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.
Top-line results of Daiichi Sankyo Co. Ltd.’s phase III Quantum-First study, testing the addition of quizartinib to chemotherapy vs. chemotherapy alone for adults with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML), found the combination therapy provided a “statistically significant and clinically meaningful improvement” in overall survival vs. standard treatment alone, meeting the trial’s primary endpoint, Ken Takeshita, global head of R&D at Daiichi Sankyo, told BioWorld.
DUBLIN – A meaty licensing deal with Regeneron Pharmaceuticals Inc. is as good a time as any to unveil a new corporate identity. Nykode Therapeutics AS, the Norwegian immunotherapy firm formerly known as Vaccibody, is banking $30 million up front, another $20 million as an equity investment, and could earn up to $875 million more in development and commercial milestones across a multiproduct deal to develop vaccines for cancer and infectious disease.
The first approval for treating advanced malignant perivascular epithelioid cell tumor (PEComa) in adults has been awarded by the FDA to Aadi Bioscience Inc.’s Fyarro. The number of patients is low, from 100 to 300 patients annually in the U.S., but the geography the company hopes to sell to is wide as it takes in Europe and China.
Immune system B cells secrete the neurotransmitter gamma amino-butyric acid (GABA), which promotes generation of anti-inflammatory macrophages and blunts the cytotoxic T cell-based response to tumors in mice.
Cytovia Therapeutics Inc. and Cellectis SA expanded their existing partnership to include new chimeric antigen receptor (CAR) target and development in China by Cytovia’s joint venture firm, Cytolynx Therapeutics Hong Kong Ltd.
Voronoi Inc. licensed global rights to its monopolar spindle1 (MPS1) inhibitor, VRN-08, and a second undisclosed asset to Pyramid Biosciences Inc. in a deal worth up $846 million that preserves Voronoi’s rights to both assets in South Korea.
Bristol Myers Squibb Co. has completed a $20 million equity investment in Compugen Ltd., part of an ongoing expansion a collaboration between the companies to combine their medicines for the potential benefit of patients with solid tumors.
New and updated preclinical and clinical data presented by biopharma firms at the Society for Immunotherapy of Cancer annual meeting, including: Harpoon, Highlight, Imcheck, Immunogenesis, Immutep, Intensity, Ionctura, Iovance, Instil, Kenjockety, Kymera, Mina, Moderna, Morphic, Nektar, Neoleukin, Nextcure, Nurix, Oncoresponse, Oncorus, Phio, Puretech, Replimune, Rubius, Scholar Rock, Second Genome, Sensei, Senti, Seven and Eight, Sotio, SQZ, Tempest, T-knife, Treadwell, Triumvira, Wugen, Xencor.
Ankyra Therapeutics Inc., a company developing new cytokine immunotherapies to boost localized antitumor immune responses, closed a $45 million series B financing. Proceeds from the round will be used to advance the Boston-based company's lead molecule, ANK-101, through IND-enabling studies and into phase I trials starting at the beginning of 2023, as well as to advance additional cytokine programs, it said.