Cell Therapy Developments: Immatics CEO Sets High Bar Amid Market Skepticism

In a landscape where investor sentiment towards cell therapy is shifting, Immatics CEO Harpreet Singh, Ph.D., is focusing on raising the bar for the company's investigational treatments. Speaking at the 2025 American Society of Clinical Oncology (ASCO) annual meeting, Singh addressed the challenges and opportunities in the cell therapy sector, emphasizing the need for compelling efficacy and improved accessibility to justify the costs and complexities associated with these treatments.

Immatics' Approach to Cell Therapy

Immatics has set ambitious internal standards for its cell therapy programs, aiming for a 40% response rate in advanced refractory settings. The company's most advanced program, IMA203, a preferentially expressed antigen in melanoma (PRAME) cell therapy, has shown promising results in recent clinical trials. In a phase 1b study, IMA203 demonstrated a 56% objective response rate among 32 heavily pretreated patients with metastatic melanoma.

Building on these results, Immatics has initiated the SUPRAME phase 3 trial, comparing IMA203 to investigator's choice of treatment in 360 patients who have previously received checkpoint inhibitor therapy. The company expects to report interim data from this study in early 2026.

Addressing Challenges in Cell Therapy Development

Singh highlighted several key areas where Immatics is working to improve the viability of cell therapy:

1. Manufacturing Efficiency: IMA203 has a relatively short manufacturing time of about 14-15 days, potentially reducing costs and improving accessibility.

2. Safety Profile: Phase 1 data from 74 patients showed manageable safety outcomes, with most cytokine release syndrome (CRS) cases being mild to moderate.

3. Patient Burden: The company is focusing on reducing patient burden by avoiding tumor surgery and high-dose IL-2 treatment as part of the regimen.

4. Outpatient Administration: The safety profile of IMA203 may allow for outpatient administration, further improving accessibility and potentially reducing costs.

Regulatory Landscape and Industry Collaboration

Despite recent structural changes at the FDA, Singh reported that Immatics' interactions with the regulatory agency have remained consistent. He expressed confidence in the pragmatism of the new FDA leadership and their understanding of the needs of cancer patients.

The pharmaceutical industry is also seeing increased collaboration between regulators and companies. A recent cell and gene therapy roundtable, attended by U.S. healthcare officials including Secretary of Health and Human Services Robert F. Kennedy, Jr., sought input from industry leaders on regulatory improvements and barriers to innovation.

As the cell therapy field continues to evolve, companies like Immatics are working to address the challenges of efficacy, safety, and commercial viability. With promising clinical data and a focus on improving patient outcomes, the sector may yet overcome current market skepticism and deliver on the potential of these innovative treatments.