Latest news with #WEE1
Yahoo
6 days ago
- 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
Yahoo
25-03-2025
- Business
- Yahoo
Zentalis Pharmaceuticals to Present Multiple Posters at the American Association for Cancer Research (AACR) Annual Meeting 2025
One poster demonstrating cell-free DNA molecular response as a potential surrogate endpoint to measure clinical efficacy of azenosertib in patients with high-grade serous ovarian cancer (HGSOC) Three additional posters highlighting the potential for broad therapeutic applications of azenosertib as both a single agent and combination therapy as shown in preclinical models SAN DIEGO, March 25, 2025 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company developing a potentially first-in-class and best-in-class WEE1 inhibitor for patients with ovarian cancer and other tumor types, today announced four poster presentations at the 2025 American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Chicago, IL. AACR poster presentation details are below: Title: 'Loss of RB1 sensitizes TP53-mutated cancer cells to WEE1 inhibition by azenosertib'Session Title: Cell Cycle Effects of Anticancer DrugsLocation: Poster Section 17, Poster Board Number 16Abstract Number: 372Date/Time: Sunday, April 27, 2024, 2:00 p.m. - 5:00 p.m. CDTPresenting Author: Gabriel Kim, PhD Title: 'Cell-free DNA molecular response predicts clinical efficacy in HGSOC patients treated with azenosertib'Session Title: Liquid Biopsy: Circulating Nucleic Acids 1Location: Poster Section 29, Poster Board Number 19Abstract Number: 3254Date/Time: Monday, April 28, 2024, 2:00 p.m. - 5:00 p.m. CDTPresenting Author: Jinkil Jeong, PhD Title: 'Azenosertib is a potent and selective WEE1 kinase inhibitor with broad antitumor activity across a range of solid tumors'Session Title: DNA Damage Response and Modulation of DNA Repair 2Location: Poster Section 15, Poster Board Number 25Abstract Number: 4208Date/Time: Tuesday, April 29, 2024, 9:00 a.m. - 12:00 p.m. CDTPresenting Author: Wen Liu, PhD Title: 'The selective WEE1 inhibitor azenosertib shows synergistic anti-tumor activity with encorafenib + cetuximab in multiple BRAFV600E models'Session Title: Targeted Therapies and Combinations 2Location: Poster Section 34, Poster Board Number 28Abstract Number: 4730Date/Time: Tuesday, April 29, 2024, 9:00 a.m. - 12:00 p.m. CDT Presenting Author: Harsh Shah, PhD The posters can be accessed through the 'Supporting Publications' tab on the 'Our Approach' section of the Zentalis website at the time of each presentation's starting session. About Azenosertib Azenosertib is a novel, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated as a monotherapy and combination clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death. About Zentalis Pharmaceuticals Zentalis® Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing azenosertib (ZN-c3), a potentially first-in-class and best-in-class WEE1 inhibitor for patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC). Azenosertib is being evaluated as a monotherapy and in combination across multiple tumor types in clinical trials and has broad franchise potential. In clinical trials, azenosertib has been well tolerated and has demonstrated anti-tumor activity as a single agent across multiple tumor types. The Company is also leveraging its extensive experience and capabilities to translate its science to advance research on additional areas of opportunity for azenosertib outside PROC. Zentalis has operations in San Diego. For more information, please visit Follow Zentalis on X/Twitter at @ZentalisP and on LinkedIn at Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the potential for cell-free DNA molecular response as a surrogate endpoint to measure clinical efficacy of azenosertib in patients with HGSOC; the potential benefits of azenosertib, including the potential for broad therapeutic applications of azenosertib as single agent and combination therapy; the potential to advance research on additional areas of opportunity for azenosertib outside PROC; the potential for azenosertib to be first-in-class and best-in-class; and the broad franchise potential of azenosertib. The terms 'opportunity' and 'potential' and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our plans, including the costs thereof, of development of companion diagnostics; our substantial dependence on the success of our lead product candidate, azenosertib; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; failure to identify additional product candidates and develop or commercialize marketable products; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; failure to obtain U.S. or international marketing approval; our product candidates may cause serious adverse side effects; inability to maintain our collaborations, or the failure of these collaborations; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption 'Risk Factors' in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release. Contact: Haibo Wang - Chief Business OfficerRon Moldaver - Investor Relationsir@ Sign in to access your portfolio
Yahoo
29-01-2025
- Business
- Yahoo
Zentalis Pharmaceuticals Announces Strategic Restructuring to Support Late-Stage Azenosertib Development
