Essential Pharma Ltd. is paying up to £70 million (US$88.7 million) to acquire Renaissance Pharma Ltd., taking ownership of Hu14.18, a treatment for high-risk neuroblastoma. The antibody has completed a 64-patient phase II trial conducted by St Jude’s Children’s Research Hospital, in which it showed an improvement in overall survival of around 50% compared to currently available therapies.
Alzheimer’s disease (AD) is recognized worldwide for its debilitating symptoms of declining cognitive function and gradual memory loss. What remains less clear is exactly what causes the neurodegenerative disease, and how to treat it. “Alzheimer’s disease is characterized by two key pathologies – beta-amyloid plaques and tau neurofibrillary tangles.” Seung-Yong Yoon, CEO of Adel Inc., told BioWorld. “Adel is looking to develop a tau-targeting drug, considering tau has been more correlated with AD symptom progression, and the industry’s need for tau pipelines.”
Japan’s Ministry of Health, Labor and Welfare approved Astellas Pharma Inc.’s Vyloy (zolbetuximab) to treat a type of advanced gastric cancer on March 26, making it the first anti-claudin 18.2 monoclonal antibody to gain regulatory clearance worldwide.
Xilio Therapeutics Inc. retreated with its lead oncology IL-2 drug, XTX-202, after phase II data indicated stable disease was the best response, prompting the company to reprioritize its pipeline and cut its workforce by 21% – but investors focused more on a $647.5 million IL-12 program deal the company signed with Gilead Sciences Inc., as well as an $11.3 million private placement financing.
An increasingly popular target across varied cancer types is the immune system regulator V-domain Ig suppressor of T-cell activation (VISTA), where a number of developers have taken early stage aim – among them Sensei Biotherapeutics Inc., with SNS-101, which Wainwright analyst Edward White believes could be the first anti-VISTA monoclonal antibody approved as a therapeutic agent. But there’s plenty of work ahead.
Japan’s Ministry of Health, Labor and Welfare approved Astellas Pharma Inc.’s Vyloy (zolbetuximab) to treat a type of advanced gastric cancer on March 26, making it the first anti-claudin 18.2 monoclonal antibody to gain regulatory clearance worldwide.
The U.S. FDA granted emergency use authorization (EUA) on March 22 for Waltham, Mass.-based Invivyd Inc.’s half-life extended monoclonal antibody (MAb) VYD-222 – making it available to prevent COVID-19 in immunocompromised adults and adolescents – but its use comes with a boxed warning for anaphylaxis.
Shanghai Henlius Biotech Inc.’s IND application for HLX-6018, a novel anti-glycoprotein-A repetitions predominant (GARP)/transforming growth factor-β1 (TGF-β1) monoclonal antibody (mAb), has received approval by China’s National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF).
South Korean biopharmaceutical company Celltrion Inc. submitted a BLA to the U.S. FDA on March 10 to gain approval for its Xolair (omalizumab; Novartis AG) biosimilar, CT-P39, across major indications of asthma, food allergy and chronic spontaneous urticaria.
Reflecting the evolving scientific understanding of Alzheimer’s disease, the U.S. FDA revised its 2018 draft guidance on developing drugs to treat early Alzheimer’s.
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