Cstone Pharmaceuticals Co. Ltd.’s orally administered Tibsovo (ivosidenib tablets) received the green light from China’s NMPA for use in adult patients with relapsed/refractory acute myeloid leukemia (r/r AML) with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation. It is the first IDH1 inhibitor to reach market in China.
At the 2022 Conference on Retroviruses and Opportunistic Infections (CROI), investigators reported on a fourth patient who has achieved HIV remission after a stem cell transplant. The patient is the first woman and the first mixed-race person to achieve HIV remission through a transplant procedure. In 2017, she was transplanted with cord blood stem cells lacking a functional CCR5 receptor, which prevents HIV from entering cells.
Blue Note Therapeutics Inc. took a new approach to expanding its pipeline of prescription digital therapeutics (PDT) with an exclusive licensing agreement with the University of Sydney for Conquerfear, a metacognitive intervention that helps cancer survivors cope with the fear of disease recurrence. Blue Note has developed its PDTs internally to date but hopes to convert Conquerfear’s elements, which are typically delivered face-to-face, into a PDT for the U.S. and Canada. As a digital therapy, the program could potentially reach many more patients.
Cstone Pharmaceuticals Co. Ltd.’s orally administered Tibsovo (ivosidenib tablets) received the green light from China’s NMPA for use in adult patients with relapsed/refractory acute myeloid leukemia (r/r AML) with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation. It is the first IDH1 inhibitor to reach market in China.
Century Therapeutics Inc.’s $3.25 billion deal with Bristol Myers Squibb Co. (BMS) was the largest of four billion-dollar-plus agreements announced Dec. 10, piggybacking on a busy week that includes the start of the 40th annual J.P. Morgan Healthcare Conference.
LONDON – Natural killer (NK) cell therapy specialist Onk Therapeutics Ltd. has raised $21.5 million in a series A, enabling it to move three lead programs into proof-of-concept animal testing and to progress manufacturing and scale-up of its cord blood-derived cells.
Clonal hematopoiesis of indeterminate potential (CHIP) was associated with a 35% reduced risk of Alzheimer's disease (AD) in studies presented at the plenary session of the American Society of Hematology (ASH) annual meeting on Sunday.
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.
