Byondis B.V., an independent, clinical stage Dutch biopharmaceutical company creating precision medicines, today announced that the first cancer patients have been dosed with its investigational antibody-drug conjugate (ADC) BYON3521.
The “First-in-Human Dose-Escalation and Expansion Trial With the Antibody-Drug Conjugate BYON3521 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients with c-MET-Expressing Locally Advanced or Metastatic Solid Tumors” (BYON3521.001/NCT05323045) is currently enrolling patients in leading oncology centers in Belgium, Italy, the Netherlands and the U.K.
“The protein c-MET is widely overexpressed in a variety of solid tumors. Based on preclinical findings, we are keen to start the Phase I study of BYON3521, with the hope of finding another option for patients in need,” said Byondis Chief Medical Officer Jan Schellens, M.D., Ph.D.
c-MET (also called tyrosine-protein kinase MET [Mesenchymal Epithelial Transition] factor or HGFR [Hepatocyte Growth Factor Receptor]) is a proto-oncogene active in normal cell division, growth and differentiation. Mutations may cause it to become an oncogene, which can promote cancer cell growth and multiplication.
“Preclinical data showed selective and potent killing of c-MET expressing tumors and a safety profile that indicated a favorable therapeutic index,” said Byondis Chief Scientific Officer Wim Dokter, Ph.D.
BYON3521 is the next Byondis ADC currently in the clinical trial phase. The company’s most advanced ADC, [vic-]trastuzumab duocarmazine (SYD985), targets HER2-expressing cancers such as metastatic breast and endometrial (uterine) cancer. Following the release of positive results from its pivotal Phase III TULIP® trial of SYD985 in metastatic breast cancer, Byondis recently submitted the Biologics License Application (BLA) to the U.S. Food & Drug Administration and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). A current Phase II trial evaluates the safety and efficacy of SYD985 as a standalone therapy for HER2-expressing recurrent, advanced, or metastatic endometrial cancers.