Poseida Therapeutics Announces Clinical Hold Lifted on Phase I Autologous CAR-T Study in Prostate Cancer
Poseida Therapeutics (Nasdaq: PSTX) announced that the FDA has lifted the clinical hold on its Phase 1 study of P-PSMA-101, an autologous CAR-T therapeutic targeting metastatic castration-resistant prostate cancer (mCRPC). The trial will resume immediately, with protocol amendments aimed at enhancing patient compliance and safety. P-PSMA-101 utilizes Poseida's piggyBac DNA Modification System and was initiated in May 2020. The company emphasizes its commitment to innovative gene engineering technologies for developing next-generation therapeutics.
- FDA lifted the clinical hold on Phase 1 study of P-PSMA-101.
- Trial resumption is expected to bolster clinical progress.
- Protocol amendments aimed at increasing patient compliance and safety.
- None.
SAN DIEGO, Nov. 2, 2020 /PRNewswire/ -- Poseida Therapeutics, Inc., (Nasdaq: PSTX), a clinical-stage biopharmaceutical company dedicated to utilizing its proprietary gene engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure, today announced the U.S. Food and Drug Administration (FDA) has lifted a clinical hold on the Company's Phase 1 study of P-PSMA-101 in metastatic castration-resistant prostate cancer (mCRPC) and plans to resume the trial immediately. P-PSMA-101 is the company's first solid tumor autologous CAR-T therapeutic candidate.
The Company has agreed to implement protocol amendments intended to increase patient compliance and safety that include modified inclusion and exclusion criteria and frequency of monitoring and laboratory testing.
About P-PSMA-101
P-PSMA-101 is an autologous CAR-T therapeutic candidate in metastatic castration-resistant prostate cancer (mCRPC). It is designed to target prostate-specific membrane antigen (PSMA), which is expressed on mCRPC cells. It was developed using Poseida's proprietary piggyBac DNA Modification System, which produces product candidates with a high percentage of stem cell memory T (TSCM) cells. A Phase 1 trial of P-PSMA-101 in mCRPC was initiated in May 2020.
About Poseida Therapeutics, Inc.
Poseida Therapeutics is a clinical-stage biopharmaceutical company dedicated to utilizing our proprietary gene engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure. We have discovered and are developing a broad portfolio of product candidates in a variety of indications based on our core proprietary platforms, including our non-viral piggyBac® DNA Modification System, Cas-CLOVER™ site-specific gene editing system and nanoparticle- and AAV-based gene delivery technologies. Our core platform technologies have utility, either alone or in combination, across many cell and gene therapeutic modalities and enable us to engineer our wholly-owned portfolio of product candidates that are designed to overcome the primary limitations of current generation cell and gene therapeutics.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Poseida's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry and the other risks described in Poseida's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Poseida undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
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SOURCE Poseida Therapeutics, Inc.
FAQ
What does the lifting of the clinical hold on PSTX's P-PSMA-101 mean?
When was the Phase 1 trial of P-PSMA-101 initiated?
What is P-PSMA-101?
What are the proposed changes to the P-PSMA-101 trial protocols?
How does the piggyBac DNA Modification System benefit PSTX's therapies?
