BEIJING – Hong Kong-headquartered Hutchison China Meditech Ltd.’s (Chi-Med) called an early stop to its phase III pivotal study of surufatinib in advanced pancreatic neuroendocrine tumors (NET) in China after it met the predefined primary endpoint of progression-free survival.
Adagene Inc., an immuno-oncology company with operations in both the U.S. and China, has raised a $69 million series D financing to support its development of two monoclonal antibodies (MAbs) and extension of its technology-driven in-house antibody design platform. Its two lead candidates are a phase I MAb targeting CD137 and a preclinical MAb targeting CTLA4.
China-based Innovent Biologics Inc. will need to get on two new tasks this year: Preparing for the first clinical trial for an anti-TIGIT antibody in China and investigating the combination therapy of its Tyvyt (sintilimab) and Sirnaomics Inc.’s STP-705.
BEIJING – China-U.S. biotech Transcenta Holding Ltd., headquartered in Shanghai and Boston, completed a series B+ financing round to secure $100 million to continue its efforts in developing oncology and bone disorder drugs and to prepare for an IPO.
A mitochondrial glutamine transporter variant is a key regulator of glutamine metabolism and metabolic reprogramming in cancer cells, and targeting such transporters could be a new strategy for controlling tumor growth.
In a deal with just $50 million up front but the potential to reach $2.5 billion, Tokyo’s Taiho Pharmaceutical Co. Ltd. and Astex Pharmaceuticals Inc., of Cambridge, U.K., are joining Merck & Co. Inc. in an exclusive worldwide research collaboration and license agreement to develop small-molecule inhibitors against several cancer targets, including the KRAS oncogene.
BEIJING – Chinese regulators granted the marketing nod to Beijing-based Beigene Ltd.‘s PD-1 antibody, tislelizumab, for treating patients with classical Hodgkin lymphoma (cHL) who have received at least two prior therapies. To be sold under the Chinese trade name Baize’an, tislelizumab is Beigene’s first drug to win approval in China, following an FDA approval for its BTK inhibitor, Brukinsa (zanubrutinib), last month. “We are preparing the commercialization of tislelizumab, and we will start supplying the drug soon,” Beigene’s media relations officer, Min Xiao, told BioWorld Asia.
Astellas Pharma Inc.’s early 2018 buyout of Universal Cells Inc. (UC) may have laid the groundwork for longer-range steps in allogeneic CAR T-cell therapy, but Xyphos Biosciences Inc. CEO James Knighton told BioWorld Asia that the buyout of his firm provides the Tokyo-based giant for now with “an incredibly elegant solution that has tremendous potential.”
A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer.