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Lyell Announces Presentation of Initial Clinical Data from the Phase 1-2 Clinical Trial of IMPT-314 for the treatment of B-cell Lymphoma at the 2024 American Society of Hematology (ASH) Annual Meeting

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Lyell Immunopharma (Nasdaq: LYEL) announced that initial clinical data from their Phase 1-2 study of IMPT-314 in large B-cell lymphoma will be presented at the 2024 ASH Annual Meeting. IMPT-314 is a dual-targeting CD19/CD20 CAR T-cell therapy being developed for aggressive B-cell non-Hodgkin's lymphoma and has received Fast Track Designation from the FDA. The presentation will be delivered by Dr. Sarah M. Larson from UCLA's David Geffen School of Medicine on December 9, 2024, focusing on the first results of this autologous bispecific CAR therapy in enriched naive and central memory T cells.

Lyell Immunopharma (Nasdaq: LYEL) ha annunciato che i dati clinici iniziali del loro studio di Fase 1-2 su IMPT-314 per il linfoma a grandi cellule B saranno presentati al Raduno Annuale ASH 2024. IMPT-314 è una terapia CAR T-cell dual-targeting CD19/CD20 in fase di sviluppo per il linfoma non-Hodgkin aggressivo a cellule B ed ha ricevuto la Designazione di Fast Track dalla FDA. La presentazione sarà tenuta dalla Dr.ssa Sarah M. Larson della David Geffen School of Medicine dell'UCLA il 9 dicembre 2024, concentrandosi sui primi risultati di questa terapia CAR bispecifica autologa in cellule T naive e di memoria centrale arricchite.

Lyell Immunopharma (Nasdaq: LYEL) anunció que los datos clínicos iniciales de su estudio de Fase 1-2 sobre IMPT-314 en linfoma de células B grandes se presentarán en la Reunión Anual ASH 2024. IMPT-314 es una terapia CAR T de doble objetivo CD19/CD20 que se desarrolla para linfoma no Hodgkin agresivo de células B y ha recibido la Designación de Fast Track por parte de la FDA. La presentación será realizada por la Dra. Sarah M. Larson de la David Geffen School of Medicine de UCLA el 9 de diciembre de 2024, centrándose en los primeros resultados de esta terapia CAR bispecífica autóloga en células T naive y de memoria central enriquecidas.

리엘 면역 제약 (Nasdaq: LYEL)은 IMPT-314에 대한 임상 1-2 단계 연구의 초기 데이터가 2024 ASH 연례 회의에서 발표될 것이라고 발표했습니다. IMPT-314는 공격적인 B 세포 비호지킨 림프종을 위해 개발 중인 CD19/CD20 이중 표적 CAR T 세포 요법으로 FDA로부터 신속 심사 대상으로 지정되었습니다. 발표는 UCLA의 데이비드 게펜 의과대학의 사라 M. 라슨 박사가 2024년 12월 9일에 진행하며, 풍부한 나이브 및 중앙 기억 T 세포에서 이 자가 이중 특이성 CAR 치료의 첫 결과에 초점을 맞출 것입니다.

Lyell Immunopharma (Nasdaq: LYEL) a annoncé que les données cliniques initiales de leur étude de Phase 1-2 sur IMPT-314 dans le lymphome à grandes cellules B seront présentées lors de la Réunion Annuelle ASH 2024. IMPT-314 est une thérapie CAR T à double ciblage CD19/CD20 en cours de développement pour le lymphome non-Hodgkin agressif à cellules B et a reçu la désignation Fast Track de la FDA. La présentation sera faite par Dr. Sarah M. Larson de la David Geffen School of Medicine de l'UCLA le 9 décembre 2024, en se concentrant sur les premiers résultats de cette thérapie CAR bispécifique autologue dans les cellules T naïves et de mémoire centrale enrichies.

Lyell Immunopharma (Nasdaq: LYEL) gab bekannt, dass erste klinische Daten aus ihrer Phase-1-2-Studie zu IMPT-314 bei großzelligen B-Zell-Lymphomen auf dem 2024 ASH Jahresmeeting präsentiert werden. IMPT-314 ist eine dual-target CAR T-Zelltherapie, die für aggressives B-Zell-Nicht-Hodgkin-Lymphom entwickelt wird und von der FDA die Fast Track-Designierung erhalten hat. Die Präsentation wird von Dr. Sarah M. Larson von der David Geffen School of Medicine der UCLA am 9. Dezember 2024 gehalten und konzentriert sich auf die ersten Ergebnisse dieser autologen bispezifischen CAR-Therapie in angereicherten naiven und zentralen Gedächtnis-T-Zellen.

