Today we are excited to announce that the results of its Phase 1 dose escalation safety and tolerability study for zelenirstat, an investigational NMT inhibitor and our lead product candidate, in refractory/ relapsed colorectal and other cancers, will be presented January 20, 2024, at the upcoming ASCO Gastrointestinal Cancers Symposium.
The Phase 1 dose escalation safety and tolerability study was conducted in 29 heavily pre-treated solid tumor and lymphoma patients who averaged 4 prior lines of therapy on which they relapsed or were refractory (R/R). Eight colorectal, two pancreatic, and one appendiceal cancer patients were among those included in the study. The most common treatment related adverse events identified in the trial were mild to moderate gastrointestinal side effects which were self-limiting and occurred in a minority of patients. A recommended Phase 2 dose (RP2D) for expansion studies was established. Zelenirstat prolonged progression free and overall survival in Phase 1 solid tumor patients receiving the RP2D. Prolonged Stable Disease was observed in patients with colorectal (320 + days on treatment and continuing with non-RECIST criteria reductions of approximately 50% in CEA (carcinoembryonic antigen) and tumor volumes) and appendiceal (160+ days on treatment and continuing with stable disease) cancer treated with the RP2D. The Company has initiated dosing in a Phase 2a expansion study of patients with B-cell non-Hodgkin lymphoma.
A poster describing the Company’s Phase 1 study safety results and efficacy signals, particularly in gastrointestinal cancer patients, will be presented at the ASCO Gastrointestinal Cancers Symposium on January 18-20, 2024, in San Francisco, CA. Our CEO, Dr. Michael Weickert, will be available during the poster session and for one-on-one meetings. The details of the poster and the full press release are found here.