Biomunex Pharmaceuticals Announces Start of Phase I Cancer Clinical Trial

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Biomunex Pharmaceuticals has announced the enrollment in 2023 of the first patient in a Phase I cancer trial conducted by Onward Therapeutics, according to a company press release.¹

This marks the first man-in trial conducted by Onward and will evaluate a bispecific antibody generated from Biomunex's proprietary BiXAb platform.

According to the release, “The Phase I study is evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumoral activity of a “first-in-class” bispecific antibody targeting two immune checkpoints (OT-A201), given as monotherapy or in combination in patients with either solid tumors or hematological malignancies.”

In preclinical studies, the antibody displayed “excellent” specificity and safety, along with good pairing, low aggregation, and high stability. It also showed important in vivo anti-tumoral activities at different doses.

"We are delighted to announce this clinical trial for the evaluation of one of the antibodies generated thanks to our unique BiXAb platform, with Onward Therapeutics," said Pierre-Emmanuel Gerard, MD, founder, president, and CEO of Biomunex, in the press release. "The achievement of this key milestone supports the scientific and technological relevance of our BiXAb platform to identify, generate and develop rapidly and efficiently novel bispecific antibodies. With this clinical trial, we hope to demonstrate the potential major impact of our antibodies in cancer patients, particularly in those with significant unmet medical needs.”

The European multicenter and open-label study is divided into two parts. The first is a dose escalation of the antibody as single agent in patients with selected advanced/metastatic solid tumors or relapsed/refractory hematological malignancies. This stage will determine the maximum tolerated and recommended Phase II doses. The second part is an expansion stage, which will further evaluate safety and preliminary anti-tumoral activity of the candidate as a monotherapy or in combination in certain scenarios.

"We are convinced of the potential of this ‘first-in-class’ bispecific antibody, capable of simultaneously targeting two immune checkpoints, based on our proprietary BiXAb platform, to provide better anti-tumor effects with a favorable therapeutic window and potentially become a true novel immunotherapeutic option for various cancers, both solid and liquid”, said Simon Plyte, PhD, chief scientific officer of Biomunex in the press release. “This clinical evaluation of our BiXAb format paves the way for the successive development of our first-in-class BiXAb-MAIT engager approach that we will rapidly advance to the clinic.”

Reference

1. Biomunex Pharmaceuticals Announces the Start of a Phase 1 Clinical Trial for Its First-in-class Bispecific Antibody for the Treatment of Cancer. News release. January 24, 2024. Accessed January 24, 2024. https://www.businesswire.com/news/home/20240124510203/en/Biomunex-Pharmaceuticals-Announces-the-Start-of-a-Phase-1-Clinical-Trial-for-Its-First-in-class-Bispecific-Antibody-for-the-Treatment-of-Cancer#:~:text=PARIS%20%26%20CAMBRIDGE%2C%20Mass.%2D%2D(,of%20cancer%2C%20announced%20today%20the