MOMA Therapeutics Announces Initiation of Phase 1 Clinical Trial for MOMA-313, a Novel Polymerase Theta Helicase Inhibitor

On August 19, 2024 MOMA Therapeutics, a clinical-stage biopharmaceutical company discovering and developing a new generation of precision therapeutics, reported that the first patient has been dosed in its Phase 1 clinical trial to assess the safety and tolerability of MOMA-313, a novel, highly potent and selective oral polymerase theta helicase inhibitor (Press release, MOMA Therapeutics, AUG 19, 2024, View Source [SID1234645997]).

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MOMA-313 is initially being developed in combination with a PARP inhibitor for patients with solid tumors harboring alterations in certain DNA repair genes, including subgroups of prostate cancer, pancreatic cancer and breast cancer.

In parallel, MOMA announced the selection of a development candidate for its second lead program, MOMA-341, an oral potent and selective covalent Werner helicase inhibitor for treatment of cancers with microsatellite instability. An IND application filing with the FDA is anticipated in the first quarter of 2025.

"We are excited to be progressing two molecules with best-in-class potential toward the benefit of cancer patients in need in such close proximity," said Asit Parikh, M.D., Ph.D., chief executive officer of MOMA. "The advance into clinical development for a company founded as an idea on paper a few years back is humbling. This progress serves as a testament to the excellence and unwavering commitment of the entire MOMA team."

"Advancing two highly potent and selective drug candidates derived from our proprietary KNOMATIC platform toward the clinic is a unique privilege," added Peter Hammerman, M.D., Ph.D., chief scientific officer of MOMA. "The goal with each candidate is to translate groundbreaking science into life-altering medicine."

About MOMA-313 and the Phase 1 Trial

MOMA-313 is a potent and selective oral polymerase theta (Polθ) helicase inhibitor. Polθ is involved in the repair of DNA double-strand breaks that arise during DNA replication. The Phase 1 trial (NCT06545942) is a multi-center, open-label study designed to evaluate the safety and tolerability of MOMA-313 as monotherapy and in combination with the PARP inhibitor olaparib for patients where a PARP inhibitor would be expected to provide benefit. Response to PARP inhibitors can be short-lived due to primary and acquired resistance. Pre-clinical studies suggest that combining a PARP inhibitor with a Polθ inhibitor could afford unique mechanistic potential to deepen and prolong that response.

About MOMA-341

MOMA is developing MOMA-341 as an oral, potent and selective covalent inhibitor of Werner helicase with a novel chemical scaffold as monotherapy and in combination with chemotherapy and immunotherapy in tumors with microsatellite instability (e.g., colorectal, gastric, endometrial cancers).

About the KNOMATIC platform

The KNOMATIC platform integrates deep structural insights, advanced hit-finding technologies, and computation-enabled lead optimization to accelerate discovery of novel therapeutics targeting families of highly dynamic proteins, such as ATPases and GTPases. MOMA-313 and MOMA-341 were discovered and developed through the application of the KNOMATIC platform.