On May 24, 2024 Pacylex Pharmaceuticals Inc. (Pacylex) is a clinical-stage pharmaceutical company developing N-myristoyltransferase (NMT) inhibitors as targeted therapies for the treatment of hematologic cancers and solid tumors, reported that complete Phase 1 clinical study results for zelenirstat, a proprietary, potent, NMTi, will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 31 to June 4, 2024, at McCormick Place in Chicago, Illinois (Press release, Pacylex Pharmaceuticals, MAY 24, 2024, View Source [SID1234645048]).
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The Phase 1 dose escalation safety and tolerability study was conducted in 29 patients with refractory/relapsed (r/r) lymphoma and refractory solid tumors who averaged 4 lines of prior therapy. Zelenirstat, administered as a once daily oral medication, was well-tolerated in Phase 1 patients up to the recommended Phase 2 dose (RP2D) with no dose limiting toxicities observed in 6 dose levels. The most common treatment related adverse events were mild to moderate gastrointestinal side effects which were self-limiting and occurred in a minority of patients.
The 7 patients receiving the recommended Phase 2 dose had significantly better progression free and overall survival than the 17 treated at lower doses; 57% had stable disease or better for six months or longer, despite having 5 different types of cancer. Prolonged Stable Disease was observed in a person with colorectal cancer that had only short-term benefit from any of the 6 prior lines of therapy; this participant continues to receive the RP2D more than a year after starting therapy and had reductions of approximately 50% in CEA (carcinoembryonic antigen) and tumor volumes.
Zelenirstat appears to work in different cancers by inhibiting the myristoylation required for assembly, translocation, and/or function of validated targets like B-cell receptor, EGFR, and VEGFR. Zelenirstat also blocks Complex I formation in mitochondria of cancer cells which shuts down oxidative phosphorylation, especially critical for metastasis and cancer stem cells.
A poster will present the complete safety results and efficacy signals from the Company’s Phase 1 study of zelenirstat, as well as evidence for mechanisms of action relevant to anticancer activity in different cancer types. The Company’s CMO, Dr. John Mackey, and CEO, Dr. Michael Weickert, will be available during the poster session and for one-on-one meetings.