MOMA-341

CAMBRIDGE, Mass.--( BUSINESS WIRE )--MOMA Therapeutics, a clinical-stage biopharmaceutical company discovering and developing a new generation of precision therapeutics, today announced the in-licensing of a next-generation selective PARP1 (poly ADP-ribose polymerase) inhibitor, now known as MOMA-989. The company also provided an update on the clinical progress of Polθ inhibitor MOMA-313 and outlined the clinical path for Werner inhibitor MOMA-341. “The addition of this selective PARP1 inhibitor to our portfolio solidifies our lead asset focus on the DNA damage response,” said Asit Parikh, M.D., Ph.D., chief executive officer of MOMA. “Our conviction in the potential for achieving practice-changing efficacy by combining MOMA-989 with our Polθ inhibitor catalyzed the licensing deal. It puts MOMA in position to generate multiple impactful clinical datasets across three thematically linked assets over the next two years.” MOMA-989: Selective PARP1 inhibitor MOMA-989 is an oral, highly potent, brain-penetrant development candidate with a potentially best-in-class compound profile. Under the terms of the exclusive license agreement with a U.S.-based biopharmaceutical partner, MOMA receives global rights to MOMA-989 and assumes responsibility for all further research, development and commercialization of the asset and related follow-on molecules. Selective targeting of PARP1 has demonstrated significant potential for patients with tumors displaying homologous recombination deficiency (HRD). MOMA anticipates filing an IND with the U.S. FDA by the end of 2025. The company plans to develop MOMA-989 for patients with HRD, both as single agent and as part of a mechanistically synergistic combination with MOMA-313. Following successful IND clearance, early single agent efficacy data is anticipated in the second half of 2026. MOMA-313: Polθ helicase inhibitor MOMA-313 is a potentially best-in-class, highly potent and selective Polθ helicase inhibitor with a favorable emerging safety profile. This profile lends MOMA-313 to broad combinability with other targeted agents including antibody drug conjugates, radioligand therapeutics, PARP inhibitors, and select chemotherapies. Preclinical data demonstrate that combining a PARP inhibitor with a Polθ inhibitor in tumors harboring alterations in HRD has unique potential to deepen and prolong therapeutic responses. MOMA-313 is currently in a Phase 1a dose escalation study designed to evaluate its potential as monotherapy and in combination with olaparib, an approved, non-selective PARP inhibitor (NCT06545942). An initial readout of olaparib combination efficacy data is anticipated in mid-2026, with development of the proprietary combination with MOMA-989 to initiate in late 2026. MOMA-341: Werner helicase inhibitor The company remains on track to file an IND for MOMA-341 during the first quarter of 2025. MOMA-341 is a highly differentiated oral, potent and selective, covalent Werner helicase inhibitor with a novel chemical scaffold that was identified via the company’s KNOMATIC TM platform. The company plans to assess the potential of MOMA-341 as a treatment for patients with cancers demonstrating microsatellite instability (MSI-H). Following successful IND clearance, MOMA anticipates an initial readout of early single agent efficacy data in mid-2026. About MOMA Therapeutics MOMA Therapeutics is a clinical-stage, next-generation precision medicine company dedicated to targeting highly dynamic proteins that underlie human disease via an oral, small molecule approach, utilizing its proprietary KNOMATIC TM platform. The platform is designed to exploit key vulnerabilities inherent to all dynamic proteins, namely their dependence on well-coordinated, stepwise changes in protein conformation. By focusing on genetically validated targets with high translation potential, MOMA is rapidly advancing its pipeline toward responses in the clinic. MOMA has existing discovery partnerships with Roche and Bayer, as well as a wholly owned pipeline. For more information on MOMA, go to www.momatx.com .

– First patient dosed in a first-in-human study to assess safety and tolerability of MOMA-313 in patients with cancers carrying mutations in DNA repair genes – – MOMA-313 is a highly potent and selective oral polymerase theta helicase inhibitor, displaying best-in-class potential – – MOMA selects MOMA-341, a potentially best-in class Werner helicase inhibitor, as development candidate for second program; IND application filing anticipated in Q1 2025 – CAMBRIDGE, MA, USA I August 19, 2024 I MOMA Therapeutics , a clinical-stage biopharmaceutical company discovering and developing a new generation of precision therapeutics, today announced 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. 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. About MOMA Therapeutics MOMA Therapeutics is a clinical-stage, next-generation precision medicine company dedicated to targeting highly dynamic proteins that underlie human disease via a small molecule approach, utilizing its proprietary KNOMATIC platform. The platform was designed to exploit key vulnerabilities inherent to all dynamic proteins, namely their dependence on well-coordinated, stepwise changes in protein conformation. By focusing on genetically validated targets with high translation potential, MOMA is rapidly advancing its pipeline toward responses in the clinic. In January 2024, MOMA announced a five-year discovery collaboration with Roche focused on critical cancer dependencies. SOURCE: MOMA Therapeutics