Lyell Immunopharma Presents New Clinical Data from Ongoing Trial of Ronde-Cel Showing High Rates of Durable Complete Responses in Patients with Large B-cell Lymphoma at the 67th ASH Annual Meeting and Exposition

SOUTH SAN FRANCISCO, Calif., Dec. 07, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today announced new clinical and translational data from the ongoing clinical trial of rondecabtagene autoleucel (ronde-cel, also known as LYL314) in patients with large B-cell lymphoma (LBCL), which were presented today in two oral presentations at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition. As of the data cutoff date of September 5, 2025, ronde-cel continued to demonstrate robust clinical responses with a manageable safety profile appropriate for outpatient administration. A 93% overall response rate, a 76% complete response rate, and median progression-free survival of 18 months were reported for patients with relapsed and/or refractory (R/R) LBCL in the third- or later-line (3L+) setting. Patients evaluated in the second-line (2L) setting (94% with difficult-to-treat primary refractory disease) achieved an 83% overall response rate and a 61% complete response rate, and 70% of patients with a complete response remained in complete response at 6 months or longer.

GlobeNewsWire • Dec 7, 2025

Lyell Immunopharma Reports Business Highlights and Financial Results for the Third Quarter 2025

Acquired exclusive global rights to LYL273, a novel GCC-targeted CAR T-cell product candidate that has demonstrated a 67% overall response rate, an 83% disease control rate and a manageable safety profile at the highest dose level studied to date in patients with refractory metastatic colorectal cancer in an ongoing U.S. Phase 1 clinical trial Received RMAT designation from the U.S. FDA for ronde-cel for the treatment of patients with relapsed or refractory LBCL receiving treatment in the second-line (2L) setting Announced that two abstracts highlighting new clinical and translational data from the Phase 1/2 clinical trial of ronde‑cel for the treatment of aggressive large B-cell lymphoma have been accepted for oral presentation at the ASH 67th Annual Meeting and Exposition in December Announced the initiation of PiNACLE - H2H, a Phase 3 head-to-head CAR T-cell therapy clinical trial in aggressive large B-cell lymphoma in the 2L setting Formed a PiNACLE – H2H Steering Committee comprised of a distinguished group of lymphoma and cell therapy experts Cash of approximately $320 million at the end of the third quarter of 2025; current cash is expected to support advancing pipeline into 2027 through key clinical milestones SOUTH SAN FRANCISCO, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today reported financial results and business highlights for the third quarter ended September 30, 2025.

GlobeNewsWire • Nov 12, 2025

Lyell Immunopharma Acquires Exclusive Global Rights to a Next-Generation CAR T-Cell Product Candidate in Clinical Development for Metastatic Colorectal Cancer

LYL273 has demonstrated a 67% overall response rate, an 83% disease control rate, and a manageable safety profile at the highest dose level studied to date in patients with refractory metastatic colorectal cancer enrolled in an ongoing U.S. Phase 1 clinical trial LYL273 is a GCC-targeted CAR T-cell product candidate armed with enhancements designed to improve CAR T-cell expansion and cancer cell killing Lyell management will host an investor webcast at 8:30 AM ET today SOUTH SAN FRANCISCO, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today announced it has strengthened its solid tumor pipeline by acquiring global rights to LYL273 (formerly GCC19CART), a novel autologous guanylyl cyclase-C (GCC)-targeted CAR T-cell product candidate for the treatment of metastatic colorectal cancer (mCRC) and other GCC-expressing cancers, from Innovative Cellular Therapeutics (ICT).

GlobeNewsWire • Nov 10, 2025

Lyell Announces Two Oral Presentations from the Phase 1/2 Clinical Trial of Ronde-Cel for the Treatment of Aggressive Large B-Cell Lymphoma at the 67th ASH Annual Meeting and Exposition

SOUTH SAN FRANCISCO, Calif., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, today announced that two abstracts highlighting new clinical and translational data from the Phase 1/2 clinical trial of rondecabtagene autoleucel (ronde-cel, also known as LYL314) for the treatment of aggressive large B-cell lymphoma (LBCL) will be presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.

GlobeNewsWire • Nov 3, 2025

Lyell Immunopharma Announces the Initiation of a Phase 3 Head-to-Head CAR T-Cell Therapy Clinical Trial in Aggressive Large B-Cell Lymphoma and Formation of Expert Steering Committee

PiNACLE - H2H will evaluate rondecabtagene autoleucel (ronde-cel) versus investigator's choice of approved CD19 CAR T-cell therapies in patients with aggressive large B-cell lymphoma receiving treatment in the second line (2L) setting Ronde-cel is Lyell's next-generation, dual-targeting CD19/CD20 CAR T-cell therapy designed to deliver improved complete response rates and longer duration of responses over currently approved CD19 CAR T-cell therapies Steering Committee of distinguished lymphoma experts established to advise on the design and conduct of this first-of-its-kind CAR T-cell clinical trial SOUTH SAN FRANCISCO, Calif., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation CAR T-cell therapies for patients with cancer, today announced the initiation of PiNACLE - H2H, a Phase 3 head-to-head CAR T-cell therapy randomized controlled trial and the formation of a Steering Committee of preeminent lymphoma experts.

GlobeNewsWire • Sep 3, 2025

Lyell Immunopharma Announces Participation in September Investor Conferences

SOUTH SAN FRANCISCO, Calif., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation CAR T-cell therapies for patients with cancer, announced today that members of its senior management team will present and participate in the following investor conferences: Morgan Stanley 23rd Annual Global Healthcare Conference on Monday, September 8th at 9:15 am Eastern Time H.C.

GlobeNewsWire • Sep 2, 2025

Lyell Immunopharma Reports Business Highlights and Financial Results for the Second Quarter 2025

SOUTH SAN FRANCISCO, Calif., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation CAR T-cell therapies for patients with cancer, today reported financial results and business highlights for the second quarter ended June 30, 2025. Lyell's lead clinical program, LYL314, is a next-generation autologous dual-targeting CD19/CD20 CAR T-cell product candidate under evaluation in PiNACLE, a single-arm pivotal trial enrolling patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) in the 3L+ setting and in a Phase 1/2 study in the 2L setting.

GlobeNewsWire • Aug 12, 2025

Lyell Immunopharma Announces up to $100 Million Equity Private Placement

SOUTH SAN FRANCISCO, Calif., July 25, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing next-generation CAR T-cell therapies for patients with cancer, today announced that it has entered into a securities purchase agreement for a private placement with certain institutional and other accredited investors, for gross proceeds of up to approximately $100 million.

GlobeNewsWire • Jul 25, 2025

Lyell: 'Hold' Rating Based On Phase 3 LYL314 LBCL Treatment Program Advancement

Lyell Immunopharma's LYL314 CAR-T therapy shows high, durable response rates in 3rd-line + Large B-Cell Lymphoma patients. The company has initiated a phase 3 trial for LYL314 in 3rd-line + LBCL following positive FDA feedback after the end-of-phase 1 meeting. A key upcoming catalyst is the planned phase 3 trial in 2nd-line + LBCL patients, expected to begin in early 2026.

Seeking Alpha • Jul 22, 2025

Lyell Immunopharma to Participate in the H.C. Wainwright “HCW@Home” Series

SOUTH SAN FRANCISCO, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing next-generation CAR T-cell therapies for patients with cancer, announced today that members of its senior management team will participate in the H.C. Wainwright “HCW@Home” Series taking place virtually on Wednesday, June 25, 2025, at 12:00 PM ET.

GlobeNewsWire • Jun 23, 2025