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
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Insights
Lyell's dual-targeting CAR T with stem-like cells shows promising complete responses in aggressive lymphoma, addressing key limitations of current therapies.
Lyell's upcoming presentation of LYL314 data represents a potentially significant advancement in CAR T-cell therapy for large B-cell lymphoma. The dual-targeting CD19/CD20 approach is particularly noteworthy as it addresses a critical limitation of current single-antigen CAR T therapies - antigen escape, where cancer cells evade treatment by downregulating the targeted antigen.
The enrichment for CD62L+ stem-like cells targets another major challenge in the field: limited persistence and durability of response. Current approved CAR T products often show impressive initial response rates but face issues with long-term durability. By incorporating cells with stem-like properties, LYL314 may achieve improved persistence and sustained anti-tumor activity.
The Regenerative Medicine Advanced Therapy and Fast Track designations from the FDA signal regulatory recognition of LYL314's potential in meeting an unmet medical need in third-line+ DLBCL. Selection for an oral presentation at ICML, a premier lymphoma conference, further validates the potential significance of these results among the scientific community.
While specific efficacy numbers aren't provided, the title's reference to "high rates of durable complete responses" suggests potentially competitive outcomes in a field where complete response rates and durability are the critical metrics. If substantiated by the full data presentation, this could represent a meaningful advance for patients with relapsed/refractory large B-cell lymphoma who currently have limited options after failing existing therapies.
Lyell's LYL314 shows promising efficacy in lymphoma with regulatory advantages, validating their differentiated technological approach in competitive CAR T market.
This announcement represents a potentially significant clinical catalyst for Lyell Immunopharma. The abstract title suggesting "high rates of durable complete responses" in relapsed/refractory large B-cell lymphoma indicates positive efficacy signals, though investors should note that specific data points aren't yet disclosed.
The dual FDA designations (RMAT and Fast Track) provide Lyell with meaningful regulatory advantages, including enhanced FDA interaction, potential accelerated approval pathways, and possibly priority review. These designations aren't granted lightly and suggest the therapy shows promise in addressing unmet needs.
Lyell's technological approach focuses on two key differentiators: dual-targeting of CD19/CD20 to prevent antigen escape and enrichment for CD62L+ stem-like cells to improve persistence. This directly addresses limitations of current approved CAR T therapies like Yescarta and Kymriah, which target only CD19 and can face durability challenges.
Selection for an oral presentation at ICML is noteworthy, as these slots are typically reserved for the most promising or practice-changing data. However, investors should recognize that Lyell faces competition in the evolution of CAR T therapy, with several companies pursuing next-generation approaches.
If the June data presentation confirms robust and durable responses, it would validate Lyell's technological platform beyond this single product candidate, potentially creating value across their pipeline. The R/R LBCL market represents a substantial commercial opportunity, though specific market implications will depend on the full data set.
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
- Location: Room B
About Lyell
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.
Contact:
Ellen Rose
Senior Vice President, Communications and Investor Relations
erose@lyell.com
FAQ
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