Welcome to our dedicated page for Lyell Immunopharma news (Ticker: LYEL), a resource for investors and traders seeking the latest updates and insights on Lyell Immunopharma stock.
Overview of Lyell Immunopharma, Inc.
Lyell Immunopharma, Inc. (Nasdaq: LYEL) is a clinical-stage biotechnology company dedicated to advancing the field of cell-based immunotherapies for cancer treatment. Headquartered in South San Francisco, California, with additional facilities in Seattle and Bothell, Washington, Lyell’s mission is to develop curative therapies for patients suffering from solid tumors and hematologic malignancies. The company applies cutting-edge technologies in T-cell reprogramming, including genetic and epigenetic modifications, to overcome barriers that have historically limited the efficacy of cell therapies in these cancers.
Core Technologies and Innovation
Lyell’s proprietary technology platform is designed to address two critical challenges in cell therapy: T-cell exhaustion and the lack of durable stemness. T-cell exhaustion refers to the diminished functionality of T cells in the tumor microenvironment, which compromises their ability to attack cancer cells. Durable stemness, on the other hand, is the ability of T cells to persist, self-renew, and maintain their cytotoxic activity over time. Lyell employs a combination of genetic reprogramming, such as c-Jun overexpression, and epigenetic reprogramming through its Epi-R™ manufacturing process to create T cells with enhanced antitumor activity and longevity.
Pipeline of Product Candidates
Lyell is advancing a diverse pipeline of product candidates targeting both solid tumors and hematologic malignancies:
- IMPT-314: A dual-targeting CD19/CD20 CAR T-cell therapy designed to treat aggressive B-cell non-Hodgkin lymphoma. This product incorporates a novel manufacturing process that enriches for naïve and central memory T cells, enhancing durability and clinical outcomes. IMPT-314 has demonstrated promising results in early clinical trials, with high complete response rates and a favorable safety profile.
- LYL119: A next-generation ROR1-targeted CAR T-cell therapy incorporating four complementary anti-exhaustion technologies. This candidate is designed to address solid tumors such as ovarian and endometrial cancers.
- LYL845: A tumor-infiltrating lymphocyte (TIL) therapy reprogrammed using Lyell’s proprietary epigenetic technologies. This program, however, has been deprioritized in favor of more differentiated CAR T-cell therapies.
Strategic Acquisitions and Collaborations
In 2024, Lyell acquired ImmPACT Bio USA Inc., a clinical-stage biotechnology company specializing in CAR T-cell therapies. This acquisition added IMPT-314 to Lyell’s pipeline, significantly enhancing its portfolio in hematologic malignancies. The deal also brought advanced manufacturing capabilities and expertise in dual-targeting CAR T-cell technologies.
Competitive Positioning
Lyell operates in a highly competitive field alongside companies like Kite Pharma and Novartis. However, its focus on addressing the unique challenges of solid tumors, combined with its proprietary anti-exhaustion and epigenetic reprogramming technologies, sets it apart. The company’s ability to develop therapies that achieve durable clinical responses positions it as a key innovator in the next generation of cell therapies.
Manufacturing and Infrastructure
Lyell’s state-of-the-art LyFE™ manufacturing facility enables the production of high-quality CAR T-cell therapies at scale. This vertically integrated approach ensures consistency and reliability in clinical trials and positions the company for future commercialization efforts.
Conclusion
Lyell Immunopharma, Inc. is at the forefront of cell therapy innovation, leveraging its proprietary technologies to develop groundbreaking treatments for cancer. With a robust pipeline, strategic acquisitions, and a focus on overcoming the limitations of current therapies, Lyell aims to transform the landscape of cancer treatment and improve outcomes for patients worldwide.
Lyell Immunopharma, Inc. (Nasdaq: LYEL) has appointed Gary Lee, Ph.D., as its new Chief Scientific Officer. Dr. Lee brings over a decade of experience in translational cell and gene therapy, aiming to advance the company’s research pipeline. This strategic move reflects Lyell's commitment to developing a multi-modality cell therapy pipeline using its innovative T-cell reprogramming technologies. Concurrently, Nick Restifo will transition to a scientific advisor role, continuing to support the company's programs.
