Immatics Announces First Patient Treated with ACTengine® IMA203 TCR-T in Combination with Checkpoint Inhibitor Opdivo® (nivolumab) in Patients with Advanced Solid Tumors
May 18 2022 - 7:00AM
- The Phase 1b
dose expansion cohort will evaluate safety, biological activity and
initial anti-tumor activity of IMA203 TCR-T targeting PRAME in
combination with nivolumab1, a PD-1 immune checkpoint inhibitor, in
patients with multiple solid tumors
- Initiation of
the combination treatment follows positive interim results from the
IMA203 monotherapy Phase 1a dose escalation cohort and
determination of provisional recommended phase 2 dose
- IMA203 targets
an HLA-A*02-presented peptide derived from the protein PRAME that
is highly prevalent and homogenously expressed at high target copy
numbers across several solid cancer indications
- IMA203 and
nivolumab combination is part of Immatics' strategy to realize the
full clinical potential of IMA203 TCR-T targeting PRAME; initial
data read-out is planned for YE 2022
Houston, Texas
and Tuebingen,
Germany, May
XX, 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 that
the first patient has been dosed in the IMA203 and nivolumab
combination Phase 1b dose expansion cohort. This cohort will
evaluate Immatics’ TCR-engineered cell therapy (TCR-T) approach
ACTengine® IMA203 targeting an HLA-A*02-presented peptide derived
from PRAME, in combination with Bristol Myers Squibb’s PD-1
checkpoint inhibitor nivolumab, in patients with advanced solid
tumors. The objectives of the study will be to evaluate the safety,
biological activity, and initial anti-tumor activity of the IMA203
and nivolumab combination. “Initiating the second of three dose
expansion cohorts is an important milestone in our comprehensive
approach to target PRAME. It builds on the successful completion of
the dose escalation part of the Phase 1 trial and the early
positive clinical data we observed with IMA203,” said Cedrik
Britten, Chief Medical Officer at Immatics. “We are excited to
elucidate how the combination with an immune checkpoint inhibitor
could enhance the potency of our engineered IMA203 T cells. We also
look forward to initiating the third Phase 1b cohort with
IMA203CD8, our next generation approach that additionally harnesses
the power of CD4 T cells.”
The IMA203 and nivolumab combination Phase 1b
dose expansion cohort is expected to enroll up to 18 patients with
different types of solid tumors across 10 clinical trial sites in
Germany and the U.S. Bristol Myers Squibb will provide Immatics,
the study sponsor of the combination trial, with nivolumab as part
of a clinical supply agreement. Nivolumab has become the standard
of care treatment for many solid cancer indications and we believe
it fits well into the IMA203 treatment and observation schedule.
According to the clinical trial protocol for ACTengine® IMA203,
nivolumab will be administered at regular intervals following
IMA203 treatment. The primary endpoint of this cohort is to assess
the safety of the combination. Anti-tumor activity resulting from
the drug combination is a secondary endpoint, which will be
assessed through imaging and measured according to the standard
Response Evaluation Criteria In Solid Tumors (RECIST).
The combination treatment of IMA203 and
nivolumab is part of Immatics' strategy to realize the full
clinical potential of IMA203 TCR-T targeting PRAME. Based on this
strategy, the company has expanded the IMA203 trial to a total of
three Phase 1b dose expansion cohorts – each designed to assess
observed objective response rates, demonstrate durability of
response, and form the basis for enrollment in pivotal studies. In
addition to the IMA203 and nivolumab combination (first patient
treated, initial data read-out planned for YE 2022), Immatics will
also investigate IMA203 as monotherapy (patient enrollment ongoing,
next data read-out planned in 2H 2022) and IMA203CD8, a
next-generation cell therapy where IMA203-engineered T cells are
co-transduced with a CD8αβ co-receptor (initiation planned for 2Q
2022, initial data read-out planned for YE 2022).
About IMA203
and target PRAMEACTengine® IMA203 T cells are
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 programs’ 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®. 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.
About ACTengine® ACTengine® is
a personalized 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. The ACTengine® Programs are
co-funded by the Cancer Prevention and Research Institute of Texas
(CPRIT).
- 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 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 |
1 Opdivo® (nivolumab) is a trademark of
Bristol-Myers Squibb Company
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