Extended cash runway into late 2027, beyond a potentially registration-enabling azenosertib data readout from DENALI Part 2 Planned workforce reduction of approximately 40% of employees Corporate event to be held on January 29, 2025 at 8:00am ET to provide key updates on azenosertib clinical data, development and regulatory path SAN DIEGO, Jan. 28, 2025 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced a restructuring of its business operations and research and development organization to support execution of late-stage development for its WEE1 inhibitor product candidate, azenosertib, and extend its cash runway beyond a data readout from its potentially registration-enabling DENALI Part 2 study, anticipated by the end of 2026. "Zentalis is sharply focused on our goal of bringing azenosertib to patients with gynecological malignancies,' said Julie Eastland, Chief Executive Officer. 'To support this goal, we have made the necessary decisions to efficiently organize our company and allocate our capital resources to extend cash runway beyond an anticipated azenosertib data readout that we believe has the potential to be registration-enabling. I want to thank all the individuals departing the Company for their valuable contributions to all Zentalis programs and the development of azenosertib. Tomorrow morning, we look forward to hosting a corporate event to share updated azenosertib clinical data and provide a development and regulatory update, including plans for our registration-intent studies, as we work to bring this therapeutic candidate forward to patients as quickly as possible.' The workforce reduction is expected to be substantially completed in the second quarter of 2025. Corporate Event DetailsOn January 29, 2025, at 8:00am ET Zentalis will host a virtual corporate event to present data from its studies of azenosertib and provide a development and regulatory update. Access to a live webcast of this event, as well as an archived recording, will be available under the 'Events & Presentations' tab on the Investors & Media section of the Company's website. Analysts who wish to join the teleconference and participate in Q&A should register here. About AzenosertibAzenosertib is a novel, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated as a monotherapy and in combination clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death. About Zentalis Pharmaceuticals Zentalis® Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers. The Company's lead product candidate, azenosertib (ZN-c3), is a potentially first-in-class and best-in-class WEE1 inhibitor for advanced solid tumors. Azenosertib is being evaluated as a monotherapy and in combination across multiple clinical trials and has broad franchise potential. In clinical trials, azenosertib has been well tolerated and has demonstrated anti-tumor activity as a single agent across multiple tumor types and in combination with several chemotherapy backbones. As part of its azenosertib clinical development program, the Company is exploring enrichment strategies targeting tumors of high genomic instability, such as Cyclin E1 positive tumors, homologous recombination deficient tumors and tumors with oncogenic driver mutations. The Company is also leveraging its extensive experience and capabilities across cancer biology and medicinal chemistry to advance its research on protein degraders. Zentalis has operations in San Diego. For more information, please visit Follow Zentalis on X/Twitter at @ZentalisP and on LinkedIn at Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the potential of azenosertib; our plans to hold a corporate event and provide updates on azenosertib clinical data, development and regulatory path, including the timing and content thereof; our planned strategic restructuring, including the planned workforce reduction, and the estimated size, timing and impact thereof; our ability to recognize the benefits of the planned strategic restructuring; our estimated cash runway; our planned development strategy for azenosertib and the timing thereof, including plans for registration-intent studies and the potential for there to be a registration-enabling data readout and the estimated timing thereof; the Company's goal of bringing azenosertib to patients with gynecological malignancies; the potential for azenosertib to be first-in-class and best-in-class; the broad franchise potential of azenosertib; and our plans with respect to the development of our product candidates, including azenosertib. The terms 'anticipate,' 'believe,' 'beyond,' 'expect,' 'forward,' 'goal,' 'look forward,' 'plan,' 'potential,' 'support,' 'to be' and 'will' and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our plans, including the costs thereof, of development of any diagnostic tools; our substantial dependence on the success of our lead product candidate, azenosertib; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; failure to identify additional product candidates and develop or commercialize marketable products; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; failure to obtain U.S. or international marketing approval; our product candidates may cause serious adverse side effects; inability to maintain our collaborations, or the failure of these collaborations; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption 'Risk Factors' in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release. Contact:Elizabeth Pingpank Hickinehickin@ in to access your portfolio
