Poseida Therapeutics to Present Clinical and Preclinical Data on Investigational Allogeneic CAR-T Cell Therapies at SITC 2024 and ASH 2024
Poseida Therapeutics (PSTX) announced upcoming presentations of new data at two major conferences. At SITC 2024, the company will present preclinical data on allogeneic CAR+TCR-T cells rich in stem cell memory T cells (TSCM) with enhanced potency for solid tumors. At ASH 2024, they will showcase additional patient response data from the P-BCMA-ALLO1 Phase 1 trial's Arm C and preclinical data from P-CD19CD20-ALLO1 for B-cell malignancies. Both therapies are being developed in collaboration with Roche. P-BCMA-ALLO1 has received RMAT designation for relapsed/refractory multiple myeloma patients.
Poseida Therapeutics (PSTX) ha annunciato la presentazione di nuovi dati in occasione di due importanti conferenze. Al SITC 2024, l'azienda presenterà dati preclinici su cellule CAR+TCR-T allogeniche arricchite di cellule T della memoria staminale (TSCM) con una potenza potenziata per i tumori solidi. All'ASH 2024, mostreranno ulteriori dati sulla risposta dei pazienti provenienti dall'Arm C della sperimentazione clinica di Fase 1 P-BCMA-ALLO1 e dati preclinici da P-CD19CD20-ALLO1 per le neoplasie a cellule B. Entrambe le terapie sono in fase di sviluppo in collaborazione con Roche. P-BCMA-ALLO1 ha ricevuto la designazione RMAT per pazienti con mieloma multiplo relapsato/refrattario.
Poseida Therapeutics (PSTX) anunció la próxima presentación de nuevos datos en dos conferencias importantes. En SITC 2024, la compañía presentará datos preclínicos sobre células CAR+TCR-T alogénicas ricas en células T de memoria de células madre (TSCM) con mayor potencia para tumores sólidos. En ASH 2024, mostrarán datos adicionales de respuesta de pacientes del Brazo C del ensayo de Fase 1 P-BCMA-ALLO1 y datos preclínicos de P-CD19CD20-ALLO1 para neoplasias de células B. Ambas terapias se están desarrollando en colaboración con Roche. P-BCMA-ALLO1 ha recibido la designación RMAT para pacientes con mieloma múltiple en recaída/refractario.
포세이다 테라퓨틱스 (PSTX)는 두 개의 주요 회의에서 새로운 데이터를 발표할 예정이라고 발표했습니다. SITC 2024에서 이 회사는 고형 종양에 대한 향상된 효능을 가진 줄기 세포 기억 T 세포(TSCM)가 풍부한 동종 CAR+TCR-T 세포에 대한 전임상 데이터를 발표합니다. ASH 2024에서는 P-BCMA-ALLO1 1상 시험의 C군에서 추가 환자 반응 데이터와 B세포 악성종양을 위한 P-CD19CD20-ALLO1의 전임상 데이터를 공개할 예정입니다. 두 치료법 모두 로슈와 협력하여 개발되고 있습니다. P-BCMA-ALLO1은 재발/내성 다발성 골수종 환자를 위한 RMAT 지정을 받았습니다.
Poseida Therapeutics (PSTX) a annoncé la présentation prochaine de nouvelles données lors de deux grandes conférences. À SITC 2024, la société présentera des données précliniques sur des cellules CAR+TCR-T allogéniques riches en cellules T mémoire de cellules souches (TSCM) avec une efficacité accrue pour les tumeurs solides. À ASH 2024, ils présenteront des données supplémentaires sur la réponse des patients issues du bras C de l'essai clinique de phase 1 P-BCMA-ALLO1, ainsi que des données précliniques de P-CD19CD20-ALLO1 pour les néoplasies à cellules B. Les deux thérapies sont développées en collaboration avec Roche. P-BCMA-ALLO1 a reçu la désignation RMAT pour les patients atteints de myélome multiple en rechute/réfractaire.
