RP-3467 / Repare Therap - LARVOL DELTA

Third Quarter 2025 Portfolio Update: RP-3467: Polθ ATPase inhibitor (Businesswire) - "As a result of the definitive agreement, Repare will no longer be reporting initial topline safety, tolerability and early efficacy data from the POLAR trial in monotherapy and in combination with Olaparib."

Trial status • Solid Tumor

Repare Therapeutics Enters into Definitive Agreement to be Acquired by XenoTherapeutics, Inc. (Businesswire) - "Transaction expected to close in the first quarter of 2026....$112.6 million in cash and cash equivalents and marketable securities as of September 30, 2025, as compared to $109.5 million at June 30, 2025....As permitted under the Arrangement Agreement, Repare continues to endeavor to license or dispose of its product candidates and/or intellectual property related to its (i) RP-3467 and Polθ program, (ii) RP-1664 program, (iii) RP-3500 (Camonsertib) program, and/or (iv) any other of the Company’s product candidates or research programs."

M&A • Solid Tumor

POLAR: Phase 1 Trial of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=26 | Active, not recruiting | Sponsor: Repare Therapeutics | Recruiting ➔ Active, not recruiting | N=52 ➔ 26

Enrollment change • Enrollment closed • Solid Tumor

Repare Therapeutics Provides Business Update and Reports Second Quarter 2025 Financial Results (Businesswire) - "RP-3467:...POLAR is a multicenter, open-label, dose-escalation Phase 1 clinical trial designed to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RP-3647 alone or in combination with olaparib in adults with locally advanced or metastatic epithelial ovarian cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer, or pancreatic adenocarcinoma. Upcoming expected milestone: Q4 2025: Topline safety, tolerability and early efficacy data from the POLAR trial in monotherapy and in combination with olaparib."

P1 data • Breast Cancer • Castration-Resistant Prostate Cancer • Epithelial Ovarian Cancer • Pancreatic Adenocarcinoma

Repare Therapeutics Provides Business and Clinical Update and Reports First Quarter 2025 Financial Results (Businesswire) - "First Quarter 2025 and Recent Portfolio Highlights:... (i) RP-3467:...Upcoming expected milestone: Q3 2025: Topline safety, tolerability and early efficacy data from the POLAR trial in monotherapy and in combination with olaparib; (ii) RP-1664:...Upcoming expected milestone: Q4 2025: Initial topline safety, tolerability and early efficacy data from the LIONS trial."

P1 data • Solid Tumor

Repare Therapeutics Announces Portfolio Re-Prioritization, Partnering Initiatives and Cost Reductions (Businesswire) - "Repare Therapeutics...announced a re-alignment of resources and a re-prioritization of its clinical portfolio to focus on the continued advancement of its Phase 1 clinical programs, RP-1664 (PLK4 inhibitor) and RP-3467 (Polθ ATPase inhibitor). Repare also announced its intention to seek partnering opportunities across its portfolio, including for lunresertib and camonsertib ('Lunre+Camo') prior to any start of pivotal development. The consequent savings of late-stage clinical funding combined with planned cost and headcount reductions are expected to extend Repare’s cash runway into mid-2027."

Commercial • Solid Tumor

Recent Pipeline Progress & Upcoming Milestones of Prioritized Clinical Programs (Businesswire) - "(i) RP-3467: Potential best-in-class Polθ ATPase inhibitor...Upcoming Expected Milestones: Q3 2025: Topline safety, tolerability and early efficacy data from the POLAR trial in monotherapy and in combination with olaparib.... (ii) Lunresertib and Camonsertib...Upcoming Expected Milestone: Q2 2025: Enrollment completion of MYTHIC trial evaluating lunresertib in combination with Debio 0123 (WEE1 inhibitor)."

Enrollment status • P1 data • Solid Tumor

POLAR: Phase 1 Trial of RP-3467 Alone and in Combination with Olaparib in Participants with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=52 | Recruiting | Sponsor: Repare Therapeutics | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Oncology • Solid Tumor

Repare Therapeutics Doses First Patient in Phase 1 Clinical Trial of RP-3467, a Polθ ATPase Inhibitor (Businesswire) - "Repare Therapeutics...announced the first patient has been dosed in the Company’s Phase 1 (POLAR) clinical trial evaluating RP-3467, a Polθ ATPase inhibitor, alone and in combination with the poly-ADP ribose polymerase (PARP) inhibitor, olaparib....The POLAR clinical trial (NCT06560632) is a multicenter, open-label, dose-escalation Phase 1 clinical trial to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RP-3467 alone or in combination with the PARP inhibitor, olaparib, in adults with molecularly selected advanced solid tumors. The study is expected to enroll approximately 52 patients with locally advanced or metastatic epithelial ovarian cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer, or pancreatic adenocarcinoma."

