Two days ahead of its Sept. 3 PDUFA date, Bristol Myers Squibb Co. received the FDA’s approval for Onureg, an oral form of azacitidine, for continuing treatment of adults with acute myeloid leukemia (AML). The indication is specifically for patients achieving first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy. BMS said Onureg is the first and only FDA-approved continued AML treatment for patients in complete remission.
DUBLIN – Shares in Polyphor AG gained as much as 12% during early trading Aug. 31 on news of a deal in China for its lead drug, balixafortide, which is currently undergoing a phase III trial in HER2-negative locally recurrent or metastatic breast cancer.
Triumvira Immunologics Inc., a U.S.-Canadian immuno-oncology startup, has raised $55 million in series A financing to back a pipeline of four new T-cell therapy candidates for the potential treatment of both liquid and solid tumors. Bayer AG's Leaps unit and Northpond Ventures led the round. China-based Oceanpine Capital and Viva Biotech Holdings also provided funds.
Vancouver, British Columbia-based Sierra Oncology Inc. during its recent earnings call offered an update on momelotinib, in phase III development for myelofibrosis. Enrollment in the study won’t be finished until the fourth quarter of 2021.
Kinnate Biopharma Inc., a San Diego-based company focused on the discovery and development of small-molecule kinase inhibitors for genomically defined cancers, has raised $98 million in a series C financing.
A phase III study evaluating a combination of a Novartis AG anti-PD-1 candidate with the well-established BRAF/MEK inhibitor combo in first-line unresectable or metastatic BRAF V600 mutant melanoma missed its primary endpoint of progression-free survival.
Onconova Therapeutics Inc.’s lead candidate in myelodysplastic syndromes took a major hit Monday as the small molecule I.V. rigosertib failed to meet the primary endpoint of significantly improved survival vs. best supportive care in higher-risk patients.
Adverse events (AEs) took the shine off Odonate Therapeutics Inc.’s long-awaited top-line data from the phase III trial called Contessa testing the oral taxane chemotherapy tesetaxel in metastatic breast cancer (MBC), and shares of the San Diego-based firm (NASDAQ:ODT) closed at $18.33, down $15.21, or 45%.
Stimulator of interferon genes (STING) is a protein that senses DNA in the cytosol, where it comes from either an infectious invader or a damaged nucleus and sets off an immune response that ultimately results in the activation of T cells. STING agonists are among the strategies that have been tested in hopes they would increase the response rate to checkpoint blockade. Now, back-to-back papers in the Aug. 21, 2020, issue of Science have detailed the preclinical development of orally available STING agonists.
Innovent Biologics Inc., of Suzhou, has out-licensed ex-China rights for its PD-1 drug Tyvyt (sintilimab) to Eli Lilly and Co. in an expanded license deal. The Chinese firm will receive $200 million upfront in the deal, the value of which could approach up to $1.03 billion.
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