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.
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.
Just weeks after two unexpected cases of blood cancer landed trials of its investigational gene therapies for sickle cell disease (SCD) and beta-thalassemia on FDA-issued clinical holds, Bluebird Bio Inc. said it's talking to regulators about their resumption after what RBC analyst Luca Issi called a "partial exoneration" of the BB-305 lentiviral vector shared between the medicines.
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.
Questions of durability came up regarding Curis Inc.’s latest data with CA-4948, but that didn’t stop shares from soaring to $6.55 by day’s end, an increase of $5.11, or 355%. The ride came after Lexington, Mass.-based Curis rolled out positive preliminary data from the firm’s ongoing open-label, single-arm phase I dose-escalation study with the compound.
DUBLIN – Priothera Ltd. closed a €30 million (US$35.4 million) series A round to shepherd an oral sphingosine 1 phosphate (S1P) receptor agonist through clinical development in patients with acute myeloid leukemia (AML) who are undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
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.
PERTH, Australia – Patients with relapsed or refractory acute myeloid leukemia (r/r AML) who have received three or more lines of therapy are often too sick to get much-needed bone marrow transplants and often run out of options.
PERTH, Australia – Patients with relapsed or refractory acute myeloid leukemia (r/r AML) who have received three or more lines of therapy are often too sick to get much-needed bone marrow transplants and often run out of options. Melbourne-based Race Oncology Ltd. hopes to change those outcomes with a new take on an old drug that slipped through the cracks in the 1980s.
