FDA Clears IND for IPN60330, First MAIT Cell Engager, Paving Way for Phase 1 in Solid Tumors
核心洞察
The FDA has completed its IND review period for IPN60330 (搜索), the first MAIT cell engager, clearing Ipsen to begin a Phase 1 trial in the United States.
IPN60330 (搜索) is a bispecific antibody built on Biomunex's BiXAb platform that engages MAIT cells and the clinically validated GPC3 (搜索) tumor antigen.
The milestone triggers a payment under the November 2024 Ipsen-Biomunex global licensing deal, where Biomunex is eligible for up to $610 million plus royalties.
The U.S. Food and Drug Administration has completed its Investigational New Drug review period for IPN60330 (搜索) (formerly BMX-502), the first MAIT cell engager, clearing the way for Ipsen to initiate a Phase 1 clinical trial in the United States, Biomunex Pharmaceuticals (搜索) announced on September 14, 2026. The product is based on Biomunex's proprietary BiXAb technology platforms and is being developed under an exclusive global licensing agreement for development, manufacture and commercialization rights announced by the two companies in 2024.
A New Therapeutic Class in Immuno-Oncology
IPN60330 (搜索) is a bispecific antibody designed to selectively engage and activate MAIT cells (Mucosal-Associated Invariant T cells), a subset of non-conventional T cells present throughout the body that are particularly enriched in mucosal and barrier tissues. The antibody simultaneously targets the GPC3 (搜索) tumor antigen, which is described as a clinically validated target highly expressed across several cancer types, to kill cancer cells across a variety of solid tumors (搜索).
Biomunex states it 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 to kill cancer cells for the treatment of solid tumors (搜索).
Preclinical Package and Regulatory Milestone
The completion of the FDA review period follows what the company describes as 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. Biomunex said the milestone demonstrates the quality of its BiXAb technologies and the expertise of its teams in generating high-quality products with strong data, and enables the company to receive the first development milestone for the product.
"This key step is the result of an intensive preclinical development effort," the company noted, adding that it marks the upcoming initiation of Ipsen's Phase I clinical trial in the USA and a significant step forward in the development of this novel therapeutic class in immuno-oncology.
Rationale: Avoiding Pan-T Cell Engagement
According to Biomunex, the 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 (搜索) — a potentially serious dose-limiting toxicity that the company describes as 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.
Licensing Terms and Milestone Payment
The completion of the FDA IND review period has triggered a milestone payment under the exclusive global licensing agreement entered into between Ipsen and Biomunex in November 2024. Under the terms of that agreement, Biomunex is eligible to receive up to $610 million in total, including an upfront payment 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 (搜索) 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.
Platform Validation
Biomunex, based in Paris, France, and Cambridge, MA, USA, specializes in the discovery and development of innovative therapeutic approaches based on biological and clinical evidence as well as AI technologies to address unmet medical needs in oncology. The company's BiXAb platform, described as "best-in-class," enables the generation of bispecific antibodies from any pair of monoclonal antibodies in a simple, rapid and cost-effective manner, and has been validated through licensing agreements and collaborations with the pharmaceutical and biotechnology industry, including Ipsen, Sanofi and Onward Therapeutics (搜索). The platform uses proprietary in silico modeling as well as generative AI, underpinned by an intellectual property and patent portfolio.