\nRepare Therapeutics Inc. (\u201cRepare\u201d or the \u201cCompany\u201d) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today reported positive data from its MYTHIC Phase 1 gynecologic expansion clinical trial evaluating the combination of lunresertib and camonsertib (Lunre+Camo) at the recommended Phase 2 dose (RP2D) in patients with endometrial cancer and platinum-resistant ovarian cancer (PROC) harboring lunre-sensitizing biomarkers.<\/p>\n
\nLunresertib is a first-in-class precision oncology small molecule PKMYT1 inhibitor which targets cell cycle regulation in Lunre BM+ tumors (CCNE1 amplifications or FBXW7 or PPP2R1A deleterious alterations). Camonsertib is a potential best-in-class oral small molecule inhibitor of ATR, a critical component of the DNA damage response pathway.<\/p>\n
\n\u201cWe are encouraged by the strong response and the clear benefit we observed in patients with endometrial and platinum-resistant ovarian cancers in the MYTHIC clinical trial,\u201d said Lloyd M. Segal, President and Chief Executive Officer of Repare. \u201cThese patients need new treatment options and our results support the potential for Lunre+Camo to make a real, positive difference if approved, particularly as a chemotherapy alternative. We have positive feedback from regulatory agencies in both the US and Europe and we look forward to getting started on a registrational Phase 3 trial of Lunre+Camo in endometrial cancer in the second half of 2025.\u201d<\/p>\n
\nThe MYTHIC clinical trial (NCT04855656<\/a>) is a first-in-human, global, open-label Phase 1 dose-escalation clinical trial to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of Lunre+Camo in patients with advanced solid tumors. As of the data cut-off date of November 14, 2024, 51 evaluable patients were enrolled in the gynecologic cancer expansion cohort of the MYTHIC trial.<\/p>\n \nAcross all tumor types treated at the optimized RP2D (n=67), Lunre+Camo therapy demonstrated a favorable and differentiated tolerability profile when compared to current and emerging therapies. The most common adverse event was anemia (26.9%, Grade 3).<\/p>\n Key Cohort Clinical Findings<\/span><\/b><\/p>\n Endometrial Cancer Patients:<\/b><\/p>\n \nThe 27 evaluable patients with endometrial cancer had a median age of 67 years. All patients exhibited high-risk profiles:<\/p>\n \nKey efficacy outcomes in evaluable patients with endometrial cancer (N=27):<\/p>\n Platinum-Resistant Ovarian Cancer Patients:<\/b><\/p>\n \nThe 24 evaluable patients with PROC had a median age of 63 years. All patients exhibited high-risk profiles:<\/p>\n \nKey efficacy outcomes in evaluable patients with PROC (N=24):<\/p>\n \n\u201cThose patients with recurrent gynecologic cancers have limited treatment options as tumors often become resistant to standard of care therapy,\u201d said Brian Slomovitz, MD, MS, FACOG, Director, Gynecologic Oncology, Co-chair of the Cancer Research Center, Mount Sinai Medical Center. \u201cThey urgently need new treatment options. Repare\u2019s differentiated, biomarker-driven approach addresses this population and may offer a solution. These data support the potential of Lunre+Camo as a new treatment option to fill this unmet need for patients with endometrial and platinum-resistant ovarian cancers.\u201d<\/p>\n \nRepare has consulted with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, who have provided guidance into the Company\u2019s registrational development plans for Lunre+Camo in gynecologic tumors, including assessment of the contribution of components, dose and schedule and preliminary alignment on the proposed registrational development approach. Repare plans to provide the final Phase 3 trial protocols for regulatory clearance imminently and intends to start the first Phase 3 Lunre+Camo trial in endometrial cancer in the second half of 2025. Additionally, the Company expects to initiate a small contribution of components trial in up to 40 patients with endometrial cancer in the first quarter of 2025.<\/p>\n \n\u201cThe results of the MYTHIC clinical trial increase our confidence in the potential to bring Lunre+Camo to patients living with this aggressive subset of recurrent endometrial cancer,\u201d said Maria Koehler, MD, PhD, Chief Medical Officer of Repare. \u201cWe are deeply grateful to the patients and investigators who participated in this trial, and we look forward to building on these promising data through the registrational clinical trials using Lunre+Camo as a potential new standard of care for those patients, if approved.\u201d<\/p>\n Conference Call and Webcast:<\/b><\/p>\n \nRepare will host a conference call and webcast today, December 12, at 4:30 p.m. ET to discuss the results. Repare\u2019s executive management team will be joined by Brian Slomovitz, MD, MS, FACOG, Director, Gynecologic Oncology, Co-chair of the Cancer Research Center, Mount Sinai Medical Center.<\/p>\n \nTo access the call, please dial (646) 357-8785 (U.S. and Canada) or (800) 836-8184 (international) at least 10 minutes prior to the start time and ask to be joined to the Repare Therapeutics call. A live webcast and presentation materials will be available in the Investor section of the Company\u2019s website at https:\/\/ir.reparerx.com\/events-and-presentations\/events<\/a>. A webcast replay will also be archived for at least 30 days.<\/p>\n About Repare Therapeutics Inc.<\/b><\/p>\n \nRepare 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\u00ae platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company\u2019s 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 Pol\u03b8 ATPase inhibitor; as well as additional, undisclosed preclinical programs. For more information, please visit reparerx.com<\/a> and follow @Reparerx on X (formerly Twitter) and LinkedIn.<\/p>\n Forward-Looking Statements<\/b><\/p>\n \nThis press release contains \u201cforward-looking statements\u201d 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 \u201cforward-looking statements. These statements may be identified by words such as \u201caims,\u201d \u201canticipates,\u201d \u201cbelieves,\u201d \u201ccould,\u201d \u201cestimates,\u201d \u201cexpects,\u201d \u201cforecasts,\u201d \u201cgoal,\u201d \u201cintends,\u201d \u201cmay,\u201d \u201cplans,\u201d \u201cpossible,\u201d \u201cpotential,\u201d \u201cseeks,\u201d \u201cwill\u201d 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 Company\u2019s future plans for clinical development of camonsertib in combination with lunresertib (Lunre+Camo), including the Company\u2019s plan to initiate a registrational Phase 3 trial of Lunre+Camo in endometrial cancer in the second half of 2025 and a contribution of components trial in the first quarter of 2025; the tolerability, efficacy and clinical progress of Lunre+Camo; the potential of Lunre+Camo as a new treatment option and standard of care for patients with endometrial and platinum-resistant ovarian cancers, if approved; camonsertib\u2019s potential as a best-in-class small molecule inhibitor of ATR; and the Company\u2019s interactions with the FDA and the European Medicines Agency regarding registrational development plans for Lunre+Camo. These forward-looking statements are based on the Company\u2019s 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\u2019s 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, fluctuations in inflation and uncertain credit and financial markets, on the Company\u2019s 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\u2019s 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\u2019s 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\u2019s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 filed with the Securities and Exchange Commission (\u201cSEC\u201d) and the Qu\u00e9bec Autorit\u00e9 des March\u00e9s Financiers (“AMF”) on November 7, 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\/<\/a>.<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20241212081329\/en\/<\/a><\/span><\/p>\n Investor Relations & Media Contact: KEYWORDS:<\/b> Massachusetts United States North America Canada<\/p>\n INDUSTRY KEYWORDS:<\/b> Oncology Health Clinical Trials Research Science Pharmaceutical Biotechnology<\/p>\n\n
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Robin Garner
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Vice President and Head of Investor Relations
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Repare Therapeutics Inc.
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investor@reparerx.com<\/a><\/p>\n
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