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Immatics Initiates Phase 1/2 Clinical Trial to Evaluate PRAME TCR Bispecific IMA402 in Patients with Advanced Solid Tumors TCER IMA402 is the first next-generation, half-life extended TCR Bispecific targeti

Key Takeaway: Immatics N.V. has announced the initiation of a Phase 1/2 clinical trial for its bispecific T cell engaging receptor, IMA402, targeting patients with advanced solid tumors expressing the PRAME antigen. The trial, which will initially enroll around 45 patients, aims to determine the maximum tolerated dose and assess safety and anti-tumor activity. It intends to leverage an adaptive design to accelerate development and plans to expand further into the US market as the trial progresses. IMA402 represents a strategic effort to harness the clinical potential of PRAME in cancer therapy.

Market Sentiment Analysis

POSITIVE FACTORS

  • Initiation of Phase 1/2 trial for IMA402 is a significant milestone.
  • The drug targets a well-established cancer target (PRAME), potentially addressing a broad patient population.
  • TCER format enhances efficacy while minimizing toxicities, promising better treatment options.
  • First clinical data is expected in 2024, indicating swift progress.

Full Press Release Details

Initiates Phase 1/2 Clinical Trial to Evaluate
PRAME TCR Bispecific IMA402 in Patients with Advanced Solid Tumors
and Houston, Texas, August 10, 2023 -
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 the initiation of a Phase 1/2 clinical
trial with its proprietary Bispecific T cell engaging receptor (TCER ) IMA402. IMA402 is the second product candidate
in Immatics' TCER pipeline of next-generation, half-life extended bispecific molecules to enter clinical development.
It targets an HLA-A*02:01-presented peptide derived from PRAME, a clinically established cancer target frequently expressed in a large
variety of solid tumors.
The Phase 1/2 clinical
trial (NCT05958121) investigates TCER
IMA402 in HLA-A*02:01-positive patients with PRAME-expressing recurrent and/or refractory solid tumors. The dose escalation part
of the study is designed as a basket trial in focus indications to accelerate signal finding. Initial focus indications are cutaneous
and uveal melanoma, ovarian cancer, lung cancer, uterine cancer and synovial sarcoma, among others.
of IMA402 to our clinical pipeline is a truly exciting step and aligns with our strategic goal to harness the full potential of PRAME,
one of the most promising cancer targets in solid tumors. With our half-life extended format, we believe IMA402 has the potential to
be an attractive treatment option by enhancing efficacy, minimizing toxicities, and providing a favorable dosing regimen for cancer patients.,"
said Cedrik Britten, Chief Medical Officer at Immatics. "We are working with urgency to bring IMA402 to a broad patient population
as quickly as possible and look forward to sharing first clinical data in 2024."
of the IMA402 Phase 1/2 trial are to determine the maximum tolerated dose (MTD) and/or the recommended doses for trial extensions, as
well as to characterize safety and
IMA402. Secondary objectives are to evaluate anti-tumor activity and assess pharmacokinetics of IMA402. The Phase 1a dose escalation
will be followed by a Phase 1b dose expansion, with the plan then to initiate a Phase 2 with indication-specific cohorts and/or combination
therapies. Immatics has implemented an adaptive design for the dose escalation with the goal to accelerate the clinical development timeline
of IMA402. Pharmacokinetics data will be assessed throughout the trial and might provide an early opportunity for adjustment of the treatment
interval based on the half-life extended TCER format. The trial is initially planned to be conducted at approximately
15 sites in Europe, with extension into the US at dose expansion stage. The Phase 1a is designed to enroll approximately 45 patients.
The trial initiation
is based on the comprehensive preclinical studies with IMA402 presented at the European Society
for Medical Oncology (ESMO) Congress 2022.
IMA402 is the second Immatics clinical program targeting PRAME, with the first being ACTengine IMA203, a TCR-T cell therapy
that is currently in Phase 1b dose expansion - see recent data release. Both approaches,
ACTengine and TCER , are distinct therapeutic modalities that we believe have the potential to provide
innovative treatment options for a variety of cancer patient populations with different medical needs.
IMA402 is a drug candidate owned by Immatics. IMA402 is Immatics' second TCER molecule from the bispecifics pipeline
and is directed against an HLA-A*02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently
expressed in a large variety of solid cancers, thereby supporting the program's potential to address a broad cancer patient population.
Immatics' PRAME peptide is present at a high copy number per tumor cell and is homogenously and specifically expressed in tumor
tissue. The peptide has been identified and characterized by Immatics' proprietary mass spectrometry-based target discovery platform,
XPRESIDENT . 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.
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.
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.
to use its website www.immatics.com as a means of disclosing material non-public information.
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
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 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. 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.
more information, please contact:
Media and Investor Relations Contact
Eva Mulder or Charlotte Spitz
Trophic Communications
Phone: +31 6 52 33 15 79
immatics@trophic.eu
Immatics N.V.
Anja Heuer Jordan Silverstein
Senior Director Corporate Communications Head of Strategy
Phone: +49 89 540415-606 Phone: +1 281 810 7545
media@immatics.com InvestorRelations@immatics.com

Frequently Asked Questions

What is IMA402 and its purpose?

IMA402 is a bispecific T cell engaging receptor targeting PRAME in cancer therapy.

What is the focus of the Phase 1/2 trial?

The trial aims to evaluate IMA402's safety and maximum tolerated dose in cancer patients.

When are initial clinical data expected?

The first clinical data for IMA402 is anticipated to be shared in 2024.

What types of cancer are being targeted?

The trial focuses on melanoma, ovarian, lung, uterine cancers, and more.

How many patients will the trial enroll?

The trial is designed to enroll approximately 45 patients initially.

Last updated: Aug 10, 2023