P-PSMA-101 employs a PSMA-specific CAR molecule and is engineered using a non-viral gene delivery system called the piggyBac™ DNA Modification System, which leverages the technology's capability to deliver up to 30 times more cargo than traditional virus-based CAR-T cell modification systems. P-PSMA-101 has demonstrated potent anti-tumor activity, persistent and durable response, significant T stem cell memory, a high concentration of P-PSMA-101 modified T-cells and no T-cell exhaustion. A unique feature of P-PSMA-101 and other Poseida CAR-T products is their exceptionally high percentage of stem cell memory T-cells, which has been shown in preclinical studies to lead to unprecedented durability of response without re-administration of treatment.
Preclinical data was presented at the 2018 Keystone Symposia titled: "PSMA-Specific CAR T-Stem Cell Memory Therapy Eliminates Solid Tumor in Prostate Cancer Model." Poseida anticipates filing an Investigational New Drug application with the US FDA and starting a clinical trial of P-PSMA-101 in 2019.
"P-PSMA-101 carries many of the same desirable features found in our P-BCMA-101 CAR-T program for the treatment of multiple myeloma that is currently demonstrating best-in-class characteristics in an ongoing clinical trial - features that may overcome the challenges that have limited the potential of CAR-T therapies in solid tumors," said Eric Ostertag, M.D., Ph.D., chief executive officer of Poseida. "We are honored that CIRM has taken an interest in our unique and differentiated approach to CAR-T product development, and has now provided grant support for two of our CAR-T programs."
In 2017, CIRM awarded Poseida a $19.8 million grant to support the clinical development of P-BCMA-101, Poseida's CAR-T immunotherapy currently in a Phase 1 clinical trial as a treatment for relapsed and refractory multiple myeloma. Early data for this clinical trial was presented at the 2018 American Association for Cancer Research Annual Meeting and showed P-BCMA-101 activity in all three patients treated at the lowest dose cohort, but without any signs of toxicity, which is unprecedented when compared to competitor trials at the same dose. Additional information about this Phase 1 clinical study of P-BCMA-101 is available at www.clinicaltrials.gov using identifier: NCT03288493
About Poseida Therapeutics Inc.
Poseida Therapeutics is translating best-in-class gene engineering technologies into lifesaving cell therapies. The company is developing CAR T-cell immunotherapies for multiple myeloma, prostate and other cancer types, as well as gene therapies for orphan diseases. P-BCMA-101 is Poseida's lead CAR-T therapy currently in Phase 1 clinical development for the treatment of multiple myeloma. Poseida has assembled a suite of industry-leading gene engineering technologies, including the piggyBac™ DNA Modification System, TAL-CLOVER™ and Cas-CLOVER™ site-specific nucleases, and Footprint-Free™ Gene Editing (FFGE). For more information, visit www.poseida.com.
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