The U.S. FDA approved Takeda Pharmaceutical Co. Ltd.’s Fruzaqla (fruquintinib) nearly 20 days ahead of its Nov. 30 PDUFA date for adults with previously treated metastatic colorectal cancer. “Fruzaqla is the first targeted therapy approved in the U.S. for mCRC regardless of biomarker status or prior types of therapies in more than a decade,” Stefanie Granado, head of Takeda’s U.S. Oncology business unit, told BioWorld.
Israeli biotech Biolinerx Ltd. will hand off the rights to its stem cell mobilizer, motixafortide, in Asia to China’s Gloria Biosciences Co. Ltd. via an out-licensing deal worth up to $280 million, news that sent stocks soaring nearly 13% on Oct. 31.
Hitching onto the emerging drug class of degrader-antibody conjugates (DAC), U.S. pharma giant Bristol Myers Squibb Co. (BMS) is picking up rights to the U.S. and Korean biotech Orum Therapeutics Inc.’s blood cancer candidate, ORM-6151, in a potential $180 million deal.
Drawn to the potential for improved selectivity and safety profiles of PARP-1-specific inhibitors over their first-generation counterparts, Merck KGaA signed an exclusive, worldwide license deal with Jiangsu Hengrui Pharmaceuticals Co. Ltd. worth up to €1.4 billion (US$1.5 billion) to gain access to the latter’s next-generation poly (ADP-ribose) polymerase (PARP)-1 inhibitor, HRS-1167.
Patients living with aggressive nasopharyngeal carcinoma (NPC) now have a new treatment option with the U.S. FDA approval of Junshi Biosciences Co. Ltd./Coherus Biosciences Inc.’s PD-1 inhibitor antibody Loqtorzi (toripalimab), which will likely become the new standard of care for NPC.
Peel Therapeutics believes evolutionary biology holds the key to developing new therapeutics for cancer and inflammation, a relatively unique approach in the world of biotech, but one that is bearing fruit: Its lead molecule is derived from camptothecin, a compound originating from the Chinese Happy Tree that is thought to have evolved as a plant defense mechanism, and it has progressed to a phase I dose escalation study in patients with advanced solid tumors.
Oncolys Biopharma Inc.’s lead compound Telomelysin (suratadenoturev, OBP-301) met the primary endpoint of exceeding the predefined threshold of local complete response, confirming clinical benefit in a phase II study in locally advanced esophageal cancer combined with radiation.
With Deciphera Pharmaceuticals Inc.’s positive top-line data in hand from the pivotal phase III study called Motion, Wall Street speculation turned to the comparative safety and regulatory odds for vimseltinib (which analysts often refer to as “vim”) in patients with tenosynovial giant cell tumor (TGCT) not amenable to surgery.
Shanghai-based Henlius Biotech Inc. and India’s Intas Pharmaceuticals Ltd. agreed upon a potential €185 million (US$195.38 million) licensing deal for Intas to develop and sell Henlius’ China NMPA-approved lung cancer drug, serplulimab, across Europe and India. Serplulimab (HLX-02) is a recombinant humanized PD-1 monoclonal antibody (MAb) injection that first gained approval as Hansizhuang in March 2022.
This summer’s phase III news from Qilu Pharmaceutical Co. Ltd. with iruplinalkib – an oral inhibitor of ALK and ROS1 tyrosine kinase – reinforced an ongoing interest in the pair of oncology targets, where a handful of developers remain busy. Most notably of late is Nuvalent Inc., which rolled out stock-boosting data Oct. 4.
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