Suzhou, China-based Cstone Pharmaceuticals Co. Ltd. has begun trading again on the Hong Kong exchange (HKEX:02616) after trading was halted on April 1 following investigations over questionable investments during the company’s year-end audit for 2021.
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.
After rolling out positive, preliminary phase I CAR natural killer cell data, Nkarta Inc. saw its stock (NASDAQ:NKTX) soar to $18.72, up $10.95, or 140.9%, as Wall Street made known its pleasure in results from the small, independent dose-finding studies with Nkarta’s two off-the-shelf lead candidates, NKX-101 and NKX-019, in two groups of blood cancer patients: those with relapsed/refractory (r/r) acute myeloid leukemia (AML) and with r/r non-Hodgkin lymphoma (NHL), respectively.
A patient’s death has prompted the FDA to place a partial clinical hold on Curis Inc.’s phase I/IIa study of emavusertib in leukemia. The patient, who had relapsed or refractory acute myeloid leukemia, experienced several conditions. One of them was rhabdomyolysis, a dose-limiting toxicity of emavusertib. Rhabdomyolysis is a breakdown of muscle fibers in the blood.
Marker Therapeutics Inc.’s update from the safety lead-in stage of its phase II study of MT-401 in treating post-transplant acute myeloid leukemia saw response in one of the six participants. The results from the study of the multitumor-associated antigen-specific T-cell product also known as zelenoleucel saw firms such as Oppenheimer cut its target price for Marker to $5 from $8 and Piper Sandler to cut its target price from $5.50 to $4.
Before taking on the role of CEO at Bluesphere Bio Inc., David Apelian would have said the most exciting work he’d done in immuno-oncology had been at Globeimmune Inc., where he’d served as chief medical officer for more than a decade, working in the field of cancer immunotherapy “back when no one believed the immune system would be something we could leverage against cancer.”
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.
