Sanofi and Regeneron gain approval for skin cancer MAb

The US FDA has approved skin cancer drug Libtayo, a programmed cell death protein-1 (PD-1) inhibitor developed through a Sanofi and Regeneron collaboration.

In 2007, Sanofi teamed up with Regeneron Pharmaceuticals to discover, develop, and commercialize fully-human therapeutic antibodies. While the discovery collaboration ended last year, Sanofi still owns a 22% stake in Regeneron.

The the firms also continue to develop and commercialize a number of monoclonal antibodies, including its metastatic cutaneous squamous cell carcinoma (CSCC) product cemiplimab which the two firms began collaborating on in 2015.

The product has been evaluated by the US Food and Drug Administration (FDA) under a priority review, and has now been approved under the brand name Libtayo.

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“With the Libtayo approval, the FDA has approved six immune checkpoint inhibitors targeting the the PD-1 / PD-L1 pathway for treating a variety of tumors, from bladder to head and neck cancer, and now advanced CSCC,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence said.

The MAb is the first and only treatment for advanced CSCC in the US, and has been given a list price, or wholesale acquisition cost, of $9,100 (€7,900) per three-week treatment cycle.

Manufacturing

Libtayo was developed using Regeneron’s VelocImmune mouse technology, a genetically modified strain in which genes encoding mouse immune system proteins have been replaced by their human equivalents.

According to teh 2015 deal, the product is made using Regeneron’s flexible manufacturing platform it says enables efficient production of bi-specific antibodies that are otherwise similar to natural antibodies.

According to the FDA label information, Libtayo is manufactured by Regeneron. However, when contacted by this publication, Regeneron spokesperson Daren Kwok was neither able to confirm this nor able to comment on the manufacturing strategy. Sanofi too, when contacted, declined to comment.

Last month, Regeneron announced plans to invest $800 million over the next seven years to expand its laboratory space, manufacturing capacity and warehouse facilities at its Rensselaer County campus, New York, creating 1,500 jobs.