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Lyell Immunopharma, Inc. (Nasdaq: LYEL) is a clinical-stage company pioneering T-cell reprogramming to create cell therapies for patients with solid tumors. By employing advanced genetic and epigenetic technologies, Lyell aims to overcome major challenges in current cell-based immunotherapies, including T-cell exhaustion and lack of durable stemness. Their innovative approach has led to a robust pipeline featuring product candidates like LYL797, LYL119, and LYL845.
Lyell's product portfolio is designed to address the unmet needs in cancer treatment. LYL797 targets ROR1-positive cancers such as triple-negative breast cancer and non-small cell lung cancer, incorporating genetic reprogramming to overexpress c-Jun and epigenetic reprogramming for enhanced durability. LYL119 is another ROR1-targeted CAR T-cell therapy that uses four reprogramming technologies for sustained function and cytotoxicity. LYL845, a tumor-infiltrating lymphocyte (TIL) product, is enhanced with Lyell's proprietary Epi-R™ protocol to improve potency and durability.
Recent achievements include the FDA granting Orphan Drug Designation for LYL845 in advanced melanoma. The company's innovative Epi-R P2 manufacturing process has shown potential to reduce TIL culture time significantly. Lyell is also advancing collaborations, such as with Outpace Bio, to develop localized IL-12 activity in tumors, enhancing the efficacy of T-cell therapies.
Lyell's business strategy has been bolstered by a strong financial position, with cash reserves extending operational capabilities into 2027. Despite macroeconomic challenges, Lyell continues to focus on generating clinical data and advancing its clinical programs, aiming to deliver transformative treatments for cancer patients.
For the latest updates on Lyell Immunopharma, including their financial performance and ongoing clinical trials, visit their official website.
Lyell Immunopharma (NASDAQ: LYEL) has announced positive initial clinical data from its Phase 1-2 trial of IMPT-314, a dual-targeting CD19/CD20 CAR T-cell therapy for B-cell lymphoma. The trial demonstrated a 94% objective response rate and 71% complete response rate in CAR T-naïve patients with large B-cell lymphoma.
The study involved 23 patients, with 17 being efficacy evaluable. Safety data showed no Grade 3+ cytokine release syndrome, and only 13% experienced Grade 3 ICANS, which resolved with standard treatment. The drug demonstrated robust expansion with peak cell expansion occurring between Days 7-28 post-infusion. Based on these results, Lyell plans to initiate a pivotal trial in 2025 for CAR T-naive patients with large B-cell lymphoma in the 3rd-line+ setting.
Lyell Immunopharma (NASDAQ: LYEL) reported Q3 2024 financial results and business highlights. The company acquired ImmPACT Bio and strengthened its pipeline with IMPT-314, a dual-targeting CD19/CD20 CAR T-cell product. Net loss was $44.6 million compared to $50.9 million in Q3 2023. Cash position stands at $460.7 million as of September 30, 2024, expected to fund operations into 2027. The company plans to present initial data from IMPT-314's Phase 1 trial at ASH 2024 and expects to initiate a pivotal trial in 2025.
Lyell Immunopharma (Nasdaq: LYEL) announced that initial clinical data from their Phase 1-2 study of IMPT-314 in large B-cell lymphoma will be presented at the 2024 ASH Annual Meeting. IMPT-314 is a dual-targeting CD19/CD20 CAR T-cell therapy being developed for aggressive B-cell non-Hodgkin's lymphoma and has received Fast Track Designation from the FDA. The presentation will be delivered by Dr. Sarah M. Larson from UCLA's David Geffen School of Medicine on December 9, 2024, focusing on the first results of this autologous bispecific CAR therapy in enriched naive and central memory T cells.
Lyell Immunopharma (NASDAQ: LYEL) has completed its acquisition of ImmPACT Bio, a private clinical-stage cell therapy company. The acquisition adds IMPT-314, a dual-targeting CD19/CD20 CAR T-cell product candidate, to Lyell's pipeline, with pivotal development expected to start in 2025 for B-cell non-Hodgkin lymphoma patients. Former ImmPACT Bio CEO Sumant Ramachandra joins Lyell's Board of Directors. The company expects its cash balance to fund operations into 2027, supporting clinical milestones across its pipeline programs.
