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
Access Advance Welcomes Meta Platforms, Inc. and Alibaba Group to the Video Distribution Patent Pool3.7.2026 01:00:00 CEST | Press release
Access Advance LLC today announced that Meta Platforms, Inc., one of the world's largest distributors of video content across its Facebook, Instagram, Threads, and WhatsApp services, has joined the Video Distribution Patent Pool (VDP Pool) as a Licensee. Meta also joined both the HEVC Advance and VVC Advance pools as a Licensee. Alibaba Group, whose video infrastructure spans a wide range of video-based services across e-commerce, entertainment, and digital media platforms, was also announced as a VDP Pool Licensee this week. Meta and Alibaba joining the VDP Pool further reinforces the program’s market leading position in resolving the licensing issues around the use of modern video codecs, including VP9, AV1, HEVC and VVC, across all the diverse business models of internet video streaming. "A significant U.S.-based company like Meta joining as a Licensee is a milestone moment for the content distribution business and the VDP Pool," said Peter Moller, CEO of Access Advance. "Meta reach
Kioxia Commences Sample Shipments of 10th-Generation BiCS FLASH™ Devices Delivering High Performance, High Capacity and Low Power Consumption3.7.2026 01:00:00 CEST | Press release
Production planned at Fab2 of Kitakami Plant Kioxia Corporation, a world leader in memory solutions, today announced that it has commenced sample shipments of 1Tb (terabit) Triple-Level-Cell (TLC) memory devices utilizing its 10th-generation BiCS FLASH™ 3D flash memory technology.1 These will be primarily integrated into the company’s enterprise and data center SSDs, strengthening Kioxia’s lineup to meet the growing demand for AI storage, which requires higher performance, higher capacity, and lower power consumption. These new products will be manufactured using state-of-the-art equipment at Kioxia’s Kitakami Plant Fab2 facility in Iwate Prefecture, Japan. By leveraging innovative CMOS directly Bonded to Array (CBA) technology2 and On-Pitch Select Gate Drain (OPS) technology,3 both adopted since the 8th-generation BiCS FLASH™, the 10th-generation technology achieves a NAND interface speed of 4.8 Gb/s,4 a 33% improvement over the 8th generation. Bit density has increased by 59% by stac
Bending Spoons S.p.A. announces closing of initial public offering2.7.2026 20:35:00 CEST | Press release
Bending Spoons S.p.A. (“Bending Spoons”), a leading technology company, today announces the closing of its initial public offering of an aggregate of 57,971,015 of its ordinary shares, at an initial public offering price of $29.00 per share. The offering consisted of 34,398,640 shares sold by Bending Spoons and 23,572,375 shares sold by certain selling shareholders (the “Selling Shareholders”). The gross proceeds from the offering to Bending Spoons, before deducting underwriting discounts and commissions and other offering expenses, was approximately $953,917,285.50. Bending Spoons did not receive any proceeds from the sale of shares by the Selling Shareholders. Bending Spoons’ ordinary shares began trading on the Nasdaq Global Select Market on July 1, 2026 under the ticker symbol “BSP”. Goldman Sachs International, J.P. Morgan, and Allen & Company LLC are acting as joint lead book-running managers for the offering. Wells Fargo Securities, BofA Securities, Jefferies, Evercore ISI, BNP
Strategic Partnership Between Record Asset Management and Admicasa2.7.2026 19:00:00 CEST | Press release
RAM Swiss Holding AG announces a strategic partnership with Admicasa Holding AG (Admicasa). RAM Swiss Holding AG is a subsidiary of LSE-listed Record Financial Group (Record) and part of the Record Asset Management (RAM) group of companies. The partnership is a milestone in the growth of Admicasa and marks an important step in the continued expansion of Record’s private markets platform. Subject to regulatory approval, the agreement, signed on 1st July 2026, provides RAM Swiss Holding AG with a 50% participation in the Admicasa Fondsleitung AG, part of Admicasa, and establishes a long-term partnership to develop investment opportunities in the Swiss and Global real estate market with a plan to expand into other asset classes in the medium term. RAM is the European asset management arm of Record, the LSE-listed specialist investment group managing USD 115 billion of assets on behalf of institutional clients worldwide. Record's client base comprises pension funds, foundations, sovereign
IQM Quantum Computers Becomes First European Quantum Computing Company Listed on a Major U.S. Exchange2.7.2026 16:47:00 CEST | Press release
IQM begins trading on Nasdaq Global Select Market under the ticker symbol “IQMX” Company enters next phase of growth as a publicly traded leader in full-stack superconducting quantum computing IQM maintains a strong pro forma cash position of EUR 337 million IQM Quantum Computers (Nasdaq: IQMX) (“IQM”, “IQM Quantum Computers” or the “Company”), a global leader in full-stack superconducting quantum computers, today became a publicly traded company following the completion of its business combination with Real Asset Acquisition Corp. (“RAAQ”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260702960460/en/ IQM Quantum Computers Becomes First European Quantum Computing Company Listed on a Major U.S. Exchange The company’s American Depositary Shares begin trading today on the Nasdaq Global Select Market under the ticker symbol “IQMX”. The listing marks a major milestone for IQM establishing the company as the first European quan
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