BMX-502 is designed to engage and activate mucosal-associated invariant T cells to target and destroy malignant cells. Credit: Pickadook/Shutterstock.

Ipsen has entered an exclusive worldwide licensing agreement with Biomunex Pharmaceuticals for BMX-502, a first-in-class bispecific antibody designed to engage and activate mucosal-associated invariant T cells (MAIT cells) to target and destroy malignant cells.

The agreement grants Ipsen exclusive worldwide rights for the development, manufacturing and commercialisation of BMX-502.

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Biomunex is set to finalise the investigational new drug (IND)-enabling package. Ipsen will take over the responsibility for preparation activities related to the Phase I trial, including the IND application submission, and all clinical development and commercialisation efforts.

Biomunex could receive up to $610m, including upfront and milestone payments, as well as tiered global royalties on sales.

Ipsen early development senior vice-president and head Mary Jane Hinrichs stated: “As we continue to grow Ipsen’s pipeline using a science-first approach to partnering across the ecosystem, we believe BMX-502 is a strong addition with first-in-class potential in solid tumours.

“This new MAIT-engager programme will complement our existing TCE portfolio as we harness the next generation of T cell engagers to overcome treatment challenges, including dose-limiting toxicity, to bring transformational new medicines to people living with solid tumours around the world.”

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BMX-502, which leverages Biomunex’s BiXAb technology, specifically targets the glypican-3 (GPC3) tumour antigen, a clinically validated target expressed in high levels in several cancer types.

It will treat tumours by activating MAIT cells, which are abundant in mucosal and barrier tissues.

Biomunex CEO, founder and president Dr Pierre-Emmanuel Gerard stated: “This agreement with such an innovative oncology company as Ipsen is proof of the relevance of the MAIT-engager approach of Biomunex, the first company worldwide to have identified the high therapeutic potential of MAIT cells in cancer treatment.

“It also represents the demonstration of the added value of our best-in-class BiXAb platform to rapidly generate innovative and promising bispecific antibodies. We are convinced that our MAIT engagers will represent a new step forward in the development of disruptive immuno-therapies for the treatment of cancer.”

In October 2024, Ipsen’s elafibranor (Iqirvo) received approval from the UK Medicines and Healthcare Products Regulatory Agency for the treatment of primary biliary cholangitis in adults.