Lyell Immunopharma announced the FDA has cleared an IND application to start a Phase 1 clinical trial for LYL132, a T-cell receptor therapy targeting NY-ESO-1 in patients with solid tumors. This therapy utilizes Lyell’s Epi-R technology, aimed at overcoming barriers in adoptive cell therapy by promoting T cell properties of durable stemness. The clinical trial will focus on advanced synovial sarcoma and myxoid/round cell liposarcoma. This clearance marks a significant milestone for Lyell, indicating progress in their collaboration with GSK and their commitment to cancer drug development.
Lyell Immunopharma, a T-cell reprogramming company, will participate in the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022, at 3:00 PM ET. The company plans to showcase its diverse pipeline, including LYL797, a CAR T-cell therapy for solid tumors, with patient screening expected by Q1 2022 and preliminary data in 2023. Additionally, Lyell will discuss its innovative technologies, Gen-R™ and Epi-R™, enhancing T-cell functions. The newly established LyFE™ Manufacturing Center will ensure quality and efficiency in cell product production.
Lyell Immunopharma has received FDA clearance for its IND application to begin a Phase 1 clinical trial for LYL797, a novel CAR T-cell therapy targeting ROR1 in solid tumors. Expected to start screening patients by Q1 2022, LYL797 aims to tackle T-cell exhaustion and enhance durable stemness using Lyell's innovative technologies, Gen-R and Epi-R. The trial will initially focus on patients with relapsed/refractory triple-negative breast cancer (TNBC) and later include those with non-small cell lung cancer (NSCLC). Initial data is anticipated in 2023.
Lyell Immunopharma has announced the commissioning of its LyFE Manufacturing Center in Bothell, WA, complying with FDA's cGMP standards. The facility, operational since April 2021, is designed to produce cell products at scale for upcoming clinical trials, including CAR, TIL, and TCR programs. It incorporates advanced data analytics for real-time monitoring and process optimization, supported by a partnership with Amazon Web Services. This infrastructure is pivotal in Lyell's efforts to address challenges in T-cell therapy, aiming for effective treatments for solid tumors.
Lyell Immunopharma, Inc. (Nasdaq: LYEL) announced that Dr. Rick Klausner has resumed his role as Chair of the Board after a temporary medical leave. CEO Liz Homans expressed gratitude for Klausner's health and his ongoing scientific guidance. Klausner emphasized the company's mission to develop curative cell therapies for solid tumors and acknowledged Cathy Friedman's leadership during his absence. The company utilizes its proprietary Gen-R and Epi-R platforms to address challenges in adoptive T cell therapy.
As of September 30, 2021, Lyell Immunopharma reported cash and investments totaling $936.4 million, bolstering its multi-modality cell therapy pipeline. The company anticipates submitting four IND applications by the end of 2022 and is actively expanding its research, development, and manufacturing capabilities.
In Q3 2021, research and development expenses rose to $31.4 million, up from $24.5 million in Q3 2020. General and administrative expenses also increased to $21.2 million from $13.6 million. The net loss widened to $48.9 million compared to $35.7 million in the prior year.
Lyell Immunopharma (LYEL) will participate in a virtual fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on September 15, 2021, at 2:00 PM ET. The event will focus on T cell reprogramming aimed at curing solid tumors. Interested parties can access a live webcast via the investor relations section of the company's website, with a replay available for 90 days afterward. Lyell is dedicated to overcoming major barriers in adoptive T cell therapy through its innovative Gen-R and Epi-R platforms.
Lyell Immunopharma (LYEL) reported significant advancements in operational capacity and financial health for the second quarter of 2021. The company achieved operational readiness at its LyFE manufacturing facility, crucial for upcoming clinical trials. As of June 30, 2021, cash, cash equivalents, and marketable securities reached $974.8 million, bolstered by $391.8 million from its IPO. While R&D expenses declined compared to 2020, G&A expenses rose due to increased stock-based compensation. The net loss decreased to $62.6 million for the quarter, indicating improved cost management.
Lyell Immunopharma, Inc. (Nasdaq: LYEL) has announced the pricing of its initial public offering (IPO) of 25,000,000 shares at $17.00 per share, aiming to raise approximately $425 million before expenses. The IPO is set to commence trading on Nasdaq on June 17, 2021, and is expected to close on June 21, 2021, pending customary conditions. Additionally, underwriters have a 30-day option to purchase up to 3,750,000 additional shares. Goldman Sachs & Co. LLC and others are leading the offering.
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