P-PSMA-101 / Roche - LARVOL DELTA

Phase 1 Trial of P-PSMA-101 CAR-T Cells in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC). (PubMed, Clin Cancer Res) - P1 | "Robust expansion of P-PSMA-101 CAR T cells resulted in toxicity but also durable responses in patients with mCRPC. Future trials of CAR T may be informed by the results with this nonviral engineering, TSCM cell-enriched approach."

IO biomarker • Journal • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CASP9

Piggybacking Towards Progress for CAR-T Cell Therapy in Prostate Cancer. (PubMed, Clin Cancer Res) - "P-PSMA-101 is a first-in-class, stem cell memory T cell-enriched, PSMA-targeting CAR-T therapy. This cellular therapy showed notable clinical activity in two patients; however, PSA50 responses were generally modest. While severe immune effector-related toxicities were observed in some patients, a novel iCasp9 safety switch was largely effective in mitigating toxicity."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CASP9

Novel Immunotherapeutic Strategies for Castration-Resistant Prostate Cancer: Mechanisms and Clinical Advances. (PubMed, Curr Issues Mol Biol) - "These collective findings suggest the potential of immunotherapy for CRPC in overcoming resistance barriers and improving patient outcomes, with bispecific T cell engagers (Xaluritamig, 59% PSA50) and PSMA-directed CAR-T therapy (P-PSMA-101, >50% PSA reduction) emerging as the most promising near-term candidates and biomarker-stratified combinations (nivolumab plus rucaparib, 84.6% PSA50, in HRR-deficient patients) illustrating the transformative power of precision patient selection; however, these findings require validation in larger, biomarker-stratified trials before definitive conclusions can be drawn. Translating this potential into clinical reality requires optimized patient selection through predictive biomarkers and rigorously validated Phase III trials to confirm durable clinical responses and long-term survival benefits."

IO biomarker • Journal • Review • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • MUC1

P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC) (clinicaltrials.gov) - P1 | N=40 | Terminated | Sponsor: Poseida Therapeutics, Inc. | N=60 ➔ 40 | Trial completion date: Sep 2036 ➔ Sep 2024 | Active, not recruiting ➔ Terminated; Study closed

Enrollment change • Trial completion date • Trial termination • Adenoid Cystic Carcinoma • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Salivary Gland Cancer • Solid Tumor • Squamous Cell Carcinoma • Urology

P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC) (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Poseida Therapeutics, Inc. | Trial primary completion date: Sep 2023 ➔ Oct 2024

CAR T-Cell Therapy • Metastases • Trial primary completion date • Adenoid Cystic Carcinoma • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Salivary Gland Cancer • Solid Tumor • Squamous Cell Carcinoma • Urology

P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC) (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Poseida Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

CAR T-Cell Therapy • Enrollment closed • Adenoid Cystic Carcinoma • Genito-urinary Cancer • Oncology • Prostate Cancer • Salivary Gland Cancer • Solid Tumor • Squamous Cell Carcinoma • Urology

Phase 1 study of P-PSMA-101 CAR-T cells in patients with metastatic castration-resistant prostate cancer (mCRPC). (ASCO-GU 2022) - P1 | "These results parallel preclinical findings that P-PSMA-101 can produce marked efficacy in mCRPC, and very low doses are highly efficacious, consistent with unique product attributes such as the TSCM phenotype and bone tropism. This is the first report demonstrating profound antitumor effects of a novel PSMA-directed CAR-T-cell platform with concordant biochemical, radiographic, and pathologic parameters, demonstrating that therapeutic benefit of unarmored CAR-T cells in a major solid tumor is possible."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CASP9 • CTCs • DHFR • IL6

Poseida Therapeutics Provides Updates and Financial Results for the Second Quarter of 2022 (PRNewswire) - "Poseida is currently evaluating P-PSMA-101 in a Phase 1 clinical trial and presented encouraging preliminary results from its Phase 1 clinical trial of P-PSMA-101 in its first solid tumor indication on February 2022 at ASCO-GU. The Company may provide a further clinical update at a scientific meeting or forum, likely in 2023."