Poseida Therapeutics (PSTX) hat die bevorstehenden Präsentationen neuer Daten auf zwei wichtigen Konferenzen angekündigt. Auf der SITC 2024 wird das Unternehmen präklinische Daten zu allogenen CAR+TCR-T-Zellen vorstellen, die reich an Stammzellgedächtnis-T-Zellen (TSCM) sind und eine erhöhte Potenz für solide Tumoren aufweisen. Auf dem ASH 2024 werden zusätzliche Patientenreaktionsdaten aus dem Arm C der Phase-1-Studie P-BCMA-ALLO1 sowie präklinische Daten von P-CD19CD20-ALLO1 für B-Zell-Malignome präsentiert. Beide Therapien werden in Zusammenarbeit mit Roche entwickelt. P-BCMA-ALLO1 hat die RMAT-Bezeichnung für Patienten mit rezidiviertem/refraktärem multiplem Myelom erhalten.
- P-BCMA-ALLO1 has received RMAT designation for multiple myeloma treatment
- Ongoing collaboration with Roche for hematologic malignancies
- Development of dual-targeting therapy (P-CD19CD20-ALLO1) showing potential advantages over single-target products
- None.
New preclinical data on allogeneic CAR+TCR-T cells rich in stem cell memory T cells (TSCM) and enhanced potency to better target solid tumors will be presented at SITC
Additional profiling of patient responses in P-BCMA-ALLO1 Phase 1 Arm C and preclinical P-CD19CD20-ALLO1 to be presented at ASH
Additionally, the Company announced presentations at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition, which will be held December 7-10 in
P-BCMA-ALLO1 is an investigational non-viral TSCM-rich allogeneic CAR-T therapy in Phase 1/1b clinical development. This investigational off-the-shelf allogeneic CAR-T cell therapy targeting BCMA has received Regenerative Medicine Advanced Therapy (RMAT) designation for adult patients with relapsed/refractory multiple myeloma after three or more prior lines of therapies. P-CD19CD20-ALLO1, the Company's first allogeneic dual CAR-T cell product candidate, targets both CD19 and CD20 antigens for the treatment of relapsed or refractory B-cell malignancies. The Company is developing P-BCMA-ALLO1 and P-CD19CD20-ALLO1 as part of a broader collaboration with Roche focused on addressing hematologic malignancies with Poseida's TSCM-rich CAR-T platform.
SITC 2024 Poster Presentation
Title: Multi-antigen Targeting with CAR and TCR Co-expression in Allogeneic Cell Therapy for Solid Tumors
- Presenting Author: Sergio M. Quinones-Parra, Ph.D., Poseida Therapeutics
- Presentation Date/Time: Saturday, November 9, 2024, at 8:00 a.m. CT (9:00 a.m. ET / 6:00 a.m. PT)
- Room: Exhibit Halls A and B, George R. Brown Convention Center
- Abstract Number: 301
ASH 2024 Poster Presentations
Title: Late Polyclonal P-BCMA-101 CAR-T Cell Re-expansion and Rapid Complete Response in a Patient with Relapsed Multiple Myeloma Treated with One Cycle of Talquetamab, More Than 3 Years After CAR-T Infusion
- Presenting Author: Anupama Kumar, M.D., Assistant Professor, Hematology, Blood & Marrow Transplant, and Cellular Therapy (HBC) Program, University of
California ,San Francisco (UCSF) - Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I
- Presentation Date/Time: Saturday, December 7, 2024, 5:30-7:30 p.m. PT (8:30-10:30 p.m. ET)
- Room: Halls G-H,
San Diego Convention Center - Abstract Number: 2083
Title: P-CD19CD20-ALLO1: Potent Fully Allogeneic CAR-T Therapy Targeting CD19 and CD20 with Superior Efficacy Over Single-Target Products
- Presenting Author: Samy Jambon, Ph.D., Poseida Therapeutics
- Session: 702. CAR-T Cell Therapies: Basic and Translational: Poster III
- Presentation Date/Time: Monday, December 9, 2024, 6:00-8:00 p.m. PT (9:00-11:00 p.m. ET)
- Room: Halls G-H,
San Diego Convention Center - Abstract Number: 4805
Title: A Phase 1 Study of P-BCMA-ALLO1, a Non-viral, Allogeneic BCMA Directed CAR-T in Relapsed/Refractory Multiple Myeloma (RRMM): Results from Optimized Lymphodepletion Cohort
- Presenting Author: Caitlin Costello, M.D., Professor of Medicine, Director of Multiple Myeloma Program, Division of Blood and Marrow Transplant, Moores Cancer Center, University of
California ,San Diego (UCSD) - Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster III
- Presentation Date/Time: Monday, December 9, 2024, 6:00-8:00 p.m. PT (9:00-11:00 p.m. ET)
- Room: Halls G-H,
San Diego Convention Center - Abstract Number: 4828
About P-BCMA-ALLO1
P-BCMA-ALLO1 is an allogeneic CAR-T product candidate licensed to Roche targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma. This allogeneic program includes a VH-based binder that targets BCMA, and interim clinical data presented at IMS in September 2024 support the Company's belief that T stem cell (TSCM)-rich allogeneic CAR-Ts have the potential to offer effective, safe and reliable treatment addressing unmet needs in multiple myeloma. The U.S. Food and Drug Administration (FDA) has granted P-BCMA-ALLO1 Orphan Drug designation for multiple myeloma and Regenerative Medicine Advanced Therapy (RMAT) designation for adult patients with relapsed/refractory multiple myeloma after three or more prior lines of therapies including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.
