Repare Therapeutics Announces Agreement with the US National Cancer Institute to Advance the Development of Camonsertib

Rhea-AI Summary

Repare Therapeutics has announced a Cooperative Research and Development Agreement (CRADA) with the US National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) to advance camonsertib, their oral ATR inhibitor for cancer treatment. The drug has shown significant anti-tumor activity in preclinical and clinical studies, particularly demonstrating prolonged progression-free survival in ATM-mutated non-small cell lung cancer patients. Recent Phase 1 results combining camonsertib with radiotherapy showed complete responses in patients with ATM-altered tumors. CTEP will focus on combination studies involving camonsertib with radiation therapy and translational studies for biomarker identification.

Positive

• Established partnership with US National Cancer Institute for camonsertib development
• Demonstrated prolonged progression-free survival in ATM-mutated lung cancer patients
• Achieved complete responses in Phase 1 trials when combined with radiotherapy

Negative

• None.

Insights

Medical Research Analyst

The CRADA agreement with the NCI represents a significant development pathway expansion for camonsertib. The collaboration provides several key advantages: access to NCI's extensive clinical trial infrastructure, cost-sharing benefits and accelerated development through multiple parallel studies.

The preliminary clinical data showing complete responses in ATM-altered tumors and prolonged progression-free survival in ATM-mutated non-small cell lung cancer patients indicates promising efficacy. The NCI's interest in combination studies with radiation therapy and biomarker development could help identify optimal patient populations and treatment strategies.

This partnership significantly de-risks the development program by leveraging government resources while maintaining Repare's commercial rights. For a company with a $150M market cap, this collaboration provides substantial value in advancing their lead asset.

CAMBRIDGE, Mass. & MONTREAL--(BUSINESS WIRE)-- Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today announced a Cooperative Research and Development Agreement (CRADA) has been executed to advance the development of camonsertib as an anticancer agent in collaboration with the Cancer Therapy Evaluation Program (CTEP) of the US National Cancer Institute (NCI), part of the US National Institutes of Health.

“This partnership with the CTEP allows the research community to investigate the full clinical potential of camonsertib more easily and we believe it will provide additional clinical development catalysts for the program,” said Lloyd M. Segal, President and Chief Executive Officer of Repare.

Camonsertib, a potential best-in-class oral small molecule ATR inhibitor, has demonstrated significant anti-tumor activity in preclinical and clinical studies. Ongoing clinical trials in patients with metastatic solid tumors are evaluating the safety and efficacy of camonsertib as monotherapy and in combination with Repare’s PKMYT1 inhibitor, lunresertib, with chemotherapy and with palliative external beam radiotherapy. Camonsertib monotherapy has demonstrated an encouraging signal of prolonged progression-free survival in patients with ATM-mutated non-small cell lung cancer. Recent Phase 1 results of camonsertib in combination with radiotherapy have shown benefit, including complete responses, in patients with ATM-altered tumors across various histologies.

The Cancer Therapy Evaluation Program (CTEP) of the NCI facilitates the development of promising cancer therapies by collaborating with researchers and industry partners. CTEP's mission is to improve the lives of cancer patients by finding better ways to treat, control and cure cancer. CTEP is interested in combination studies involving camonsertib and various aspects of radiation therapy, and translational studies to identify predictive biomarkers.

About Repare Therapeutics Inc.

Repare Therapeutics is a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes lunresertib (also known as RP-6306), a PKMYT1 inhibitor currently in Phase 1/2 clinical development; camonsertib (also known as RP-3500), a potential leading ATR inhibitor currently in Phase 1/2 clinical development; RP-1664, a Phase 1 PLK4 inhibitor; RP-3467, a Phase 1 Polθ ATPase inhibitor; as well as additional, undisclosed preclinical programs. For more information, please visit reparerx.com and follow @Reparerx on X (formerly Twitter) and LinkedIn.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and securities laws in Canada. All statements in this press release other than statements of historical facts are “forward-looking statements. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the design, progress and results of the Phase 1 clinical trial of camonsertib in combination with radiotherapy treatment for genotypically-selected cancers; and the Company’s future plans for clinical development of camonsertib; and the tolerability, efficacy and clinical progress of the Company’s product candidates, including camonsertib; and the benefits and ability to discover further targets and clinical candidates from the Company’s discovery platform. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause the Company’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including the conflict in Ukraine and the conflict in the Middle East, heightened inflation and uncertain credit and financial markets, on the Company’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; the Company’s ability to realize the benefits of its collaboration and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. Other factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified in the section titled "Risk Factors" in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 filed with the Securities and Exchange Commission (“SEC”) and the Québec Autorité des Marchés Financiers ("AMF") on November 7, 2024, 2024. The Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. For more information, please visit reparerx.com and follow Repare on X (formerly Twitter) at @RepareRx and on LinkedIn at https://www.linkedin.com/company/repare-therapeutics/.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241112194263/en/

Investor Relations & Media Contact:

Robin Garner

Vice President and Head of Investor Relations

Repare Therapeutics Inc.

investor@reparerx.com

Source: Repare Therapeutics Inc.

FAQ

What is the new partnership announced by Repare Therapeutics (RPTX) for camonsertib?

Repare Therapeutics announced a Cooperative Research and Development Agreement (CRADA) with the US National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) to advance camonsertib development.

What clinical results has camonsertib shown in cancer treatment for Repare Therapeutics (RPTX)?

Camonsertib has shown prolonged progression-free survival in ATM-mutated non-small cell lung cancer patients and complete responses in Phase 1 trials when combined with radiotherapy in patients with ATM-altered tumors.

What will the CTEP focus on in their research of Repare Therapeutics' (RPTX) camonsertib?

CTEP will focus on combination studies involving camonsertib with radiation therapy and conducting translational studies to identify predictive biomarkers.