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Business Wire
14 hours ago
- Health
- Business Wire
Debiopharm's ADC Research Gains Momentum With Launch of First-in-human Trial Assessing Debio 1562M in Acute Myeloid Leukemia Patients
LAUSANNE, Switzerland--(BUSINESS WIRE)-- Debiopharm ( a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow's standards of care to cure cancer and infectious diseases, today announced that the first patient has been dosed in the first-in-human clinical trial evaluating the safety, tolerability, and antileukemic activity of Debio 1562M monotherapy in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML). This phase 1/2 trial (NCT06969430) will lay the groundwork for further development as it will allow the characterization of the safety and tolerability of the drug, dose optimization, and define the product's activity. AML remains a significant unmet need in oncology, particularly for older adults who account for the majority of cases. Despite advances in our understanding of AML biology and the introduction of new therapies, outcomes remain dismal for many patients—especially those who are not candidates for intensive treatments such as traditional chemotherapy or stem cell transplantation. While intensive chemotherapy and targeted therapies are available, they have not substantially improved long-term outcomes across all patient populations. The 5-year overall survival (OS) rate remains at just 32% 1, with a median OS as low as 7 months in certain populations. 2 This stark therapeutic gap leaves thousands of patients without viable treatment options each year, highlighting an urgent need for innovative interventions capable of extending survival. Transformative solutions are critical to improving both prognosis and quality of life for this underserved population within the AML treatment landscape. 'It's time for AML research to advance with more precise therapeutic options,' expressed Marianna Muller, Senior Medical Director, Oncology, Debiopharm. 'This study will help us better understand the potential of Debio 1562M and how it could provide an effective new treatment while minimizing tolerability challenges for patients facing this very difficult disease with high unmet medical need.' CD37, a cell-surface antigen, has been shown to be a relevant ADC target in AML due to its broad expression on blasts and leukemic stem cells along with efficient internalization. 3 Research reveals that this increased expression is restricted to malignant cells compared to healthy hematopoietic stem cells and is correlated with poor patient outcomes. 3 Debio 1562M is a next generation ADC targeting CD37 with 1 st -in-class potential. The compound was designed using Debiopharm's Trifecta approach optimizing 3 key components: naratuximab - an anti-CD37 monoclonal antibody, Multilink™ proprietary linker technology, and a microtubule inhibitor as cytotoxic payload. In pre-clinical studies, Debio 1562M showed anti-leukemic activity across all AML subtypes as well as superior activity vs. the current standard-of-care and targeted therapies in AML models. Debiopharm has been involved in targeted drug delivery for more than a decade, developing MultiLink™—our unique and versatile proprietary ADC technology suite, key components of which are integrated into this product. We recognize how critical the need is for AML patients and remain dedicated to addressing it through our ADC expertise. As our pre-clinical results have shown promising antitumor activity and tolerability in this hard-to-treat leukemia, we're looking forward to seeing what this clinical stage research with Debio 1562M could reveal,' mentioned Bertrand Ducrey, CEO of Debiopharm. Debiopharm's ADC Expertise We're developing fit-for-purpose antibody-drug conjugates (ADCs) through a tailored 'Trifecta' approach: strategic target selection, innovative MultiLink™ linker technology, and smart payload choices. Our ADC portfolio includes first-in-class or best-in-class candidates: Debio 1562M, a CD37-targeted ADC for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), and Debio 0532, an HER3-targeted ADC for solid tumors, as well as other undisclosed targets. We are actively partnering to access innovative targets, co-develop, or out-license our ADC programs. Key partnerships include options to in-license bispecific antibodies targeting HER2-HER3 and HER3-EGFR. To enable both high drug-to-antibody ratios (DAR) and high stability, our ADCs are designed with our proprietary MultiLink™ linker technology. We have strong in-house capabilities and in-depth expertise spanning ADC conjugation and optimization, pharmacokinetics/pharmacodynamics (PK/PD), toxicology, translational, pharmaceutical (CMC) and clinical development, and supply chain management. We continue to invest in and explore potential game-changing technologies, such as novel and dual payloads. 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 [1] National Cancer Institute. 2020. SEER Cancer Stat Facts: Acute Myeloid Leukemia. Available at: [2] Meyers J, et al. Applied health economics and health policy. 2013 11 (3): 275-286. [3] Lisa Ivanschitz, AACR 2025 Abstract # 1160
