Fast Track process of the FDA is intended to accelerate the development and review of drugs that address serious conditions and fill unmet medical needs.
Lunresertib along with camonsertib is currently under investigation in Repare’s MYTHIC Module 2 Phase I dose expansion clinical trial at the recommended Phase II dose in those patients suffering from ovarian and endometrial cancers that exhibit CCNE1 amplification or FBXW7 or PPP2R1A mutations.
The latest Fast Track designation follows a previous one for the same combination in treating adult patients with CCNE1 amplified, or FBXW7 or PPP2R1A mutated endometrial cancer, in Q3 2023.
Repare anticipates presenting data from the MYTHIC Module 2 dose expansion cohorts, involving approximately 20-30 patients each with ovarian and endometrial cancer, in the fourth quarter of 2024.
Repare chief medical officer and executive vice president Maria Koehler said: “The FDA’s decision to grant Fast Track designation supports our goal of quickly and efficiently developing the lunresertib-camonsertib combination for patients with genomically-defined platinum-resistant ovarian cancer.
“Ovarian cancer patients need therapies that provide long-term benefit beyond that observed with standard of care. Our precision medicine approach targets treatment to patients who could most benefit from a well-tolerated alternative to chemotherapy.”
Repare’s approach to cancer treatment involves its SNIPRx platform, which leverages genome-wide, CRISPR-enabled technology to discover and develop targeted therapies. The company’s pipeline includes several other candidates in various stages of clinical and preclinical development, focusing on genomic instability and DNA damage repair.
Its pipeline includes camonsertib (RP-3500), a potential leading ATR inhibitor currently in Phase I/II clinical development; lunresertib (RP-6306), a PKMYT1 inhibitor currently in Phase I/II clinical development; RP-3467, a preclinical Polθ ATPase inhibitor programme; RP-1664, a Phase I PLK4 inhibitor.