A real-world study found evolocumab cut fatal or nonfatal heart attack risk 20% vs ezetimibe in adults with ASCVD and prior statin use.
|Podcasts|January 28, 2021
Ready for the future – Trends in Bioprocessing
Author(s)Eppendorf
As the industry shifts its focus from blockbuster drugs to niche drugs for targeted patient populations, the market for biologics is evolving. Batch sizes are decreasing and the global footprint is expanding, leading to a greater need for efficiency in development and manufacturing, in order to make drugs more quickly and at a lower cost. Relying on slow R&D processes in this fast-changing environment will prevent you from not only increasing your speed to market but also standing out among your competitors. By adapting to today’s demands using smart bioprocessing, you can help drive efficiency in your laboratory and contribute to the economical and reliable production of next-generation molecules.
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FDA grants accelerated approval to Johnson & Johnson’s subcutaneous EGFR/MET bispecific Rybrevant Faspro for previously treated head and neck squamous cell carcinoma, T-Therapeutics raises a $133 million Series B to take TCR-CD3 bispecifics into clinical trials, and Alethio Therapeutics raises a $90 million Series A to advance its first-in-class G6B antibody for essential thrombocythemia.
Johnson & Johnson's amivantamab (Rybrevant Faspro) won accelerated FDA approval for pretreated recurrent head and neck cancer.
Oxford spinout Alethio Therapeutics closed a $90 million Series A to take ATX-011, a monoclonal antibody against the G6B receptor, into Phase 1/2a studies in essential thrombocythemia. It is also developing a G6B-targeted ADC for myelofibrosis.
T-Therapeutics closed an oversubscribed $133 million Series B backed by Eli Lilly, JJDC, and others. The funding will take its first T-cell receptor bispecifics in cancer and autoimmune disease into clinical trials.
China’s NMPA grants priority review to Akeso’s PD-1/VEGF bispecific ivonescimab with chemotherapy for first-line biliary tract cancer, VeonGen Therapeutics aligns with FDA on a phase 3 design for its dual-AAV Stargardt gene therapy VG801, and Caldera Therapeutics’ IL-23p19×TL1A bispecific CLD-423 shows a half-life of more than 40 days in a phase 1a trial.
FDA’s draft framework would let sponsors add patient-specific genome editing variants to an approved BLA using in vitro data. Here is what the guidance proposes, what evidence it asks for, and what remains unresolved.
Healthy-volunteer data show sustained TL1A suppression and a profile supporting infrequent subcutaneous dosing. Caldera also licensed a second bispecific, targeting IL-17 and TL1A, from Qyuns Therapeutics.
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