“We significantly advanced our pipeline in 2023 and presented strong data from key programs, notably for lunresertib in combination with camonsertib, and for camonsertib in combination with PARP inhibitors. In addition, we presented compelling preclinical data sets for
Presented initial clinical data from the Phase 1/2 TRESR and ATTACC trials evaluating camonsertib (
RP-3500/RG6526, now partnered globally with Roche) in combination with three poly (ADP-ribose) polymerase (PARP) inhibitors in a Clinical Trials Plenary Session at the 2023 American Association for Cancer Research(AACR) Annual Meeting. Camonsertib, a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase), showed 48% overall clinical benefit rate in patients with advanced solid tumors across tumor types regardless of choice of PARP inhibitor or platinum resistance, with a favorable safety and tolerability profile. Data from the TRESR trial were also published in Nature Medicine highlighting the clinical benefit of camonsertib in advanced solid tumors.
Presented initial positive data from its ongoing Phase 1 MYTHIC trial evaluating lunresertib (
RP-6306) alone and in combination with camonsertib in patients with advanced solid tumors harboring CCNE1 amplification or FBXW7 or PPP2R1A deleterious alterations at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Initial combination data included an overall RECIST response rate of 50% in patients with heavily pre-treated gynecological tumors at the preliminary recommended Phase 2 dose.
Disclosed polo-like kinase 4 (PLK4) as the target of its
RP-1664development program and reported comprehensive preclinical data for both RP-1664and the Company’s Polθ inhibitor, RP-3467, both of which we expect to enter clinical trials in 2024. RP-1664demonstrated potent and selective inhibition of PLK4 and synthetic lethality in TRIM37-high tumor cells in preclinical studies. RP-3467demonstrated complete, sustained regressions preclinically in combination with PARP inhibitors, and compelling anti-tumor activity in combination with radioligand therapy (RLT) and chemotherapy.
Announced a partnership with
Debiopharmto explore the potential clinical synergy of Debio 0123, a highly selective clinical WEE1 inhibitor, and lunresertib in a trial expected to start in H1 and for which the companies have developed substantial pre-clinical validation. Repare will sponsor the global study as a new arm in the ongoing MYTHIC study with costs being shared equally by Debiopharmand Repare.
Enrollment of patients is ongoing in the camonsertib arm of Roche’s TAPISTRY trial (NCT04589845), a Phase 2, global, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy in patients with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations. With multiple patients in advanced stages of screening, dosing of the first patient with camonsertib is expected in the near term, which would result in the achievement of a
$40 millionmilestone payment from Roche to Repare. In October 2023, Roche also dosed the first patient in a camonsertib-based arm in its Phase 1b/2 clinical trial of multiple immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (Morpheus Lung; NCT03337698).
Announced the appointment of
Susan M. Molineaux, Ph.D., to its Board of Directors. Dr. Molineauxcurrently serves as President and Chief Executive Officer at Para Therapeutics and previously served as Chief Executive Officer of Calithera Biosciences and of Proteolix. Additionally, Repare expanded its senior leadership team with the appointment of Daniel Bélanger as EVP of Human Resources.
Anticipated Key Milestones in 2024:
Initiation of a Phase 1 dose escalation study of
RP-1664, a potential first-in-class, oral PLK4 inhibitor, in adult and adolescent patients with TRIM37-high solid tumors in the first half of 2024.
- Initiation of a Phase 1/1b study of lunresertib and Debio 0123, a WEE1 inhibitor, in the first half of 2024.
- Report initial data from the Phase 1 MINOTAUR study evaluating lunresertib in combination with FOLFIRI for the treatment of advanced solid tumors in the first half of 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.
Cash Position and Financial Guidance
Repare ended 2023 with approximately
About Repare Therapeutics’ SNIPRx® Platform
Repare’s SNIPRx® platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx® screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.
SNIPRx® is a registered trademark of
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and securities laws in
Vice President and Head of Investor Relations