As the American Society of Clinical Oncology meeting nears, presenters are talking up their prospects, including Biomea Fusion Inc. with early data from experiments testing BMF-219, an oral, irreversible covalent menin inhibitor – one in an intriguing class that has sparked efforts by various developers.
Connect Biopharma Holdings Ltd. pointed to positive secondary endpoint data and a numerical trend on the primary endpoint in favor of its S1P receptor modulator, CBP-307, in ulcerative colitis, but those results weren’t enough to keep the stock (NASDAQ:CNTB) from falling by more than 57% to close at 82 cents, as investors focused on the primary endpoint miss and the company’s decision to partner the program going forward.
Beigene Ltd. reported that its global phase III trial of PD-1 inhibitor tislelizumab in combination with chemotherapy met the primary endpoint of overall survival in first-line advanced esophageal cancer.
Australia’s Therapeutic Goods Administration will begin conducting routine risk-based good clinical practices (GCP) inspections for clinical trials of drugs and biologics. The agency outlined in final guidance how it would prioritize inspections, what the process would look like and how it would report and follow up on inspections.
A handful of developers are advancing drug prospects in the localized scleroderma (LS) space, with candidate mechanisms that range from cell-based gene therapy to IL-4 or IL-6 antagonism to PDE4 blocking, and with efforts that involve approved as well as experimental compounds.
Arecor Therapeutics plc has presented early stage clinical data from a novel concentrated insulin formulation, which it hopes will outperform marketed rivals by allowing lower volume and reduced frequency doses. Cambridge, U.K.-based Arecor presented data at the International Advanced Technologies and Treatments for Diabetes meeting from AT-278, an investigational meal-time concentrated (500 U/mL) novel formulation of insulin.
New trial results presented by Shionogi & Co. Ltd. at the 32nd European Congress of Clinical Microbiology and Infectious Diseases showed the company’s 3CL protease inhibitor, S-217622, was well-tolerated, with the potential to rapidly clear SARS-CoV-2, Simon Portsmouth, executive medical director at Shionogi, told BioWorld.
Among the attention-getters at the American Association for Cancer Research meeting April 8-13 was protein-degradation specialist Kymera Therapeutics Inc., which made the preclinical case for its approach in murine double minute 2 (MDM2) research vs. an inhibitor. The MDM2 space has grown increasingly busy in recent years, with large and small biopharma concerns moving ahead with research in all phases of development.
Backed by fresh phase III data showing a combination of the IDH1 gene inhibitor Tibsovo (ivosidenib) and azacitidine significantly improved event-free survival and overall survival for adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) vs. azacitidine alone, Cstone Pharmaceuticals Co. Ltd. is working to bring the treatment to Chinese AML patients “as soon as possible,” a spokesperson told BioWorld.
Protagonist Therapeutics Inc. continues having a tough time. The latest is a steep stock drop after a phase II trial in ulcerative colitis (UC) missed its primary endpoint, but the company insists the data are good enough to move into phase III. Top-line data showed a 450-mg BID dose of PN-943 in treating moderate to severe UC missed its primary endpoint, which was the number of participants achieving clinical remission at week 12 compared to placebo.
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