Biomunex Announces the Upcoming Start of Clinical Development of IPN60330, the First MAIT Engager, a New Therapeutic Class in Oncology, Following the Completion of the FDA Review Period

• Biomunex Pharmaceuticals announces that the U.S. Food and Drug Administration (FDA) has completed the review period for the Investigational New Drug (IND) application for IPN60330, paving the way for the upcoming launch of a Phase 1 clinical trial for this first MAIT cell engager, a new therapeutic class in immuno-oncology.
• IPN60330 is a bispecific antibody engaging MAIT cells, a subset of non-conventional T cells present throughout the body, and the clinically validated tumor antigen GPC3 to kill cancer cells across a variety of solid tumors.
• Achieving this key milestone demonstrates the quality of Biomunex’s proprietary BiXAb® technologies and the expertise of its teams in generating high-quality products with strong data and enables the Company to receive the 1^st development milestone for this innovative product.

PARIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biomunex Pharmaceuticals, a biopharmaceutical company specialized in the discovery and development of innovative therapeutic approaches, today announced that the U.S. Food and Drug Administration (FDA) has completed its Investigational New Drug (IND) review period for Ipsen’s IPN60330 (formerly BMX-502), the first MAIT cell engager (also referred to as a “MAIT engager”) based on Biomunex’s proprietary BiXAb® technology platforms, and for which Biomunex and Ipsen announced an exclusive global licensing agreement for development, manufacture and commercialization rights in 2024.

This key step is the result of an intensive preclinical development effort, encompassing full drug bioproduction for the Phase 1 trial, regulatory studies and animal toxicology studies, conducted by the Biomunex team in partnership with Ipsen. It marks the upcoming initiation of Ipsen’s Phase I clinical trial in the USA, a significant step forward in the development of this novel therapeutic class in immuno-oncology.

IPN60330 is a bispecific antibody designed to selectively engage and activate MAIT cells (Mucosal-Associated Invariant T cells), a subset of T cells present throughout the body, which are particularly enriched in mucosal and barrier tissues, and targets the GPC3 tumor antigen to kill cancer cells. GPC3 is a clinically validated target, highly expressed across several cancer types.

The completion of the FDA review period is a further demonstration of the quality of Biomunex’s proprietary BiXAb® technologies. This first MAIT engager should overcome some of the limitations of classical pan-T cell engagers, which activate all T cells, including regulatory T cells, and can induce cytokine release syndrome, a potentially serious dose-limiting toxicity that represents a true problem for physicians and their cancer patients. MAIT engagers have the potential to provide a broader therapeutic window compared to classical pan-T cell engagers for treating specific tumor types. Moreover, an improved therapeutic window with MAIT engagers should permit a stronger response from the adaptive immune system leading to improved and durable responses.

This new milestone has triggered a milestone payment linked to the completion of the FDA IND review period ahead of the upcoming entry into clinical development, under the exclusive global licensing agreement entered into between Ipsen and Biomunex in November 2024. In the context of this agreement, Biomunex is eligible to receive up to $610 million in total, including an upfront already received, contingent upon successful development, regulatory and commercial milestones, in addition to tiered global royalties on sales.

“The upcoming start of the clinical development program in the United States for IPN60330 is a recognition of the quality of our collaboration with Ipsen. Moreover, that’s a major milestone in our development, demonstrating the strength of our BiXAb® technology platforms, as well as the expertise of our teams in generating breakthrough innovation,” said Dr Simon Plyte, CSO of Biomunex. “It finally underscores our ability to develop innovative programs in partnership with a world-renowned pharmaceutical partner, with the potential to open new avenues in cancer immunotherapy,” added Dr Pierre-Emmanuel Gerard, founder, President and CEO of Biomunex.

About Biomunex Pharmaceuticals: www.biomunex.com

Biomunex Pharmaceuticals is a biopharmaceutical company based in Paris, France, and Cambridge, MA, USA, specializing in the discovery and development of innovative therapeutic approaches based on solid data and biological and clinical evidence, as well as AI technologies to address unmet medical needs in oncology.

Biomunex has created and developed the BiXAb® technologies, an innovative next-generation platform for bispecific and multi-specific antibodies, enabling the development of disruptive therapeutic strategies, and using proprietary in silico modeling as well as generative AI, underpinned by a broad and robust intellectual property and patent portfolio.

The “best-in-class” BiXAb platform, which enables the generation of bispecific antibodies from any pair of monoclonal antibodies in a simple, rapid, and cost-effective manner, has been validated through licensing agreements and collaborations with the pharmaceutical and biotechnology industry, including Ipsen, Sanofi, and Onward Therapeutics.

Biomunex is the first company in the world to develop a cancer immunotherapy approach that uses bispecific antibodies, based on the BiXAb technologies to specifically target, engage, and redirect MAIT cells, a subpopulation of T cells naturally present throughout the body, particularly in mucosal and barrier tissues, to kill cancer cells for the treatment of solid tumors.