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
Ohmium Appoints Hydrogen Veteran as Chief Commercial Officer27.7.2026 10:05:00 CEST | Press release
Ohmium International Inc., a leading manufacturer of cutting-edge, high-efficiency, modular Proton Exchange Membrane (PEM) electrolyzers, today announced the appointment of Mark Griffin as Chief Commercial Officer (CCO). Griffin will serve as the executive lead of the Ohmium Sales and Marketing organization, driving revenue growth, customer acquisition, and the expansion of a global ecosystem of developers, industrial collaborators, and strategic partners. His appointment brings fresh momentum to Ohmium’s commercial stance as green hydrogen transitions from early adoption into mainstream industrial deployment. Griffin brings over two decades of experience in energy, including work in hydrogen and renewables. At ScottishPower, he spent five years leading hydrogen market development and business energy sales, spearheading two multi-megawatt green hydrogen projects totaling more than £220 million. Both projects were government-subsidized and structured around 15-year decarbonization offta
Uptime Institute Partners with the Governorate of Nineveh to Advance Iraq’s Digital Infrastructure at the U.S.-Iraq Business Summit27.7.2026 09:02:00 CEST | Press release
A landmark partnership signed during Prime Minister Ali Al-Zaidi’s historic U.S. delegation positions Iraq for a new era of resilient, world-class digital infrastructure Uptime Institute today announced a landmark strategic partnership with the Governorate of Nineveh, signed at the U.S. Chamber of Commerce U.S.-Iraq Business Summit to accelerate the region’s digital transformation and advance Iraq’s national digital agenda. The agreement was signed on July 17, 2026, during the official U.S. visit of Iraqi Prime Minister Ali Al-Zaidi. Uptime Institute participated as part of the official delegation at a historic summit that yielded more than 50 agreements valued at over USD $60 billion, signaling a powerful new era of economic cooperation, investment, and technological innovation between the United States and Iraq. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727139625/en/ Signing of landmark strategic partnership with A
Objectway Expands Into Capital Markets With Its Project to Acquire French Specialist SLIB, Pushing Forward Its Pan-European Growth Strategy27.7.2026 08:45:00 CEST | Press release
Strong complementary offering and expertise create new opportunities for strengthening strategic presence in France and broadening end-to-end proposition across key European markets.Key takeaways With this transaction, Objectway will extend its direct presence in France, adding another leading financial centre to its current footprint in major European hubs such as Italy, Germany, Switzerland, Benelux and the UK. Objectway will expand its offering across the investment services value chain, adding capital markets capabilities to its existing proposition for wealth management, private banking and asset management. SLIB will also broaden Objectway's client base with major European asset servicers, broker-dealers and banks, alongside strengthening Objectway's long-standing relationships with shared clients such as BNP Paribas. Objectway, the pan-European wealthtech solution partner for banking, wealth and asset management firms, today announced that it has entered into exclusive negotiati
Ant Group Unveils Ling-3.0-Flash Delivering Top-Tier Performance at a Fraction of the Parameter Scale27.7.2026 08:00:00 CEST | Press release
Ant Group today announced the release of Ling-3.0-Flash, a next-generation native hybrid-reasoning foundational model engineered specifically for production-grade AI agent workflows. Designed to deliver rapid response capabilities, it serves as a high-speed execution node that offers a superior balance of intelligence density and cost-efficiency. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260726584441/en/ Ling-3.0-Flash delivers strong performance across multiple core benchmarks. Featuring 124B total parameters with only 5.1B active parameters per token, Ling-3.0-Flash achieves remarkable performance despite its streamlined footprint. It matches or surpasses industry-leading models with two to three times its parameter scale across core benchmarks, including foundational reasoning, instruction following, and long-context processing. Architectural Innovation for Efficiency Ling-3.0-Flash moves away from the traditional ap
SES Statement On FCC Upper C-band Auction Decision27.7.2026 07:30:00 CEST | Press release
SES, a leading space solutions company, issued the following statement following the U.S. Federal Communications Commission approval of the Upper C-band Report & Order that makes 160 megahertz of the Upper C-band available in the contiguous United States for flexible-use, next-generation terrestrial wireless services via a system of competitive bidding. The required auction of the Upper C-band will be completed no later than July 2027, with spectrum clearing deadlines in 2030 and 2031. Gross incentive payments of approximately $5.6 billion to SES are contingent on spectrum clearing within the transition deadlines. The Order also confirms reimbursement of reasonable and necessary Upper C-band transition costs as approved by the clearinghouse. SES CEO Adel Al-Saleh Commented: “We commend Chairman Carr and the FCC staff for their diligence, speed, and hard work. We remain fully committed to working cooperatively with the FCC and all stakeholders as the process progresses. We are pleased t
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