Repare Therapeutics Inc. (Nasdaq: RPTX) announced a strategic reprioritization of its research and development activities, focusing on advancing its clinical-stage oncology programs. This move aims to streamline operations and dedicate resources to promising precision oncology programs, with multiple clinical milestones expected in the near term. The company anticipates potential near-term registration-enabling studies for its lead candidates.
As part of this strategic refocus, Repare plans to reduce its overall workforce by approximately 25%, primarily affecting the preclinical group. This restructuring is projected to result in non-recurring cash payments of $1.5 million to $2.0 million in the third quarter of 2024. However, it is expected to generate annual savings of approximately $15.0 million, extending the company's cash runway into the second half of 2026.
Lunresertib (RP-6306) Development
Lunresertib, a first-in-class, oral small molecule inhibitor of PKMYT1, is currently under evaluation in the MYTHIC dose expansion clinical trial. Repare anticipates reporting data from this trial in the fourth quarter of 2024. The trial assesses lunresertib in combination with camonsertib at the recommended Phase 2 dose (RP2D) in patients with platinum-resistant ovarian and endometrial cancers harboring CCNE1 amplification or FBXW7 or PPP2R1A mutations. The company is optimistic about potentially initiating a registrational trial in 2025.
Furthermore, lunresertib is being investigated in combination with Debio 0123, a selective, brain-penetrant WEE1 inhibitor, in Module 4 of the MYTHIC trial. This module focuses on patients with advanced solid tumors harboring CCNE1 amplification or FBXW7 or PPP2R1A deleterious alterations. Initial data from Module 4 of the MYTHIC trial are expected in 2025.
Recent data from the MINOTAUR trial, evaluating lunresertib and FOLFIRI, demonstrated promising efficacy and duration of therapy in heavily pretreated patients with tumors harboring CCNE1 amplification and FBXW7 mutation alterations, warranting further development.
Camonsertib (RP-3500) Development
Camonsertib, a potential best-in-class oral small molecule inhibitor of ATR, is being evaluated as a monotherapy in the ongoing non-small cell lung cancer (NSCLC) expansion of the Phase 2 TRESR clinical trial. The TRESR trial has shown a promising signal of prolonged progression-free survival in patients with ATM-mutated NSCLC. Repare expects to report initial data from the TRESR trial in 2025.
RP-1664 Development
RP-1664, a first-in-class, highly selective, oral inhibitor of PLK4, is being evaluated as a monotherapy in the Phase 1 LIONS clinical trial in adult and adolescent patients with TRIM37-high solid tumors. Following safety evaluation in the LIONS trial, the company plans to rapidly advance RP-1664 into a Phase 1/2 trial in pediatric patients with high-risk, recurrent neuroblastoma, where there is a high prevalence of TRIM37-altered tumors.
RP-3467 Development
RP-3467, a potential best-in-class Polθ ATPase inhibitor, is expected to enter a Phase 1 dose-finding clinical trial in the fourth quarter of 2024.
