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
Convatec Survey Challenges Assumptions About Leakage in Ostomy Care6.10.2026 09:00:00 CEST | Press release
New global findings highlight the role of peristomal skin health in improving outcomes and confidence for people living with an ostomy Convatec, a leading medical products and technologies company focused on solutions for the management of chronic conditions, today released Rethinking leakage in ostomy care, new international research highlighting a significant gap in how peristomal skin health is understood and managed in ostomy care. The findings indicate that skin health plays a critical role in preventing leakage, and supporting confidence in daily life, yet remains widely under-recognised in routine care. For many people, leakage is not only a clinical or product issue; it can shape whether they feel able to travel, exercise, socialise or take part fully in everyday life. More than half of respondents said they avoid such activities due to worry about their ostomy. The results of the survey, which included more than 1,800 people living with an ostomy and over 400 healthcare profes
Oulu2026 Boosts Tourism as Björk, Art and Technology Lead the European Capital of Culture Year’s Finale6.10.2026 09:00:00 CEST | Press release
The Oulu2026 European Capital of Culture programme has attracted visitors to northern Finland and contributed to strong tourism growth. According to Visit Oulu statistics, Oulu recorded nearly 475,000 registered overnight stays between January and August 2026, an increase of 12 per cent year on year. International overnight stays rose by 21 per cent to more than 96,600, while domestic overnight stays increased by 9 per cent. The trend continued in August, when international overnight stays grew by almost 29 per cent year on year. Hundreds of events combining art, technology, science, music, theatre and sport continue throughout the final months of 2026. “The programme’s diversity is clearest in the final months. There is something for culture enthusiasts and families alike, with experiences that cannot be found anywhere else. If ever there was a time to visit Oulu, it is now,” says Samu Forsblom, Programme Director of Oulu2026. A major highlight is the Lumo Art & Tech Festival, taking
Ant International and HSBC Expand Real-Time Treasury Management Services to the Middle East6.10.2026 08:30:00 CEST | Press release
Collaboration extends Ant International’s use of tokenised deposits in UAE, supporting faster treasury transactions Ant International today announced an expanded collaboration with HSBC to enhance real-time treasury management services in the Middle East. By leveraging HSBC’s global Tokenised Deposit Service (TDS), Ant International aims to improve the efficiency of its treasury operations across the region. As part of the collaboration, Ant International has successfully completed pilot transactions across two payment corridors connecting the United Arab Emirates and Hong Kong: Intra-UAE dirham transfers: Real-time, dirham-denominated tokenised deposit transactions within the UAE. Cross-border US dollar payments initiated from the UAE: US dollar-denominated tokenised deposit transfers between the UAE and international markets, including Hong Kong and Singapore. These transactions were initiated via WhaleRTP – Ant International’s proprietary, blockchain-based real-time treasury managem
RoslinCT Awarded £7.25 million Scottish Enterprise R&D Grant to Advance Digital Cell Therapy Manufacturing6.10.2026 08:00:00 CEST | Press release
RoslinCT, a leading global cell therapy Contract Development and Manufacturing Organization (CDMO), today announced it has been awarded a Research & Development grant from Scottish Enterprise to accelerate the digital transformation of its manufacturing operations in Scotland. The funding, supported by a Scottish Enterprise R&D grant of up to £7.25 million, forms part of RoslinCT's ambitious digital expansion plan, a multi-year initiative designed to enhance the company's integrated digital and AI capabilities and further strengthen Scotland's position as a global hub for advanced cell and gene therapy manufacturing. The programme will enable the development of a digitally integrated manufacturing environment, improving operational efficiency, data connectivity and manufacturing excellence across RoslinCT's operations. By creating a more connected and data-driven manufacturing environment, RoslinCT will be better positioned to support clients throughout the product lifecycle, helping b
30 Years of Restylane®: Reshaping the Aesthetics Field Through Science-Led, Patient-Centric Innovation6.10.2026 07:00:00 CEST | Press release
Galderma celebrates the 30th anniversary of Restylane, its pioneering range of hyaluronic acid (HA) injectables that established the category as the first to market1 With three decades of innovation across technology, packaging, and treatment areas, Restylane continues to meet growing aesthetic needs, including emerging areas such as medication-driven weight loss, skin quality and menopause1-11 This year’s milestones include the approvals of Restylane Shaype™ in the European Union (EU) for enhancement of the chin region, the new state-of-the-art Restylane syringe in the EU, United States (U.S.), and Canada, and Restylane Volyme™* in the U.S. for temple hollowing, with a dual-layer patent-pending technique leveraging both needle and cannula12-18 With more than 80 clinical trials, 180 publications, around 407,000 patients evaluated for safety, and 77 million treatments administered worldwide, Restylane remains a pioneer in science-backed aesthetic innovation and continues to shape the fu
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