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Oblenio Bio has dosed the first patients in a phase 1a trial of tri-specific T-cell engager LBL-051 for refractory autoimmune disease.

New clinical updates this week highlight progress across rare disease gene therapy, food allergy immunotherapy, and immuno-oncology, with developers advancing treatments for high unmet need through regulatory milestones and early clinical development.

In an interview with BioPharm International, Stephanie Fradette, head of Biogen’s Rare Neurology Development Unit, discussed FDA Breakthrough Therapy designation for salanersen and early Phase 1b data evaluating the therapy in individuals with spinal muscular atrophy who had suboptimal responses following gene therapy.

Laurent Levy, founder and CEO of Nanobiotix, discusses why physics-based therapeutics could complement traditional biology-driven drug development and explains how the company's NanoPrimer platform is designed to improve delivery of complex medicines.

Rocket Pharmaceuticals has reported a positive safety update for RP-A501 from the first 3 patients treated under a modified phase 2 protocol in Danon disease.

FDA has granted fast track designation to Aravax's PVX108, a peptide immunotherapy for peanut allergy, ahead of phase 2 data.

Opus Genetics has enrolled the last patient in its registrational Phase 3 trial of OPGx-LCA5, an AAV8 gene therapy for LCA5-associated inherited retinal disease, keeping the program on track for a potential first-in-disease approval.

China's NMPA has approved an IND for a Phase Ib/II trial combining Leads Biolabs' PD-L1/4-1BB bispecific antibody opamtistomig with standard regimens in metastatic colorectal cancer, extending the drug's reach into one of oncology's most immunotherapy-resistant tumor types.

Precision analytics and flexible manufacturing are helping to advance safer, scalable bispecific antibodies, antibody-drug conjugates, and central nervous system monoclonal antibodies from development to patients.

Planning the analytical strategy for product release should be started as early as possible to ensure product quality and regulatory success.

Novo Nordisk's ziltivekimab failed to reduce cardiovascular events in the phase 3 ZEUS trial despite confirmed IL-6 target engagement.

The EC has approved AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan ADC for 1st-line metastatic TNBC, which showed a 5.0-month overall survival benefit over chemotherapy.

Polpharma Biologics and Fresenius Kabi announced that the FDA and EMA have accepted for review PB016, a proposed biosimilar to Takeda's Entyvio (vedolizumab), with Fresenius Kabi holding exclusive global commercialization rights outside the Middle East and North Africa.