BI- AND MULTI-SPECIFIC ANTIBODIES DEVELOPED BY BIOMUNEX

BIOMUNEX discovers and develops new treatments based on disruptive data driven biological approaches in oncology for patients with unmet medical needs, using the bi- and multi-specific antibody technology BiXAb®.

BIOMUNEX’ main objective is to invent disruptive biological approaches. The first antibody ever developed is a first-in-class humanized BiXAb molecule, that targets two immune checkpoints, and is expected to increase the therapeutic index and efficacy in patients as compared to a dual targeting by two independent mAbs. With its potential synergistic anti-cancer effects, this BiXAb is being evaluated in Phase 1 as a new treatment for selected solid tumors and hematological malignancies.

In 2018, the Nobel prize for Medicine was awarded to an approach based on antibodies that blocked the PDL1/PD1 immune checkpoint axis and attenuation of this checkpoint continues to yield positive clinical responses, as judged the regular updates presented at different ASCO (American Society of Clinical Oncology) or ESMO (European Society for Medical Oncology) congresses and many others. The first BiXAb based on a dual immune checkpoint is on schedule to soon be in clinical development for the treatment of solid tumors and hematological malignancies.

This first-in-class BiXAb antibody has demonstrated not only good pairing, low aggregation, high stability, excellent manufacturability but also excellent specificity and safety, and displayed important in-vivo anti-tumoral activities at different doses with the potential for a wider therapeutic window as compared to its parental antibodies. Based on the proprietary structure generated from the BiXAb® technology of BIOMUNEX, this antibody possesses a functional Fc domain in contributing to ADCC activity against tumor cells.

In co-development with ONWARD Therapeutics, BIOMUNEX has announced in January 2024 the start of a Phase 1 clinical trial for this bispecific antibody for the treatment of different cancers, either solid tumors or hematological malignancies. This first-in-man trial conducted by ONWARD Therapeutics, under the license and co-development agreement, is a Phase 1 clinical trial, evaluating the safety, tolerability, pharmacokinetics, immunogenicity and preliminary anti-tumoral activity of this BiXAb antibody, given as monotherapy or in combination. This start of the Phase 1 demonstrates the potential of the BiXAb platform to generate clinical candidates.

Overall, all BiXAb programs have demonstrated the superior added value of the BiXAb® technology compared to traditional multi-specific antibodies formats: rapid production, quick generation of the IP covering the molecule, excellent drug like properties, manufacturability and low COGS (Cost of Goods Sold), and finally versatility and multi-specific capabilities.

Several patent family have been filed to protect such disruptive approaches.