Immatics Announces European Clinical Expansion of its Adoptive Cell Therapy Programs
August 18 2020 - 7:00AM
- First patient has been treated in Germany in Immatics’
ACTengine® IMA202-101 trial
- German regulatory agency, Paul-Ehrlich-Institute (PEI), granted
approval to commence another clinical ACTengine® trial in Germany
investigating Immatics’ IMA203 product candidate
- Three clinical trial sites in Germany have started recruiting
patients for Immatics’ ACTengine® IMA200 trial series
Tuebingen, Germany and Houston, Texas,
August 18, 2020 – Immatics N.V. (NASDAQ:
IMTX, “Immatics”), a clinical-stage biopharmaceutical company
active in the discovery and development of T cell redirecting
cancer immunotherapies, announced today the treatment of the first
patient in the IMA202-101 trial in Europe following the Clinical
Trial Application (CTA, the equivalent of an IND approval by FDA)
approval by Paul-Ehrlich-Institute (PEI), the regulatory body for
cell and gene therapies in Germany. In addition, Immatics has been
granted regulatory approval by PEI to initiate another phase I
clinical trial in Germany to evaluate safety, tolerability and
initial signs of clinical efficacy of IMA203.
The clinical trials of the IMA200 series will
investigate up to three novel cancer immunotherapies, which include
IMA202 (NCT03441100) and IMA203 (NCT03686124). IMA202 and IMA203
are designed to target unique peptides derived from either
melanoma-associated antigen 1 (“MAGEA1”) or preferentially
expressed antigen in melanoma (“PRAME”), respectively. Both are
built on Immatics’ proprietary ACTengine® approach in which the
patient’s own T cells are genetically engineered to express an
exogenous T cell receptor (TCR) directed against true cancer
targets. By introducing this novel cancer specific TCR, the goal is
to redirect and selectively activate the patient’s T cells to fight
the tumor. The studies will investigate the safety and tolerability
of Immatics’ Adoptive Cell Therapies (ACT) in patients with
target-positive solid cancers and seek initial signals of
anti-tumor activity. Moreover, persistence of the infused
engineered T cells will be monitored in the patient’s blood as T
cell persistence is considered a major pre-requisite to obtain an
anti-tumor response. The aim is to develop innovative personalized
immunotherapies targeting a patient’s tumor selectively and
effectively.
The initial group of clinical trial sites in
Germany includes the University Hospital Carl Gustav Carus in
Dresden, the University Hospital Bonn and the University Hospital
of Würzburg. Previous patients in the IMA200 series were initially
enrolled at The University of Texas MD Anderson Cancer Center in
Houston, Texas, and more recently at the Columbia University Irving
Medical Center in New York and the UPMC Hillman Cancer Center in
Pittsburgh, Pennsylvania.
Cedrik Britten, MD, Chief Medical Officer of
Immatics commented: “As part of our strategy to increase the
geographical foot-print for our clinical sites, we are currently
expanding them in the US and in Europe. We are delighted to have
gained a new regulatory approval from PEI and to have treated the
first patient in Germany. This expansion elevates our clinical
organization to a global level and adds operational flexibility
that has become even more important in light of the global COVID-19
pandemic. We look forward to continuing to collaborate with leading
clinicians to advance our mission of delivering the power of T
cells to cancer patients on both sides of the Atlantic.”
Dr. Martin Wermke, Coordinating Investigator and
Head of the Early Clinical Trial Unit of the National Center for
Tumor Diseases Dresden (NCT/UCC) at the University Hospital Carl
Gustav Carus in Dresden, Germany, commented: “Having been involved
since the early stages of this clinical research, I am excited to
witness the next phase of development of this fascinating pipeline
of immunotherapies. I am confident that Immatics’ innovative T cell
therapies hold the potential to alter the future therapeutic
landscape of solid and hematologic malignancies.”
Additional information about the clinical
studies is available at www.immatics.com/clinical-programs/ and
www.clinicaltrials.gov.
About Immatics’ Adoptive Cell TherapiesAdoptive
Cell Therapy (ACT) is a therapeutic approach that uses natural or
engineered T cells to fight cancer. Immatics has developed three
innovative, proprietary approaches to produce Adoptive Cell
Therapies: ACTengine®, off-the-shelf ACTallo® and the multi-target
pilot trial ACTolog®.
About ACTengine®Immatics’
clinical product class ACTengine® is a personalized approach for
patients with advanced solid cancers. Patient’s own T cells are
genetically modified to express a novel proprietary TCR cognate to
one of Immatics’ cancer targets identified by its proprietary
XPRESIDENT® target discovery platform.
About the ACTengine® clinical trials
(IMA201, IMA202 and IMA203)
- The primary objective of these
clinical studies is to evaluate the safety and tolerability of the
ACTengine® approach in target-positive solid cancer patients.
- The secondary objectives are the
evaluation of the persistence of T cells in vivo and the assessment
of anti-tumor activity.
- Patients are potentially eligible
for ACTengine® cell therapy if the target of interest is present on
the patient’s tumor as demonstrated by biomarker profiling
(IMADetect™).
- Each TCR used in these trials has
been selected from the human T cell repertoire and developed using
Immatics’ XCEPTOR™ platform targeting highest specificity.
- The ACTengine® T cell products are
manufactured at The Evelyn H. Griffin Stem Cell Therapeutics
Research Laboratory in collaboration with The University of Texas
Health Science Center at Houston (UTHealth).
- Immatics has developed a
proprietary manufacturing process, optimized to generate T cell
products within a short manufacturing period. TCR-transduced T
cells are activated and multiplied outside of the body before being
infused into the patient.
Patient receiving an investigational therapy based on Immatics’
ACTengine® approach.
Notes to
Editors
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’ pipeline consists of two distinct
therapeutic modalities of Adoptive Cell Therapies and TCR
Bispecifics. Adoptive Cell Therapy programs are developed in
collaboration through Immatics US with The University of Texas MD
Anderson Cancer Center and co-funded by the Cancer Prevention and
Research Institute of Texas (CPRIT). The ACT T cell products are
manufactured at the Evelyn H. Griffin Stem Cell Therapeutics
Research Laboratory in collaboration with UTHealth.
For regular updates about Immatics, visit
www.immatics.com. You can also follow us on 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 Securities and Exchange Commission (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.
- Immatics_European Clinical Expansion_FINAL_EN
For more information, please contact:
For media enquiries
Gretchen Schweitzer or Jacob Verghese, PhD
Trophic Communications
Phone: +49 89 2388 7731
immatics@trophic.eu
Investor Relations Contact
John Graziano
Solebury Trout
Phone: +1 646-378-2942
jgraziano@soleburytrout.com
Immatics N.V.
Anja Heuer
Corporate Communications
Phone: +49 89 540415-606
media@immatics.com
Jordan Silverstein
Head of Strategy
Phone: +1 281-810-7545
InvestorRelations@immatics.com
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