Repare Therapeutics to Regain Global Rights to Camonsertib

Rhea-AI Summary

Repare Therapeutics regains control of potential best-in-class oral small molecule ATR inhibitor, camonsertib, following termination of collaboration agreement with Roche. The company will now have full rights to develop and commercialize camonsertib, a promising precision oncology medicine that has shown clinical proof-of-concept in multiple tumor types and genotypes. Repare's deep clinical pipeline includes four wholly-owned synthetic lethal therapies.

Insights

Oncology Doctor

The termination of Repare Therapeutics' collaboration with Roche and the subsequent regaining of full development and commercialization rights for camonsertib represents a significant pivot in the drug's trajectory. From an oncological perspective, camonsertib's role as an ATR inhibitor is noteworthy due to the enzyme's involvement in DNA damage response, a critical pathway in cancer cell survival. ATR inhibitors, like camonsertib, have the potential to sensitize cancer cells to DNA damage, making them more susceptible to treatments such as chemotherapy and radiation. The clinical proof-of-concept across various tumor types and genotypes enhances the potential for camonsertib to address unmet needs in precision oncology. The preliminary results from the MYTHIC trial, particularly the 50% RECIST objective response in heavily pre-treated gynecologic tumors, are promising and suggest that camonsertib could offer a new line of treatment for patients with limited options.

Financial Analyst

The financial implications for Repare Therapeutics are multifaceted following the end of their partnership with Roche. Firstly, the $40 million milestone payment from Roche provides a short-term financial buffer, which, coupled with the company's current capital, is expected to fund operations into mid-2026. This runway is crucial for Repare to progress camonsertib through clinical development independently. Secondly, regaining full rights to camonsertib allows Repare to potentially establish new partnerships or retain a larger share of future revenues if the drug reaches the market. However, investors should be aware of the increased financial risk associated with single-handedly advancing a clinical program without the support of a large pharmaceutical partner like Roche. The market's response to this news will depend on investor confidence in Repare's ability to successfully develop and commercialize camonsertib on its own.

Market Research Analyst

The precision oncology market is rapidly evolving, with an increasing emphasis on therapies that target specific genetic mutations. Camonsertib's potential as a best-in-class oral ATR inhibitor places it within a niche yet growing segment of this market. The clinical benefits demonstrated in the MYTHIC trial suggest that camonsertib could capture significant market share, especially in indications where it has shown a high response rate. Repare's strategic move to regain control over camonsertib could be seen as a calculated risk to capture the full value of the drug, assuming successful development and regulatory approval. It is essential to monitor the evolving competitive landscape and the entry of new ATR inhibitors, which could influence camonsertib's market positioning and pricing strategy upon potential commercialization.

Repare will regain control of its potential best-in-class oral small molecule ATR inhibitor

CAMBRIDGE, Mass. & MONTREAL--(BUSINESS WIRE)-- Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, announced today that it will regain global development and commercialization rights to camonsertib (RP-3500), a potential best-in-class oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase), following termination of its collaboration agreement with Roche.

Roche notified Repare that, effective May 7, 2024, it is terminating its worldwide license and collaboration agreement for the development and commercialization of camonsertib following a review of Roche’s pipeline and evolving external factors. Repare regains full control of all rights for camonsertib, a potential best-in-class inhibitor of ATR.

“Camonsertib is a valuable, high-potential precision oncology medicine that has achieved clinical proof-of-concept in multiple tumor types and genotypes both as monotherapy and in combination, as previously reported. We have been continuously running clinical trials for camonsertib since July 2020 and are excited to steward the progress of this promising therapy,” said Lloyd M. Segal, President and Chief Executive Officer of Repare. “While we are disappointed to end this collaboration, we appreciate the contributions Roche has made to the program. With the return of camonsertib, Repare’s deep clinical pipeline consists of four wholly-owned synthetic lethal therapies.”

