Presentations to highlight new nonclinical data on product candidates, new technologies, innovations designed to shorten TIL manufacturing and clinical trials in progress
SOUTH SAN FRANCISCO, Calif., Sept. 27, 2023 (GLOBE NEWSWIRE) — Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical‑stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for patients with solid tumors, announced today that six abstracts highlighting its broad pipeline of clinical and preclinical product candidates as well as a shortened TIL manufacturing process have been accepted for presentation at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) taking place in San Diego, Nov. 1-5, 2023.
“Our presentations at SITC highlight the progress we are making on several fronts to advance new product candidates and technologies designed to generate potent and durable cell therapies for patients with solid tumors,” stated Dr. Gary Lee, chief scientific officer at Lyell. “At SITC, we look forward to sharing new preclinical findings on product candidates and emerging technologies, data on our Epi-R P2 manufacturing process which is designed to shorten TIL product delivery time to patients, and highlighting the design of our two ongoing Phase 1 clinical trials in progress.”
Four presentations highlight new nonclinical data from pipeline product candidates and research programs, including a new technology being advanced through a collaboration with Outpace to enable context-dependent, localized IL-12 activity to enhance solid tumor T cell therapies; and Lyell’s novel Epi-R P2 manufacturing process to shorten manufacturing time for tumor infiltrating lymphocyte (TIL) therapy.
Two additional presentations highlight the design of Lyell’s ongoing Phase 1 clinical trials in progress: LYL797, a ROR1-targeted CAR T-cell therapy being evaluated in a Phase 1 trial in patients with relapsed refractory triple-negative breast cancer and non-small cell lung cancer, and LYL845, a tumor infiltrating lymphocyte (TIL) therapy being evaluated in a Phase 1 trial in advanced solid tumors.
Details on the six poster presentations are below:
Epi-R™ P2 protocol produces a scalable polyclonal TIL product with a greater expansion success rate across hot and cold tumors in shorter culture time
Preclinical development of LYL119, a ROR1-targeted CAR T-cell product incorporating four novel T-cell reprogramming technologies to overcome barriers to effective cell therapy for solid tumors
Protein design and inducible expression allow context-dependent, localized IL-12 activity to enhance solid tumor T cell therapies
Rejuvenation of tumor–infiltrating lymphocytes (TIL) through Partial Reprogramming
Phase 1 trial of LYL797, a ROR1-targeted CAR T-cell therapy enhanced with genetic and epigenetic reprogramming, in advanced triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC)
Phase 1 trial of LYL845, an autologous tumor-infiltrating lymphocyte (TIL) therapy enhanced with epigenetic reprogramming, for the treatment of advanced solid tumors
About Lyell Immunopharma, Inc.
Lyell is a clinical-stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for patients with solid tumors. Lyell is currently enrolling a Phase 1 clinical trial evaluating a ROR1-targeted CAR T-cell therapy in patients with relapsed refractory triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC) and a second Phase 1 clinical trial evaluating reprogrammed tumor infiltrating lymphocytes (TIL) in patients with advanced melanoma, NSCLC and colorectal cancer. The technologies powering its product candidates are designed to address barriers that limit consistent and long-lasting responses to cell therapy for solid tumors: T-cell exhaustion and lack of durable stemness, which includes the ability to persist and self-renew to drive durable tumor cytotoxicity. Lyell is applying its proprietary ex vivo genetic and epigenetic reprogramming technologies to address these barriers in order to develop new medicines with improved durable clinical outcomes. 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 planned clinical trials; the growing pipeline and potential clinical benefits and therapeutic potential of Lyell’s product candidates; the potential for the Epi-R P2 manufacturing process to produce a scalable polyclonal TIL product with a greater expansion success rate across hot and cold tumors in shorter culture time; Lyell’s collaboration with Outpace Bio and the potential to enable context-dependent, localized IL-12 activity to enhance solid tumor T cell therapies; the potential of Lyell’s reprogramming technologies to overcome primary barriers to successful adoptive cell therapy in solid tumors to improve clinical responses in patients; the potential for Lyell’s rejuvenation of TIL through partial reprogramming; 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: macroeconomic conditions and the lingering effects of the COVID-19 pandemic; geopolitical instability; Lyell’s ability to submit planned INDs or initiate and execute 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 preclinical, 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; 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, 2022, filed with the Securities and Exchange Commission (SEC) on February 28, 2023, and the Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, filed with the SEC on August 8, 2023. 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
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