Immatics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for ACTengine® IMA203 TCR-T Monotherapy
October 24 2023 - 7:00AM
Immatics Receives FDA Regenerative Medicine Advanced Therapy (RMAT)
Designation for ACTengine® IMA203 TCR-T Monotherapy
- RMAT designation granted by FDA CBER for IMA203 cell therapy in
multiple PRAME-expressing tumors including cutaneous and uveal
melanoma, ovarian cancer and other cancer types
- Regulatory activities underway with an initial focus on a
registration-directed trial in melanoma as step one to leverage the
full breadth of PRAME
Houston, Texas and
Tuebingen, Germany, October 24, 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 that
its IMA203 TCR-T program has received Regenerative Medicine
Advanced Therapy (RMAT) designation from the FDA Center for
Biologics Evaluation and Research (CBER) in multiple relapsed
and/or refractory HLA-A*02:01-positive and PRAME-expressing
cancers, including cutaneous melanoma, uveal melanoma, endometrial
carcinoma, synovial sarcoma, and ovarian cancer. IMA203 is a TCR-T
cell therapy targeting PRAME, a protein frequently expressed in a
large variety of solid tumors.
“The FDA RMAT designation for multiple
indications underscores the broad potential of IMA203 and the
benefits it may provide for advanced-stage solid tumor patients.
This is an important regulatory milestone and a recognition of our
clinical development progress for this program,” said Cedrik
Britten, Chief Medical Officer of Immatics. “The close support from
the FDA resulting from the RMAT status enhances our efforts to
accelerate bringing IMA203 to cancer patients by enabling real-time
discussions on patient populations, trial design and CMC.”
Established under the 21st Century Cures Act,
RMAT designation is a dedicated program designed to expedite the
development and review processes for promising pipeline products,
including cell therapies, that includes all the benefits of Fast
Track and Breakthrough designation programs. An investigational
cell therapy is eligible for RMAT designation if it meets the
definition of regenerative medicine therapy, it is intended to
treat, modify, reverse, or cure a serious or life-threatening
disease; and preliminary clinical evidence indicates that the
therapy has the potential to address unmet medical needs for that
disease. Advantages of the RMAT designation include early
interactions with the FDA that may be used to discuss potential
surrogate or intermediate endpoints for accelerated approval and
potential ways to satisfy post-approval requirements, potential
priority review of the biologics license application (BLA) and
other opportunities to expedite development and review.
Based on publicly available information1, it is
the Company’s understanding that this is the first time that FDA
has granted a RMAT designation for an oncology drug candidate for
more than two solid tumor indications. As of Sep 30, 2023, the U.S.
FDA has received at least 238 requests for RMAT designations and
granted 922.
About IMA203 and target
PRAMEACTengine® IMA203 T cells are directed against an
HLA-A*02:01-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 homogeneously and specifically expressed in tumor tissue. The
peptide has been identified and characterized by Immatics’
proprietary mass spectrometry-based target discovery platform,
XPRESIDENT®. Through its proprietary TCR discovery and engineering
platform XCEPTOR®, Immatics has generated a highly specific T cell
receptor (TCR) against this target for its TCR-based cell therapy
approach, ACTengine® IMA203.
ACTengine® IMA203 TCR-T is currently being
evaluated in three ongoing Phase 1b dose expansion cohorts in
last-line patients: Cohort A IMA203 GEN1 monotherapy, Cohort B
IMA203 in combination with an immune checkpoint inhibitor
(deprioritized) and Cohort C IMA203CD8 GEN2 monotherapy, where
IMA203 engineered T cells are co-transduced with a CD8αβ
co-receptor.
About ACTengine®ACTengine® is a
personalized cell therapy approach for patients with advanced solid
tumors. The patient’s own T cells are genetically engineered to
express a novel, proprietary TCR directed against a defined cancer
target. The modified T cells are then reinfused into the patient to
attack the tumor. The approach is also known as TCR-engineered cell
therapy (TCR-T). All Immatics’ ACTengine® product candidates can be
rapidly manufactured utilizing a proprietary manufacturing process
designed to enhance T cell engraftment and persistence in vivo.
The ACTengine® T cell products are manufactured
at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory
in collaboration with UTHealth.
- END -
About ImmaticsImmatics 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.
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
Twitter, Instagram 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 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.
For more information, please
contact:
Media |
Eva Mulder or Charlotte Spitz |
|
Trophic Communications |
|
Phone: +31 65 2331 579 |
|
immatics@trophic.eu |
|
Investor Relations |
|
Sabrina Schecher, Ph.D. |
|
Senior Director, Investor Relations |
|
Phone: +49 89 262002433 |
|
InvestorRelations@immatics.com |
|
1 Source: https://bioinformant.com/rmat/2 Source: FDA -
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/cumulative-cber-regenerative-medicine-advanced-therapy-rmat-designation-requests-received-fiscal
- FINAL_RMAT Designation IMA203_24Oct2023
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