CAR-T therapy is a form of cell therapy, which uses immune cells to attack cancer. The advent of CAR-T therapies has revolutionized treatment of some blood-based cancers by demonstrating profound initial response rates and, in some cases, the ability to cure. Despite these response rates, several key limitations have curtailed broad adoption of early-generation CAR-T products. Limitations include safety concerns and an inability to treat solid-tumor cancers. We believe we can overcome these limitations to create safer and more effective medicines for cancer and potentially other diseases.
How are CAR-T therapies made?
Today, CAR-T therapies are customized to each patient by removing a specific set of cells from the individual’s blood, modifying the cells in a lab to intensify the immune system’s response to cancer, and re-injecting the cells into the patient. These are known as autologous therapies. Poseida is developing autologous therapies as well as allogeneic therapies, which are created using the cells of a universal donor and produced in large quantities, so it is available for on-demand use. Poseida plans to develop allogeneic versions of all of our hematological and solid tumor product candidates.
How is Poseida’s CAR-T approach different?
Our proprietary gene engineering technologies are used to create potential therapies predominantly composed of a specific T cell subset, stem cell memory, or TSCM, which we believe can address the limitations of other CAR-T therapies, including duration of response, the ability to treat solid tumors and safety concerns. This is possible because unlike other approaches, Poseida does not rely on viral vectors to manufacture therapies. Instead, we use a non-viral gene engineering technology that also enables other benefits, including the ability to treat solid tumors and ensure a safer product through the inclusion of a “safety switch” gene in every therapy.
Which diseases will Poseida seek to treat?
Initially, Poseida’s product candidates are focused on multiple myeloma and castrate-resistant prostate cancer, or CRPC. Our most advanced program P-BCMA-101, is an autologous CAR-T therapy being developed to treat patients with relapsed/refractory multiple myeloma. We plan to begin a potential registrational clinical trial for P-BCMA-101 in the first half of 2019, moving toward a potential biologics license application, or BLA, filing with the U.S. Food and Drug Administration by the end of 2020.
Our mission at Poseida is to develop cell and gene therapies with the capacity to cure.
“It’s hard to fight every day, but keep the fight.”
It’s been more than a year since US Navy pilot Byron was treated with Poseida’s investigational new CAR-T therapy called P-BCMA-101 for relapsed/refractory multiple myeloma. With his strength returning and the cancer cells in his blood declining, Byron has been able to lead a normal life, cherishing time with his family on surfing trips and ski trips. Byron’s advice is to “hang in there, the future is coming faster than you think. It’s hard to fight every day, but keep the fight.”