MOMA-313 / MOMA Therapeutics - LARVOL DELTA

MOMA-313-001: Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=220 | Recruiting | Sponsor: MOMA Therapeutics | N=158 ➔ 220

Enrollment change • Monotherapy • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Genito-urinary Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor

DNA repair and synthetic lethality (AACR-NCI-EORTC 2025) - "Here, I will review DNA Polymerase Theta (PolQ) as a potential therapeutic for the treatment of HRD associated tumors and present new data regarding MOMA-313, a highly potent and selective inhibitor of PolQ currently in Phase I clinical development. I will also discuss inhibition of the Werner (WRN) helicase, a synthetic lethal target in tumors with microsatellite instability (MSI), in which the WRN protein is required to resolve TA dinucleotide repeats and present new preclinical data regarding MOMA-341, a novel WRN inhibitor. These two opportunities represent dual approaches to expand the repertoire of agents targeting tumors with specific defects in genomic maintenance."

Synthetic lethality • Microsatellite Instability • Oncology • BRCA • HRD • MSI • POLQ • WRN

Discovery of MOMA-313, a potent and selective inhibitor of the Polθ DNA helicase domain for the treatment of HR-deficient tumors (AACR 2025) - P1 | "Low doses of MOMA-313 drive the regression of HR-deficient tumor xenografts when combined with the PARP inhibitor olaparib, including in models with limited response to olaparib alone. MOMA-313 has been optimized to achieve high target coverage at a low human dose, a strong safety profile, and broad combinability especially with PARP inhibitors, where mechanistic synergy may drive deeper responses and prevent clinical resistance in HR-deficient tumors. Clinical evaluation of MOMA-313 is ongoing (NCT06545942), with monotherapy and PARP inhibitor combination arms."

Oncology • BRCA • BRCA1 • BRCA2 • POLQ

Orally administered MOMA-313 as monotherapy or combination therapy in participants with advanced or metastatic solid homologous recombination (HR)-deficient tumors: Phase 1 study design (AACR 2025) - P1 | "MOMA-313 will be administered orally either as a single agent or as combination therapy with a PARP inhibitor, olaparib, in patients with HR-deficient solid tumors. Enrollment of initial cohorts began in the United States in August 2024, with sites in the UK and Spain planned to open in 2025. Clinical trial information: NCT06545942."

Combination therapy • Metastases • Monotherapy • P1 data • Breast Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA • POLQ

MOMA Therapeutics to Present Multiple Posters at the American Association for Cancer Research Annual Meeting 2025 (Businesswire) - "MOMA Therapeutics...today announced three poster presentations at the 2025 American Association for Cancer Research (AACR) Annual Meeting, being held April 25 – 30, 2025 in Chicago, IL."

Clinical data • Solid Tumor

MOMA Therapeutics Provides Corporate Update… (Businesswire) - "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. The company remains on track to file an IND for MOMA-341 during the first quarter of 2025....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."

IND • P1 data • Breast Cancer • Microsatellite Instability • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer

MOMA-313 is a potent, selective Polθ inhibitor that enhances response to PARP inhibition in HR-deficient tumor models (EORTC-NCI-AACR 2024) - "Polθ inhibition represents a novel approach for treatment of HR-deficient tumors that enhances activity of PARP inhibitors in preclinical models and may both deepen and lengthen response to PARP inhibitors in the clinical setting without significant additive toxicity. MOMA-313 is a novel, potent, and selective Polθ helicase inhibitor currently in Phase 1 testing as monotherapy and in combination with olaparib in HR-deficient tumors."

Preclinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • BRCA2 • CASP3 • POLQ

MOMA-313-001: Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=158 | Recruiting | Sponsor: MOMA Therapeutics | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatology • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor

MOMA Therapeutics Announces Initiation of Phase 1 Clinical Trial for MOMA-313, a Novel Polymerase Theta Helicase Inhibitor (Businesswire) - "MOMA Therapeutics...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....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."

Trial status • Solid Tumor

Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=158 | Not yet recruiting | Sponsor: MOMA Therapeutics

Combination therapy • Metastases • Monotherapy • New P1 trial • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatology • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor