August 22, 2020
Byondis B.V. (formerly Synthon Biopharmaceuticals B.V.) today announced that the first cancer patients have started treatment with its investigational antibody-drug conjugate (ADC) SYD1875.
The First-in-Human Dose-Escalation and Expansion Study with the Antibody-Drug Conjugate SYD1875 will evaluate the safety, pharmacokinetics and preliminary efficacy of SYD1875 in patients with 5T4-expressing, locally advanced or metastatic solid tumors. While 5T4 plays an important role in the development of cancer, there are currently no drugs that target this specific tumor antigen. Patients are currently being enrolled in leading European oncology centers: Institut Jules Bordet in Brussels, Belgium; Institut Bergonié in Bordeaux, France; and Centre Oscar Lambret in Lille, France.
“It is exciting and gratifying to know that SYD1875 has progressed to the clinical study phase, giving us the opportunity to explore the potential of another promising antibody-drug conjugate,” said Byondis CEO Marco Timmers, Ph.D. “Our ADC technologies aim to outsmart relentless cancers and improve patient outcomes by offering better tumor-killing properties with lower side effects.”
SYD1875 is the second Byondis ADC to progress to clinical studies. The company’s anti-HER2 ADC [vic-]trastuzumab duocarmazine (SYD985) is its most advanced ADC, targeting a range of HER2-expressing cancers such as metastatic breast cancer and endometrial (uterine) cancer.
More on the SYD1875.001 Study
The SYD1875.001 study will recruit roughly 90 patients, aged 18 and over, with histologically-confirmed, locally advanced or metastatic cancers that have progressed on standard therapy or for which no standard therapy exists. The study will be conducted in two parts: Dose Escalation and Dose Expansion.
Part 1, Dose Escalation, will enroll patients with any tumor type to determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE). Part 2, Dose Expansion, will enroll groups of patients with one of three types of cancers. These patients will receive the RDE determined in Part 1 to evaluate the efficacy and safety of SYD1875 in these cohorts. All patients in both parts of the study will receive SYD1875 infusions every three weeks until cancer progression or unacceptable toxicity.
About SYD1875, a Next Generation Antibody-Drug Conjugate
SYD1875 uses Byondis’ unique, proprietary linker-drug (LD) and site-specific conjugation technologies. Although marketed ADCs have improved therapeutic indices compared to classical non-targeted chemotherapeutic agents, there is still room for improvement.
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