Skip to main content

Immatics N.V.

For the period ended Jun 1, 2026. Filed Jun 1, 2026.

View on SEC.gov

About this filing

What a company based outside the US has published at home or sent to its shareholders. It is how many foreign companies share results and news between annual reports.

Jun 1, 2026 · Filed Jun 1, 2026

Use the contents to explore the available documents and sections.

IMTX$6.36+2.9%Stored close · as of Nov 6, 2026
See the whole filing, with its images and exhibits
Contents

IMA401 Data Release

On May 31, 2026, the Company announced extended data from the ongoing Phase 1 clinical trial evaluating its TCR bispecific (TCER®) candidate IMA401 targeting MAGEA4/8 in heavily pretreated patients with solid tumors, including head and neck cancer and lung cancer.

Patient Population. As of the March 2, 2026 data cutoff, 61 heavily pretreated patients with recurrent and/or refractory solid tumors across more than 15 different tumor types were treated with IMA401 with or without pembrolizumab, an immune checkpoint inhibitor (“ICI”). Patients had a median of three prior lines of systemic therapy (range: 1 – 8). 44 patients were treated at RP2D (1 – 2 mg), with 32 receiving monotherapy and 12 receiving the combination of IMA401 and pembrolizumab. Among these patients, head and neck cancer represented the largest subgroup treated at RP2D (n=14).

Safety Data. IMA401 demonstrated manageable tolerability. The tolerability profile of IMA401 with or without pembrolizumab was consistent across patient populations. The most frequent treatment-related adverse events (“TRAEs”) were expected and manageable CRS and transient lymphopenia, consistent with the mechanism of action, as well as neutropenia, mostly transient and manageable. No patient experienced ICANS. Five DLTs occurred (which were manageable in four cases) but no DLTs occurred at RP2D with dexamethasone premedication, and the MTD was not reached. Tolerability of IMA401 at RP2D in combination with pembrolizumab was consistent with IMA401 as a monotherapy at RP2D, with no overlapping and/or additive toxicity observed. At RP2D, tolerability was observed to be favorable, supporting broad combinability of IMA401. The following table shows TRAEs for IMA401 as monotherapy and IMA401 at RP2D with and without pembrolizumab:

a All TRAEs at least possibly related to IMA401 infusion and/or pembrolizumab infusion with grade 1-2 occurring in at least 10% of all patients, all events with ≥ Grade 3; bin patients with and without dexamethasone pre-medication; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyltransferase.

a All TRAEs at least possibly related to IMA401 infusion and/or pembrolizumab infusion with grade 1-2 occurring in at least 10% of all patients, all events with ≥ grade 3 and typical ICI-associated toxicities; b IMA401 dose in pembrolizumab expansion cohorts were 1 mg (n=8) or 1.5 mg (n=4).

Anti-Tumor Activity. Patients treated with IMA401 at RP2D as a monotherapy or in combination with pembrolizumab demonstrated clinical activity across multiple solid tumor indications, including melanoma, sqNSCLC, head and neck cancer and others:

·For head and neck cancer patients (largest patient subgroup treated at RP2D), cORR was 29% (4/14), DCR was 64% (9/14) and mDOR was 8.8 months. The 12-month overall survival (“OS”) rate was 63% and the six-month progression-free survival (“PFS”) rate was 43%. All responders achieved deep tumor reduction ranging from 60% – 100% and three of four responders were ongoing at data cutoff.
·For melanoma patients: cORR was 33% (2/6) and DCR was 67% (4/6). Both confirmed responses lasted beyond six months post treatment, with one ongoing for >2.5 years.
·A patient case highlighted a patient with ICI-resistant sqNSCLC who received IMA401 plus pembrolizumab in fifth-line (prior best overall response: stable disease) and achieved a partial response with shrinkage of all target lesions.

a Two patients not shown in plot due to clinical progression before post-infusion scan. b One patient not shown in plot due to clinical progression before post-infusion scan. BL, Baseline; BOR, Best overall response; (c)PR, (confirmed) partial response; H&N, head and neck cancer; PD, progressive disease; RECIST, response evaluation criteria in solid tumors; SD, stable disease.

Preclinical Data. Target expression data from analyzed tumor samples showed that > 90% of patients with sqNSCLC are positive for PRAME and/or MAGEA4/8, and ~60% of patients with sqNSCLC are positive for both

targets, suggesting that a combination therapy against both targets could boost anti-tumor activity and counteract potential tumor escape mechanisms. IMA401/IMA402 combination demonstrated synergistic anti-tumor activity in MAGEA4/8 and PRAME double-positive tumor cell lines.

ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.