Sanofi will use Biomunex Pharmaceuticals’ proprietary BiXAb® platform for generating and optimizing bi- and multi-specific antibodies to develop new treatments in immuno-oncology and other therapeutic areas.

The companies have signed a licensing agreement whose value was not disclosed. The collaboration with Sanofi is the first partnership for Biomunex, a Paris-based biotech founded in 2014 to discover and develop innovative bispecific antibody therapeutics that combine bispecific antibodies with checkpoint inhibitors to address unmet medical needs, with a focus on cancer.

“This licensing agreement is a major milestone for Biomunex,” company founder and CEO Pierre-Emmanuel Gerard, MD, said in a statement. “It demonstrates the high value of the BiXAb technology and is the starting point for our collaboration strategy with pharmaceutical companies to discover and develop cutting-edge bi- and multi-specific antibodies, giving patients new treatment options.”

“We believe that the proceeds from this deal, together with the funding round that we expect to finalize in the near future, will help us accelerate the development of Biomunex’ proprietary BiXAb bi- and multi-specific antibody programs in immuno-oncology and other therapeutic areas towards clinical development,” Gerard added.

As of 2016, Biomunex disclosed that it had raised €1.5 million ($1.7 million) consisting of seed funding from business “angel” investors, as well as grants from France’s Ministry of Research and the French public investment bank Bpifrance.

Biomunex says its lead candidate, BMX-002, has shown superior in vivo efficacy in pancreatic cancer, with initial preclinical studies also demonstrating its potential in several other solid tumor cancers, such as head & neck, gastric, and colon cancers.

“Plug and play” platform

In addition to cancer therapeutics, BiXAb—a next-generation modular “plug and play” platform that incorporates existing antibodies as building blocks—is also designed to generate bispecific antibodies in other therapeutic areas, including immune-mediated inflammatory diseases and infectious diseases. The platform can also be expanded to generate tri- or tetra-specific antibodies, Biomunex added.

“We do not need to spend time trying to optimize our construct or our engineering,” Eugene Zhukovsky, PhD, the company’s chief scientific officer, told GEN in 2017. “We spend time on doing biological evaluation to select the most efficacious bispecific antibodies.”

Also in Biomunex’ pipeline is BMX-101, an immunotherapeutic being developed for multiple myeloma and other hematological malignancies by applying immune checkpoint inhibition. The company maintains collaborations with academic researchers that include Institut de Recherche en Cancérologie de Montpellier, adding that new programs are being established with additional academic teams.

Sanofi agreed to pay Biomunex an initial upfront payment, as well as additional potential payments tied to achieving clinical, regulatory and commercial milestones.

For Sanofi, the agreement with Biomunex marks the second deal announced this month focused on building a pipeline of antibodies for cancer immunotherapies.

On January 7, Sanofi and Regeneron Pharmaceuticals restructured what was originally a potentially $2 billion-plus global immuno-oncology antibody partnership launched in 2015. The companies extended the alliance past mid-2020, granted Sanofi opt-in rights to two clinical-stage bispecific antibody programs, and allowed Regeneron to retain all rights to its other immuno-oncology discovery and development programs.

The two programs for which Sanofi gained rights are the BCMAxCD3 and MUC16xCD3 bispecific programs. Sanofi can opt-in to the programs when proof of concept is achieved or when the allocated funding is expended.

Under the restructured agreement, Sanofi agreed to pay Regeneron $462 million representing the balance of payments due under the original agreement, which covers the Sanofi share of the immuno-oncology discovery program costs for the last quarter of 2018 and up to $120 million in development costs for the two selected clinical-stage bispecific antibodies, plus a termination fee for the other programs under the original agreement.

Regeneron agreed to commit up to $70 million to further develop the BCMAxCD3 bispecific antibody for multiple myeloma, and up to $50 million to further develop the MUC16xCD3 bispecific for mucin-16 expressing cancers.

Development, commercialization details

After opting in, Sanofi agreed to lead development and commercialization of the BCMAxCD3 bispecific and fund 100% of development costs, with Regeneron reimbursing up to 50% out of its share of collaboration profits. Sanofi and Regeneron will share global profits equally.

Also after opt-in, Regeneron agreed to lead MUC16xCD3 bispecific development and lead commercialization in the U.S., and Sanofi will lead outside the U.S. The companies agreed to share development costs and global profits equally.

Not affected by the restructured agreement is the ongoing Sanofi-Regeneron collaboration for the development and commercialization of Libtayo® (cemiplimab-rwlc), a programmed death-1 (PD-1) antibody, On September 28, 2018, the FDA approved Libtayo for metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation—the first treatment specifically approved and available for advanced CSCC in the U.S.

Sanofi has exercised its option to co-promote Libtayo in the U.S., with Regeneron entitled to a milestone payment of $375 million tied to Lobtayo and other PD-1 targeting products—plus other products licensed under the companies’ agreement and sold in combination with any licensed products targeting PD-1—equaling or exceeding $2 billion in any consecutive 12-month period, according to Regeneron’s Form 10-Q filing  for the third quarter of 2018.

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