Lyell Immunopharma, a leading biotechnology company, has made a strategic move to bolster its position in the rapidly growing cell and gene therapy market. The company has announced a definitive agreement to acquire ImmPACT Bio, a privately-owned clinical-stage biotechnology company specializing in chimeric antigen receptor (CAR)-T cell therapies. This acquisition aligns with Lyell's focus on advancing its CAR-T clinical programs, with LYL119 and ImmPACT's IMPT-314 being the lead candidates.

Unlocking the Potential of CAR-T Therapies

Doubling Down on CAR-T Therapies

Lyell's decision to acquire ImmPACT Bio and discontinue the development of its ROR1-targeted CAR-T product, LYL797, and its tumor-infiltrating lymphocyte (TIL) therapy, LYL845, reflects the company's strategic shift towards prioritizing its CAR-T clinical programs. This move is driven by the growing market potential of CAR-T therapies, which GlobalData estimates to be worth more than billion by 2029.The acquisition of ImmPACT Bio brings Lyell's lead therapy, IMPT-314, a bispecific CAR therapy targeting CD19 and CD20, which is currently being evaluated in a Phase I/II trial for the treatment of relapsed/refractory (r/r) aggressive B cell non-Hodgkin lymphoma. Lyell plans 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, further solidifying its commitment to this promising therapeutic approach.

Navigating Challenges and Optimizing Therapies

Lyell's initial experience with LYL797 was not without its challenges. The company reported cases of pneumonitis in patients with lung metastases enrolled in a Phase I study, leading to modifications in the trial's dosing schedule to separate dose escalation into two cohorts based on lung involvement. This setback highlights the importance of careful patient selection and dose optimization in the development of CAR-T therapies, particularly for solid tumors.By focusing its resources on the more promising LYL119, a ROR1-targeted CAR-T therapy, Lyell demonstrates its ability to learn from past experiences and adapt its strategy to maximize the potential of its pipeline. 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, further diversifying its CAR-T portfolio.

Strengthening the Pipeline through Acquisition

The acquisition of ImmPACT Bio not only adds IMPT-314 to Lyell's pipeline but also aligns with the company's commitment to advancing its CAR-T clinical programs. By integrating ImmPACT's expertise and resources, Lyell aims to accelerate the development and commercialization of these promising therapies.The deal terms, which include a million cash payment and the issuance of 37.5 million shares of Lyell common stock, as well as potential milestone-based payments, demonstrate Lyell's confidence in the value of ImmPACT's assets and the strategic importance of this acquisition. The company's expectation that its cash reserves will last into 2027 after the acquisition further underscores its financial stability and ability to support the continued development of its CAR-T pipeline.

Capitalizing on the Momentum in Cell and Gene Therapies

Lyell's focus on CAR-T therapies aligns with the broader trends in the cell and gene therapy market. Multiple CAR-T cell therapies have already been approved in the US, with Gilead Sciences' Yescarta (axicabtagene ciloleucel) generating .5 billion in sales last year, highlighting the commercial potential of these innovative treatments.By doubling down on its CAR-T clinical programs and leveraging the expertise and assets of ImmPACT Bio, Lyell positions itself to capitalize on the growing demand for effective cell and gene therapies. This strategic move underscores the company's commitment to advancing the field and delivering transformative treatments to patients in need.