SYD985 Marketing Authorization Application Soon to Be Submitted to the EMA
NIJMEGEN, Netherlands and WEDEL, Germany, May 3, 2022 /PRNewswire/ -- Byondis B.V., an independent, Dutch clinical stage biopharmaceutical company creating precision medicines, has entered into a License and Collaboration Agreement and a Supply Agreement with medac GmbH, a privately owned pharmaceutical company based in Germany. Byondis and medac will partner to commercialize Byondis' lead program, anti-HER2 antibody-drug conjugate (ADC) trastuzumab duocarmazine (SYD985), pending approval by the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), as well as other regulatory authorities in Europe.
Under the terms of the agreement, medac receives an exclusive license to commercialize SYD985 in the EU, the UK and further European countries, in all approved indications. Byondis will receive an undisclosed upfront payment and sales royalties. Byondis will also be eligible for payments upon achievement of certain development and sales milestones.
"This collaboration with medac on SYD985 is a crucial step in ensuring that the therapy, once approved, is available to patients, who desperately need other treatment options," said Byondis Founder and Chairman Jacques Lemmens, Ph.D.
"Like Byondis, medac is committed to developing novel therapies, especially in areas of unmet medical need. We believe in the potential of Byondis and SYD985 and look forward to bringing this next generation ADC to patients who need it," said medac Managing Director, CEO Jörg Hans.
Byondis CEO Marco Timmers, Ph.D. added: "We are pleased to have found in medac a true partner who shares our passion for innovation and making a difference in the lives of patients."
SYD985 targets a range of HER2-expressing cancers such as metastatic breast and endometrial (uterine) tumors. Data from the SYD985 pivotal Phase III TULIP® study (SYD985.002) in HER2-positive unresectable locally advanced or metastatic breast cancer showed statistically significant progression-free survival (PFS) results compared to physician's choice (PC) treatment. TULIP continues to study overall survival and a Marketing Authorization Application (MAA) for this initial clinical indication will soon be submitted to the EMA. The ADC is also in a Phase II multiregional clinical trial to evaluate its safety and efficacy in patients with HER2-expressing recurrent, advanced or metastatic endometrial cancer (SYD985.003).
About trastuzumab duocarmazine (SYD985), a Next Generation Antibody-Drug ConjugateTrastuzumab duocarmazine (SYD985) incorporates Byondis' distinctive, proprietary duocarmazine linker-drug (LD) technology ByonZine®. The ADC is comprised of the anti-HER2 monoclonal antibody trastuzumab, and a cleavable linker-drug called valine-citrulline-seco-DUocarmycin-hydroxyBenzamide-Azaindole (vc-seco-DUBA).
The antibody part of trastuzumab duocarmazine binds to HER2 on the surface of the cancer cell and the ADC is internalized by the cell. After proteolytic cleavage of the linker, the inactive cytotoxin is activated and DNA damage is induced, resulting in tumor cell death. SYD985 is considered a form of targeted chemotherapy.
About ByondisDriven to improve patients' lives, Byondis is an independent, privately held, clinical stage biopharmaceutical company creating innovative precision medicines targeting intractable cancers and autoimmune diseases. The company is developing new biological entities (NBEs) and new chemical entities (NCEs) using proprietary molecular concepts, such as ByonZine®, its duocarmazine linker-drug (LD) technology, and ByonShieLD®, its site-specific conjugation technology, to generate next generation antibody-drug conjugates (ADCs).
Byondis' broad development portfolio comprises preclinical as well as early- and late-stage clinical programs. The company has a dedicated team of more than 400 employees, including highly educated scientists and skilled technicians working in state-of-the-art R&D and Good Manufacturing Practice manufacturing facilities on its Nijmegen campus in the Netherlands. Byondis regularly collaborates with leading global biotechnology and pharmaceutical companies, as well as many academic research institutions. For more information, visit www.byondis.com.
About medac GmbHmedac GmbH is a privately held, global pharmaceutical company with a growing pharmaceutical and diagnostics business. Since its foundation in Germany in 1970, medac has been specializing in the treatment of diseases within the indication areas oncology, hematology, urology and autoimmune disorders. medac is committed to the refinement of existing and the development of new therapeutic products – always with the focus on improving patients' quality of life. medac has become known for developing innovative products also in less common indications. This dedication has resulted in a comprehensive portfolio of pharmaceutical products that help make a difference in the lives of patients. medac continually invests in its product development and manufacturing as well as logistic capacities to meet both patients' needs and the demands of healthcare professionals. For more information visit https://international.medac.de/home/
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