Poseida Therapeutics Presents New Case Study Demonstrating Reactivation of CAR-T Therapy with a T-Cell Engager in a Patient with Relapsed Multiple Myeloma
Poseida Therapeutics (Nasdaq: PSTX) presented new data at the SOHO Annual Meeting from a case study of a patient with relapsed multiple myeloma treated with P-BCMA-101, their investigational autologous CAR-T therapy. The study demonstrated reactivation of CAR-T cells and a repeat stringent complete response (sCR) over 3 years after initial treatment.
Key highlights:
- First reported instance of a T-cell engager reactivating CAR-T therapy
- Patient achieved sCR and remained in remission for nearly 2 years after initial treatment
- Upon relapse, treatment with talquetamab led to CAR-T cell reactivation and another sCR
- Patient remains in sCR off all therapy for over 9 months
This case study showcases the potential of Poseida's T stem cell memory (TSCM)-rich CAR-T therapies, which are a core element of their next-generation, off-the-shelf allogeneic CAR-T cell therapies.
Poseida Therapeutics (Nasdaq: PSTX) ha presentato nuovi dati durante l'Assemblea Annuale SOHO da uno studio di caso di un paziente con mieloma multiplo relapsato trattato con P-BCMA-101, la loro terapia investigativa CAR-T autologa. Lo studio ha dimostrato riattivazione delle cellule CAR-T e una risposta completa rigorosa (sCR) ripetuta oltre 3 anni dopo il trattamento iniziale.
Principali punti salienti:
- Primo caso riportato di un attivatore delle cellule T che riattiva una terapia CAR-T
- Il paziente ha raggiunto un sCR ed è rimasto in remissione per quasi 2 anni dopo il trattamento iniziale
- Al momento della recidiva, il trattamento con talquetamab ha portato alla riattivazione delle cellule CAR-T e a un altro sCR
- Il paziente rimane in sCR senza alcuna terapia per oltre 9 mesi
Questo studio di caso mette in luce il potenziale delle terapie CAR-T ricche di cellule staminali T (TSCM) di Poseida, che sono un elemento centrale delle loro terapie CAR-T allogeniche di nuova generazione pronte all'uso.
Poseida Therapeutics (Nasdaq: PSTX) presentó nuevos datos en la Reunión Anual de SOHO a partir de un estudio de caso de un paciente con mieloma múltiple en recaída tratado con P-BCMA-101, su terapia CAR-T autóloga en investigación. El estudio demostró reactivación de células CAR-T y una respuesta completa rigurosa (sCR) reiterada más de 3 años después del tratamiento inicial.
Aspectos destacados:
- Primer caso informado de un activador de células T que reactiva la terapia CAR-T
- El paciente logró sCR y permaneció en remisión durante casi 2 años después del tratamiento inicial
- Tras la recaída, el tratamiento con talquetamab llevó a la reactivación de células CAR-T y otra sCR
- El paciente permanece en sCR sin ninguna terapia durante más de 9 meses
Este estudio de caso muestra el potencial de las terapias CAR-T ricas en células madre T (TSCM) de Poseida, que son un elemento central de sus terapias CAR-T alogénicas de próxima generación listas para usar.
Poseida Therapeutics (Nasdaq: PSTX)는 SOHO 연례 회의에서 P-BCMA-101로 치료한 재발성 다발성 골수종 환자의 사례 연구에서 새로운 데이터를 발표했습니다. 이 연구는 CAR-T 세포의 재활성화와 초기 치료 3년 후 반복적인 엄격한 완전 반응(sCR)을 시연했습니다.
주요 하이라이트:
- CAR-T 요법을 재활성화한 T세포 유도체의 첫 번째 보고 사례
- 환자는 sCR을 달성하고 초기 치료 후 거의 2년 동안 관해 상태를 유지했습니다
- 재발 시, talquetamab 치료가 CAR-T 세포의 재활성화 및 또 다른 sCR로 이어졌습니다
- 환자는 모든 치료 없이 9개월 이상 sCR 상태를 유지하고 있습니다
이 사례 연구는 Poseida의 T세포 기억 세포(TSCM)로 풍부한 CAR-T 요법의 잠재력을 보여줍니다. 이는 차세대 사용 준비가 완료된 동종 CAR-T 세포 요법의 핵심 요소입니다.
Poseida Therapeutics (Nasdaq: PSTX) a présenté de nouvelles données lors de la Réunion Annuelle SOHO à partir d'une étude de cas d'un patient atteint de myélome multiple en rechute traité avec P-BCMA-101, leur thérapie CAR-T autologue en cours d'investigation. L'étude a démontré la réactivation des cellules CAR-T et une réponse complète stricte (sCR) répétée plus de 3 ans après le traitement initial.
