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 Announces New Effective Discount Rates for Its Multi-Codec Bridging Agreement, Starting on January 1, 202711.11.2026 20:18:00 CET | Press release
Access Advance LLC today announced that the Licensors of the HEVC Advance and VVC Advance Patent Pools have independently approved a two-step, phased reduction in the effective royalty discount available under the Multi-Codec Bridging Agreement (MCBA) for Licensees of both pools who sign the MCBA on or after January 1, 2027. Licensees that join both the HEVC Advance and VVC Advance Patent Pools and execute the MCBA on or before December 31, 2026, will secure the current MCBA rates, resulting in an effective discount of up to 50%. Licensees that sign on or after January 1, 2027 will receive a reduced discount as further described below. The MCBA is an administrative agreement, not a separate license, that lets Licensees of both HEVC Advance and VVC Advance Patent Pools pay a single, reduced royalty rate for products that include both HEVC and VVC codecs. Today the MCBA rate for a dual-codec product is the same as the VVC Advance single codec product rate; up to 50% of what a Licensee wo
Angel Aligner Unveils Six Innovations for 202711.11.2026 17:23:00 CET | Press release
Angel Elevates the Orthodontic Specialty by Focusing on Complex-Case Solutions Angelalign Technology Inc. (6699.HK) (“Angel”), a global clear aligner leader, has unveiled six new clinical innovations, including SuperElastic (MC-SE)* aligner material, a Deepbite Solution for significantly expanded indications, and the Adapt-MATMsystem for next generation growth guidance for young patients. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261110338654/en/ Unveiling Angel's 2027 Innovations. Orthodontists and opinion leaders have long remarked about Angel’s clinical excellence. Orthodontics educator and thought leader Dr. David Sarver said: “In over 4 decades, I’ve never had a parent say I’d be happy if you ensure that my child’s treatment results are average.” Angel is committed to elevating the orthodontic specialty well above the average, especially as more competition and harder referral cases demand outstanding results. Bind
Abu Dhabi Future Health Summit Concludes with Research Partnerships and New Programmes to Advance Prevention and Health Innovation11.11.2026 15:58:00 CET | Press release
Partnerships span drug discovery, clinical research, preventive and reproductive health Launch of an AI Clinician Framework and a Trusted Research Environment for health and genomic data Four whitepapers address genomics, therapeutics, fertility and wearable technologies New programmes support health innovators and entrepreneurs More than 17,300 visitors from 85 countries, with 130 speakers across 45 sessions Held under the patronage of His Highness Sheikh Khaled bin Mohamed bin Zayed Al Nahyan, Crown Prince of Abu Dhabi and Chairman of the Abu Dhabi Executive Council, Abu Dhabi Future Health Summit 2026 concluded with agreements and initiatives spanning drug discovery, clinical research, preventive and reproductive health, alongside research and entrepreneurship programmes that will sustain collaboration beyond the Summit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261111545964/en/ The Summit is the annual flagship gath
De' Longhi Group: Record Results for the Quarter, With Revenue Growing by 7.7% and Net Profit Pertaining to the Group Progressing Significantly by 19%11.11.2026 15:58:00 CET | Press release
The Board of Directors of De' Longhi S.p.A. approved the consolidated results1 for the nine months of 2026. In the nine months the Group achieved: revenues for € 2,621.3 million, up by 6.5% with respect to 2025 (+7.7% at constant currency); an adjusted2 Ebitda of € 455.2 million, equal to 17.4% on revenues (vs. 15.8% with respect to last year); a net income pertaining to the Group equal to € 225.8 million (+20.4% with respect to last year); a positive net financial position equal to € 606.0 million. CEO Fabio de' Longhi commented: “The Group delivered its thirteenth consecutive quarter of organic revenue growth, underscoring our proven ability to capitalize on industry opportunities and respond promptly to market evolution, while ensuring consistent performance across both divisions. The professional business recorded a strong acceleration, spanning all geographies and brands, with revenues growth exceeding 35% for both the quarter and the nine-month period, this against an already par
Starr Chile Assigned A Rating from AM Best11.11.2026 14:30:00 CET | Press release
Starr, a global insurance and investment organization, today announced that the global credit rating agency AM Best has assigned Starr International Seguros Generales S.A. (Starr Chile) a Financial Strength Rating of A (Excellent) and a Long-Term Issuer Credit Rating of a+ (Excellent). The outlook for both credit ratings is positive. The rating reflects Starr’s strong balance sheet and Starr Chile’s successful implementation of Starr’s business model. AM Best also cited Starr’s operating performance, a favorable business profile and enterprise risk management as key factors supporting the positive rating. “This strong rating is another important endorsement of Starr’s business model as we continue to build our presence in Latin America,” said Jeff Greenberg, chairman and co-CEO of Starr. “It reflects the financial strength, underwriting discipline and experienced teams that underpin our business around the world, reinforcing the confidence brokers and clients can place in Starr.” Starr
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