Cambridge, Mass. — Biomunex Pharmaceuticals said the U.S. Food and Drug Administration has completed its review period for the Investigational New Drug application for IPN60330, clearing the way for the planned start of a Phase 1 clinical trial in the United States.
IPN60330, formerly known as BMX-502, is being developed by Ipsen under an exclusive global licensing agreement with Biomunex. The drug is described as the first MAIT cell engager based on Biomunex’s proprietary BiXAb technology platforms.
The bispecific antibody is designed to selectively engage and activate mucosal-associated invariant T cells, or MAIT cells, while targeting the GPC3 tumor antigen on cancer cells. GPC3 is expressed across several cancer types.
Biomunex said the FDA milestone follows preclinical development work that included drug production for the Phase 1 trial, regulatory studies and animal toxicology studies conducted in partnership with Ipsen.
“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 Simon Plyte, Ph.D., Chief Scientific Officer of Biomunex.
The company said MAIT engagers are designed to address some of the limitations associated with traditional pan-T cell engagers, including the risk of cytokine release syndrome. Biomunex said the approach could offer a broader therapeutic window and support stronger and more durable immune responses.
The completion of the FDA review period also triggered a milestone payment under the licensing agreement between Biomunex and Ipsen signed in November 2024.
Under the agreement, Biomunex is eligible to receive up to $610 million, including an upfront payment already received and additional development, regulatory and commercial milestone payments, as well as tiered royalties on global sales.
“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,” said Pierre-Emmanuel Gerard, Ph.D., Founder, President and Chief Executive Officer of Biomunex.
