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Tuebingen, Germany and Houston, Texas, September 10, 2022 – Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced a comprehensive preclinical data set for its T cell engaging receptor (TCER®) product candidate IMA402 at the European Society for Medical Oncology (ESMO) Congress 2022 held in Paris, France, from September 9 to 13, 2022. IMA402 is the company’s second program in its TCR Bispecifics pipeline and is directed against an HLA-A*02:01-presented peptide derived from PRAME, a cancer target broadly expressed in many solid tumors. The data are available as an ePoster on the ESMO platform at 9 AM on Saturday, September 10, and will be presented during the poster session from noon to 1 PM CEST on Monday, September 12.
Immatics TCER® molecules are "off-the-shelf" TCR Bispecifics engineered with two binding regions: a TCR domain and a T cell recruiter domain.
1) Clinical Trial Application (CTA) is the equivalent of an Investigational New Drug (IND) application in Europe
Data Highlights:
TCER® format is optimized for efficacy and safety
Compelling preclinical data
Clinical trial evaluating IMA402 in patients with solid tumors to start in 2023
“Improving drug safety, efficacy and dosing schedule are key considerations in the field of bispecific T cell engaging molecules. The promising preclinical results for our next-generation, half-life extended TCER® IMA402 reflect the potential of our TCR Bispecific approach for patients with solid tumors,” commented Carsten Reinhardt, M.D., Ph.D., Chief Development Officer at Immatics. “We look forward to initiating the IMA402 Phase 1/2 clinical trial in 2023 as part of our strategy to tackle PRAME with two distinct therapeutic modalities. We believe PRAME is the most promising, clinically validated T cell target for solid cancers to date and with our cell therapy and bispecific approaches, we are well positioned to provide innovative treatment options for a variety of cancer patient populations with different medical needs.”
To enable the start of the Phase 1/2 trial in 2023, Immatics has completed the manufacturing process development for IMA402 and manufacturing of the clinical batch is on track for 2H 2022. The Phase 1 part of the trial will start with a minimal anticipated biological effect level (MABEL) dose of IMA402 and will have an adaptive design aimed at accelerating dose escalation to determine the recommended Phase 2 dose (RP2D). HLA-A*02:01-positive patients with different solid tumors expressing PRAME will initially receive weekly infusions of IMA402. Pharmacokinetics data will be assessed throughout the trial and might provide an opportunity to adapt the treatment interval. The Phase 2a dose expansion part of the trial will be designed to comprise several cohorts to further evaluate IMA402 in specific indications and combination therapies. Submission of the IND1 application is planned for Q2 2023.
The ESMO Congress 2022 poster presentation is available on Immatics’ website using this link.
About TCER®
Immatics’ half-life extended TCER® molecules are next-generation, 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 of specialized medical centers.
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About Immatics
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.
For regular updates about Immatics, visit www.immatics.com. You can also follow us on Instagram, Twitter and LinkedIn.
Forward-Looking Statements:
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or Immatics’ future financial or operating performance. For example, statements concerning the timing of product candidates and Immatics’ focus on partnerships to advance its strategy are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “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 filings with the SEC. Nothing in this presentation 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. Immatics 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 and Investor Relations Contact |
| Jacob Verghese or Eva Mulder |
| Trophic Communications |
| Phone: +49 89 2070 89831 or +31 6 52 33 1579 |
| immatics@trophic.eu |
| Immatics N.V. | |
| Anja Heuer | Jordan Silverstein |
| Director, Corporate Communications | Head of Strategy |
| Phone: +49 89 540415-606 | Phone: +1 281 810 7545 |
| media@immatics.com | InvestorRelations@immatics.com |
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