Immatics disclosed that its next‑generation TCR bispecifics, IMA402 targeting PRAME and IMA401 targeting MAGEA4/8, have achieved clinical proof‑of‑concept in Phase 1a trials. In 80 heavily pre‑treated patients treated with IMA402 across dose levels of 0.02 mg to 30 mg, the program recorded a 30 % confirmed objective response rate (cORR), including a 29 % response in melanoma and two confirmed responses in ovarian carcinoma. IMA401, administered to 55 patients at doses ranging from 0.0066 mg to 2.5 mg, achieved a 25 % cORR in head‑and‑neck cancer and a 29 % response in melanoma. Both programs reported favorable tolerability, with low‑grade cytokine release syndrome and transient lymphopenia.
The deep, durable responses observed in heavily pre‑treated patients validate Immatics’ TCER® platform and demonstrate that redirecting T cells to tumor‑specific antigens can produce meaningful clinical benefit even in late‑line settings. The data suggest that the bispecifics can engage tumor cells across multiple solid‑tumor types, reinforcing the company’s strategy to target a broad PRAME franchise and expanding the therapeutic scope of its TCR‑based technology.
Chief Development Officer Carsten Reinhardt emphasized that the results “confirm the clinical potential of our TCR bispecifics and provide a strong foundation for accelerated development.” He noted that the early efficacy signals, coupled with the manageable safety profile, position the programs for rapid progression into larger, more definitive studies.
Immatics plans to advance both candidates into Phase 1b dose‑expansion cohorts at the provisional recommended phase 2 dose ranges, with the goal of confirming safety and efficacy in a broader patient population. Combination studies with checkpoint inhibitors are slated to evaluate synergistic activity, while a separate expansion into squamous non‑small‑cell lung cancer will test the bispecifics in a high‑prevalence tumor type. These next steps are designed to broaden the clinical evaluation and accelerate the company’s pipeline toward regulatory approval.
The milestone strengthens Immatics’ competitive positioning in the emerging TCR‑based therapy space, where few companies have demonstrated clinical proof‑of‑concept in solid tumors. By validating its platform in multiple tumor types, Immatics can attract additional partnerships and potentially secure a foothold in markets that currently lack effective targeted immunotherapies. The data also provide a compelling narrative for investors and stakeholders, highlighting the company’s ability to translate its proprietary technology into tangible clinical outcomes.
No specific market reaction data are available at this time, and the company has not issued guidance on financial metrics related to the trial results.
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