Lyell fully commits to CAR-T, acquires ImmPACT Bio, and streamlines pipeline

Lyell Immunopharma has formalized an agreement to acquire ImmPACT Bio, a clinical-stage biotechnology firm known for its work in chimeric antigen receptor (CAR)-T cell therapies. This acquisition is significant for Lyell, as it plans to concentrate all its efforts on CAR-T cell clinical programs. This strategic move includes focusing on key candidates, LYL119 and ImmPACT's IMPT-314.

Simultaneously, Lyell has decided to halt the development of two of its existing programs: LYL797, a CAR-T cell product targeting ROR1, and LYL845, a tumor-infiltrating lymphocyte (TIL) therapy. The decision to discontinue LYL845 was based on clinical data that did not meet the company's stringent criteria for further development. As a result, Lyell will also terminate all preclinical TIL and rejuvenation programs.

The acquisition deal involves a payment of $30 million in cash and 37.5 million shares of Lyell common stock to ImmPACT Bio shareholders. Additionally, ImmPACT shareholders stand to receive milestone-based payments that include 12.5 million shares of Lyell common stock and a low single-digit royalty on future US net sales of IMPT-314. The acquisition is anticipated to be finalized by the end of the year, and Lyell projects that its cash reserves will extend into 2027 post-transaction.

ImmPACT Bio's leading therapy, IMPT-314, is a bispecific CAR therapy that targets CD19 and CD20. This therapy is presently being evaluated in a Phase I/II trial for patients with relapsed/refractory aggressive B cell non-Hodgkin lymphoma. Lyell plans to present the trial data later this year and aims to commence a pivotal trial for IMPT-314 as a third-line treatment for patients unexposed to CAR-T cell therapy by 2025.

By focusing solely on CAR-T clinical programs, Lyell is looking to align itself with the growing cell and gene therapy market, which is estimated to reach over $81 billion by 2029. Numerous CAR-T cell therapies have already received approval in the United States, with Gilead Sciences' Yescarta (axicabtagene ciloleucel) being particularly successful, generating $1.5 billion in sales last year.

In light of the acquisition, Lyell has also shifted its focus from LYL797 to another ROR1-targeted CAR-T cell therapy, LYL119. LYL797 was being tested in a Phase I trial for advanced solid tumors, but the trial encountered issues, including cases of pneumonitis in patients with lung metastases. The initial patient data indicated that Grade 3 or higher pneumonitis was observed in patients with triple-negative breast cancer (TNBC) and lung metastases. Consequently, Lyell adjusted the trial's dosing schedule to segregate dose escalation based on lung involvement.

Looking ahead, Lyell intends to initiate a Phase I trial for LYL119 in patients with platinum-resistant ovarian cancer or relapsed/refractory endometrial cancer either later this year or early next year. This move showcases Lyell's commitment to advancing its CAR-T cell therapy pipeline while adapting to the challenges faced in earlier trials.

In summary, Lyell's acquisition of ImmPACT Bio and the subsequent strategic refocusing on CAR-T programs are poised to strengthen its position in the burgeoning cell and gene therapy market. With lead candidates LYL119 and IMPT-314, Lyell is setting the stage for future advancements in the treatment of various cancers, marking a significant step forward in its clinical development efforts.