Latest news with #Debio0123
Business Wire
16-07-2025
- Business
- Business Wire
Repare Therapeutics Enters Exclusive Worldwide Licensing Agreement with Debiopharm for Lunresertib
CAMBRIDGE, Mass. & MONTREAL--(BUSINESS WIRE)--Repare Therapeutics Inc. ('Repare' or the 'Company') (Nasdaq: RPTX), a clinical-stage precision oncology company, today announced it has entered into an exclusive worldwide licensing agreement with Debiopharm International S.A. ('Debiopharm'), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow's standards of care to cure cancer and infectious diseases, for lunresertib, a first-in-class precision oncology PKMYT1 inhibitor. 'The exclusive worldwide licensing agreement with Debiopharm allows for the continued development of lunresertib, a novel PKMYT1 inhibitor, that has demonstrated encouraging results across multiple clinical trials in difficult-to-treat solid tumors. This agreement builds upon the success of Repare and Debiopharm's existing collaboration studying the combination of lunresertib and Debio 0123,' said Steve Forte, President, Chief Executive Officer and Chief Financial Officer of Repare. 'Our recent business development efforts have continued to enable Repare to focus on the advancement of our clinical priorities and sustained value creation. We remain focused on two ongoing Phase 1 clinical trials with readouts expected in the second half of 2025: the LIONS trial evaluating our RP-1664 PLK4 inhibitor and the POLAR trial evaluating our RP-3467 Polθ ATPase inhibitor.' Under the terms of the agreement, Repare will receive a $10 million upfront payment, and is eligible to receive up to $257 million in potential clinical, regulatory, commercial and sales milestones, including up to $5 million in potential near-term payments, and single-digit royalties on global net sales. Repare and Debiopharm entered into a clinical study and collaboration agreement in January 2024 to explore the synergy between lunresertib and Debio 0123, a potential best-in-class, brain penetrant and highly selective WEE1 inhibitor. Debiopharm will assume sponsorship of the MYTHIC study and take over existing and future development activities related to lunresertib. 'We are excited to enter into this worldwide license agreement with Repare for lunresertib. Based on very promising Phase 1/1b clinical data, we believe the combination of lunresertib and Debio 0123 is highly synergistic and could potentially drive rapid and deep tumor regressions,' said Bertrand Ducrey, CEO of Debiopharm. 'We believe the synthetic lethality approach of lunresertib in combination with Debio 0123 will allow us to bring this innovative precision therapy to patients with difficult to treat cancers.' Continued Prioritization of RP-3467 and RP-1664 Moving forward, Repare will remain focused on the advancement of its two ongoing Phase 1 clinical trials, POLAR and LIONS. The POLAR clinical trial is a multicenter, open-label, dose-escalation Phase 1 clinical trial designed to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RP-3467, a small molecule inhibitor of polymerase theta (Polθ) that is a synthetic lethality target associated with BRCA mutations and other genomic alterations, alone or in combination with olaparib in adults with locally advanced or metastatic epithelial ovarian cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer, or pancreatic adenocarcinoma. Topline safety, tolerability and early efficacy data from the Phase 1 POLAR clinical trial of RP-3467 alone and in combination with olaparib is expected in the third quarter of 2025. The LIONS clinical trial is a first-in-human, multicenter, open-label Phase 1 clinical trial designed to investigate safety, pharmacokinetics, pharmacodynamics and the preliminary efficacy of RP-1664, a first-in-class, highly selective, oral inhibitor of Polo-like kinase 4 (PLK4) that is a synthetic lethality target associated with TRIM37 overexpression. Initial topline safety, tolerability and early efficacy data from the Phase 1 LIONS clinical trial of RP-1664 is expected in the fourth quarter of 2025. About Repare Therapeutics Inc. Repare Therapeutics is a clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. Repare Therapeutics has developed highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company's clinical-stage pipeline includes RP-3467, a Phase 1 Polθ ATPase inhibitor and RP-1664, a Phase 1 PLK4 inhibitor. For more information, please visit and follow @Reparerx on X (formerly Twitter) and LinkedIn. Debiopharm's Commitment to Patients Debiopharm aims to develop innovative therapies that target high unmet medical needs in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then hand stewardship to large pharmaceutical commercialization partners to maximize patient access globally. For more information, please visit Follow us, we are on 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 Company's out-license of lunresertib to Debiopharm, including the potential benefits of the transaction and the achievement and receipt of milestone payments and royalties under the license agreement; the Company's anticipated cash runway; the timing, progress and results of the Company's ongoing Phase 1 LIONS and POLAR clinical trials; and the potential, tolerability, efficacy and clinical progress of the Company's product candidates, including the potential of lunresertib to treat patients with difficult-to-treat solid tumors as a monotherapy or in combination with Debio 0123. 