Poseida Therapeutics, Inc. has entered into a broad strategic collaboration and license agreement with Roche, focused on developing allogeneic CAR-T therapies directed to hematologic malignancies.
The global collaboration covers the research and development of multiple existing and novel off-the-shelf cell therapies against targets in multiple myeloma, B-cell lymphomas and other hematologic indications.
“We are excited to partner and collaborate with Roche, one of the world’s largest biotechnology companies, which has a successful track record in the discovery, development and commercialization of innovative medicines,” said Mark Gergen, CEO of Poseida.
“Roche is 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. Working together, we look forward to advancing novel allogeneic cell therapies based upon Poseida’s technologies for patients battling cancer.”
Under the agreement, Roche will receive from Poseida either exclusive rights or options to develop and commercialize allogeneic CAR-T programs in Poseida’s portfolio that are directed to hematologic malignancies. This includes P-BCMA-ALLO1, an allogeneic CAR-T for the treatment of multiple myeloma, and for which a phase 1 study is under way, and P-CD19CD20-ALLO1, an allogeneic dual CAR-T for the treatment of B-cell malignancies with an IND expected in 2023.
The companies will also collaborate in a research program to create and develop next-generation features and improvements for allogeneic CAR-T therapies, from which they would jointly develop additional allogeneic CAR-T product candidates directed to existing and new hematologic targets.
For the Poseida portfolio programs licensed or optioned to Roche and the parties’ future collaboration programs, Poseida will conduct phase 1 studies and manufacture clinical materials before transitioning the programs to Roche for further development and commercialization. Roche will be solely responsible for the late-stage clinical development and global commercialization of all products tfrom the collaboration.
“We are excited to partner with Poseida to further explore the potential of allogeneic cell therapies to transform cancer care by developing off-the-shelf products that can address high unmet medical needs for a broad patient population,” said James Sabry, global head of pharma partnering at Roche.
“Poseida’s differentiated platform technologies complement our ongoing internal efforts and partnerships to discover and develop cell therapies as a next generation of medicines for patients.”
Under the agreement, Poseida will receive $110 million upfront and could receive up to $110 million in near-term milestones and other payments in the next several years. In addition, Poseida is eligible to receive research, development, launch, and net sales milestones and other payments potentially up to $6 billion in aggregate value, as well as tiered net sales royalties into the low double digits, across multiple programs.
“We are thrilled that Roche has embraced the opportunity to partner with us and use Poseida’s unique allogeneic approach to develop CAR-T product candidates,” said Devon J. Shedlock, chief scientific officer, cell therapy, at Poseida.
“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.”
About Poseida Therapeutics
Poseida Therapeutics is a clinical-stage biopharmaceutical company using genetic engineering platform technologies to create next generation cell and gene therapeutics.
The company has discovered, and is developing, a broad portfolio of product candidates in a variety of indications based on its core platforms, including non-viral piggyBac DNA Delivery System, Cas-CLOVER Site-specific Gene Editing System and nanoparticle- and AAV-based gene delivery technologies.
The technologies can be used – either alone or in combination – across many cell and gene therapeutic modalities.