Positive
  • FDA Fast Track Designation received for IMPT-314
  • Dual-targeting therapy approach (CD19/CD20) potentially offering broader treatment coverage
Negative
  • None.

Insights

The announcement of initial clinical data presentation for IMPT-314 at ASH represents a routine conference presentation disclosure without revealing actual trial results or meaningful data. While IMPT-314's dual-targeting CD19/CD20 CAR T-cell therapy for B-cell lymphoma is promising, especially with its Fast Track Designation, this news merely confirms a future presentation slot.

The Phase 1-2 trial data presentation scheduled for December 9, 2024, could potentially be significant, but without the actual results being disclosed in this announcement, there's no material impact on investment decisions at this time. Investors should wait for the actual data presentation at ASH to evaluate the therapy's efficacy and safety profile.

SOUTH SAN FRANCISCO, Calif., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies, today announced that an abstract highlighting initial clinical data from the Phase 1-2 study of IMPT-314 in large B-cell lymphoma will be presented by Sarah M. Larson, M.D., Associate Professor, Department of Medicine, Medical Director, Immune Effector Cell Therapy Program, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, at the 66th American Society of Hematology (ASH) Annual Meeting taking place in San Diego, CA, December 7 – 10, 2024. IMPT-314 is a dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell product candidate being developed for patients with aggressive B-cell non-Hodgkin’s lymphoma.

IMPT-314 has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of relapsed/refractory aggressive B-cell lymphoma.

Details of the presentation are below:

First Results of IMPT-314, an Autologous Bispecific CD19/CD20 Chimeric Antigen Receptor (CAR) in Enriched Naive and Central Memory T Cells, for the Treatment of Large B Cell Lymphoma (LBCL)

  • Session Name: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster III
  • Publication Number: 4824
  • Presentation Date & Time: Monday, December 9, 2024, 6:00 PM - 8:00 PM
  • Location: San Diego Convention Center, Halls G-H

About Lyell
Lyell is a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. Lyell is based in South San Francisco, California with facilities in Seattle and Bothell, Washington. To learn more, please visit www.lyell.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: Lyell’s anticipated progress, business plans, business strategy and clinical trials; Lyell’s advancement of its pipeline and its research, development and clinical capabilities; the potential clinical benefits and therapeutic potential of Lyell’s product candidates; the advancement of Lyell’s technology platform; the potential benefits, if any, from the Fast Track Designation from the U.S. Food and Drug Administration for the treatment of relapsed/refractory aggressive B-cell lymphoma; and other statements that are not historical fact. These statements are based on Lyell’s current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: the effects of macroeconomic conditions, including any geopolitical instability and actual or perceived changes in interest rates and economic inflation; Lyell’s ability to submit planned INDs or initiate or progress clinical trials on the anticipated timelines, if at all; Lyell’s limited experience as a company in enrolling and conducting clinical trials, and lack of experience in completing clinical trials; Lyell’s ability to manufacture and supply its product candidates for its clinical trials; the nonclinical profiles of Lyell’s product candidates not translating in clinical trials; the potential for results from clinical trials to differ from nonclinical, early clinical, preliminary or expected results; significant adverse events, toxicities or other undesirable side effects associated with Lyell’s product candidates; the significant uncertainty associated with Lyell’s product candidates ever receiving any regulatory approvals; Lyell’s ability to obtain, maintain or protect intellectual property rights related to its product candidates; implementation of Lyell’s strategic plans for its business and product candidates; the sufficiency of Lyell’s capital resources and need for additional capital to achieve its goals; and other risks, including those described under the heading “Risk Factors” in Lyell’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (SEC) on February 28, 2024, and the Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 7, 2024. Forward-looking statements contained in this press release are made as of this date, and Lyell undertakes no duty to update such information except as required under applicable law.

Contact:
Ellen Rose
Senior Vice President, Communications and Investor Relations
erose@lyell.com


FAQ

What is IMPT-314 and what is it being developed for?

IMPT-314 is a dual-targeting CD19/CD20 CAR T-cell therapy being developed for patients with aggressive B-cell non-Hodgkin's lymphoma.

When will Lyell (LYEL) present IMPT-314 clinical data at ASH 2024?

Lyell will present the initial clinical data from IMPT-314's Phase 1-2 trial on December 9, 2024, from 6:00 PM to 8:00 PM at the San Diego Convention Center.

Has IMPT-314 received any FDA designations for Lyell (LYEL)?

Yes, IMPT-314 has received Fast Track Designation from the FDA for the treatment of relapsed/refractory aggressive B-cell lymphoma.

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