Ipsen and Biomunex announce exclusive global licensing agreement for first-in-class MAIT cell engager in immuno-oncology

• Ipsen secures exclusive global rights to develop, manufacture and commercialize BMX-502, a pre-clinical novel T cell engager (TCE) with first-in-class potential
• BMX-502 is a bispecific antibody engaging MAIT cells, a subset of non-conventional T cells, and targeting the clinically validated tumor antigen GPC3 to kill cancer cells

PARIS, FRANCE; 03 December 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) and Biomunex Pharmaceuticals today announced an exclusive global licensing agreement for BMX-502. BMX-502 is a bispecific antibody that engages and activates a subset of cytotoxic T cells called Mucosal-Associated Invariant T cells (MAIT cells) and targets the GPC3 tumor antigen, to kill cancer cells. GPC3 is a clinically validated target, highly expressed across several cancer types.1 MAIT cells are present throughout the body, highly enriched in many specific tissues of the body, particularly in mucosal and barrier tissues. BMX-502 offers a promising approach to treating tumors in these tissues.2,3

Developed using Biomunex’s proprietary BiXAb technology, BMX-502 selectively engages MAIT cells and leverages their unique properties to maximize anti-tumor activity. MAIT engagers should overcome some of the limitations of current pan-T cell engager therapies, including activation of regulatory T cells and cytokine release syndrome, side effects that are difficult to manage for patients and represent a significant burden on the healthcare system.4 MAIT engagers have the potential to provide a more robust therapeutic window compared to classical pan-T cell engagers in specific tumor types.

“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 tumors,” said Mary Jane Hinrichs, SVP and Head of Early Development at Ipsen. “This new MAIT-engager program 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 tumors around the world.”

“This agreement with such an innovative oncology company as Ipsen is proof of the relevance of 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. We look forward to initiating and supporting the development of BMX-502 alongside Ipsen,” added Dr. Pierre-Emmanuel Gerard, founder, President and CEO of Biomunex.

Under the terms of the agreement, Biomunex will complete the IND-enabling package. Ipsen will assume responsibility for Phase I preparation activities, including submission of the Investigational New Drug (IND) application, and all subsequent clinical-development and global commercialization activities. Biomunex is eligible to receive up to $610 million, including upfront, contingent upon successful development, regulatory and commercial milestones, in addition to tiered global royalties on sales.

ENDS

About Ipsen

We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience.

Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 80 countries.

Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.

About Biomunex Pharmaceuticals

Biomunex Pharmaceuticals is a biopharmaceutical company based in Paris (France) and Cambridge, MA, USA, led by an international and experienced team. Biomunex specializes in the discovery and development of breakthrough immunotherapeutic approaches, based on solid data and proven biological and clinical evidence, to address unmet medical needs in oncology.

Biomunex has created and developed BiXAb®, a robust, “Plug and Play”, next-generation bi- and multi-specific antibody technology platform, using a proprietary computational modeling approach, with a very robust IP and patent portfolio. The BiXAb platform allows the generation of bispecific antibodies from any pair of monoclonal antibodies in a simple, fast and cost-effective manner.

Biomunex is the first company worldwide developing MAIT engagers, an immuno-oncology approach that allows, through bispecific antibodies from its BiXAb platform, to specifically target and engage MAIT cells, to kill cancer cells, for the treatment of solid tumors.

Ipsen contacts

Email: [e-mail]

Investors

Nicolas Bogler | [phone]

Media (Global)

Jennifer Smith-Parker | [phone]

Media (France)

Anne Liontas | [phone]

Biomunex Pharmaceuticals contacts

Media - NewCap

Arthur Rouillé | [phone] – [e-mail]

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References

1 Guo et al. Glypican-3: A New Target for Diagnosis and Treatment of Hepatocellular Carcinoma. Journal of Cancer 2020. 11(8): 2008-2021. Last accessed: November 2024 2 Godfrey et al. The biology and functional importance of MAIT cells. Nature Immunology. 2019. 20:110-1128 Last accessed: November 2024 3 Petley et al. MAIT cells regulate NK cell-mediated tumor activity. 2021 Nature Communications 12:4746 last accessed November 20244 Biomunex Presentation, AACR 2024. Available here: https://www.biomunex.com/wp-content/uploads/2024/05/Poster-AACR-2024-FINALIZED.pdf . Last accessed November 2024

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• Ipsen PR_Biomunex_03122024