Aperçus clés :
- Première instance rapportée d'un engageur de cellules T réactivant une thérapie CAR-T
- Le patient a atteint un sCR et est resté en rémission pendant près de 2 ans après le traitement initial
- Lors de la rechute, le traitement par talquetamab a conduit à la réactivation des cellules CAR-T et à un autre sCR
- Le patient reste en sCR sans aucune thérapie depuis plus de 9 mois
Cet étude de cas met en lumière le potentiel des thérapies CAR-T riches en cellules mémoire T (TSCM) de Poseida, qui sont un élément central de leurs thérapies CAR-T allogéniques de nouvelle génération prêtes à l'emploi.
Poseida Therapeutics (Nasdaq: PSTX) hat auf dem SOHO-Jahrestreffen neue Daten aus einer Fallstudie eines Patienten mit rezidiviertem multiples Myelom präsentiert, der mit P-BCMA-101, ihrer experimentellen autologen CAR-T-Therapie, behandelt wurde. Die Studie zeigte Reaktivierung von CAR-T-Zellen und eine wiederholte strenge vollständige Remission (sCR) über 3 Jahre nach der Erstbehandlung.
Wichtige Highlights:
- Erster gemeldeter Fall eines T-Zell-Aktivators, der eine CAR-T-Therapie reaktiviert
- Der Patient erreichte sCR und blieb fast 2 Jahre nach der Erstbehandlung in Remission
- Bei Rückfall führte die Behandlung mit Talquetamab zur Reaktivierung der CAR-T-Zellen und zu einer weiteren sCR
- Der Patient bleibt über 9 Monate ohne Therapie in sCR
Diese Fallstudie zeigt das Potenzial von Poseidas T-Stammzellen-Erinnerungszellen (TSCM)-reichen CAR-T-Therapien, die ein zentrales Element ihrer next-generation, einsatzbereiten allogenen CAR-T-Zelltherapien darstellen.
- Demonstration of CAR-T cell reactivation and repeat sCR over 3 years after initial treatment
- Patient achieved nearly 2 years of remission after initial P-BCMA-101 treatment
- Patient remains in sCR for over 9 months after T-cell engager therapy, off all treatments
- Showcases potential of TSCM-rich CAR-T therapies, a key differentiator for Poseida's programs
- Upcoming clinical data presentation for P-BCMA-ALLO1 at International Myeloma Society Annual Meeting
- Strategic shift from autologous to allogeneic approach in November 2022
- Patient relapsed after initial 22.5 months of remission
Insights
This case study demonstrates a significant breakthrough in CAR-T therapy for multiple myeloma. The reactivation of CAR-T cells years after initial treatment is unprecedented and could revolutionize long-term management of the disease. The stringent complete response (sCR) achieved twice - initially and after reactivation - underscores the potential durability of TSCM-rich CAR-T therapies.
The persistence of CAR-T cells for over three years is remarkable, as most current therapies show rapid decline within six months. This longevity, attributed to the high TSCM content, could lead to more sustainable remissions and reduced need for repeated treatments. The successful reactivation using a T-cell engager opens new possibilities for "boosting" CAR-T therapies, potentially extending their efficacy without full re-administration.
From a clinical perspective, this case study is groundbreaking. The patient's response to P-BCMA-101 and subsequent reactivation with talquetamab demonstrates a novel approach to managing relapsed multiple myeloma. The nine-month remission after just one week of T-cell engager therapy is exceptional, especially considering the patient's prior relapse.
The benign lymphocytosis observed is intriguing, suggesting a controlled immune response rather than disease progression. This could indicate a safer profile for combined CAR-T and T-cell engager therapies. However, we must cautiously interpret these results from a single case. Larger studies are needed to confirm reproducibility and assess potential risks. If validated, this approach could significantly reduce treatment burden and improve quality of life for multiple myeloma patients.
Poseida Therapeutics' breakthrough in CAR-T therapy reactivation could significantly impact its market position. The company's focus on TSCM-rich therapies appears to be paying off, potentially differentiating its products in the competitive cell therapy landscape. The transition from autologous to allogeneic approaches aligns with industry trends towards more scalable and cost-effective treatments.
Investors should note the strategic collaboration with Roche, a major player in oncology. This partnership validates Poseida's technology and provides financial support for development. The upcoming data presentations at scientific meetings could be catalysts for stock movement. However, it's important to remember that this is early-stage research and commercialization is likely years away. The company's ability to replicate these results in larger studies and navigate regulatory pathways will be critical for long-term success.
