Immatics Initiates Phase 1 Clinical Trial to Evaluate Lead TCR Bispecific IMA401 in Patients with Advanced Solid Tumors
May 10 2022 - 7:00AM
- Patient
enrollment for IMA401 Phase 1 trial started at first clinical site
in Germany
- The study will
evaluate safety, tolerability, and initial anti-tumor activity of
IMA401 in patients with recurrent and/or refractory solid
tumors
- TCER® IMA401
targets MAGEA4/8 and will be developed in collaboration with
Bristol Myers Squibb
Tuebingen,
Germany and Houston,
Texas, May
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 the
initiation of a Phase 1 clinical trial with its T cell engaging
receptor (TCER®) IMA401 for patients with recurrent and/or
refractory solid tumors. IMA401 is the most advanced product
candidate from Immatics’ TCR Bispecific pipeline targeting an
HLA-A*02-presented peptide derived from both MAGEA4 and MAGEA8.
TCER® IMA401 will be developed in collaboration with Bristol Myers
Squibb. Immatics is responsible for conducting the Phase 1 clinical
trial.
The primary objectives of the clinical trial
(NCT#05359445) are to determine the maximum tolerated dose (MTD)
and/or the recommended phase 2 dose (RP2D) for IMA401 in
biomarker-positive (HLA-A*02:01 and MAGEA4/8) patients with
recurrent and/or refractory solid tumors. Secondary objectives are
to characterize safety and tolerability, evaluate initial
anti-tumor activity and assess pharmacokinetics of IMA401. The
Phase 1 trial consists of a dose-escalation (Phase 1a) portion that
will be followed by a dose-expansion (Phase 1b) portion to treat
patients at the recommended dose level. The trial is planned to be
conducted at up to 15 centers in Germany, with the first site
already being initiated. The Phase 1 trial is designed to enroll
approximately 50 patients.
“IMA401 is the first TCER® candidate from our
TCR Bispecifics pipeline entering clinical development, and expands
our clinical portfolio with an exciting new TCR-based immunotherapy
approach that can be supplied off-the-shelf compared to autologous
cell therapies,” said Cedrik Britten, Chief Medical Officer at
Immatics. “Our innovative TCER® format leads to an
extended-half-life and incorporates novel binding-moieties that are
designed to maximize efficacy while minimizing toxicities in
patients. Our TCER® IMA401 could treat a range of solid tumors and
therefore meet currently unmet needs of a broad patient population.
This is best achieved with a strong pharma partner which we have
found in Bristol Myers Squibb.”
Immatics entered into a global exclusive license
agreement with Bristol Myers Squibb in December 2021 for the IMA401
program under which both companies will collaborate to advance the
program through clinical development.
Immatics’ TCR Bispecific pipeline includes a
second TCER® product candidate, IMA402, which targets PRAME.
Manufacturing of the clinical IMA402 batch is planned for the
second half of 2022 and initiation of the Phase 1 trial is planned
in 2023. Immatics’ TCER® pipeline is further strengthened by
additional innovative TCER® program(s), IMA40X, in preclinical
development.
About IMA401IMA401 is Immatics’
most advanced TCER® molecule that targets an HLA-A*02-presented
(human leukocyte antigen) 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
copy number per tumor cell than a MAGEA4 peptide targeted in other
clinical trials. Following preclinical proof-of-concept data,
including complete remissions of transplanted human-derived tumors
in xenograft mouse models, the Phase 1 trial investigates IMA401 in
patients with tumors of high MAGEA4/8 prevalence, such as squamous
non-small cell lung carcinoma (sqNSCLC), small cell lung cancer
(SCLC), head and neck squamous cell carcinoma (HNSCC), bladder,
uterine, esophageal and ovarian carcinomas, as well as melanoma,
sarcoma subtypes and other solid cancer types.
About TCER®Immatics’ 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 of specialized medical
centers.
- 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.
For regular updates about Immatics, visit
www.immatics.com. 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 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 Stephanie May |
|
Trophic Communications |
|
Phone: +49 89 2070 89831 |
|
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 |
Immatics NV (NASDAQ:IMTX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Immatics NV (NASDAQ:IMTX)
Historical Stock Chart
From Apr 2023 to Apr 2024