Immatics Achieves Clinical Proof-of-Concept of its Next-Generation TCR Bispecific (TCER®) Pipeline with Data on IMA402 (PRAME) and IMA401 (MAGEA4/8) and Announces Next Development Steps
Immatics Achieves Clinical Proof-of-Concept of its Next-Generation TCR Bispecific (TCER®) Pipeline with Data on IMA402 (PRAME) and IMA401 (MAGEA4/8) and Announces Next Development Steps
- IMA402 and IMA401 TCR Bispecifics showed favorable tolerability at RP2D as well as deep and durable responses in heavily pre-treated, last-line patients with a range of solid tumors
- IMA402 PRAME Bispecific at RP2D range resulted in a 30% cORR (6/20) across all indications, including 29% (4/14) in melanoma and 2/3 confirmed responses in ovarian carcinoma
- IMA401 MAGEA4/8 Bispecific at ≥1 mg resulted in a 25% cORR (2/8) in head and neck cancer, 29% cORR (2/7) in melanoma and promising clinical activity in sqNSCLC
- Phase 1a dose escalation completed for both trials; data support IMA402 PRAME Bispecific development opportunities in cutaneous melanoma, gynecologic cancers and in combination with IMA401 MAGEA4/8 Bispecific in sqNSCLC
- Phase 1b dose expansion for IMA402 initiated
Houston, Texas and Tuebingen, Germany, November 12, 2025 – Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, today announced updated Phase 1a dose escalation data from both product candidates in its TCR Bispecifics (TCER®) pipeline, IMA402 PRAME Bispecific and IMA401 MAGEA4/8 Bispecific, as well as next steps for clinical development.
“Our off-the-shelf TCR Bispecifics have a proprietary next-generation format with half-life extension that is designed to combine optimized tolerability and potent anti-tumor activity while supporting patient-convenient dosing,” said Carsten Reinhardt, M.D., Ph.D., Chief Development Officer at Immatics. “We have now achieved clinical proof-of-concept for both product candidates and seen their potential to make a meaningful impact on patients with limited treatment options through deep and durable responses. We look forward to continuing to drive the development of our bispecifics to advance accessible, innovative therapies that can reach more patients and make a lasting difference in cancer care.”
“Today marks the beginning of a new phase for Immatics, expanding our reach beyond cell therapy and establishing a leading position in the TCR Bispecifics field, with a clear commitment to advancing the clinical development of our bispecifics pipeline,” said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. “Building on these data, we are excited to evaluate our IMA402 PRAME Bispecific now across multiple targeted cancer patient populations with significant unmet treatment needs and in potentially synergistic combinations. We are especially enthusiastic about the potential for profound benefit by combining IMA402 with IMA401, our MAGEA4/8 Bispecific, in patients with squamous non-small cell lung cancer, a large, highly underserved and difficult-to-treat indication.”
Carsten Reinhardt, M.D., Ph.D., and Harpreet Singh, Ph.D., will present the complete TCR Bispecifics dataset and next development steps during a conference call and webcast today, November 12, at 8:30 am EST/2:30 pm CET. The presentation is accessible on the ‘Events & Presentations’ page on the Investors & Media section of the Company’s website.
For detailed information, please visit: https://investors.immatics.com/news-releases/news-release-details/immatics-achieves-clinical-proof-concept-its-next-generation-tcr
About Immatics TCR Bispecifics (TCER®)
Immatics’ next-generation half-life extended TCER® molecules are antibody-like “off-the-shelf” biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. The design of the TCER® molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. Immatics’ proprietary biologics are engineered with two binding regions: a TCR domain and a T cell recruiter domain. The TCER® format is designed to maximize efficacy while minimizing toxicities in patients. It contains a high-affinity TCR domain that is designed to bind specifically to the cancer target peptide on the cell surface presented by an HLA molecule. The antibody-derived, low-affinity T cell recruiter domain is directed against the TCR/CD3 complex and recruits a patient’s T cells to the tumor to attack the cancer cells. With a low-affinity recruiter aiming for optimized biodistribution and enrichment of the molecule at the tumor site instead of the periphery, TCER® are engineered to reduce the occurrence of immune-related adverse events, such as cytokine release syndrome. In addition, the TCER® format consists of an Fc-part conferring half-life extension, stability, and manufacturability. TCER® are “off-the-shelf” biologics and thus immediately available for patient treatment. They can be distributed through standard pharmaceutical supply chains and provide the opportunity to reach a large patient population without the need for specialized medical centers.
About PRAME
PRAME is a target expressed in more than 50 cancers. Immatics is the global leader in precision targeting of PRAME and has the broadest PRAME franchise with the most PRAME indications and modalities. The Immatics PRAME franchise currently includes three product candidates, two therapeutic modalities and a combination therapy that target PRAME: anzu-cel (IMA203) PRAME cell therapy, IMA203CD8 PRAME cell therapy (GEN2), IMA402 PRAME bispecific, anzu-cel in combination with Moderna’s PRAME cell therapy enhancer.
About IMA402 PRAME Bispecific
IMA402 is a molecule from Immatics’ TCR Bispecifics (TCER®) pipeline directed against an HLA-A*02:01-presented peptide derived from PRAME
IMA402 is currently being evaluated in a Phase 1 trial in patients with solid tumors expressing PRAME. IMA402 is part of Immatics’ strategy to leverage the full clinical potential of targeting PRAME, one of the most promising targets for TCR-based therapies.
About IMA401 MAGEA4/8 Bispecific
IMA401 is a molecule from Immatics’ TCR Bispecifics pipeline that targets an HLA-A*02:01-presented peptide derived from two different cancer-associated proteins, melanoma-associated antigen 4 and/or 8 (“MAGEA4/8”). The MAGEA4/8 peptide has been identified and validated by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT® and is presented at a 5-fold higher target density (copy number per tumor cell) than the MAGEA4 peptide targeted in other clinical trials.
IMA401 is currently being evaluated in a Phase 1 basket trial in patients with MAGEA4/8-positive solid tumors. The MAGEA4/8 peptide has a high prevalence in several solid tumor indications such as head and neck squamous cell carcinoma (HNSCC), squamous cell non-small cell lung cancer (sqNSCLC), as well as melanoma and other solid cancer types.
About Immatics
Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics.
Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates, you can also follow us on LinkedIn and Instagram.
Forward-Looking Statements
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or the Company’s future financial or operating performance. For example, statements concerning timing of data read-outs for product candidates, observations from the Company’s clinical trials, the timing, outcome and design of clinical trials, the nature of clinical trials (including whether such clinical trials will be registration-enabling), the timing of IND, CTA or BLA filings, estimated market opportunities of product candidates, the Company’s focus on partnerships to advance its strategy, and other metrics are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “plan”, “target”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions and other risks, uncertainties and factors set forth in the Company’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission (SEC). Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification.
For more information, please contact:
Media
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Immatics N.V.
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