Regeneron Pharmaceuticals and Flagship startup Tessera Therapeutics have inked a global collaboration to develop and commercialize TSRA-196, Tessera’s lead investigational in vivo Gene Writing program for the treatment of alpha-1 antitrypsin deficiency (AATD), an inherited disease that can affect the lungs, liver or both organs.
Per the deal, the companies will share worldwide development costs and potential future profits relating to TSRA-196 equally. Tessera will receive $150 million as a cash upfront payment and equity investment from Regeneron. Tessera is also eligible to receive additional near and mid-term development milestone payments totaling $125 million.
Tessera — founded in 2018 by life sciences venture capital company, Flagship Pioneering — will lead the initial first-in-human trial, while Regeneron will lead subsequent global development and commercialization.
There are currently no FDA-approved therapies that address the underlying genetic cause of AATD, and treatment options remain limited to weekly intravenous augmentation therapy for patients with lung disease. TSRA-196 is designed to precisely correct the genetic mutation underlying AATD, with the goal of restoring production of functional alpha-1 antitrypsin (AAT) protein through a one-time, durable treatment option for patients.
Tessera expects to file an IND and multiple clinical trial applications for TSRA-196 with the U.S. FDA by the end of the year.
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