NIJMEGEN, THE NETHERLANDS -- Byondis B.V., an independent clinical stage biopharmaceutical company creating innovative targeted medicines for patients with cancer, announces the first patient dosed in its Phase 1 dose escalation and expansion BYON4228.002 clinical trial to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of novel SIRPα-directed monoclonal antibody (mAb) BYON4228 alone and in combination with pembrolizumab in patients with advanced or metastatic solid tumors.

BYON4228 is a potential best-in-class novel mAb that targets and blocks the CD47-SIRPα axis, responsible for tumors’ ability to escape from recognition and destruction by the immune system. By targeting SIRPα and not CD47, BYON4228 offers selective targeting of myeloid cells and avoids disruption of other biologically meaningful CD47-dependent interactions. In preclinical studies, BYON4228 was found to potentiate the tumor killing capacity of tumor-targeting mAbs tested without the toxicity associated with CD47 agents.

“Building on strong preclinical data, we believe that there is broad potential for BYON4228 alone and in combination with tumor-targeting mAbs, checkpoint inhibitors and antibody drug conjugates and other modalities across hematological and solid tumors,” said Louis Denis, MD, Chief Medical Officer, Byondis. “We look forward to evaluating the results of this trial to support the clinical development of BYON4228 alone and in combination with other agents and to bring a new therapeutic option to patients with high unmet medical need.”

Part 1 of the BYON4228.002 trial will evaluate the safety of BYON4228 alone and in combination to determine the maximum tolerated dose (MTD), or optimal biological dose (OBD) if the MTD is not reached, and recommended combination dose regimen(s) for expansion (RDE(s)). The second part of the trial will evaluate the objective tumor response rate (ORR). The secondary objectives of this trial are safety, pharmacokinetics, immunogenicity and preliminary efficacy. The trial will be conducted at multiple sites across Europe, including the United Kingdom, Belgium and Spain.