Poseida Therapeutics has received the Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational stem cell memory (TSCM) T cell-based allogeneic CAR [chimeric antigen receptor]-T cell therapy, P-BCMA-ALLO1.
This therapy is currently in Phase I/Ib clinical development for patients with relapsed/refractory multiple myeloma.
The RMAT designation, which encompasses the benefits of both the fast track and breakthrough therapy programmes, is based on encouraging early data from the Phase I study of P-BCMA-ALLO1, which has shown potential in efficacy and safety profile, as well as rapid “off-the-shelf” accessibility for patients.
Poseida Therapeutics CEO and president Kristin Yarema stated: “The RMAT designation for P-BCMA-ALLO1, our lead programme, is based on impressive early clinical data from our ongoing Phase 1 study and further validates its potential to address the unmet needs of patients with relapsed/refractory multiple myeloma.
“Importantly, our data has shown clinical responses in very sick, refractory patients, including those that have received prior BCMA-targeted therapies. With both RMAT and orphan drug designations for P-BCMA-ALLO1, we look forward to working closely with the FDA as we continue to advance this next-generation, off-the-shelf allogeneic CAR-T therapy, including the recently initiated Phase 1b portion of the trial.”
Poseida Therapeutics is set to present new clinical data from the Phase I study at the 21st International Myeloma Society Annual Meeting in Rio de Janeiro from 25 to 28 September 2024.
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Your download email will arrive shortly
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalData
Further clinical updates on P-BCMA-ALLO1 are anticipated in the second half of 2024. These updates will be co-ordinated with Roche, which has entered a strategic collaboration with Poseida for multiple investigational allogeneic CAR-T therapies targeting blood cancers.
P-BCMA-ALLO1, an allogeneic CAR-T product candidate targeting B-cell maturation antigen (BCMA), is licensed to Roche for the treatment of relapsed/refractory multiple myeloma.
The allogeneic programme features a VH-based binder targeting BCMA.
Clinical data presented at the American Society of Hematology (ASH) meeting in December 2023 support the potential of TSCM-rich allogeneic CAR-Ts to offer effective and safe treatments for multiple myeloma.
The FDA’s RMAT designation for P-BCMA-ALLO1 applies to adult patients with relapsed/refractory multiple myeloma who have undergone at least three prior lines of therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. The therapy has also received orphan drug designation for multiple myeloma.
Poseida Therapeutics, a clinical-stage biopharmaceutical company, leverages its proprietary genetic editing platforms and in-house good manufacturing practice cell therapy manufacturing capabilities.
The company has established strategic collaborations with industry leaders such as Roche and Astellas to advance cell therapies for cancer patients.
