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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

Key Takeaway: Lyell Immunopharma announced the presentation of initial clinical data for its IMPT-314 product candidate at the upcoming 2024 ASH Annual Meeting. The dual-targeting CAR T-cell therapy targets aggressive B-cell lymphoma and has been granted Fast Track Designation by the FDA. The data will be presented by Dr. Sarah M. Larson at the conference, which is taking place in San Diego. Despite positive developments, the company faces various risks and uncertainties related to its clinical trials and regulatory approvals.

Market Sentiment Analysis

POSITIVE FACTORS

  • Initial clinical data presentation at a prestigious ASH Annual Meeting.
  • IMPT-314 has received Fast Track Designation from the FDA for treatment.
  • Product candidate demonstrates potential benefits for aggressive B-cell lymphoma.

CONCERNS & RISKS

  • Potential risks and uncertainties regarding the progress of clinical trials.
  • Concerns about the nonclinical profiles not translating into clinical success.
  • Significant uncertainty around regulatory approvals for the product candidates.

Full Press Release Details

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
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.
Senior Vice President, Communications and Investor Relations

Tags

non-hodgkins lymphoma

Frequently Asked Questions

What is IMPT-314?

IMPT-314 is a dual-targeting CD19/CD20 CAR T-cell therapy aimed at treating aggressive B-cell non-Hodgkin’s lymphoma.

When will IMPT-314's clinical data be presented?

Initial clinical data for IMPT-314 will be presented on December 9, 2024, at ASH.

What designation has IMPT-314 received from the FDA?

IMPT-314 has received Fast Track Designation for treating relapsed/refractory aggressive B-cell lymphoma.

Where is the presentation for IMPT-314 taking place?

The presentation will be held at the San Diego Convention Center in Halls G-H.

Who is presenting the IMPT-314 data?

Dr. Sarah M. Larson from UCLA will present the data on IMPT-314.

Last updated: Nov 5, 2024