NEW YORK – MOMA Therapeutics on Monday said it has treated the first patient with advanced homologous recombination (HR)-deficient cancer with its polymerase theta helicase inhibitor MOMA-313 in a Phase I trial.
Cambridge, Massachusetts-based MOMA, which stands for "molecular machines," is initially studying MOMA-313 in combination with a PARP inhibitor based on preclinical studies suggesting that the combination has better efficacy in solid tumors compared to single-agent PARP inhibitors.
In the trial, MOMA researchers are enrolling about 158 patients in two treatment arms and are assessing the safety and tolerability of MOMA-313 alone and in combination with AstraZeneca's PARP inhibitor Lynparza (olaparib) as the primary endpoint. They will also determine a recommended Phase II dose for MOMA-313 and evaluate efficacy endpoints, including objective response rate, progression-free survival, and overall survival.
In one study arm, patients with advanced HR-deficient disease will receive MOMA-313 by itself, and in a second arm, patients will receive MOMA-313 with Lynparza. The trial will have two parts for the second arm: a dose escalation part and a dose optimization part. During the dose-escalation part, the trial will include patients with advanced or metastatic HR-deficient solid tumors who are not eligible for curative therapy but are eligible for PARP inhibitors. During the dose-optimization part, researchers will study MOMA-313 and Lynparza in patients with HR-deficient metastatic prostate cancer, metastatic breast cancer, or metastatic pancreatic cancer.
The company has also chosen a Werner helicase inhibitor, MOMA-341, to clinically test in cancer patients with microsatellite instability. MOMA said it expects to file an investigational new drug application for this candidate with the US Food and Drug Administration in the first quarter of 2025.