Biomunex announces the clinical development of a new therapeutic class in 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
24 Sept 2026
Biomunex Pharmaceuticals has 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 (mucosal-associated invariant T cells) cell engager (also referred to as a ‘MAIT engager’) based on Biomunex’s proprietary BiXAb® technology platforms.
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, 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.
“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.
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What is IPN60330, and how does the MAIT cell engager target cancer?
IPN60330, formerly BMX-502, is Ipsen’s bispecific antibody based on Biomunex’s BiXAb® technology. It selectively engages and activates mucosal-associated invariant T (MAIT) cells while targeting the GPC3 tumor antigen to kill cancer cells. GPC3 is highly expressed across several cancer types.
Why is the FDA IND review completion important for IPN60330’s clinical development?
The U.S. Food and Drug Administration’s completion of the Investigational New Drug review period enables Ipsen’s upcoming Phase I clinical trial in the United States. It follows Biomunex and Ipsen’s preclinical development work, including drug bioproduction, regulatory studies, and animal toxicology studies.
What potential advantages do MAIT engagers offer over classical pan-T cell engagers?
MAIT engagers may provide a broader therapeutic window by selectively activating MAIT cells. Classical pan-T cell engagers activate all T cells, including regulatory T cells, and can cause cytokine release syndrome. An improved therapeutic window could support stronger adaptive immune responses and potentially improve response durability.