Pharma Focus Europe

Biomunex Pharmaceuticals commences Phase 1 Clinical Trial for its pioneering Bispecific Antibody designed for Cancer Treatment

Thursday, January 25, 2024

Biomunex Pharmaceuticals, a prominent French biopharmaceutical company specializing in advanced immunotherapy development through bi- and multi-specific antibodies from its BiXAb platform, has announced the initiation of a Phase 1 clinical trial in 2023. This trial is being conducted by Onward Therapeutics SA, a global biotechnology company focused on cancer treatment.

In earlier studies, the proprietary antibody from Biomunex's BiXAb platform exhibited favorable characteristics, including good pairing, low aggregation, high stability, excellent manufacturability, specificity, and safety. Additionally, it demonstrated significant in vivo anti-tumoral activities at various doses.

The initiation of this clinical trial is part of the license and co-development agreement established in 2021 between Biomunex and Onward Therapeutics. This agreement comprises an upfront payment, potential milestone payments linked to clinical, regulatory, and commercial achievements, as well as tiered royalties on global net sales.

Biomunex, expressed enthusiasm for achieving this significant milestone and underscored the potential impact of their antibodies on cancer patients with unmet medical needs. The Phase 1 trial, a European multicenter, open-label study, comprises two parts.

The first part involves dose escalation of the BiXAb candidate as a single agent in patients with advanced/metastatic solid tumors or relapsed/refractory hematological malignancies. The primary focus is on safety and tolerability, determining the maximum tolerated and recommended Phase 2 doses. The second part is an expansion stage concentrating on further safety evaluation and preliminary anti-tumoral activity of the candidate as monotherapy or in combination for selected solid tumors and hematological malignancies.

Biomunex, highlighted the potential of this "first-in-class" bispecific antibody to simultaneously target two immune checkpoints. This approach, based on the BiXAb platform, aims to provide enhanced anti-tumor effects with a favorable therapeutic window, presenting a promising immunotherapeutic option for various cancers, both solid and liquid. The successful clinical evaluation of the BiXAb format sets the stage for advancing their first-in-class BiXAb-MAIT engager approach to the clinic.



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