On December 18, 2023, Kronos Bio, Inc. (the "Company") reported an update on its pipeline (Press release, Kronos Bio, DEC 18, 2023, View Source [SID1234638681]). After a review of data from the phase 1b portion of its phase 1b/2 trial of lanraplenib, a SYK inhibitor, in combination with gilteritinib in FLT3-mutated relapsed/refractory acute myeloid leukemia, the Company has decided not to proceed to phase 2. This decision was based on a review of the data from 24 patients across the four dose cohorts (20 – 90 mg lanraplenib in combination with 120 mg gilteritinib). While there were blast reductions in some patients, no complete response (CR) or CR with partial hematologic recovery (CRh) was observed, with a number of patients discontinuing early in treatment. Patients in the study were older, more heavily pre-treated and frailer than the relapsed/refractory patients in earlier studies. Many patients experienced non-drug related infectious disease complications leading to discontinuation during the first two months of treatment without achieving the count recovery needed to achieve a CR or CRh. The Company believes there could be utility for lanraplenib in other indications and is open to further development of lanraplenib with a partner.
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The Company also announced the designation a new development candidate, KB-9558, which targets the lysine acetyltransferase (KAT) domain of p300, a critical node of the IRF4 transcription regulatory network (TRN). IRF4 is a key driver in multiple myeloma. KB-9558 is the second molecule to emerge from the Company’s proprietary product engine, and is currently in IND-enabling studies, which are expected to be completed in the fourth quarter of 2024.
The Company’s first internally discovered molecule, KB-0742, an inhibitor of CDK9, has demonstrated on-mechanism, single agent anti-tumor activity and a manageable safety profile in pre-treated patients with transcriptionally addicted solid tumors. KB-0742 recently cleared the 80 mg dose in the dose escalation portion of the ongoing phase 1/2 trial. Patients currently in the two expansion cohorts will now be able to receive the 80 mg dose. The Company expects to provide data from the expansion phase of the trial in mid-2024.