Despite missing a phase II study’s primary endpoint in moderate to severe asthma, Sanofi SA sees a way forward to a phase III program in the crowded disease space. Preliminary results showed the annualized exacerbation rate endpoint wasn’t met at the highest dosage of amlitelimab. Those numbers, at week 48, showed nominal significance at the medium dose.
In a roadmap to change animal testing requirements for INDs, the U.S. FDA said its new approach will improve drug safety, hasten the evaluation process, and lower costs for companies and patients. It’s another step in a process of changing rules put in place decades ago.
In a roadmap to change animal testing requirements for INDs, the U.S. FDA said its new approach will improve drug safety, hasten the evaluation process, and lower costs for companies and patients. It’s another step in a process of changing rules put in place decades ago.
Beigene Ltd. said it is shutting down development of its anti-TIGIT antibody, ociperlimab (BGB-A1217), after the humanized IgG1-variant monoclonal antibody failed a phase III trial in lung cancer. The move is one of many in a string of anti-TIGIT immunotherapy failures.
Beigene Ltd. said it is shutting down development of its anti-TIGIT antibody, ociperlimab (BGB-A1217), after the humanized IgG1-variant monoclonal antibody failed a phase III trial in lung cancer. The move is one of many in a string of anti-TIGIT immunotherapy failures.
Writing in Cell Reports, researchers from the National Institute of Allergy and Infectious Diseases (NIAID) and collaborators have presented a multifaceted analysis and structure-function study of a panel of human monoclonal antibodies (hmAbs) targeting AMA1 elicited by natural Plasmodium falciparum infection in a malaria-endemic region in Mali.
In a study published in Nature Neuroscience, researchers from Tiziana Life Sciences Ltd. and collaborators investigated the potential of nasal delivery of the CD3 foralumab to reduce neuroinflammation and enhance microglial phagocytosis in a traumatic brain injury (TBI) model.
Roivant Sciences Ltd. CEO Matt Cline said the firm’s unit Immunovant Inc. with FcRn blocker batoclimab has established “frankly a new bar” in myasthenia gravis (MG) as the New York-based firm reported top-line results from its phase III study and first data from period 1 of the phase IIb study with the same drug in chronic inflammatory demyelinating polyneuropathy. The data look promising, and Immunovant intends to use the findings to help advance second-generation FcRn prospect IMVT-1402 in both indications. Potentially registrational trials are planned. The U.S. FDA has granted IND clearance.
China’s National Medical Products Administration (NMPA) approved the country’s first injectable teprotumumab biosimilar from Innovent Biologics Inc. under the brand name of Sycume (teprotumumab N-01) to treat thyroid eye disease on March 14. The NMPA on March 15 accepted Simcere Pharmaceutical Group Ltd.’s NDA of deunoxavir marboxil (ADC-189) tablets, a product originally developed by Jiaxing Andicon Biotech Co. Ltd. to treat influenza A and B.
APG-777 is an anti-IL-13 humanized monoclonal antibody (mAb) designed to block Th2 inflammatory signaling mediated by the IL-13Rα1/IL-4Rα complex, while APG-990 is a fully human anti-OX40L mAb that that blocks type 1/2/3 inflammatory signaling. Apogee Therapeutics Inc. is studying the combination effects of APG-777 and APG-990 as potential therapy for atopic dermatitis (AD).
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