Trial status • Breast Cancer • Castration-Resistant Prostate Cancer • Ovarian Cancer • Pancreatic Adenocarcinoma

Repare Therapeutics Announces Strategic Reprioritization to Focus on Broad Clinical Portfolio (Businesswire) - "Repare Therapeutics Inc...today announced the strategic reprioritization of its research and development activities to focus its efforts on the advancement of its portfolio of clinical-stage oncology programs. With multiple upcoming clinical milestones and potential near-term registration-enabling studies, the Company is streamlining its operations to focus on the advancement of its lunresertib, camonsertib, RP-1664 and RP-3467 programs while materially reducing the scale of its preclinical research and discovery activities...'We remain on track to report data from our MYTHIC dose expansion trial evaluating lunresertib in combination with camonsertib in patients with ovarian and endometrial cancers in the fourth quarter of 2024, with the potential to begin a registrational trial in 2025.'"

New trial • P1 data • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

POLAR: Phase 1 Trial of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=52 | Not yet recruiting | Sponsor: Repare Therapeutics

Combination therapy • Metastases • New P1 trial • Oncology • Solid Tumor

Repare Therapeutics Provides Business and Clinical Update and Reports Second Quarter 2024 Financial Results (Businesswire) - "Second Quarter 2024 and Recent Portfolio Highlights:...(i) RP-1664: Actively enrolling patients into the Phase 1 LIONS trial evaluating RP-1664, a potential first-in-class selective PLK4 inhibitor, in adult and adolescent patients with TRIM37-high advanced solid tumors and other biomarkers. The Company expects to rapidly advance RP-1664 into a Phase 1/2 clinical trial in pediatric patients with high risk, recurrent neuroblastoma, where the patients have a high prevalence of TRIM37-altered tumors, after evaluating the safety profile in the LIONS trial; (ii) RP-3467: Initiation of a Phase 1 dose finding trial of RP-3467, a potential best-in-class Polθ ATPase inhibitor, is expected in the fourth quarter of 2024."

Enrollment status • New P1 trial • New P1/2 trial • Neuroblastoma

Repare Therapeutics Provides Business and Clinical Update and Reports First Quarter 2024 Financial Results (Businesswire) - "Summary of Expected Milestones: H1 2024: Initial Phase 1 MINOTAUR (lunresertib + FOLFIRI combination) data to be reported at ESMO GI in June 2024; H2 2024: (i) Camonsertib monotherapy expansion to NSCLC in TRESR; (ii) Initiation of Phase 1 clinical trial of RP-3467; (iii) Additional data from dose expansion cohorts for the MYTHIC lunresertib + camonsertib combination in ovarian and endometrial cancers by end of Q4 2024."

New P1 trial • P1 data • Trial status • Endometrial Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Solid Tumor

Repare Therapeutics Provides Corporate Update and Highlights Anticipated Key 2024 Milestones (Businesswire) - "Anticipated Key Milestones in 2024: Report data from the dose expansion cohorts of the Phase 1 MYTHIC study evaluating lunresertib in combination with camonsertib in selectively advanced solid tumors in the second half of 2024; Repare has closed enrollment in the Phase 1 MAGNETIC study evaluating lunresertib in combination with gemcitabine for the treatment of advanced solid tumors. The Company expects to report initial data from this study in the second half of 2024; Initiation of a Phase 1 dose finding study of RP-3467, a potential best-in-class Polθ inhibitor, in the second half of 2024."

Enrollment closed • New P1 trial • P1 data • Oncology • Solid Tumor

Repare Therapeutics Unveils Two Programs Expected to Enter Clinical Trials in 2024: RP-1664, an Oral PLK4 Inhibitor, and RP-3467, an Oral Polθ Inhibitor (Businesswire) - "Repare Therapeutics Inc...disclosed polo-like kinase 4 (PLK4) as the target of its RP-1664 development program and reported comprehensive preclinical data for both RP-1664 and the Company’s Polθ inhibitor, RP-3467....RP-1664 demonstrated robust and dose-dependent monotherapy activity in multiple TRIM37-high preclinical models across a variety of tumor types, including breast cancer, non-small cell lung cancer (NSCLC) and neuroblastoma. The Company plans to initiate a Phase 1 dose escalation study of RP-1664 in adult and adolescent patients with TRIM37-high solid tumors in the first half of 2024....RP-3467 demonstrates synergy with PARP inhibitor activity, resulting in durable, complete tumor regressions in multiple preclinical models....The Company plans to initiate a Phase 1 dosing finding clinical trial of RP-3467 in the second half of 2024."

New P1 trial • Preclinical • Breast Cancer • Lung Cancer • Neuroblastoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Repare Therapeutics Provides Business Update and Reports Third Quarter 2023 Financial Results (Businesswire) - "RP-1664 IND-enabling studies, which began in the first quarter of 2023, are nearing completion and Repare expects to initiate a clinical trial in the first half of 2024. RP-3467 is Repare’s wholly-owned Polθ inhibitor, currently in IND-enabling studies, which began in the second quarter of 2023 and remain ongoing. Repare expects to initiate a clinical trial in the second half of 2024."

New trial • Preclinical • Oncology