Yahoo
28-01-2025
- Business
- Yahoo
Zentalis Pharmaceuticals Announces Strategic Restructuring to Support Late-Stage Azenosertib Development
Extended cash runway into late 2027, beyond a potentially registration-enabling azenosertib data readout from DENALI Part 2 Planned workforce reduction of approximately 40% of employees Corporate event to be held on January 29, 2025 at 8:00am ET to provide key updates on azenosertib clinical data, development and regulatory path SAN DIEGO, Jan. 28, 2025 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced a restructuring of its business operations and research and development organization to support execution of late-stage development for its WEE1 inhibitor product candidate, azenosertib, and extend its cash runway beyond a data readout from its potentially registration-enabling DENALI Part 2 study, anticipated by the end of 2026. "Zentalis is sharply focused on our goal of bringing azenosertib to patients with gynecological malignancies,' said Julie Eastland, Chief Executive Officer. 'To support this goal, we have made the necessary decisions to efficiently organize our company and allocate our capital resources to extend cash runway beyond an anticipated azenosertib data readout that we believe has the potential to be registration-enabling. I want to thank all the individuals departing the Company for their valuable contributions to all Zentalis programs and the development of azenosertib. Tomorrow morning, we look forward to hosting a corporate event to share updated azenosertib clinical data and provide a development and regulatory update, including plans for our registration-intent studies, as we work to bring this therapeutic candidate forward to patients as quickly as possible.' The workforce reduction is expected to be substantially completed in the second quarter of 2025. Corporate Event DetailsOn January 29, 2025, at 8:00am ET Zentalis will host a virtual corporate event to present data from its studies of azenosertib and provide a development and regulatory update. Access to a live webcast of this event, as well as an archived recording, will be available under the 'Events & Presentations' tab on the Investors & Media section of the Company's website. Analysts who wish to join the teleconference and participate in Q&A should register here. About AzenosertibAzenosertib is a novel, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated as a monotherapy and in combination clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death. About Zentalis Pharmaceuticals Zentalis® Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers. The Company's lead product candidate, azenosertib (ZN-c3), is a potentially first-in-class and best-in-class WEE1 inhibitor for advanced solid tumors. Azenosertib is being evaluated as a monotherapy and in combination across multiple clinical trials and has broad franchise potential. In clinical trials, azenosertib has been well tolerated and has demonstrated anti-tumor activity as a single agent across multiple tumor types and in combination with several chemotherapy backbones. As part of its azenosertib clinical development program, the Company is exploring enrichment strategies targeting tumors of high genomic instability, such as Cyclin E1 positive tumors, homologous recombination deficient tumors and tumors with oncogenic driver mutations. The Company is also leveraging its extensive experience and capabilities across cancer biology and medicinal chemistry to advance its research on protein degraders. Zentalis has operations in San Diego. For more information, please visit Follow Zentalis on X/Twitter at @ZentalisP and on LinkedIn at Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the potential of azenosertib; our plans to hold a corporate event and provide updates on azenosertib clinical data, development and regulatory path, including the timing and content thereof; our planned strategic restructuring, including the planned workforce reduction, and the estimated size, timing and impact thereof; our ability to recognize the benefits of the planned strategic restructuring; our estimated cash runway; our planned development strategy for azenosertib and the timing thereof, including plans for registration-intent studies and the potential for there to be a registration-enabling data readout and the estimated timing thereof; the Company's goal of bringing azenosertib to patients with gynecological malignancies; the potential for azenosertib to be first-in-class and best-in-class; the broad franchise potential of azenosertib; and our plans with respect to the development of our product candidates, including azenosertib. The terms 'anticipate,' 'believe,' 'beyond,' 'expect,' 'forward,' 'goal,' 'look forward,' 'plan,' 'potential,' 'support,' 'to be' and 'will' and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our plans, including the costs thereof, of development of any diagnostic tools; our substantial dependence on the success of our lead product candidate, azenosertib; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; failure to identify additional product candidates and develop or commercialize marketable products; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; failure to obtain U.S. or international marketing approval; our product candidates may cause serious adverse side effects; inability to maintain our collaborations, or the failure of these collaborations; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption 'Risk Factors' in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release. Contact:Elizabeth Pingpank Hickinehickin@
