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Lyell Immunopharma Presents First in Human Trial Design of LYL797 at ESMO 2022

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Lyell Immunopharma (Nasdaq: LYEL) announces the presentation of a poster at the ESMO Congress 2022 on the Phase 1 trial design for LYL797, a CAR T-cell therapy aimed at treating solid tumors. This innovative therapy utilizes Lyell’s Gen-R™ and Epi-R™ technologies to enhance T-cell functionality against challenges like exhaustion. The trial targets patients with advanced solid tumors, including triple-negative breast cancer and non-small cell lung cancer. The poster session occurred on September 12, 2022, in Paris, providing insights into Lyell's commitment to curative cell therapies.

Positive
  • Presentation of the first-in-human Phase 1 trial for LYL797 at a prestigious medical congress.
  • LYL797 aims to address significant challenges in adoptive cell therapy through innovative technologies.
  • Focus on advanced solid tumors, expanding treatment options for patients with limited therapies.
Negative
  • None.

SOUTH SAN FRANCISCO, Calif., Sept. 12, 2022 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical‑stage T-cell reprogramming company dedicated to developing curative cell therapies for patients with solid tumors, announced today that a poster describing the first-in-human Phase 1 trial design for LYL797, Lyell’s ROR1-targeted CAR T-cell therapy enhanced with genetic and epigenetic reprogramming for the treatment of solid tumors, is being presented today at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris, France.

“This first-in-human Phase 1 trial is designed to provide important data on the potential of Lyell’s innovative reprogramming technologies to endow T cells with durable anti-tumor functionality,” stated Dr. Tina Albertson, chief medical officer of Lyell. “These reprogramming technologies are designed to overcome primary barriers to sustained response to adoptive cell therapy for patients with solid tumor cancers, namely T-cell exhaustion and lack of durable stemness.”

Details on the presentation are below:

Phase 1 Study of LYL797, a ROR1-targeted CAR T-cell therapy with genetic and epigenetic reprogramming for the treatment of advanced solid tumors

  • Category: Investigational Immunotherapy
  • Date, Time & Location: September 12, 2022, 9 a.m. CET to 5 p.m. CET, Hall 4
  • Presentation number: 777TiP

About LYL797

LYL797 is an investigational chimeric antigen receptor (CAR) T-cell therapy for patients with receptor tyrosine kinase-like orphan receptor 1-positive (ROR1+) solid tumors. LYL797 incorporates Gen-R™ and Epi-R™, Lyell’s novel reprogramming technologies designed to overcome primary barriers to successful adoptive cell therapy: T-cell exhaustion and lack of durable stemness. The Phase 1 trial will assess LYL797 in patients with relapsed/refractory triple-negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC). More information can be found on ClinicalTrials.gov by searching NCT05274451.

About Lyell Immunopharma, Inc.

Lyell is a clinical-stage T-cell reprogramming company dedicated to developing curative cell therapies for patients with solid tumors. The Company is advancing a pipeline of therapies designed to address what it believes are the primary barriers that limit consistent, reliable and curative responses to adoptive T-cell therapy: T-cell exhaustion and lack of durable stemness, which includes the ability to proliferate, persist and self-renew, as well as generate differentiated effector cell progenies to provide durable anti-tumor functionality. Lyell is applying its proprietary ex vivo genetic and epigenetic reprogramming technology platforms, Gen-R™ and Epi-R™, to address these barriers in order to develop new medicines with improved, durable and potentially curative clinical outcomes. Lyell is based in South San Francisco, California and 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 potential clinical benefits and therapeutic potential of Lyell’s product candidates; the potential of Lyell’s reprogramming technologies to endow T cells with anti-tumor functionality and the ability of such reprogramming technologies to overcome primary barriers to sustained response to adoptive cell therapy, T-cell exhaustion and lack of durable stemness; 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 the evolving 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 ability to manufacture and supply its product candidates for its clinical trials; the preclinical 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; implementation of Lyell’s strategic plans for its business and product candidates; Lyell’s reliance on GSK to advance the development of its NY-ESO-1 programs; 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 most recently filed periodic reports on Form 10-K and Form 10-Q and in Lyell’s future reports to be filed with the SEC. 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 LYL797 from Lyell Immunopharma?

LYL797 is an investigational CAR T-cell therapy targeting ROR1-positive solid tumors, utilizing genetic and epigenetic reprogramming.

When was the Phase 1 trial for LYL797 presented?

The Phase 1 trial design for LYL797 was presented on September 12, 2022.

Where was the LYL797 trial design presented?

The trial design was presented at the ESMO Congress 2022 in Paris.

What types of cancer does LYL797 target?

LYL797 targets advanced solid tumors, specifically relapsed/refractory triple-negative breast cancer and non-small cell lung cancer.

What is the main goal of the LYL797 trial?

The main goal is to gather data on the effectiveness of Lyell's reprogramming technologies in enhancing T-cell functionality against solid tumors.

Lyell Immunopharma, Inc.

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