Lyell Immunopharma has announced its acquisition of ImmPACT Bio, strengthening its clinical pipeline with IMPT-314, a dual-targeting CD19/CD20 CAR T-cell therapy. The deal involves $30 million in cash and 37.5 million Lyell shares upfront, plus potential milestone-based shares and royalties. Data from IMPT-314's Phase 1-2 trial in large B-cell lymphoma will be presented later this year, with a pivotal trial expected in 2025. Lyell is discontinuing development of LYL797, LYL845, and earlier TIL programs to focus on next-generation CAR T-cell therapies. The company expects its cash runway to extend into 2027 following the transaction's close in Q4 2024.
Lyell Immunopharma, Inc. (Nasdaq: LYEL) announced the acceptance of three abstracts for presentation at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Houston, TX, from Nov. 6-10, 2024. The presentations will highlight Lyell's pipeline of clinical product candidates and anti-exhaustion technology for cell therapies targeting solid tumors and hematologic malignancies.
Key presentations include:
- Translational data from the LYL797 Phase 1 clinical trial, demonstrating solid tumor infiltration and cell killing by reprogrammed ROR1 CAR T cells
- Multiomic profiling of LYL119, a reprogrammed ROR1 CAR T product with reduced exhaustion and enhanced memory characteristics
- Utilization of Stim-R™ Technology to reduce irradiated feeder cells in tumor infiltrating lymphocyte culture process
These presentations will provide insights into Lyell's progress in developing innovative cell therapies for cancer treatment.
Lyell Immunopharma (Nasdaq: LYEL), a clinical-stage T-cell reprogramming company, has announced its participation in the Goldman Sachs Cell Therapy Day on October 1. Lynn Seely, MD, Lyell's President & CEO, will be part of a panel discussion focusing on next-generation cell therapies in oncology at 11:50 a.m. ET.
The company, which is advancing a diverse pipeline of cell therapies for patients with solid tumors or hematologic malignancies, will provide a webcast of the presentation through the Investors section of their website at www.lyell.com. A replay of the webcast will be available on the company's website following the presentation date.
Lyell Immunopharma (Nasdaq: LYEL), a clinical-stage T-cell reprogramming company, has announced its participation in two upcoming investor conferences in September 2024. The company's senior management team will present at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 4th at 10:45 am ET and the H.C. Wainwright 26th Annual Global Investment Conference on September 9th at 8:30 am ET.
Lyell Immunopharma specializes in developing cell therapies for patients with solid tumors or hematologic malignancies. Interested parties can access live webcasts of the presentations through the Investors section of Lyell's website. Replays will be available on the company's website following each presentation.
Lyell Immunopharma (NASDAQ: LYEL) reported Q2 2024 results and business highlights:
- LYL797 Phase 1 trial showed 40% objective response rate and 60% clinical benefit rate in triple-negative breast cancer at highest dose
- Expanded LYL797 development into four new tumor types
- FDA cleared IND for LYL119, a next-gen ROR1-targeted CAR T-cell therapy
- $491.1 million in cash and equivalents as of June 30, 2024
- Net loss of $45.8 million for Q2 2024, compared to $63.9 million in Q2 2023
- R&D expenses decreased to $40.3 million from $47.5 million year-over-year
- G&A expenses decreased to $12.3 million from $19.0 million year-over-year
- Cash runway extended into 2027
Lyell Immunopharma has announced initial clinical data from its Phase 1 trial of LYL797, a ROR1-targeted CAR-T cell product enhanced with anti-exhaustion technology. Key findings include a 40% objective response rate (ORR) and a 60% clinical benefit rate (CBR) at the highest dose of 150 million CAR T cells in patients with triple-negative breast cancer (TNBC). The trial demonstrated that LYL797 can proliferate, infiltrate tumors, and kill cancer cells. No dose-limiting toxicities were reported in patients without lung metastases, although treatable pneumonitis was observed in those with lung involvement. Lyell is expanding the trial to include other ROR1+ cancers and has submitted an IND for LYL119, their next-generation product. An investor webcast will be held today at 8:30 am ET.
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