SOUTH SAN FRANCISCO, Calif. - Lyell Immunopharma, Inc. (NASDAQ:LYEL), a clinical-stage company focused on cell therapies for solid tumors, reported initial data from a Phase 1 clinical trial of LYL797, a new treatment for triple-negative breast cancer (TNBC). The study showed a 40% objective response rate and a 60% clinical benefit rate at the highest dose of 150 x 10^6 CAR T cells.
The trial included patients with relapsed/refractory TNBC, demonstrating that LYL797, enhanced with anti-exhaustion technology, could effectively expand, infiltrate tumors, and kill cancer cells. Patients without lung metastases experienced manageable side effects, mainly mild cytokine release syndrome and headaches. However, pneumonitis was observed in patients with lung metastases, leading to a more gradual dose escalation in this group.
Dr. David R. Spigel, Chief Scientific Officer at the Sarah Cannon Research Institute and lead investigator, expressed optimism about the dose-dependent antitumor activity and the potential to deliver more meaningful benefits as dosing increases. He mentioned that all patients now receive prophylactic steroids to manage pneumonitis.
Lyell Immunopharma is expanding the trial to include other tumor types, such as ROR1+ ovarian and endometrial cancers, and has completed an IND submission for LYL119, another CAR T cell product candidate targeting ROR1.
The initial dataset comprised 20 patients, with a 100% manufacturing success rate for the therapy. The trial continues with separate cohorts for patients with and without lung involvement. Translational data suggest that the treatment maintains a targeted stem-like and effector memory cell phenotype, which is crucial for sustained effectiveness.
The results are based on a press release statement and were discussed during an investor webcast by Lyell's management and Dr. Spigel. The company plans to advance its next-generation product candidate, LYL119, with more potent anti-exhaustion technology, into clinical trials later this year.
InvestingPro Insights
Lyell Immunopharma's recent clinical trial data for its LYL797 therapy has generated interest in the company's approach to treating triple-negative breast cancer. In light of this development, a closer look at the company's financial health and market performance offers additional context for investors considering the company's prospects.
InvestingPro data reveals that Lyell Immunopharma holds a market capitalization of $520.08 million, indicating a modest size within the biotechnology sector. The company's Price/Book ratio, as of the last twelve months leading up to Q1 2024, stands at 0.86, suggesting that the stock may be undervalued relative to the company's assets. Still, investors should note the significant revenue decline of -99.92% over the same period, which underscores the challenges Lyell faces in generating sales growth.
Two InvestingPro Tips highlight critical aspects of Lyell's financial situation. Firstly, the company holds more cash than debt on its balance, which provides some financial flexibility. Secondly, analysts do not anticipate the company will be profitable this year, reflecting the high costs associated with developing new therapies and the early stage of its product pipeline.
For investors seeking a thorough analysis, InvestingPro provides additional insights into Lyell Immunopharma's financial metrics and market performance. There are 10 more InvestingPro Tips available, which can help investors make a more informed decision about the potential risks and rewards of investing in Lyell. Interested readers can access these tips on InvestingPro's platform and use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
Despite the promising clinical results, Lyell's financials and stock performance reflect the inherent uncertainties of investing in clinical-stage biotech companies. With a comprehensive view of both the scientific progress and financial data, investors are better equipped to gauge the company's trajectory and make investment decisions aligned with their risk tolerance and investment goals.
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