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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

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.

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.

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.

Inmagene Initiates Phase 2b Trial of IMG-007 Anti-OX40 Antibody for Moderate-to-Severe Atopic Dermatitis

Monoclonal Antibody
  • Inmagene Biopharmaceuticals has dosed the first patient in its ADAPTIVE Phase 2b trial evaluating IMG-007, a non-depleting anti-OX40 monoclonal antibody, for moderate-to-severe atopic dermatitis treatment.
  • The randomized, placebo-controlled trial will enroll approximately 220 patients across four treatment arms to evaluate multiple subcutaneous dose regimens over 52 weeks total.
  • IMG-007 features an extended half-life of 34.7 days and silenced antibody-dependent cell-mediated cytotoxicity function, potentially minimizing safety risks while enabling convenient dosing.
  • Topline results from the dose-finding study are expected in Q4 2026 and will guide optimal dosing regimens for future Phase 3 clinical trials.

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 Bioeq AG Partner to Bring Ranibizumab Biosimilar to Sub-Saharan Africa

Monoclonal Antibody
  • Bio Usawa Biotechnology and Bioeq AG announced a partnership to commercialize ranibizumab biosimilar BioUcenta™ across Sub-Saharan Africa, targeting diabetic macular edema and wet age-related macular degeneration.
  • The collaboration addresses a critical healthcare gap as more than 24 million Africans lived with diabetes in 2024, with diabetic retinopathy threatening sight in up to one-third of patients.
  • BioUcenta™, already approved in Europe and the United States, will be administered via intravitreal injection to block abnormal blood vessel growth and prevent fluid leakage in the retina.
  • This partnership represents a new model for global health equity, demonstrating how strategic collaborations can extend life-saving medical advances to underserved populations facing preventable blindness.

Oncternal Therapeutics Sells ROR1-Targeting Programs to Ho'ola Therapeutics for $68 Million Deal

Monoclonal AntibodyCAR-T
  • Oncternal Therapeutics has sold its zilovertamab monoclonal antibody and ONCT-808 CAR-T cell therapy programs to Ho'ola Therapeutics for $3 million upfront and up to $65 million in milestone payments.
  • Both investigational therapies target ROR1 (Receptor Tyrosine Kinase-Like Orphan Receptor 1), with zilovertamab being a monoclonal antibody and ONCT-808 an autologous CAR-T therapy using zilovertamab's binding domain.
  • Following the asset sale completed on June 27, 2025, Oncternal has appointed Craig R. Jalbert to oversee the company's wind-down operations and future distribution of milestone payments.
  • The milestone structure includes up to $5 million for development achievements, $40 million for regulatory approvals, and $20 million for sales thresholds across major markets including the US, Europe, and Japan.

Amgen's Bemarituzumab Shows Significant Survival Benefit in Phase 3 Gastric Cancer Trial

Monoclonal AntibodyTargeted TherapyOncology
  • Amgen's Phase 3 FORTITUDE-101 trial met its primary endpoint, demonstrating that bemarituzumab plus chemotherapy significantly improved overall survival compared to chemotherapy alone in patients with FGFR2b-positive gastric cancer.
  • The study enrolled 547 patients across 300 sites in 37 countries, targeting those with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer who were non-HER2 positive.
  • Bemarituzumab represents the first positive Phase 3 results for an FGFR2b-targeted monoclonal antibody in gastric cancer, addressing a critical unmet need in a disease that causes over 650,000 deaths globally each year.
  • While the treatment showed efficacy, ocular adverse events occurred with greater frequency and severity in the bemarituzumab arm compared to the Phase 2 experience.

Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

NCT05052801Active, Not RecruitingPhase 3
Amgen
Posted 3/7/2022

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.

NCT05111626Active, Not RecruitingPhase 3
Amgen
Posted 3/14/2022

WuXi Biologics Launches WuXiHigh²2.0 Platform Achieving Record 230 mg/mL Protein Concentrations

Monoclonal Antibody
  • WuXi Biologics has launched WuXiHigh²2.0, a high-throughput formulation development platform that enables protein concentrations up to 230 mg/mL, surpassing the current FDA-approved maximum of 200 mg/mL.
  • The platform reduces viscosity by up to 90% while maintaining formulation stability through proprietary excipient blends and high-throughput prediction instruments.
  • High-concentration biologics offer significant advantages including reduced injection volumes, improved dosing efficiency, and enhanced patient adherence, with over 20% of FDA-approved monoclonal antibodies now using high-concentration formulations.
  • The technology addresses key manufacturing challenges of high viscosity and aggregation that typically complicate production and compromise product stability in high-concentration biologics.

Faron Research Reveals Novel Immune Evasion Mechanism, Validates Bexmarilimab's Therapeutic Approach

Monoclonal Antibody
  • Faron-supported research published in Theranostics identified secreted Clever-1 (sClever-1) as a key immunosuppressive mediator that impairs T-cell responses and contributes to anti-PD-1 therapy resistance in cancer patients.
  • The study analyzed plasma samples from 139 breast cancer patients and 193 bexmarilimab-treated participants, demonstrating that sClever-1 levels were significantly elevated in cancer patients compared to healthy individuals.
  • Bexmarilimab treatment significantly reduced circulating sClever-1 levels in patients, correlating with decreased T-cell engagement and providing mechanistic validation for the drug's immune-activating properties.
  • High sClever-1 levels were associated with resistance to anti-PD-1 checkpoint inhibitors, suggesting potential utility as a biomarker for guiding immunotherapy treatment strategies.
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