Yahoo
28-01-2025
- Business
- Yahoo
Genialis Advances Biomarker Discovery to Reduce Risk in Cancer Drug Development Targeting DNA Damage Response Pathways
Extending their collaboration, Genialis and Debiopharm continue working towards a patient classifier to support WEE1 clinical development BOSTON, January 28, 2025--(BUSINESS WIRE)--Genialis, the RNA biomarker company, today announced an extension of its collaboration with Debiopharm, a Swiss-based global biopharmaceutical company, to develop a predictive biomarker for WEE1-targeted therapy. This extension builds on a 2024 agreement to define and discover biomarkers within the DNA damage response (DDR) biological space to predict the clinical benefit of one or more drugs in Debiopharm's pipeline. Debiopharm's WEE1 asset is currently in Phase 1 clinical research and is being studied in monotherapy and in combination in collaboration with international partners. "As an industry, we must redefine what it means to develop a biomarker that is highly effective in selecting patients for the right therapies," said Luke Piggott, PhD, Principal Scientist at Debiopharm. "Genialis is leveraging advanced artificial intelligence and RNA-sequencing data to classify patients into responder/non-responder groups based on a comprehensive evaluation of relevant biological mechanisms. This approach has shown great promise in our early work together, and we look forward to further refining this innovative solution to get therapies that are more precisely targeted and effective for patients." DDR is a promising arena for the development of precision medicines, highlighted by the approvals of various PARP inhibitors indicated for ovarian, breast, pancreatic, and prostate cancers associated with BRCA mutations. Other druggable DDR targets, such as ATR, ATM, and WEE1, show potential in preclinical and early clinical trials, but also face challenges balancing toxicity and efficacy. While BRCA-indicated PARP therapies have received approvals in various clinical settings, most drugs under development lack accurate and informative biomarkers to guide clinical trial and treatment decisions. One solution addressing the lack of biomarkers in the DDR space is the Genialis™ Supermodel, an AI-powered foundation model known as a large molecular model, or "LMM." This technology enables rapid configuration of biomarkers across the entire landscape of cancer drug targets, including DDR. Trained on hundreds of thousands of globally diverse RNA-seq samples, the Genialis Supermodel generates biomarkers that stratify response groups, identify mechanisms of response and resistance, and suggest combination therapies. "A persistent challenge in developing DDR therapies is the lack of truly predictive biomarkers to guide patient selection and optimize clinical outcomes. Most cancers cannot be adequately characterized by individual mutations or proteins, or even a composite of these," said Rafael Rosengarten, Ph.D., CEO of Genialis. "The Genialis Supermodel is the cornerstone of our biomarker programs, driving innovation across a broad range of cancer drug targets. We're taking the success we've had with KRAS-targeted therapies and applying a similar approach to the DDR drug space. I am confident our work with Debiopharm will move the needle for WEE1 and am excited to explore the rest of the target-rich DDR landscape." Today's announcement follows the recent dispatch from Tempus AI (NASDAQ: TEM), a leader in AI-driven precision medicine, announcing a multi-year agreement with Genialis to leverage Tempus' multimodal dataset for the validation of new RNA-based biomarker algorithms across various cancer types. Genialis will be attending the 8th Annual DDR Inhibitors Summit in Boston, January 28-30, 2025, and presenting an abstract with Debiopharm at the American Association for Cancer Research (AACR) Annual Meeting 2025 meeting in April. To schedule a meeting or learn more about Genialis Supermodel, please visit or email biomarkers@ About Genialis Genialis is creating a world where healthcare delivers the best possible outcomes for patients, families, and communities. As the RNA biomarker company, Genialis develops clinically-actionable biomarkers informed by the world's most diverse cancer data to guide precision medicine. Partnering with leading pharmaceutical and diagnostic companies, Genialis is transforming medicine through data. Learn more at About Debiopharm Debiopharm develops innovative therapies that target high unmet medical needs in oncology and infectious diseases. Bridging the gap between disruptive discovery products and international patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally. For more information, please visit View source version on Contacts Media Contacts Andrea VuturoVuturo Group for Genialisandrea@ +1 (415) 689-8414 Sign in to access your portfolio