Reactivation of P-BCMA-101 CAR-T cells and a repeat stringent complete response (sCR) more than 3 years after original CAR-T therapy
Demonstrates potential of stem cell memory T cells (TSCM), a key differentiator for Poseida's CAR-T programs
"This case study demonstrates the remarkable potential of T stem cell memory-based therapies, providing a strong anti-myeloma response with a long-term remission and notably CAR-T cell persistence," said Thomas G. Martin, M.D., Clinical Professor of Medicine, Adult Leukemia and Bone Marrow Transplantation Program and Director of Hematology, Blood and Marrow Transplantation and Cellular Therapy at UCSF, and co-leader of the Cancer Immunology & Immunotherapy Program at the UCSF Helen Diller Family Comprehensive Cancer Center. "Most notably, we believe this is the first time that a T-cell engager has been seen to reactivate a CAR-T therapy, and the evidence suggests that this reactivation drove a second wave of CAR-T cell proliferation that led to another complete response three years after the initial successful CAR-T treatment. This patient is now off all anti-myeloma treatments and living in remission for more than nine months following 1 week of TCE therapy, a truly amazing outcome."
"These patient clinical data demonstrate the power of TSCM CAR-T cells, which are a core element of all our investigational next-generation, off-the-shelf allogeneic CAR-T cell therapies," said Syed Rizvi, M.D., Chief Medical Officer of Poseida Therapeutics. "P-BCMA-101 demonstrated durable persistence due to the high TSCM content in the final product. This long-term persistence and engraftment led to activation by the TCE several years after initial CAR-T therapy. The high TSCM content and durable persistence is a unique feature of all autologous and allogeneic Poseida CAR-T."
Background Information and Oral Presentation Highlights
Patients with relapsed/refractory multiple myeloma who receive BCMA-directed CAR-T therapy can achieve deep and durable remissions, but most patients relapse. Detection of CAR-positive cells wanes rapidly over the first six months, and significant re-expansion of CAR-T cells has not been demonstrated previously in the clinical setting.
In this case study, a 57-year-old female patient with relapsed multiple myeloma received P-BCMA-101, an investigational TSCM-rich autologous CAR-T therapy. TSCM cells are a subset of T cells that have unique properties: They are long-lived, multi-potent and self-replicating and can engraft and create differentiated cells.
Two months after receiving treatment, the patient achieved a partial response that deepened into a stringent complete response and remained in remission for nearly 2 years (22.5 months). More than three years after receiving P-BCMA-101, she relapsed and was treated with one cycle of talquetamab, a T-cell engaging bispecific antibody that targets CD3 and GPRC5D. Upon receiving talquetamab, the patient developed a brisk lymphocytosis. Evaluation of peripheral blood revealed high levels of P-BCMA-101 CAR-T cells. Thorough molecular analysis revealed that the lymphocytosis was benign and reactive. The patient achieved complete remission with slow resolution of lymphocytosis. The patient continues to be in sCR and off all therapy more than nine months after receiving the last and only full dose of the T-cell engaging therapy.
Poseida's lead investigational allogeneic CAR-T program, P-BCMA-ALLO1, is currently being evaluated in patients with relapsed/refractory multiple myeloma. The Company will report new clinical data at the International Myeloma Society 21st Annual Meeting, which is being held in
In November 2022, Poseida made the strategic decision to transition its cell therapy focus from an autologous to an allogeneic approach. The Company believes the future of cell therapy and its ability to offer new treatment options lies in an allogeneic approach in which T cells are derived from healthy donors rather than from the patients themselves. Poseida has applied learnings from its autologous programs to support the development of its allogeneic pipeline.
About P-BCMA-ALLO1
P-BCMA-ALLO1 is an investigational allogeneic CAR-T therapy licensed to Roche that targets B-cell maturation antigen (BCMA) for the treatment of patients with relapsed/refractory multiple myeloma. This allogeneic program includes a VH-based binder that targets BCMA. Phase 1 clinical data presented at ASH 2023 supports the Company's belief that TSCM-rich allogeneic CAR-Ts have the potential to offer an effective, safe and reliable treatment addressing unmet needs in multiple myeloma. The U.S. Food and Drug Administration granted Orphan Drug Designation to P-BCMA-ALLO1 for the treatment of multiple myeloma. Additional information about the Phase 1 study is available at www.clinicaltrials.gov (NCT04960579).
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 certain cancers and rare diseases. The Company's pipeline includes investigational allogeneic CAR-T cell therapies for both solid tumors and hematologic cancers 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 piggyBac® 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 regulatory submissions and approvals and clinical data updates; anticipated timelines and milestones with respect to the Company's development programs and manufacturing activities and capabilities; the potential capabilities and benefits of the Company's technology platforms and product candidates, including the efficacy, safety and reliability profile of such product candidates; the quotes from Drs. Martin and Rizvi; 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 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; and the other risks described in the Company'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. 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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