DEBIOPHARM
28.5.2024 14:15:27 CEST | Business Wire | Press release
Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, today announced that it has entered a clinical collaboration with MEDSIR (www.medsir.org), a Spanish and US-based, international and innovative research organization in clinical oncology. The study will evaluate the safety and efficacy of Debio 0123 (Debiopharm's investigational, potential best-in-class WEE1 inhibitor) together with sacituzumab govitecan (Trodelvy®; an antibody-drug conjugate [ADC] owned and commercialized by Gilead Sciences, Inc. [Gilead]). Sites for this Phase 1b/2 investigator-initiated trial in patients with previously treated advanced breast cancer will be opened in Europe, UK, and the USA.
“We are thrilled about the launch of this study exploring the combination of our WEE1 inhibitor with Trodelvy and are looking forward to seeing the potential benefits in breast cancer patients” said Esteban Rodrigo Imedio, Executive Medical Director, Oncology, Debiopharm.
Hormone receptor-positive (HR+)/HER2- is the most common type of breast cancer and it accounts for 70% of all breast cancers. It groups estrogen-receptor (ER) and/or progesterone-receptor (PR) expressing cells. Almost one in three cases of early-stage breast cancer eventually become metastatic, and among patients with HR+/HER2- metastatic disease, the five-year relative survival rate is 30%. As patients with HR+/HER2- metastatic breast cancer become resistant to endocrine-based therapy, their primary treatment option is limited to single-agent chemotherapy. For patients treated with single-agent chemotherapy, the prognosis remains poor [1]. Despite having a more favorable outcome than other breast cancer subtypes like HER2-positive and triple-negative breast cancers (TNBC), relapse still occurs and there remains a high unmet medical need for this patient population [2-3]. TNBC is an aggressive type of breast cancer that accounts for 10-15% of all breast cancers. It is called “triple negative” as it does not express ER, PR or HER2 receptors. Because of its aggressive nature, TNBC has a high risk of metastasis either at diagnosis or at time of relapse after initial curative therapy, which explains the poor prognosis many TNBC patients face. Compared to other types of breast cancer, the relapse rate as well as the mortality rate in the 5 years after diagnosis is significantly higher [4-5].
“It’s great to see companies like Debiopharm that are open to investigating novel combination strategies to support breast cancer patients. I look forward to seeing potential benefits for patients” Dr. Tim Robinson, Principal Investigator, University of Bristol.
Sacituzumab govitecan is a Trop-2-directed ADC currently approved globally for patients with 2L metastatic TNBC and pre-treated HR+/HER2- metastatic breast cancer The clinical trial will enroll patients with HR[+]/HER2[-] metastatic breast cancer and metastatic TNBC, and will be sponsored by MEDSIR, and fully funded by Debiopharm. Gilead will provide supply of sacituzumab govitecan.
“We are honored to develop this Investigator Sponsor Trial (IST) in collaboration with Debiopharm and Gilead to explore new approaches to breast cancer treatment. Together, we're committed to advancing patient care and fostering important partnerships in the oncology field. I believe our work with Debio 0123 and sacituzumab govitecan holds great promise for patients” said Dr. Javier Cortés, MEDSIR Senior Scientific Lead.
The foundations for this clinical trial were set by the promising preclinical data suggesting an existing synergy between Debiopharm’s Debio 0123 and Gilead’s sacituzumab govitecan. These results will be disclosed at the American Association for Cancer Research (AACR) annual meeting 2024 under the title “Anti-tumor activity of Debio 0123 in combination with sacituzumab govitecan in preclinical models of breast cancer” [6].
About Debio 0123
Debio 0123 is a brain-penetrant, highly selective WEE1 kinase inhibitor. WEE1 is a key regulator of the G2/M and S phase checkpoints, activated in response to DNA damage, allowing cells to repair their DNA before resuming their cell cycle. WEE1 inhibition, particularly in combination with DNA damaging agents, induces an overload of DNA breaks. In conjunction with abrogation of other checkpoints such as G1, the compound pushes the cells through cell cycle without DNA repair, promoting mitotic catastrophe and inducing apoptosis of cancer cells. Currently investigated in clinical trials for solid tumors in monotherapy and combination, Debio 0123 is being developed to respond to high unmet needs of patients living with the burden of difficult-to-treat cancers.
About MEDSIR
Founded in 2012, MEDSIR works closely with its partners to drive innovation in oncology research. Based in Spain and the United States, the company manages all aspects of clinical trials, from study design to publication, utilizing a global network of experts and integrated technology to streamline the process.
The company offers proof-of-concept support and a strategic approach that helps research partners experience the best of both worlds from industry-based clinical research and investigator-driven trials. To promote independent cancer research worldwide, MEDSIR has a strategic alliance with Oncoclínicas, the leading oncology group in Brazil with the greatest research potential in South America. Learn how MEDSIR brings ideas to life: www.medsir.org.
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 www.debiopharm.com
We are on Twitter. Follow us @DebiopharmNews at http://twitter.com/DebiopharmNews.