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 tariffs and other trade policies, the conflict in Ukraine and the conflict in the Middle East, fluctuations in 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 Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission ('SEC') and the Québec Autorité des Marchés Financiers ("AMF") on March 3, 2025, and in other filings made with the SEC and AMF from time to time, including the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025. 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 and follow Repare on X (formerly Twitter) at @RepareRx and on LinkedIn at
Yahoo
29-05-2025
- Business
- Yahoo
Debiopharm Ignites Oncology Innovation With Clinical and Translational Data on Debio 0123 at the 2025 ASCO Annual Meeting in Chicago
Debiopharm announces an abstract publication and three poster presentations on Debio 0123, a highly selective WEE1 inhibitor, in multiple solid tumor indications. LAUSANNE, Switzerland, May 29, 2025--(BUSINESS WIRE)--Debiopharm ( a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow's standard-of-care to cure cancer and infectious diseases, today unveiled its upcoming contributions to the 2025 Annual American Society of Clinical Oncology (ASCO) Meeting in Chicago, Illinois. The contributions feature three clinical poster presentations and one translational research abstract publication, highlighting Debio 0123's potential across solid tumors. Among them is new data from the Debio 0123-SCLC-104 trial in small-cell lung cancer, offering insights into the candidate's therapeutic potential in this difficult-to-treat disease. A Trial in Progress (TiP) poster from the investigator-initiated MedSir study—co-authored by Debiopharm—will present the design and methodology of the study investigating the combination of Debio 0123 with Trodelvy® in breast cancer patients. In parallel, a separate TiP poster for the Debio 0123-102 monotherapy study will outline the framework and objectives of the ongoing dose expansion phase. "Presenting our latest data on Debio 0123 at ASCO 2025 is a proud milestone for our team," said Angela Zubel, Chief Development Officer at Debiopharm. "This research highlights the promise of WEE1 inhibition as a precision strategy to target the vulnerabilities of aggressive cancers. Our goal is to push the boundaries of innovation to bring transformative therapies to patients who urgently need new options." Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology ASCO 2025 Contribution Title Presenter/Author Abstract #e15127 *Publication only In silico evaluation of the interaction of P-gp and 3A4 substrates with the WEE1 inhibitor Debio 0123 and clinical application in the Debio 0123-104 combination trial with carboplatin and etoposide. Anne Bellon, PhD, PharmD Debiopharm Abstract #TPS3172 Poster Bd #: 479b Phase IB/II study to evaluate safety and preliminary efficacy of the WEE1 inhibitor Debio 0123 in combination with sacituzumab govitecan (SG) in triple-negative or hormone receptor–positive (HR+)/HER2-negative (HER2–) advanced breast cancer (ABC): The WIN-B study. Maria Gion, MD, PhD Medical Oncologist at Ramón y Cajal University Hospital *Medsir and Debiopharm Session Title: Gynecologic Cancer ASCO 2025 Contribution Title Presenter/Author Abstract #TPS5634 Poster Bd #: 524a Debio 0123, a highly selective WEE1 inhibitor in adult patients with advanced solid tumors: A phase 1 dose escalation and expansion monotherapy study. Maria M. Rubinstein, MD Memorial Sloan Kettering Cancer Center, New York, NY Session Title: Lung Cancer—Non–Small Cell Local-Regional/Small Cell/Other Thoracic Cancers ASCO 2025 Contribution Title Presenter/Author Abstract #8098 Poster Bd #: 219 Debio 0123, a highly selective WEE1 inhibitor, in combination with carboplatin (C) and etoposide (E), in patients (pts) with recurrent small cell lung cancer (SCLC): Determination of recommended dose (RD) from a phase 1 escalation. Valentina Gambardella, MD, PhD Department of Medical Oncology, Hospital Clínico Universitario, INCLIVA Biomedical Research Institute, University of Valencia, Valencia, Spain About DNA-Damage Repair (DDR) When cells have damaged DNA, they need to undergo a repair process called DDR to be able to survive. Cancer cells rely heavily on DDR as they divide and grow uncontrollably. Inhibition of DDR, particularly in combination with other anticancer agents, prevents cancer cells from repairing their DNA, which ultimately activates a self-destruction program in cancer cells. DDR inhibitors such as Debiopharm's WEE1 inhibitor Debio 0123 are being tested in clinical and preclinical studies. Debiopharm's commitment to patients Debiopharm aims to develop innovative therapies that target high unmet medical needs primarily in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then hand stewardship to large pharmaceutical commercialization partners to maximize patient access globally. For more information, please visit Follow us on LinkedIn: View source version on Contacts Debiopharm Contact Dawn BonineHead of Tel: +41 (0)21 321 01 11
Associated Press
29-05-2025
- Business
- Associated Press
Debiopharm Ignites Oncology Innovation With Clinical and Translational Data on Debio 0123 at the 2025 ASCO Annual Meeting in Chicago
LAUSANNE, Switzerland--(BUSINESS WIRE)--May 29, 2025-- Debiopharm ( ), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow's standard-of-care to cure cancer and infectious diseases, today unveiled its upcoming contributions to the 2025 Annual American Society of Clinical Oncology (ASCO) Meeting in Chicago, Illinois. The contributions feature three clinical poster presentations and one translational research abstract publication, highlighting Debio 0123's potential across solid tumors. Among them is new data from the Debio 0123-SCLC-104 trial in small-cell lung cancer, offering insights into the candidate's therapeutic potential in this difficult-to-treat disease. A Trial in Progress (TiP) poster from the investigator-initiated MedSir study—co-authored by Debiopharm—will present the design and methodology of the study investigating the combination of Debio 0123 with Trodelvy® in breast cancer patients. In parallel, a separate TiP poster for the Debio 0123-102 monotherapy study will outline the framework and objectives of the ongoing dose expansion phase. 'Presenting our latest data on Debio 0123 at ASCO 2025 is a proud milestone for our team,' said Angela Zubel, Chief Development Officer at Debiopharm. 'This research highlights the promise of WEE1 inhibition as a precision strategy to target the vulnerabilities of aggressive cancers. Our goal is to push the boundaries of innovation to bring transformative therapies to patients who urgently need new options.' Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Session Title: Gynecologic Cancer Session Title: Lung Cancer—Non–Small Cell Local-Regional/Small Cell/Other Thoracic Cancers About DNA-Damage Repair (DDR) When cells have damaged DNA, they need to undergo a repair process called DDR to be able to survive. Cancer cells rely heavily on DDR as they divide and grow uncontrollably. Inhibition of DDR, particularly in combination with other anticancer agents, prevents cancer cells from repairing their DNA, which ultimately activates a self-destruction program in cancer cells. DDR inhibitors such as Debiopharm's WEE1 inhibitor Debio 0123 are being tested in clinical and preclinical studies. Debiopharm's commitment to patients Debiopharm aims to develop innovative therapies that target high unmet medical needs primarily in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then hand stewardship to large pharmaceutical commercialization partners to maximize patient access globally. For more information, please visit Follow us on LinkedIn: View source version on CONTACT: Debiopharm Contact Dawn Bonine Head of Communications [email protected] Tel: +41 (0)21 321 01 11 KEYWORD: ILLINOIS EUROPE SWITZERLAND UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: ONCOLOGY HEALTH CLINICAL TRIALS RESEARCH SCIENCE PHARMACEUTICAL BIOTECHNOLOGY SOURCE: Debiopharm Copyright Business Wire 2025. PUB: 05/29/2025 08:00 AM/DISC: 05/29/2025 07:59 AM
Business Wire
22-04-2025
- Business
- Business Wire
Debiopharm to Reveal Insights From Their ADC, DDR Inhibitor, and Antibody Conjugation Technology Research at the 2025 AACR Conference in Chicago
