Biomunex Showcases MAIT Engager Preclinical Data at 2025 SITC

Biomunex to Present Preclinical Data on MAIT Engager Platform at 2025 SITC Annual Meeting

Biomunex Pharmaceuticals, an innovative French biopharmaceutical company advancing the next generation of antibody-based immunotherapies, announced that it will present new preclinical data from its proprietary MAIT engager platform at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2025). The conference will take place November 5–9, 2025, in National Harbor, USA, and is considered one of the premier forums for the global immuno-oncology community.

Biomunex, known for its pioneering work in the discovery and development of bispecific and multispecific antibody therapeutics, is positioning its MAIT engager technology as a promising new class of cancer immunotherapy platforms that could significantly expand treatment options for solid tumors.

Showcasing MAIT Engager Platform at SITC 2025

At SITC 2025, Biomunex will deliver significant scientific updates through both an oral presentation and a poster. Dr. Simon Plyte, Chief Scientific Officer at Biomunex, has been invited to present a talk on November 8 titled “The MAIT Engager platform: rapid generation of several MAIT T cell engagers with significantly improved safety profile and large therapeutic window” (Abstract 1197). In addition, the company will exhibit a research poster related to the platform on November 7.

Being selected for an oral presentation at SITC underscores the growing interest and enthusiasm surrounding the MAIT engager platform. Participation at this level allows Biomunex to share detailed scientific findings with leading researchers, clinicians, and industry stakeholders engaged in advancing immunotherapies that effectively and safely target cancer.

MAIT Engagers: A Novel Class of Bispecific Antibodies

Biomunex’s MAIT Engagers are designed to represent a new therapeutic class within immuno-oncology. Unlike classical T-cell engagers (TCEs), which predominantly drive cytotoxic responses through CD3-positive T cells, MAIT engagers are engineered bispecific antibodies that selectively recognize Mucosal-Associated Invariant T (MAIT) cells, and redirect them to recognize and destroy tumor cells.

MAIT cells are a specialized subset of innate-like T cells naturally present within mucosal tissues and peripheral blood. Because of their immunoregulatory characteristics, unique activation pathways, and innate-like rapid response, MAIT cells offer a different and potentially safer immune-activating mechanism compared to conventional T cells. Biomunex aims to exploit these biological properties to develop therapies capable of overcoming historical limitations associated with first-generation T cell–engaging therapies.

Through dual binding capability, MAIT engagers facilitate the recognition, activation, and directed cytotoxic activity of MAIT immune cells against malignant cells. This bridging underlies their therapeutic potential: to activate tumor-targeted immune responses that are both potent and more manageable from a safety standpoint than conventional bispecific T cell engagement.

Improved Therapeutic Window and Safety Profile

The preclinical data that Biomunex will present at SITC highlights several differentiating features of the MAIT engager platform. A major focus will be on comparing the MAIT engager approach to classical CD3+ T cell engagers, showing how MAIT engagers may demonstrate a superior safety profile.

Typical CD3-mediated TCEs can activate a wide population of T cells, which can lead to multiple side effects such as cytokine release syndrome (CRS) and activation of regulatory T cells (Tregs), both of which pose challenges for clinical management and reduce therapeutic efficacy. CRS, in particular, remains a key concern in the development and broader use of TCEs.

Because MAIT engagers are designed to selectively activate MAIT immune subsets rather than broadly triggering polyclonal T cell activation, they may reduce or avoid many of the severe or dose-limiting side effects associated with contemporary TCE approaches. The more targeted activation is expected to offer a wider therapeutic window, enabling treatment at effective dose levels while maintaining acceptable tolerability.

The strong preclinical findings suggest that MAIT engagers are at least as potent as classical CD3-based TCEs but present fewer safety risks, potentially increasing their suitability in solid tumor settings. This improved profile could expand patient eligibility for immune-engaging therapies and broaden therapeutic use.

Potential to Deliver Durable Anti-Tumor Responses

Biomunex reports that its MAIT engager platform can induce what is known as the “SPARK effect”—a form of sustained anti-tumor cytotoxic activity that continues beyond initial immune activation. If this translates clinically, MAIT engagers could initiate anti-cancer responses capable of being maintained over a longer duration, even after treatment discontinuation.

Such long-lasting responses are highly desirable in immuno-oncology, where durability is a key indicator of clinical success. These results reinforce the potential of MAIT engagers as promising therapeutic tools capable of providing persistent immune surveillance and long-term disease control.

Moving Toward Clinical Evaluation

Biomunex

Based on favorable preclinical performance, including robust tumor-killing activity and encouraging safety signals, Biomunex anticipates transitioning its first MAIT engager candidate into clinical development in the near future. Clinical initiation would represent a major milestone in validating this emerging therapeutic paradigm and solidifying MAIT engagement as a novel mechanism of action for cancer therapy.

If successful, MAIT engagers could transform treatment options for patients across a range of cancer types, particularly solid tumors that have historically shown resistance to TCE-based therapies or pose safety challenges.

As Dr. Simon Plyte commented,

MAIT engagers are an attractive approach for the treatment of cancer with breakthrough potential for redefining the standard of care for solid tumors. Presenting these preclinical data as both an oral communication and poster during the 40th SITC meeting is a unique opportunity to share the scientific and medical potential of this innovative approach with the broader community.”

Biomunex Advances Next-Generation Immuno-Oncology Pipeline

In addition to advancements related to its MAIT engager portfolio, Biomunex continues to strengthen its position as a key innovator in oncology. The company is recognized for its distinctive BiXAb® antibody engineering platform, a proprietary “plug-and-play” technology that facilitates rapid and efficient generation of multispecific antibody candidates with strong biophysical properties.

The BiXAb platform provides flexibility in designing novel bi- and multi-specific antibodies with excellent manufacturability, accelerating preclinical development and enabling faster advancement into clinical evaluation. Biomunex states that this rapid generation capability—combined with high drug-like properties and potential to scale efficiently—makes BiXAb one of the most versatile multispecific platforms currently available.

Biomunex’s first BiXAb-derived candidate is already in Phase 1 clinical development through industry partnership. The therapy is being assessed both as a monotherapy and in combination settings for patients with various solid tumors and hematologic cancers.

Strong Industry Collaboration, Including Ipsen Agreement

Biomunex’s emerging technology has been recognized across the pharmaceutical industry, drawing increasing interest in potential collaborations and strategic partnerships. The company’s recent licensing agreement with Ipsen—announced earlier in the year—marks a significant milestone, reinforcing the commercial viability and scientific promise of its pipeline.

BMX-502, one of Biomunex’s lead assets, was licensed to Ipsen and exemplifies the company’s ability to produce first-in-class or best-in-class antibody therapeutics with clear translational potential. The deal adds to an expanding roster of partnerships and demonstrates Biomunex’s capability in delivering competitive therapeutic modalities that advance clinical care.

As Dr. Pierre-Emmanuel Gérard, founder and president of Biomunex, noted:

The last few months have marked the beginning of a new chapter in Biomunex’s development with the signing of a major agreement with Ipsen. These collaborations validate the strength of our technologies and reinforce our mission to provide impactful immunotherapies for cancer patients.”

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