Immatics N.V. disclosed that its second‑generation PRAME‑targeted T‑cell therapy, IMA203CD8, produced encouraging early results in a Phase 1a dose‑escalation study presented at the ESMO Immuno‑Oncology Congress in London, UK. The study enrolled 78 heavily pre‑treated patients with advanced solid tumors expressing PRAME, including melanoma, ovarian carcinoma, and synovial sarcoma, and evaluated seven escalating dose levels up to 12.5 × 10⁹ TCR T cells.
Safety data were favorable. Lymphopenia from lymphodepletion and low‑grade cytokine release syndrome (CRS) were the most common treatment‑emergent adverse events, with CRS occurring in 35 % of patients as Grade 1, 50 % as Grade 2, 9 % as Grade 3, and 1 % as Grade 4. No Grade 5 events or immune‑effector cell–associated neurotoxicity were reported, underscoring the manageable toxicity profile of the platform.
Efficacy signals were notable. Among 69 evaluable patients, 21 achieved confirmed objective responses, 18 of which were durable for at least one year. In the ovarian carcinoma cohort of 11 patients, two confirmed partial responses were observed, one of which remains an ongoing metabolic complete response at the highest dose level of 7.1 × 10⁹ TCR T cells. These results represent a meaningful improvement over the first‑generation IMA203 data, which reported a 46 % objective response rate in 69 evaluable patients, and suggest that the second‑generation platform may enhance both potency and durability across multiple tumor types.
Chief Medical Officer Cedrik Britten emphasized that the data validate Immatics’ strategy to expand the PRAME franchise beyond melanoma. “The early signals from IMA203CD8 confirm the tumor‑agnostic potential of our platform and reinforce our confidence that we can deliver meaningful benefit to patients with advanced PRAME‑positive cancers,” Britten said. The company’s robust cash position of $505.8 million as of Q3 2025 provides the runway to advance IMA203CD8 into pivotal trials and to continue developing complementary PRAME‑targeted modalities, including bispecifics and first‑generation cell therapies.
The clinical data reinforce Immatics’ position as a leader in PRAME‑targeted immunotherapy and open a pathway to treat a broader spectrum of solid tumors. The safety profile, coupled with durable responses in heavily pre‑treated patients, positions IMA203CD8 as a strong candidate for accelerated development and potential regulatory approval in the coming years.
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