Lyell Immunopharma has entered a definitive agreement to acquire ImmPACT Bio, a privately-owned clinical-stage biotechnology company specialising in chimeric antigen receptor (CAR)-T cell therapies.
Concurrently, the company has discontinued the development of two programmes - LYL797, its ROR1-targeted CAR-T cell product; and LYL845, a tumour-infiltrating lymphocyte (TIL) therapy. Lyell noted that clinical data for LYL845 “did not meet our rigorous pre-determined criteria for continued development”, adding that the company plans to discontinue all preclinical TIL and rejuvenation programmes.
Lyell is expected to pay $30m in cash and 37.5 million shares of Lyell common stock for the acquisition. The ImmPACT shareholders will also be in line to receive milestone-based payments of contingent consideration consisting of 12.5 million shares of Lyell common stock and a “low single-digit” royalty on future US net sales of IMPT-314.
The deal is expected to close by the end of the year. Lyell noted that it expects its cash reserves to last into 2027 after closing the acquisition.
ImmPACT’s lead therapy is IMPT-314, a bispecific CAR therapy targeting CD19 and CD20. It is being evaluated as a treatment for relapsed/refractory (r/r) aggressive B cell non-Hodgkin lymphoma in a Phase I/II trial (NCT05826535).
The company intends to present data from the trial later this year, with Lyell planning to start a pivotal trial for IMPT-314 as a third-line treatment for patients who have not yet been exposed to CAR T-cell therapy in 2025.
Lyell intends to focus all its resources on CAR-T clinical programmes. GlobalData estimates the cell and gene therapy market to be worth more than $81bn by 2029. Multiple CAR-T cell therapies have been approved in the US, the most successful of these is Gilead Sciences’ Yescarta (axicabtagene ciloleucel) generating $1.5bn in sales last year.
GlobalData is the parent company of Pharmaceutical Technology.
Lyell noted that instead of LYL797, which was being evaluated as a treatment for advanced solid tumours in a Phase I trial (NCT05274451), it will focus on another ROR1-targeted CAR-T cell therapy, LYL119. The company plans to start a Phase I trial evaluating LYL119 in patients with platinum-resistant ovarian cancer or r/r endometrial cancer this year or early next year.
Lyell had a rough start with LYL797, with the company reporting cases of pneumonitis in patients with lung metastases enrolled in a Phase I study. The initial dataset consisted of 20 patients, 16 with triple-negative breast cancer (TNBC) and four with non-small cell lung cancer (NSCLC). The company noted that the adverse event of Grade 3 or higher pneumonitis occurred only in patients with TNBC and lung metastases. As a result, Lyell modified the trial’s dosing schedule to separate dose escalation into two cohorts based on lung involvement.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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