Sources
[1] Rugo et al., ASCO 2022 Abstract #LBA1001
[2] American Cancer Society. 2021
[3] McAndrew NP, Finn RS. 2022
[4] Dass SA, Tan KL, Selva Rajan R, Mokhtar NF, Mohd Adzmi ER, Wan Abdul Rahman WF, Tengku Din TADA, Balakrishnan V. 2021
[5] American Cancer Society. 2023
[6] Piggott et al., AACR 2024 Abstract #3370
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240528066531/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Lattice to Showcase Advanced Edge AI Solutions at the FPGA-forum 202628.1.2026 22:00:00 CET | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable leader, today announced its exhibition plan for the upcoming FPGA-forum 2026 taking place February 11 – 12, 2026 in Trondheim, Norway. As part of the event, Lattice Corporate Vice President of Software Solutions and Applications Engineering Eleena Ong will deliver a keynote presentation exploring how rapidly maturing AI technologies can turn FPGA platforms into innovation canvases for a much broader range of developers, sparking new application possibilities. Lattice will also deliver a technical presentation and host a demo showcase focused on how its low power FPGA solutions are advancing connectivity and edge AI applications. Who: Lattice Semiconductor What / When (GMT+1): Lattice Demo Showcase (Table #3), Feb 11-12 Keynote Feb. 11, 9:30 a.m. “Unlocking the Next Wave of FPGA Innovators with Generative and Agentic AI” Technical Presentation Feb. 12, 10 a.m. “Smaller. Cooler. Smarter: Lattice FPGAs’ Path to Uncompromised
Egon Zehnder Elects German Herrera as New Chair28.1.2026 20:01:00 CET | Press release
Herrera succeeds Michael Ensser, who will remain an active member of the Firm after his term in a planned transition. Egon Zehnder, the world’s premier leadership advisory firm, today announced that, in accordance with its established governance and three-year election cycle, German Herrera has been elected as the Firm’s next Chair by its worldwide partnership. Herrera will assume the role effective March 1, 2026. He will succeed Michael Ensser, who has held the position since 2022, in a planned succession at the conclusion of his regular term. Herrera joined the Firm in 1998 in Bogotá and has helped shape the Firm’s global presence, taking on a broad range of leadership roles, from co-leading the Global Family Business Advisory Practice to serving on the Executive Committee and the Market Council. Most recently, Herrera has guided Egon Zehnder’s U.S. market through a period of impressive growth and transformation, which today includes 15 offices and more than 150 consultants. As the f
De' Longhi Group - Record Preliminary 2025 Revenues of €3.8 Billion, up 10.4% at Constant Exchange Rates28.1.2026 19:25:00 CET | Press release
The Group closed 2025 with brilliant results and solid growth at constant currency across both divisions throughout the year, further confirmed by an organic expansion of 8.2% in Q4 Below are the preliminary 2025 revenues for the De’ Longhi S.p.A. Group: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260128191504/en/12 months, revenues at € 3,801.5 million, growing at 8.7% (+10.4% at constant currency); fourth quarter, revenues at € 1,340.0 million, growing at 5.7% (+8.2% at constant currency). Fabio de' Longhi, CEO of the Group, stated: "The Group achieved solid growth at constant currency of 10.4% in 2025, characterized by consistent results throughout the year. We are particularly pleased with the excellent performance achieved in the fourth quarter, which successfully overcame the challenges posed by the current market environment. The household division consolidated its recent growth momentum during the quarter, with or
Organon Completes Divestiture of JADA® System to Laborie28.1.2026 18:45:00 CET | Press release
Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today the successful closing of the sale of its JADA® System to Laborie Medical Technologies Corp. Please see our prior announcement for a summary of the transaction terms. Indications for Use The JADA® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. Contraindications Ongoing intrauterine pregnancy Untreated uterine rupture Unresolved uterine inversion Current cervical cancer Known uterine anomaly Current purulent infection of vagina, cervix, or uterus For C-sections: Cervix <3 cm dilated before use of JADA Warnings Avoid excessive force when inserting JADA into the uterus or trauma to uterine wall may occur, including perforation. The safety and effectiveness of the JADA System in delivery at a gestational age <34 weeks or, if multiples, uter
Laserfiche Expands AI Data Capture with Auto-Classification to Transform Data into Business Intelligence28.1.2026 16:00:00 CET | Press release
New intelligent features automatically organize and classify documents, transforming how organizations manage information at scale. Laserfiche — the leading SaaS provider of intelligent content management — today announced major enhancements to its AI-powered data extraction tool, Smart Fields. The update introduces automated document classification and tagging, allowing organizations to move from unstructured content to informed decisions in seconds. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260128228490/en/ Using natural language prompts instead of rigid, ruled-based OCR, Smart Fields can now identify document type — such as invoices, taxpayer identification forms, or student transcripts — and automatically apply the correct metadata template using AI. Users can also use Smart Fields to automatically add informational and security tags to files that meet certain criteria, defined using a natural language prompt. Users
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom