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SOUTH SAN FRANCISCO - Lyell Immunopharma’s (NASDAQ:LYEL) LYL314 therapy demonstrated an 88% overall response rate and 72% complete response rate in patients with large B-cell lymphoma (LBCL) treated in the third- or later-line setting, according to data released Tuesday. The clinical-stage biotech company, currently valued at $150.6 million, has seen its stock surge recently, with InvestingPro data showing strong returns over the past month despite broader market volatility.
The clinical-stage company reported that 71% of patients who achieved complete response maintained this status for at least six months. The data comes from a multi-center Phase 1/2 trial involving 25 patients in the third- or later-line treatment setting. According to InvestingPro analysis, while the company maintains a healthy balance sheet with more cash than debt and a strong current ratio of 7.49, it continues to invest heavily in research and development.
In second-line patients, initial data showed a 91% overall response rate with 64% achieving complete response. All seven patients with complete response maintained this status at their last assessment.
LYL314 is an autologous dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell therapy that has received both Regenerative Medicine Advanced Therapy and Fast Track designations from the FDA.
The therapy demonstrated a manageable safety profile suitable for outpatient administration, with no Grade 3 or higher cytokine release syndrome reported among the 51 patients treated. Immune effector cell-associated neurotoxicity syndrome occurred at Grade 3 or higher in 14% of patients, with a median time to complete resolution of 5 days.
"Based on these robust data, and our recent End-of-Phase 1 meeting with the FDA, we have initiated PiNACLE, a single-arm pivotal trial of LYL314 in patients with large B-cell lymphoma in the third- or later-line setting," said Lynn Seely, Lyell’s President and CEO, in the press release statement.
The company plans to initiate a pivotal trial evaluating LYL314 in the second-line setting by early 2026. The PiNACLE trial is expected to enroll approximately 120 patients with various forms of relapsed or refractory large B-cell lymphoma who have not previously received CAR T-cell therapy. With analyst price targets ranging from $12 to $20, significantly above the current trading price of $10.17, market watchers appear optimistic about the company’s potential. For deeper insights into Lyell’s financial health and growth prospects, including 10+ additional exclusive ProTips, visit InvestingPro.
In other recent news, Lyell Immunopharma, Inc. announced that the U.S. Food and Drug Administration has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lymphoma therapy, LYL314. This designation is expected to accelerate the development and review process of the therapy, which has shown promising results in early trials. In a recent Phase 1/2 trial, LYL314 achieved an overall response rate of 94% among patients with relapsed or refractory large B-cell lymphoma, with 71% reaching complete response. In another development, Lyell Immunopharma plans to close its West Hills manufacturing facility, resulting in a reduction of approximately 73 jobs. The decision comes after successfully transferring technology to its Bothell, Washington facility, which will now handle the manufacturing of LYL314. The closure is projected to incur costs between $3.0 million and $4.0 million, primarily from severance and related expenses. Lyell also reiterated its financial guidance for 2025, expecting net cash use between $175 million and $185 million, extending its cash runway into 2027. Additionally, the company announced the departure of Chief Business Officer Matthew Lang, who will remain as an advisor until September 2025.
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