Kronos Bio to Present Clinical Update on Phase 1/2 Trial of KB-0742 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

— KB-0742 continues to demonstrate a manageable safety and tolerability profile with no grade 3/4 neutropenia observed —

— KB-0742 continues to show dose linear pharmacokinetics up to 80mg three-days-on, four-days-off dose, including increased target engagement at the 80mg vs. 60mg doses —

— The escalation cohort at 80mg four-days-on, three-days-off is currently enrolling, and the expansion cohort at this dose is expected to begin enrollment in the third quarter of 2024 —

SAN MATEO, Calif. and CAMBRIDGE, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to developing small molecule therapeutics that address cancers and other diseases driven by deregulated transcription, today announced the presentation of new data from its ongoing Phase 1/2 study, KB-0742-1001, a first-in-human, open-label dose escalation and cohort expansion study of KB-0742 in patients with relapsed or refractory solid tumors or non-Hodgkin lymphoma, in a poster session at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting being held from May 31 – June 4, 2024 in Chicago, Illinois and online.

“We are pleased that KB-0742 continues to demonstrate a manageable safety and tolerability profile as it progresses through dose escalation,” said Norbert Bischofberger, Ph.D., president and chief executive officer, Kronos Bio, Inc. “These data indicate a deepening reduction of CDK9-sensitive transcripts at the 80mg dose as compared to the 60mg dose. In addition, MYC reductions were observed in paired biopsy tumor tissues. This data provides us with confidence that the 80mg four-days-on, three-days-off dose and schedule will show increased patient benefit. We are currently enrolling the dose escalation arm at the 80mg four-days-on, three-days-off schedule and look forward to opening the expansion cohort in the third quarter of this year.”

The poster features:

• Data from 103 patients with transcription factor (TF) fusion or MYC driven tumors treated with KB-0742 at 60mg (n=82) and 80 mg (n=21) three-days-on/four-days-off in escalation and expansion cohorts.
• Patients enrolled in the study had received a median of three prior treatments (range: 0-9).
• The most frequently reported treatment-emergent adverse events (AE) were manageable mild to moderate nausea (69.9%) and vomiting (52.4%).
• Notably, no grade 3/4 neutropenia was observed.
• Patients remained on treatment for an average of >2 cycles and a maximum of 14 completed cycles.
• Less than 10% of patients discontinued treatment due to adverse events.
• Two case studies, a platinum-resistant ovarian cancer (OC) patient, and a non-small-cell-lung cancer (NSCLC) patient with five prior lines of therapy will be presented. These patients exhibited anti-tumor activity including stable disease responses of 71 days for the NSCLC patient and greater than 195 days for the OC patient, who continues on therapy.
• Pharmacokinetic modeling indicates that the 80mg four-days on three-days off dose schedule results in a greater than ten-fold increase in time above a preclinically determined efficacy threshold compared to the 60mg three-days-on four-days-off dose schedule.

Based on the promising initial data presented at ASCO and the pharmacokinetic modeling the Company expects to see increased efficacy in the 80mg four-day-on, three-day-off expansion cohort which is expected to begin enrolling in the third quarter of 2024.