Roche inks $110m allogeneic CAR-T deal with Poseida

Switzerland’s Roche has jumped deeper into the allogeneic cell therapy space through an off-the-shelf CAR-T collaboration and license deal with Poseida Therapeutics.

Pharma giant Roche’s adventure in the cell and gene space began with gene therapies, acquiring Spark Therapeutics in 2019 for $4.3 billion and instantly adding one of just a handful of approved products. Luxturna (voretigene neparvovec), a one-time gene therapy for an inherited retinal disease, was approved by the US Food and Drug Administration (FDA) in December 2017.

Having delved deeper into gene therapies through partnerships with Dyno Therapeutics and Shape Therapeutics, the firm last September made its first play in the cell therapy space through a $150 million upfront deal with Adaptimmune to develop and commercialize allogeneic cell therapies to treat multiple oncology indications.

Now it has been revealed the firm is broadening out its interest in off-the-shelf cell therapies through a collaboration with California-headquartered Poseida.

With an upfront payment of $110 million, Poseida will grant Roche an exclusive, worldwide license to develop, manufacture and commercialize allogeneic CAR-T cell therapy products from each of its existing P-BCMA-ALLO1 and P-CD19CD20-ALLO1 programs, targeting multiple myeloma (MM) and B Cell diorders, respectively the firm said in an SEC filing. Roche also has the option to acquire the license for so-called Tier 2 programs – CAR-T cell therapy products targeting MM and Hematologic malignancies Poseida’s pipeline – and team on additional allogeneic programs going forward.

“The parties will conduct an initial, two-year research program to explore and preclinically test a specified number of agreed-upon next generation therapeutic concepts relating to allogeneic CAR-T therapies,” the filing states.

“Subject to Roche’s election and payment of a specified fee, the parties would subsequently conduct a second research program of 18 months under which the parties would explore and preclinically test a specified number of additional agreed-upon next generation therapeutic concepts relating to allogeneic CAR-T therapies. Roche may designate up to six heme malignancy-directed, allogeneic CAR-T programs from the two research programs, for each of which the Company will perform research and development activities through selection of a development candidate for IND-enabling activities.”

In a statement, Poseida CEO Mark Gergen described Roche as “an ideal strategic partner for Poseida with its industry-leading R&D capabilities in oncology, complementary technologies and expertise, and global regulatory and commercial capabilities.”

CSO Devon Shedlock added: “Using our proprietary technologies and manufacturing process including our booster molecule, we have the potential to develop and manufacture a product with high levels of stem cell memory T cells, which are correlated with potent antitumor efficacy in the clinic, at a scale that can potentially reach more patients and enable broad commercial use.”