In an exclusive licensing agreement, Astrazeneca plc will get the global rights to research, develop and commercialize protein stimulator of interferon genes, STING inhibitor compounds, from F-star Therapeutics Inc. Astrazeneca is responsible for currently preclinical STING inhibitor compounds from F-star, which retains rights to all its STING agonists in clinical development for treating cancer.
Following battles over its price and accelerated approval, Biogen Inc. and Eisai Co. Ltd.’s Aduhelm (aducanumab) now has newly approved prescribing information from the FDA that limits the patient population and sales along with it. The updated Indications and usage now reads that the anti-amyloid beta monoclonal antibody should be used only in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. That’s the patient population in which treatment was initiated in clinical trials that led to approval. The company said the new wording “clarifies the indication.” The original FDA-approved language cleared the drug for much broader use in Alzheimer’s.
A collaboration between Oncosec Medical Inc. and Merck and Co. that yielded positive phase II study data has paved the way for a phase III study between the two companies. Oncosec’s DNA-plasmid interleukin-12 (IL-12) Tavo (tavokinogene telseplasmid) will be combined with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) in a randomized, global phase III study for treating late-stage metastatic melanoma.
Arrivent Biopharma Inc. has raised a series A financing worth up to $150 million to in-license compounds from China and bring them to the rest of the world. Arrivent’s focus is in oncology and its first in-licensed asset is furmonertinib, a third-generation EFGR tyrosine kinase inhibitor from Shanghai-based Allist Pharmaceuticals Co. Ltd.
Despite an FDA advisory committee’s narrow ruling that Provention Bio Inc.’s teplizumab has benefits that outweigh the risks in treating diabetes, the agency sent the company a complete response letter (CRL) regarding the diabetes therapy’s priority BLA. The CRL came the evening of July 2, Provention said, the PDUFA date that had been set months before.
Arrowhead Pharmaceuticals Inc. said it voluntarily paused a phase I/II study of its RNAi candidate for treating cystic fibrosis (CF) out of an “abundance of caution” while considering its next steps. “This may delay our pulmonary program a bit, but it’s just part of drug development,” said Christopher Anzalone, Arrowhead’s CEO. The halt was prompted by signals of local lung inflammation found in an ongoing chronic toxicology study in rats.
New top-line data from Kintara Therapeutics Inc.’s phase II study of its lead candidate, VAL-083, in recurrent glioblastoma multiforme were incrementally better than data released in April, and that’s just fine with CEO Saiid Zarrabian. “Normally, in my experience, top-line data usually regresses a little,” Zarrabian told BioWorld. “The fact that it improved could be a reflection of the small size of the study, but it adds a little more interest to top-line data.”
Arrivent Biopharma Inc. has raised a series A financing worth up to $150 million to in-license compounds from China and bring them to the rest of the world. Arrivent’s focus is in oncology and its first in-licensed asset is furmonertinib, a third-generation EFGR tyrosine kinase inhibitor from Shanghai-based Allist Pharmaceuticals Co. Ltd.
A not-unexpected complete response letter (CRL) for Nexobrid, being developed by Mediwound Ltd., delayed the therapy’s approval and knocked the company’s share values backward. Nexobrid, proteolytic enzymes enriched in bromelain for treating for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns, had a June 29 PDUFA date.
A new study from researchers at the Washington University School of Medicine In St. Louis demonstrated evidence of a long-lasting immune response, possibly one that could last for years, from receiving Pfizer Inc.’s mRNA COVID-19 vaccine.
