Lyell Immunopharma to Acquire ImmPACT Bio and Focus on Next-Gen CAR T-cell Therapies

Lyell Immunopharma, Inc. has announced a definitive agreement to acquire ImmPACT Bio USA Inc., a clinical-stage biotechnology company. This acquisition is set to enhance Lyell’s clinical pipeline, particularly with the addition of ImmPACT's lead program, IMPT-314. IMPT-314 is a dual-targeting CAR T-cell product candidate that targets CD19 and CD20 for the treatment of hematologic malignancies, including large B-cell lymphoma. This dual-targeting approach aims to improve the efficacy and persistence of CAR T-cell therapies.

According to Lyell's CEO, Dr. Lynn Seely, the acquisition aligns with the company's vision of providing durable clinical benefits to cancer patients through next-generation cell therapies. The ongoing Phase 1-2 trial data of IMPT-314 indicates the product's potential to deliver better complete response rates and duration of response compared to existing CD19 CAR T-cell therapies for patients with aggressive B-cell lymphoma who have not previously undergone CAR T-cell therapy. The initial data from this trial is expected to be presented at a major medical conference this year, with a pivotal trial slated to start in 2025.

ImmPACT’s CEO, Dr. Sumant Ramachandra, expressed pride in his team's achievements and confidence in Lyell's capability to further develop IMPT-314. This product candidate was initially licensed from UCLA and has shown promising results in early clinical trials, achieving a 92% objective response rate and a 77% complete response rate among patients with relapsed/refractory aggressive non-Hodgkin lymphoma.

The ongoing Phase 1-2 trial by ImmPACT is evaluating the safety and efficacy of IMPT-314 in patients with relapsed/refractory aggressive B-cell lymphoma. Preliminary data show encouraging results, with plans to present detailed findings at a medical conference later this year. The U.S. FDA has granted Fast Track Designation to IMPT-314 for the treatment of these conditions.

Following the acquisition, Lyell plans to focus on its most advanced CAR T-cell programs, including IMPT-314 and LYL119. LYL119 incorporates enhanced anti-exhaustion technology and has demonstrated promising preclinical results, particularly in non-small cell lung cancer models. Lyell will discontinue the development of other programs, such as LYL797, LYL845, and earlier-stage TIL programs, in order to concentrate resources on these key therapies.

Financially, the transaction includes an upfront payment of $30 million in cash and 37.5 million shares of Lyell common stock, with additional contingent considerations based on future clinical milestones and royalties on net sales. The agreement has received unanimous approval from the boards of both companies and is expected to close by the fourth quarter of 2024, pending regulatory approvals and customary closing conditions.

This strategic move is expected to extend Lyell's cash runway into 2027, supporting the achievement of significant clinical milestones, including the initiation of a pivotal trial for IMPT-314 in 2025. Post-acquisition, Lyell will gain worldwide rights to ImmPACT’s pipeline, reinforcing its commitment to advancing innovative CAR T-cell therapies for cancer and autoimmune diseases.

The acquisition reflects Lyell's ongoing dedication to developing cutting-edge treatments that offer lasting clinical benefits for patients with challenging malignancies. By integrating ImmPACT's promising technologies, Lyell aims to enhance its capabilities in the field of next-generation CAR T-cell therapies.