Innate Pharma SA inked a licensing deal that grants Takeda Pharmaceutical Co Ltd exclusive worldwide rights to research and develop antibody-drug conjugates using a panel of selected Innate antibodies against an undisclosed target, with a primary focus in celiac disease.
The role of G protein-coupled receptor 35 (GPR35) in gastrointestinal (GI) diseases has been genetically validated for some time, with several pharmaceutical companies advancing programs designed to tackle the target; however, most of these efforts to date have focused on increasing GPR35 activity. ThirtyFiveBio’s approach is different: The newly founded virtual biotech company believes that antagonizing the target and thereby blocking unwanted GPR35 signaling may be a more appropriate way to address GI conditions, including digestive tract cancers.
89bio Inc.’s top-line phase IIb data from the 216-subject study called Enliven testing pegozafermin in nonalcoholic steatohepatitis (NASH) pushed shares (NASDAQ:ETNB) to a closing price March 22 of $13.68, up $2.75, or 25%. The drug, due next for phase III investigation, is a glycopegylated analogue of fibroblast growth factor 21.
Livzon Pharmaceutical Group Inc. licensed rights to zastaprazan, a gastroesophageal reflux disease (GERD) treatment candidate, from Onconic Therapeutics Inc. in a $127.5 million deal. Under the agreement, Livzon, which is based in Guangdong, China, obtains the exclusive rights to develop, license, manufacture and commercialize the candidate in greater China. In turn, Seoul, Korea-based Onconic will obtain a $15 million up-front payment, and up to $112.5 million in development, licensing and commercialization milestone payments.
Bridge Biotherapeutics Inc.’s small-molecule Pellino-1 inhibitor, BBT-401, failed to meet the primary efficacy endpoint in a phase II trial in ulcerative colitis (UC). The phase II mid-to-high dose cohort study included 38 patients with active UC enrolled at 37 clinical sites across the U.S., New Zealand, South Korea, Poland and Ukraine.
Carephar Pharmaceutical Co. Ltd. obtained marketing approval for keverprazan (KFP-H008) from China’s NMPA for use in duodenal ulcer and reflux esophagitis treatments, allowing it to tap an increasingly competitive market.
One of the most important transformations in the pharmaceutical industry over the next decade is the ability to modify genes or expression and go after any target, Cargene Biopharma Inc. CEO Kathy He told BioWorld, explaining that small molecules and large molecules can only go after 15% of the known targets. But the technology platform of short-interfering RNA (siRNA) opens a huge opportunity to make those inaccessible targets available, she said.
Hightide Therapeutics Inc. closed a $107 million series C round that will advance multiple global development programs for lead candidate HTD-1801, including a phase III trial in type 2 diabetes.
Phathom Pharmaceuticals Inc.’s shares sank 31% on news that the U.S. FDA will not take action on the company’s NDA for oral small-molecule potassium-competitive acid blocker vonoprazan by the Jan. 11 PDUFA date.
“Far superior to what almost anyone expected,” was how H.C. Wainwright analyst Ed Arce described the top-line readout for Madrigal Pharmaceuticals Inc.’s phase III study of resmetirom, which hit both of its dual endpoints in patients with nonalcoholic steatohepatitis (NASH) and is expected to form the basis of an accelerated approval application to the U.S. FDA in the first half of 2023.