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

Poseida Therapeutics to Present Interim Results from Phase 1 Trial of P-PSMA-101 at ASCO Genitourinary Cancers Symposium (PRNewswire) - P1 | N=60 | NCT04249947 | Sponsor: Poseida Therapeutics, Inc. | "Poseida Therapeutics...announced interim results from its Phase 1 clinical trial of P-PSMA-101....These data are being presented today at the 2022 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in a poster presentation....10/14 (71%) patients demonstrated measurable declines in PSA levels; 5/14 (36%) patients showed a decline in PSA levels of 50% or more; One patient demonstrated evidence of complete tumor elimination and remains in a durable response of greater than ten months at the time of this presentation."

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

Virtual R&D Day (BioSpace)

Live event

Poseida Therapeutics to Present Interim Results from Phase 1 Trial of P-PSMA-101 at ASCO Genitourinary Cancers Symposium (PRNewswire) - "'The responses we have seen in this trial are impressive and speak to the innovative nature and potential of Poseida's CAR-T cell therapy platform,' said Susan F. Slovin...who is presenting at the Symposium. 'This interim update on the P-PSMA-101 trial shows the exceptional efficacy of this novel anti-PSMA CAR-T cell product. Thus far, at very low doses P-PSMA-101 has shown to produce a robust and durable anti-tumor response in heavily pretreated patients with mCRPC, including one pathologic complete response.'"

Media quote • P1 data

Poseida Therapeutics to Host Virtual R&D Day on February 23, 2022 (PRNewswire) - "Poseida Therapeutics, Inc...announced that it will host a virtual R&D Day at 10:00 am - 1:30 pm ET / 7:00 - 10:30 am PT on Wednesday, February 23, 2022....External speakers will include Susan F. Slovin, M.D., Ph.D., Associate Vice Chair of Academic Administration at Memorial Sloan Kettering Cancer Center and an investigator on a Phase 1 trial evaluating P-PSMA-101, the Company's autologous CAR-T candidate for the treatment of metastatic castrate resistant prostate cancer (mCRPC); and Luca Gattinoni, M.D., Director of the Division of Functional Immune Cell Modulation, Leibniz Institute for Immunotherapy at the University of Regensburg in Germany. Dr. Gattinoni is a member of the Company's Immuno-Oncology Scientific Advisory Board."

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: Poseida Therapeutics, Inc.; N=40 ➔ 60

CAR T-Cell Therapy • Clinical • Enrollment change • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urology

Poseida Therapeutics Provides Program Updates and Financial Results for the Third Quarter of 2021 (PRNewswire) - "PSMA Program: An additional update on the P-PSMA-101 program is expected in the first half of 2022."

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Urothelial Cancer

Poseida Therapeutics Presents Preliminary Results from Phase 1 Trial of P-PSMA-101 at the 6th Annual CAR-TCR Summit (Poseida Therapeutics) - "'This innovative Poseida PSMA-directed CAR T cell platform has demonstrated a robust anti-tumor response in patients with metastatic castration resistant prostate cancer,' commented Susan F. Slovin....'This is the first time that I have seen such impressive responses with an immunotherapy product. The responses of my patients in the trial are far beyond my expectations.'"

Media quote • P1 data

Poseida Therapeutics falls after reporting early data from prostate cancer trial (SeekingAlpha) - "Poseida Therapeutics (PSTX -17.5%) is trading lower in morning hours on below-average volume after the company reported preliminary results from a Phase 1 study for P-PSMA-101 in patients with metastatic castrate-resistant prostate cancer (mCRPC)."

P1 data • Stock price • Genito-urinary Cancer • Oncology • Prostate Cancer

Poseida Therapeutics Presents Preliminary Results from Phase 1 Trial of P-PSMA-101 at the 6th Annual CAR-TCR Summit (PRNewswire) - "As of the cutoff date, the study had enrolled a total of nine patients with mCRPC....Five patients dosed showed measurable declines in PSA levels; Three patients treated showed a greater than 50% decline in PSA levels and had concordant improvements in PSMA-PET imaging; P-PSMA-101 demonstrated a favorable safety and tolerability profile."