LAUSANNE, Switzerland--(BUSINESS WIRE)--Debiopharm ( a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow's standard-of-care to cure cancer and infectious diseases and develop new antibody linker technologies, will release promising new data for two of its pipeline products at the 2025 Annual American Association for Cancer Research (AACR) meeting in Chicago, Illinois. Furthermore, a joint poster presentation with Oncodesign Services ( will highlight the applicability of its antibody conjugation technology, AbYlink™, in the preparation of conjugates for use in non-invasive preclinical imaging. Comprehensive preclinical results will be presented for Debio 1562M, a next-generation Antibody-Drug Conjugate (ADC) targeting the cell surface glycoprotein CD37 soon to undergo first-in-human evaluation. Two preclinical data releases will be included in the poster display sessions for Debio 0123, a selective WEE1 kinase inhibitor disrupting the DNA-damage response (DDR) of cancer cells. The first data release shows how Debio 0123 can be used in combination with the PKMYT1 inhibitor lunresertib as a promising therapeutic strategy in ovarian and breast cancer. The company will also unveil new impactful findings stemming from its collaboration with Genialis, showing how machine learning has the potential to enhance the ability to predict responders to Debio 0123, thus further advancing the understanding and application of WEE1 biology and response to inhibitors. Additionally, in the framework of a licensing agreement and a collaborative endeavor to support innovative research, Debiopharm and Oncodesign Services will present promising new data illustrating how AbYlink™ conjugation technology can facilitate the production of conjugates for use in preclinical research in cancer treatment. 'The pre-clinical results to be released during the AACR are laying a solid foundation for future research,' explained Angela Zubel, Chief Development Officer, Debiopharm. 'The two drug research approaches of ADCs and DDR inhibition are harnessing novel modalities and targets with the potential to outsmart hard-to-treat liquid and solid tumors, revolutionizing patient outcomes. Our AbYlink™ technology demonstrates great potential in the context of antibody radio conjugates against cancer and shows promise for broader use and wider applications.' Poster Session Title: Artificial Intelligence and Machine Learning for Therapeutic Election and Discovery AACR 2025 Poster Presentation Debiopharm compound Title Presenter -Mon, April 28 th -Poster display: 2:00-5:00pm -Abstract #3659 -Poster Section: 45 -Poster Board #: 21 Debio 0123 Biology-driven, machine learning-based development of a biomarker to predict response to WEE1 inhibitor Debio 0123 Kristian Urh, Genialis Expand Poster Session Title: Radiation Treatment Combinations for Tumors, Normal Tissue About DNA-Damage Repair (DDR) When cells have damaged DNA, they need to undergo a repair process called DDR to be able to survive. Cancer cells rely a lot on DDR as they divide and grow uncontrollably. Inhibition of DDR, particularly in combination with other anticancer agents, prevents cancer cells from repairing their DNA, which ultimately activates a self-destruction program in cancer cells. DDR inhibitors such as Debio 0123, a WEE1 inhibitor from Debiopharm, are being tested in clinical and preclinical studies. Debiopharm's ADC portfolio We're developing fit-for-purpose antibody drug conjugates through a tailored 'Trifecta' approach: strategic target selection, innovative Multilink™ linker technology and smart payload choices. Our broad and balanced portfolio of 1st-in-class and best-in-class ADCs includes Debio 0633 (undisclosed target), Debio 1562M, a CD37-targeted ADC for the treatment of acute myeloid leukemia (AML) Myelodysplastic syndromes (MDS), Debio 0532, an HER3-targeted ADC for solid tumors, as well as other ADCs for undisclosed targets including a proprietary bispecific ADC. Key partnerships also comprise options to in-licence bispecific antibodies targeting HER2-HER3 and HER3-EGFR along with other antibodies for undisclosed targets. To allow both high DAR and high stability, our ADCs are designed with our innovative proprietary Multilink™ linker technology. We're leveraging key collaborations and our in-house capabilities including ADC conjugation, optimization, PK/PD, toxicology, translational medicine, clinical development and supply chain to produce novel ADCs that respond to the high unmet needs of cancer patients. About AbYlink™ AbYlink™ is a versatile and rapid regio-selective chemical conjugation technology for use to prepare diagnostic or therapeutic conjugates. This one step method results in stable conjugation at defined and invariable sites on the Fc domain of an antibody or the like, with no impact on antigen-binding regions. It enables a seamless and reproducible conjugation of payloads (e.g. a chelator for radiolabeling, a fluorescent dye or a drug) to antibodies or ADCs. The universal applicability of the technology has been demonstrated for various antibody isotypes and payloads. Debiopharm's commitment to cancer patients Debiopharm develops innovative therapies that target high unmet medical needs in oncology and infectious diseases. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential assets and technologies for in- licensing, clinically demonstrate their safety and efficacy, and then select pharmaceutical commercialization partners to maximize patient access globally.