P-BCMA-ALLO1 is currently being evaluated in a Phase 1/1b trial in patients with multiple myeloma. Additional information about the trial is available at www.clinicaltrials.gov using identifier: NCT04960579.
About P-CD19CD20-ALLO1
P-CD19CD20-ALLO1 is an allogeneic CAR-T cell therapy product candidate being developed for relapsed or refractory B-cell malignancies in partnership with Roche. P-CD19CD20-ALLO1 expresses two fully functional CAR molecules to target cells that express either CD19 or CD20. The dual targeting approach employed in P-CD19CD20-ALLO1 aims to overcome the antigen escape limitations of CD19-only targeted CAR-T therapies by simultaneously targeting both CD19 and CD20. In addition to the dual targeting, P-CD19CD20-ALLO1 uses a novel CD19 binder that showed greater potency in in vivo preclinical models when compared to the canonical FMC63 Single-chain variable fragment (scFv) binder. P-CD19CD20-ALLO1 is an off-the-shelf CAR-T therapy for which patients do not have to undergo apheresis and wait for cells to be manufactured, which can potentially overcome the limitation of autologous CAR-T therapies associated with significant manufacturing times. P-CD19CD20-ALLO1 is being studied in a Phase 1 study in B-cell malignancies. Additional information about the trial is available at www.clinicaltrials.gov using identifier: NCT06014762.
About Poseida Therapeutics, Inc.
Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated allogeneic cell therapies and genetic medicines with the capacity to cure. The Company's pipeline includes investigational allogeneic CAR-T cell therapies for hematologic cancers, autoimmune diseases, and solid tumors, as well as investigational in vivo genetic medicines that address patient populations with high unmet medical need. The Company's approach is based on its proprietary genetic editing platforms, including its non-viral transposon-based DNA delivery system, Cas-CLOVER™ Site-Specific Gene Editing System, Booster Molecule and nanoparticle gene delivery technologies, as well as in-house GMP cell therapy manufacturing. The Company has formed strategic collaborations with Roche and Astellas to unlock the promise of cell therapies for cancer patients. Learn more at www.poseida.com and connect with Poseida on X and LinkedIn.
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. Such forward-looking statements include statements regarding, among other things, expected plans with respect to clinical trials, including timing of clinical data updates; anticipated timelines and milestones with respect to the Company's development programs; the potential capabilities and benefits of the Company's technology platforms and product candidates; and the Company's plans and strategy with respect to developing its technologies and product candidates. 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 the Company'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, the fact that interim data from the Company's clinical trials may change as more patient data become available and remain subject to audit and verification procedures that could result in material differences from the final data; the Company's reliance on third parties for various aspects of its business; risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry; the Company's ability to retain key scientific or management personnel; the Company's ongoing and planned clinical trials; whether any of the Company's product candidates will be shown to be effective, safe or reliable; the Company's ability to finance continued operations; the fact that the Company will have limited control over the efforts and resources that Roche devotes to advancing development programs under its collaboration agreement with Roche; the fact that the Company may not receive the potential fees, reimbursements and payments under its collaboration agreement with Roche; the ability of Roche to early terminate the collaboration, such that the Company may not fully realize the benefits of the collaboration; and the other risks and uncertainties described in the Risk Factors section of the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 5, 2024, and in other filings the Company makes with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company 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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