Immatics Presents Comprehensive Preclinical Data Set for TCR Bispecific Candidate IMA402 Targeting PRAME at European Society for Medical Oncology (ESMO) Congress 2022
September 10 2022 - 03:06AM
GlobeNewswire Inc.
- TCER® IMA402 is a next-generation, half-life extended TCR
Bispecific targeting an HLA-A*02:01-presented peptide derived from
PRAME
- In preclinical studies, IMA402 demonstrated enhanced anti-tumor
activity in vivo and reduced T cell engager-associated toxicities
as part of overall favorable in vitro safety profile
- Pharmacokinetic characteristics of half-life extended IMA402
suggest potential for a favorable dosing regimen in patients with
prolonged drug exposure at therapeutic levels
- 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
- Phase 1/2 clinical trial on track to start in 2023;
submission of the CTA/IND1 application is planned for 2Q 2023
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
- The IMA402 TCER®
utilizes a high-affinity TCR designed to specifically bind to
an HLA-A*02:01-presented peptide derived from PRAME on tumor
cells
- The T cell
recruiter domain is a proprietary low-affinity T cell recruiter
against the TCR/CD3 complex that demonstrates superior in vivo
tumor control compared to analogous TCER® molecules designed with
higher-affinity variants of a widely used antibody recruiter
- The IMA402 TCER®
is optimized to reduce T cell engager-associated toxicities in
patients, which is demonstrated by reduced recruiter-mediated
cytokine release in vitro
Compelling preclinical data
- IMA402 showed
potent and selective activity against PRAME-positive tumor cell
lines in vitro
- In vivo studies
in mice demonstrated dose-dependent anti-tumor activity of IMA402.
Sufficiently high drug doses were key to achieving the desired
anti-tumor effects over a prolonged period
- In vitro safety
assessment including toxicity screening against 20 normal tissue
types, whole blood cytokine release assessment and alloreactivity
evaluation confirmed favorable safety profile for IMA402
- The half-life
extended format of IMA402 confers a serum half-life of >1 week
in mice suggesting a favorable dosing regimen and prolonged drug
exposure at therapeutic levels when compared to TCR Bispecifics
lacking half-life extension strategies
Clinical trial evaluating IMA402 in patients with solid
tumors to start in 2023
- IMA402 is
designed to allow high dosing not limited by toxicities with the
goal of reaching relevant therapeutic doses in tumor tissue and
achieve a meaningful clinical benefit in patients
“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.
- 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 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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