Camonsertib is also part of Repare’s ongoing Phase 1 MYTHIC trial evaluating the combination of camonsertib and lunresertib, a first-in-class, oral small molecule inhibitor of PKMYT1, in patients with molecularly selected, advanced solid tumors. In October 2023, Repare presented data on the camonsertib and lunresertib combination, demonstrating clear evidence of clinical benefit across multiple tumor types and all selected genotypes, with an overall response of 33.3% across all tumor types and 50% RECIST objective response in patients with heavily pre-treated gynecologic tumors at the preliminary recommended Phase 2 dose of the combination. Repare expects to report additional camonsertib and lunresertib combination therapy data from the expansion cohorts of this trial in the second half of 2024. ​

Repare has met all obligations under the Roche agreement to date, and recently earned a $40 million milestone payment from Roche. Repare continues to expect that its existing cash, cash equivalents, and marketable securities will provide sufficient capital to fund planned operations into mid-2026.

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.

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 preclinical PLK4 inhibitor program; RP-3467, a preclinical Polθ ATPase inhibitor program; as well as additional, undisclosed preclinical programs. For more information, please visit reparerx.com.

SNIPRx^® is a registered trademark of Repare Therapeutics Inc.

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 termination of Repare’s collaboration with Roche; the potential of camonsertib as a best-in-class oral small molecule ATR inhibitor; the clinical development of lunresertib and camonsertib; the timing of the expected combination therapy data from the expansion cohorts of the MYTHIC trial; and Repare’s cash runway. 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 impacts of macroeconomic conditions, including the COVID-19 pandemic, the conflict in Ukraine, the Hamas-Israel conflict, 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 risk that Repare may not realize the potential benefits of this collaboration with Roche; the discovery, development and potential commercialization of potential product candidates using Repare’s SNIPRx^® platform technology and under the strategic collaboration agreement, including the development of camonsertib; 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 Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission (“SEC”) and the Québec Autorité des Marchés Financiers ("AMF") on February 28, 2023, and its other documents subsequently filed with or furnished to the SEC and AMF, including the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 filed with the SEC on November 9, 2023. 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 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/20240212526076/en/

Repare Contact:

Robin Garner

Vice President and Head of Investor Relations

Repare Therapeutics Inc.

investor@reparerx.com

Investors:

Matthew DeYoung

Argot Partners

repare@argotpartners.com

Media:

David Rosen

Argot Partners

david.rosen@argotpartners.com

212-600-1902

Source: Repare Therapeutics Inc.

FAQ

What is the significance of Repare Therapeutics regaining control of camonsertib?

Repare Therapeutics will now have full global development and commercialization rights to camonsertib, a potential best-in-class oral small molecule inhibitor of ATR, after terminating its collaboration agreement with Roche.

What is camonsertib and its role in Repare's pipeline?

Camonsertib is a valuable precision oncology medicine that has shown clinical proof-of-concept in multiple tumor types and genotypes. It is part of Repare's ongoing Phase 1 MYTHIC trial, evaluating its combination with lunresertib in patients with advanced solid tumors.

What recent data has Repare presented regarding camonsertib and lunresertib combination therapy?

Repare presented data in October 2023, showing clear evidence of clinical benefit across multiple tumor types and genotypes with the camonsertib and lunresertib combination. The overall response rate was 33.3% across all tumor types and 50% RECIST objective response in patients with heavily pre-treated gynecologic tumors.

How does Repare plan to proceed with camonsertib and lunresertib combination therapy?

Repare expects to report additional data from the expansion cohorts of the Phase 1 MYTHIC trial in the second half of 2024, further evaluating the camonsertib and lunresertib combination therapy in patients with advanced solid tumors.

What financial outlook does Repare have following the termination of the collaboration agreement with Roche?

Repare recently received a $40 million milestone payment from Roche and anticipates that its existing cash, cash equivalents, and marketable securities will be sufficient to fund planned operations into mid-2026.