Dutch pharmaceutical company Byondis has begun dosing subjects in a Phase I trial of BYON4228 for treating advanced or metastatic solid tumours.
The BYON4228.002 trial is designed to assess the monoclonal antibody’s (mAb) efficacy, pharmacodynamics, safety and pharmacokinetics, both as a stand-alone treatment and in conjunction with pembrolizumab.
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Part one of the dose escalation and expansion trial will focus on determining BYON4228’s safety in order to establish the maximum tolerated dose (MTD), or the optimal biological dose if the MTD is not reached.
This part of the trial will also recommend combination dose regimens for expansion.
The second part will assess the objective tumour response rate, with secondary objectives including pharmacokinetics, preliminary efficacy, safety and immunogenicity.
The study is set to take place at several sites across Spain, the UK, Belgium and other European countries.
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By GlobalDataBYON4228 is a signal regulatory protein alpha (SIRPα) mAb that specifically targets the cluster of differentiation 47 (CD47) SIRPα axis, which enables tumours to evade the immune system.
As well as the BYON4228.002 trial, the drug is also being studied in a separate Phase I trial among subjects with relapsed/refractory CD20-positive B-cell non-Hodgkin’s lymphoma, both as a single agent and in conjunction with Rituximab.
Byondis chief medical officer Louis Denis said: “Building on strong preclinical data, we believe that there is broad potential for BYON4228 alone and in combination with tumour-targeting mAbs, checkpoint inhibitors and antibody drug conjugates, and other modalities across haematological and solid tumours.
“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.”
Byondis is an independent, clinical-stage biopharmaceutical company focused on developing targeted cancer therapies.
Based in Nijmegen, the company’s development portfolio currently includes both preclinical and early-stage clinical programmes.