Yahoo
29-05-2025
- Business
- Yahoo
Bispecific Antibody Drug Conjugates Clinical Trials Bispecific ADC Market Size Insight
Chinese Pharmaceutical Companies Dominating Global Research & Development Landscape Of Bispecific ADC Market Says Kuick Research In New Report Delhi, May 29, 2025 (GLOBE NEWSWIRE) -- Global Bispecific Antibody Drug Conjugates Clinical Trials, Regulatory Approvals and Future Market Opportunity Outlook 2029 Report: Report Answers Question On Why There Exist Need For Bispecific Antibody Drug Conjugates First Bispecific Antibody Drug Conjugates Commercial Approval Expected By 2029 Insight On Bispecific Antibody Drug Conjugates In Clinical Trials : > 60 Drug Conjugates China Dominating Bispecific Antibody Drug Conjugates Clinical Trials: > 35 Drug Conjugates Majority Of Bispecific Antibody Drug Conjugates For Breast Cancer Bispecific Antibody Drug Conjugates Clinical Trials Insight By Company, Country, Indication and Phase Bispecific Antibody Drug Conjugates In Combination Therapy By Indication and Clinical Phase Key Companies Involved In Development Of Bispecific Antibody Drug Conjugates Download Report: Bispecific antibody drug conjugates (BsADCs) are an innovative class of therapeutics that combine the dual-targeting capabilities of bispecific antibodies with the cytotoxic payloads characteristic of traditional antibody drug conjugates (ADCs). Unlike conventional ADCs, which typically target a single antigen, BsADCs engage two different antigens simultaneously, enhancing specificity and efficacy against cancer cells. This unique mechanism enables BsADCs to not only deliver cytotoxic agents directly to the tumor site but also improve selectivity for cancer cells, potentially reducing off-target effects. The development of BsADCs is supported by various advanced technology platforms. For instance, Alphamab Oncology has developed a proprietary ADC platform that allows for the precise construction of bispecific constructs. Similarly, Bi-Cygni Therapeutics employs its BiVictriX platform to enhance the efficacy and safety profiles of its bispecific antibodies. Debiopharm's Multilink™ platform is another example that enables the creation of multifunctional biotherapeutics. These technology platforms play a crucial role in optimizing the design and development of BsADCs, streamlining the path from research to clinical application. One of the most advanced bispecific antibody drug conjugates currently in development is BL B01D1, created by Sichuan Baili Pharmaceutical and its subsidiary, SystImmune. This candidate is undergoing clinical trials in China, showcasing the country's rapid advancements in this therapeutic area. With a focus on addressing unmet medical needs, BL B01D1 exemplifies the potential of BsADCs to provide effective treatment options for patients facing challenging cancers. The ongoing trials will provide valuable data on its safety and efficacy, contributing to the broader understanding of bispecific therapies. China has emerged as a dominant force in the development of BsADCs, with a significant number of clinical trials underway. This landscape is marked by intense competition, as various companies strive to launch their candidates and establish themselves as leaders in this burgeoning field. Notable players include ABL Bio, Bristol Myers Squibb, Amgen, Debiopharm, Doma Bio, ProEn Therapeutics, AstraZeneca, and Innovent Biologics. Each of these companies is racing to bring their innovative therapies to market, aiming to be the first in their class. As the market for bispecific antibody drug conjugates becomes increasingly competitive, the ongoing research and development will likely yield numerous advancements that could redefine cancer treatment paradigms. The potential of BsADCs to deliver targeted therapy more effectively than conventional ADCs makes them an exciting prospect in oncology. With continued investment and innovation, these therapeutics could significantly improve patient outcomes, offering new hope in the fight against cancer. The landscape is rapidly evolving, and as clinical data emerges, the true impact of bispecific antibody drug conjugates will begin to take shape, highlighting their role in the future of cancer treatment. CONTACT: Neeraj Chawla Research Head Kuick Research neeraj@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
