As favor in the general market swings away from cell therapy, Immatics’ CEO is choosing to focus on what he can control: raising the bar for his biotech’s investigational treatment.
“I at least partially understand the sentiment—some of that skepticism has been founded on business models in cell therapy that are difficult in their commercial viability,” Immatics CEO Harpreet Singh, Ph.D., said about general industry pullback over the last year or so.
“Cell therapy is different. We make these patients jump through a hoop that is different than just delivering a biologic,” he told Fierce Biotech in an interview on the sidelines of the 2025 American Society of Clinical Oncology annual meeting in Chicago.
In turn, Immatics' CEO believes it is his responsibility to make sure that hoop is worth making the leap for.
“We have to make sure that that hoop is as big as possible so it's [an] easy jump for the physician and the patient, and we have to make sure that the extent of the benefit—and also the relationship with benefit and risk—is so overwhelmingly good that this actually compensates the cost of therapy.”
To ensure this, the CEO is setting high internal bars for efficacy, safety and accessibility.
Immatics’ first standard is a self-set 40% response rate in an advanced refractory setting, give or take a few degrees depending on the tumor type, according to Singh.
“A lot of therapies that are in these settings do not meet that bar that we have set ourselves, but that was important for us … because that really also justifies the expense,” he explained.
Immatics’ most advanced program, IMA203, is a preferentially expressed antigen in melanoma (PRAME) cell therapy. Earlier this week, the biotech shared phase 1b data linking the one-time infusion to a 56% objective response rate among 32 heavily pretreated patients with metastatic melanoma.
The biotech has moved the cell therapy into a phase 3 trial, dubbed SUPRAME, that is testing IMA203 against an investigator’s choice of treatment in 360 patients who have previously received a checkpoint inhibitor treatment. Immatics expects to have interim data from the study in the beginning of next year.
Beyond efficacy, Immatics has focused on reducing patient burden and cutting down on certain costs by not involving tumor surgery or a high-dose IL-2 treatment as part of the regimen.
The CEO also said IMA203 takes about seven days to manufacture and seven to release, equating to a turnaround time of about 14 or 15 days. The cell therapy’s safety profile may also allow it to be administered in an outpatient setting, according to Singh.
According to phase 1 safety data from 74 patients, the most common treatment-emergent adverse events tied to IMA203 were cytopenias associated with lymphodepletion, a preparation step before infusion. Cases of cytokine release syndrome (CRS), an adverse event often tied to cell therapies, were mostly mild or moderate, with 37% of patients experiencing grade 1 CRS and 47% with a grade 2 event.
These factors—plus lessons from the first FDA approval of a cell therapy for solid tumors in 2024—are allowing Immatics to “pull all the right levers to make sure that we have the best efficacy, the best efficacy, best safety and the lowest cost of goods,” Singh said.
The biotech is planning for a potential commercial launch tied to SUPRAME in the third quarter of 2027, a market debut Immatics intends to fund without a partner’s help. At this point in time, Immatics has “no interest” in out-licensing its PRAME programs, Singh said.
“It's not always easy for a biotech company to commercialize drugs to the maximum extent possible,” the CEO explained. “However, cell therapy is a little different.”
The specialized nature of cell therapy—how it is delivered and the types of patients it is delivered to—actually behooves biotechs with built-in infrastructure, compared to bigger pharmas that may not possess all the resources cell therapy requires.
“At this point, the market entry is something we think we can do on our own,” Singh said.
Singh is choosing to focus on those levers he has control over versus the general market sentiment around cell therapy, especially given the immense highs and lows of the last five years.
Back in 2020, there were preclinical-stage cell therapy companies that had multibillion-dollar market caps. Now, clinical-stage cell therapy companies with “unprecedented data in late settings” are met with skepticism, he said.
“I would describe both of these states as extremes,” Singh said. “So, we should be cautious not to take that too seriously when the pendulum is at one of these extreme ends.”
When asked about recent structural changes at the FDA, the CEO said Immatics’ interactions with the regulatory agency haven’t changed.
“We have been in touch with the FDA for many years and the people that we interact with remain there and they are responsive,” he said, adding that the biotech’s SUPRAME trial design “will resonate with any type of FDA leadership.”
“I think the new leadership is very pragmatic and knowledgeable to understand what needs to be delivered to cancer patients,” Singh said.
He pointed to the FDA listening tour with six stops across the nation designed to gather input from biotech and pharma leaders as an example of that pragmatism.
June 5, U.S. healthcare officials held a cell and gene therapy roundtable asking industry players what they would like to see—plus which regulations they would like to be done away with.
“We're going to rely on you to come up with the solutions,” Department of Health and Human Services Secretary Robert F. Kennedy Jr. told the panelists. “And we're going to do everything in our power to sweep away the barriers from you getting those solutions to market and getting them funded, and do everything that we can to support you.”