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer

Poseida Therapeutics Reports Program Updates and Financial Results for the Second Quarter of 2021 (PRNewswire) - "P-PSMA-101 is a solid tumor autologous CAR-T product candidate being developed to treat patients with metastatic castrate-resistant prostate cancer (mCRPC) currently in an ongoing Phase 1 dose escalation trial, with an additional update on the program expected later in the third quarter of 2021....P-MUC1C-ALLO1 is proceeding as planned, with an anticipated IND filing and initiation of Phase 1 clinical trial by the end of 2021."

Clinical • IND • New P1 trial • Breast Cancer • Gynecologic Cancers • Oncology • Prostate Cancer • Solid Tumor

Poseida Therapeutics Reports Program Updates and Financial Results for the Fourth Quarter and Full Year 2020 (PRNewswire) - "BCMA Program: (i) P-BCMA-101: Phase 1 dose expansion enrollment continues, with an expected update on this program later in 2021; (ii) P-BCMA-ALLO1: The program is proceeding toward an IND filing, which is expected in the first half 2021; PSMA Program: P-PSMA-101 is a solid tumor autologous CAR-T product candidate being developed to treat patients with metastatic castrate resistant prostate cancer (mCRPC) currently in an ongoing Phase 1 dose escalation trial...The Company intends to provide an additional update on this program later in 2021; MUC1-C Program: P-MUC1C-ALLO1 is proceeding, with an anticipated IND filing and initiation of Phase 1 clinical trial by the end of 2021."

IND • New P1 trial • P1 data • Trial status • Breast Cancer • Genito-urinary Cancer • Gynecologic Cancers • Hematological Malignancies • Multiple Myeloma • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor

Poseida Therapeutics Reports Operational Update and Financial Results for Third Quarter 2020 (PRNewswire) - "P-PSMA-101: The Company now expects to provide an initial data update in mid-2021; P-BCMA-101: Phase 1 dose expansion enrollment continues, although at a slower pace than planned due in part to the COVID-19 pandemic. Further, the Company expects to make a Phase 2 dosing decision on P-BCMA-101 by early 2021."

Clinical data • Trial status • Genito-urinary Cancer • Hematological Malignancies • Multiple Myeloma • Oncology • Prostate Cancer

Poseida Therapeutics Announces Clinical Hold Lifted on Phase I Autologous CAR-T Study in Prostate Cancer (PRNewswire) - "Poseida Therapeutics, Inc...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....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."

FDA event • Genito-urinary Cancer • Oncology • Prostate Cancer

P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Poseida Therapeutics, Inc.; Suspended ➔ Recruiting

Clinical • Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urology

Poseida Therapeutics (PSTX) Phase 1 clinical trial for P-PSMA-101 in metastatic castrate resistant prostate cancer has been placed on clinical hold following patient death (Streetinsider.com) - "...Poseida Therapeutics, Inc...announced that following notification to the U.S. Food and Drug Administration (FDA) of a pause in enrollment pursuant to the protocol to investigate a patient death, it has received communication from the FDA that the Company’s Phase 1 clinical trial for P-PSMA-101 in metastatic castrate resistant prostate cancer has been placed on clinical hold...The patient in question had metastatic castrate-resistant prostate cancer, had failed treatment with multiple anti-cancer agents and was treated with P-PSMA-101 in late July...There has also been no cytokine release syndrome or neurotoxicity reported to date."

Cytokine release syndrome • Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer

INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Poseida Therapeutics, Inc. and Encourages Investors with Losses of $100,000 to Contact the Firm (Businesswire) - "The Schall Law Firm...announces that it is investigating claims on behalf of investors of Poseida Therapeutics, Inc...or violations of the securities laws...The Company then disclosed on August 18, 2020, that the FDA had placed a clinical hold on its Phase 1 clinical trial of the autologous CAR-T therapy P-PSMA-101 in patients with metastatic castration-resistant prostate cancer."

Corporate lawsuit • Genito-urinary Cancer • Oncology • Prostate Cancer

Poseida Sinks On Prostate Cancer CAR-T Clinical Hold (Scripintelligence) - "Poseida’s technologies are designed to deliver safer, more effective cell and gene therapies, but the first trial for its autologous PSMA-targeting CAR-T therapy was put on a clinical hold after a patient died."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer