug discovery.
  • The company's breakthrough Chai-2 platform achieves a near-20% hit rate in fully de novo antibody design, dramatically outperforming traditional methods and previous computational approaches.
  • Former Pfizer Chief Scientific Officer Mikael Dolsten joins the board, bringing experience from advancing 150 molecules into clinical trials and delivering 36 approved medicines.
  • The AI platform can generate successful antibody binders from scratch using only target antigen and epitope information, potentially transforming therapeutic development timelines.

Novo Nordisk Advances Coramitug to Phase 3 for ATTR Cardiomyopathy Following Successful Phase 2 Trial

Monoclonal Antibody
  • Novo Nordisk announced plans to initiate Phase 3 trials for coramitug, a potential first-in-class amyloid depleter antibody for ATTR amyloidosis with cardiomyopathy, following successful completion of a Phase 2 study.
  • The Phase 2 trial evaluated once-monthly intravenous coramitug versus placebo in 105 patients with ATTR cardiomyopathy, measuring functional endpoints including six-minute walking test and NT-proBNP changes.
  • Prothena Corporation, the original developer of coramitug, stands to receive milestone payments from a deal worth up to $1.2 billion as Novo Nordisk advances the therapy through clinical development.
  • The advancement addresses significant unmet medical needs in ATTR cardiomyopathy patients who face high mortality risk and morbidity from amyloid deposition in vital organs.

Astria Therapeutics Secures $16 Million Japan Partnership for Hereditary Angioedema Treatment Navenibart

Monoclonal AntibodyRare Disease
  • Astria Therapeutics has granted exclusive development and commercialization rights for navenibart in Japan to Kaken Pharmaceutical in a deal worth up to $32 million.
  • Navenibart is a long-acting monoclonal antibody currently in Phase 3 trials designed for the preventative treatment of hereditary angioedema.
  • The partnership includes an upfront payment of $16 million, potential milestone payments of another $16 million, and tiered royalties up to 30 percent.
  • Kaken will support the ongoing ALPHA-ORBIT Phase 3 trial in Japan and manage regulatory submissions for commercialization.

FDA Approves Tocilizumab-anoh Biosimilar for Cytokine Release Syndrome Treatment

Monoclonal AntibodyDrug Approval
  • The FDA approved tocilizumab-anoh (Avtozma) IV formulation on August 6, 2025, for treating cytokine release syndrome in patients aged 2 years and older.
  • This approval achieves full indication alignment between the biosimilar and its reference drug tocilizumab (Actemra), expanding access to high-quality biologics.
  • Cytokine release syndrome is a potentially life-threatening condition causing widespread inflammation and organ damage through excessive cytokine release.
  • The IV formulation is expected to be available in the United States on August 31, 2025, following a patent settlement agreement with Genentech.

A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis

NCT05489224CompletedPhase 3
Celltrion
Posted 9/14/2022

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