Another drug from the emerging menin inhibitor drug class has hit safety issues, after the FDA put an early stage acute myeloid leukemia trial of Kura Oncology Inc.’s KO-539 on partial clinical hold because of a patient death. The news from Kura follows safety issues that emerged from Syndax Pharmaceuticals Inc.’s rival SNDX-5613, where an issue with QT prolongation emerged in at least 5% of patients in otherwise encouraging phase I/II trial results announced in April.
Aptose Biosciences Inc. has bought over the worldwide rights to Hanmi Pharmaceutical Co. Ltd.’s myeloid kinome inhibitor in a deal worth up to $420 million. Seoul, South Korea-based Hanmi has granted Aptose exclusive worldwide rights to HM-43239 for all indications. The candidate was developed for relapsed or refractory acute myeloid leukemia.
A phase III trial of Rafael Pharmaceuticals Inc.’s devimistat in pancreatic cancer has failed, sending shares in its publicly listed holding company through the floor. Shares in Rafael Holdings (NYSE:RFL) closed Oct. 28 down 73% to $8.09, for a loss of $22.08 after an independent data monitoring committee also recommended a separate phase III trial of devimistat in acute myeloid leukemia should be stopped due to lack of efficacy.
While Aprea Therapeutics Inc.’s data disclosed July 21 from the phase II trial with eprenetapopt – also known as APR-246, a reactivator of mutant tumor suppressor protein p53 – plus azacitidine (AZA) whetted interest in taking aim at the “guardian of the genome,” the company’s fortune took an unexpected turn when the FDA smacked a partial clinical hold on work with the duo.
Advaxis Inc.’s long journey is ending happily by way of a merger with Biosight Ltd. that leaves the new firm with $50 million to help advance aspacytarabine (BST-236), a prodrug of cytarabine for acute myeloid leukemia and myelodysplastic syndromes.
San Diego-based Biotheryx Inc. has raised $92 million in series E financing led by Farallon Capital Management to advance multiple molecular glues, proteolysis-targeting chimeras and monovalent degraders toward the clinic. Its first molecular glue program, BTX-1188, is expected to enter the clinic by the end of this year.
Charlene Liao, Immune-Onc Therapeutics Inc.’s CEO told BioWorld she has a solid plan for using the company’s new $73 million series B1 and B2 financing. “It is time to go beyond T cells and to consider myeloid checkpoints as the next wave of cancer immunotherapies,” she said. Immune-Onc will use the funding to target myeloid checkpoints, especially leukocyte immunoglobulin-like receptor subfamily B, as it continues to develop its blood cancer and solid tumor therapies.
As developers continue their race in the anti-CD47 space, Gilead Sciences Inc. remains high profile with magrolimab, which has reached phase III development for myelodysplastic syndromes. Meanwhile, Alx Oncology Inc., of Burlingame, Calif., is emerging with potentially the first drug targeting the CD47-SIRPa axis to treat solid tumors as well as hematologic malignancies.
HONG KONG – Tapping into synergies it sees between the U.S. and Chinese biotech industries, Suzhou, China-based Ascentage Pharma Group International is aiming to get its most advanced candidate, HQP-1351, to market this year.