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Byondis’ Investigational Antibody-Drug Conjugate Selected for Trial in Early-Stage Breast Cancer

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Byondis B.V. (formerly Synthon Biopharmaceuticals) has announced that Quantum Leap Healthcare Collaborative™ (Quantum Leap) selected the company’s investigational antibody-drug conjugate (ADC) SYD985 ([vic-]trastuzumab duocarmazine) for a new investigational treatment arm in its ongoing I-SPY 2 TRIAL™ for neoadjuvant treatment of locally advanced breast cancer. This treatment arm will focus on treatment for HER2-low early-stage breast cancer.

The I-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis) is a standing Phase II randomized, controlled, multicenter study aimed at rapidly screening and identifying promising treatments in specific subgroups of women with newly-diagnosed, high-risk, locally advanced breast cancer (Stage II/III). Quantum Leap, sponsor of the I-SPY 2 TRIAL, leads a pre-competitive consortium that includes the U.S. Food & Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 16 major U.S. cancer research centers.

The new I-SPY 2 treatment arm will evaluate SYD985 against standard of care therapy in Stage II/III early-stage, high-risk breast cancer patients, with a focus on tumors with heterogeneous and low HER2 expression. Byondis will supply the investigational drug and provide financial and regulatory support. Quantum Leap, as sponsor, will provide the clinical sites and clinical expertise.

According to Byondis’ CEO Marco Timmers, Ph.D., "We are pleased to collaborate with Quantum Leap, the FDA and other key stakeholders to study the potential of ADC SYD985 as a neoadjuvant therapy in a wider spectrum of breast cancer tumors. Our hope is that we can improve on current disease outcomes for cancer patients in an early stage of disease."

SYD985 is Byondis’ most advanced ADC, targeting a range of HER2-positive cancers such as metastatic breast cancer (MBC) and endometrial (uterine) cancer. The company is currently conducting a Phase III study of SYD985 (TULIP® or SYD985.002) to compare its efficacy and safety to physician's choice treatment in patients with HER2-positive unresectable locally advanced or metastatic breast cancer. Previously, the FDA granted fast track designation for SYD985 based on promising data from heavily pre-treated last-line HER2-positive MBC patients participating in a two-part Phase I clinical trial (SYD985.001).