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Lyell Immunopharma Announces Oral Presentation of New Clinical Data from the Phase 1/2 Trial of LYL314 for the Treatment of Large B-cell Lymphoma at the International Conference on Malignant Lymphoma (ICML) 2025

Key Takeaway: Lyell Immunopharma announced that new clinical data from the Phase 1/2 trial of LYL314 for large B-cell lymphoma will be presented at the ICML 2025 conference. The product candidate, a dual-targeting CD19/CD20 CAR T-cell therapy, has shown high rates of durable complete responses in patients. Additionally, LYL314 has been granted regulatory designations from the FDA, highlighting its potential in treating aggressive lymphoma. The presentation is scheduled for June 18, 2025, in Lugano, Switzerland.

Market Sentiment Analysis

POSITIVE FACTORS

  • New clinical data from the Phase 1/2 trial exhibit promising preliminary results.
  • LYL314 has received Regenerative Medicine Advanced Therapy and Fast Track designations from the FDA.
  • Presentation at an esteemed international conference showcases Lyell's advancements in CAR T-cell therapies.

Full Press Release Details

SOUTH SAN FRANCISCO, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, today announced that an abstract highlighting new clinical data from the Phase 1/2 trial of LYL314 (formerly IMPT-314) in large B-cell lymphoma will be presented as an oral presentation at the International Conference on Malignant Lymphoma (ICML) 2025 taking place in Lugano, Switzerland June 17-21, 2025.
LYL314 is a dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell product candidate in development for patients with aggressive large B-cell lymphoma. LYL314 has received Regenerative Medicine Advanced Therapy and Fast Track designations from the U.S. Food and Drug Administration for the treatment of patients with relapsed and/or refractory diffuse large B-cell lymphoma in the 3rd or later line setting.
Details of the presentation are below:
LYL314, a CD19/CD20 CAR T-cell candidate enriched for CD62L+ stem-like cells, achieves high rates of durable complete responses in R/R large B-cell lymphoma
Session Name: Focus on New Cellular Therapies
Presentation Date & Time: June 18, 2025, 5:40 pm CEST (11:40 am ET)
Presenting Author: Akil Merchant, MD, Associate Professor and Co-Director of the Lymphoma Program at the Samuel Oschin Cancer Center, Cedars-Sinai Medical Center, Los Angeles, CA
Presentation Number: 106
Lyell is a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with hematologic malignancies and solid tumors. To realize the potential of cell therapy for cancer, Lyell utilizes a suite of technologies to endow CAR T cells with attributes needed to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical responses, including the ability to resist exhaustion, maintain qualities of durable stemness and function in the hostile tumor microenvironment. 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 Regenerative Medicine Advanced Therapy and Fast Track designations from the U.S. Food and Drug Administration for the treatment of patients with relapsed and/or refractory diffuse large B-cell lymphoma in the 3rd or later line setting; 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 disruptions to the global credit and financial markets as a result of tariffs and recession concerns; 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, 2024, filed with the Securities and Exchange Commission (SEC) on March 11, 2025. 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.
Senior Vice President, Communications and Investor Relations

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Frequently Asked Questions

What is LYL314 developed for?

LYL314 is designed for patients with aggressive large B-cell lymphoma.

When will LYL314's clinical data be presented?

The presentation will be on June 18, 2025, at 5:40 pm CEST.

Who is presenting LYL314's data at ICML 2025?

Akil Merchant, MD, will present the data at ICML 2025.

What designations has LYL314 received from the FDA?

LYL314 has received Regenerative Medicine Advanced Therapy and Fast Track designations.

What are the benefits of Lyell’s CAR T-cell therapies?

They aim to provide durable tumor cytotoxicity and long-lasting clinical responses.

Last updated: May 1, 2025