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Immatics Reports Interim Clinical Data from ACTengine IMA203 and IMA203CD8 TCR-T Monotherapies Targeting PRAME in an Ongoing Phase 1 Trial Company to host conference call and webcast today, November 8, at 8

Key Takeaway: Reports Interim Clinical Data from ACTengine IMA203 and IMA203CD8 TCR-T Monotherapies Targeting PRAME in an Ongoing Phase 1 Trial to host conference call and webcast today, November 8, at 8:30 am EST/2:30 pm CET data with focus on melanoma patients presented at the Internationa

Full Press Release Details

Reports Interim Clinical Data from ACTengine IMA203 and IMA203CD8 TCR-T Monotherapies Targeting PRAME in an Ongoing Phase 1 Trial
to host conference call and webcast today, November 8, at 8:30 am EST/2:30 pm CET
data with focus on melanoma patients presented at the International Congress
of the Society for Melanoma Research today, November 8
Texas and Tuebingen, Germany, November 8, 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 interim data from the ongoing Phase 1 trial with ACTengine
IMA203 in patients with recurrent and/or refractory solid cancers. The update is focused on IMA203 GEN1 in melanoma at the recently defined
recommended Phase 2 dose (RP2D) and the first clinical data for IMA203CD8 GEN2.
Treatment with IMA203 GEN1 monotherapy in Phase
1a and Phase 1b Cohort A at RP2D demonstrated durable objective responses in melanoma patients with one patient exceeding 12 months and
two patients exceeding 15 months post infusion and a 50% (6/12) confirmed objective response rate (cORR). In line with previous results,
IMA203 GEN1 monotherapy was well tolerated at total doses up to 10x109 TCR-T cells infused.
In addition, the first data on the company's
second-generation product candidate IMA203CD8 demonstrated 56% (5/9) cORR with enhanced pharmacology and a differentiated response pattern
compared to IMA203 GEN1. The company plans to develop IMA203 GEN1 in melanoma and to pursue development of IMA203 in ovarian cancer, uterine
cancer, NSCLC, triple-negative breast cancer and other tumor types preferentially with IMA203CD8 GEN2.
The melanoma-focused data on IMA203 GEN1 will be
presented today by Martin Wermke, MD, Professor at the University Hospital Dresden and Coordinating Investigator of the ACTengine
IMA203 TCR-T trial, at the 20th International Congress of the Society for Melanoma Research in Philadelphia, PA, taking place
November 6th-9th, 2023.
In addition, Dr. Wermke together with Cedrik Britten,
MD, Chief Medical Officer at Immatics will provide the complete data update during a conference
call and webcast today, November 8 at 8:30 am EST/2:30 pm CET. The presentation is available on Immatics'
website - covering the complete data set including Phase 1a, Phase 1b Cohort A and the deprioritized Cohort B
(IMA203 GEN1 combined with nivolumab).
"A cancer diagnosis can be the start of a
daunting journey characterized by devastating setbacks when conventional therapies fail. I believe that the updated data on IMA203 GEN1
shows meaningful benefit and long-term durability in melanoma patients," said Martin Wermke, MD, Coordinating Investigator of the
ACTengine IMA203 TCR-T trial. "With the maturation of the clinical data set, it becomes progressively evident to me that targeting
PRAME with Immatics' IMA203 TCR-T approach has the potential to provide a durable benefit for advanced-stage checkpoint- and BRAF-inhibitor
refractory melanoma patients."
"Today, we are excited to report on the continued
clinical progress for our ACTengine IMA203 TCR-T cell therapies, which we believe have demonstrated meaningful clinical benefit for
last-line solid cancer patients treated with IMA203 or its second-generation product candidate IMA203CD8. We now plan to progress IMA203
into a registration-enabling Phase 2 trial in melanoma as quickly as possible, while we believe that our second-generation approach is
exhibiting unique patterns in pharmacology guiding our development efforts towards other
tumor types such as ovarian, uterine, lung and
triple-negative breast cancer," commented Dr. Cedrik Britten, Chief Medical Officer at Immatics. "We plan to provide an update
on the clinical development plan for IMA203 in the first quarter of 2024 as well as updates across the entire clinical TCR cell therapy
and bispecifics portfolio throughout 2024."
Clinical data on anti-tumor activity and
IMA203 GEN1 in melanoma patients treated
at RP2D: IMA203 GEN1 demonstrates a high rate of objective responses with ongoing durability of more than 15 months after
IMA203CD8 GEN2 in Cohort C:
First clinical data set on IMA203CD8 shows an enhanced pharmacology profile with a differentiated response pattern compared to IMA203
Overview of patient characteristics and anti-tumor
activity across IMA203 clinical trial cohorts
IMA203 GEN1 IMA203CD8 GEN2
All Comers (N=45) Melanoma Subgroup (N=13 out of 45) All Comers (N=12)
Phase 1a Cohort A Phase 1a + Cohort A Cohort C
Efficacy population* N=27 Thereof N=7 at RP2D N=18 at RP2D N=13 at RP2D N=12
Dose level DL1-4 DL4/5 DL4/5 DL3/DL4a/DL4b
ORR 48% (13/27) 50% (9/18) 62% (8/13) 58% (7/12)
cORR 19% (5/27) 47% (8/17) 50% (6/12) 56% (5/9)
mDOR [months] 4.4 (2.4, 23.0) Not reached Not reached Not reached
mFU [months] Not defined # 10.8 14.4 4.8
* Patients with at least one available tumor response
assessment post infusion; # All patients were PD at data cut-off; Initial ORR: Objective response rate according to RECIST
1.1 at any post infusion scan; Confirmed ORR (cORR): Confirmed objective response rate according to RECIST 1.1 for patients with at least
two available post infusion scans or patients with progressive disease (PD) at any prior timepoint, patients with ongoing unconfirmed
PR not included in cORR calculation; Duration of response (DOR) in confirmed responders is defined as time from first documented response
until disease progression/death. Patients with ongoing response will be censored at date of data cut-off. Median DOR (mDOR) is analyzed
by using the Kaplan-Meier method; Median Follow-up (mFU) is analyzed by using the reverse Kaplan-Meier method.
The full data analysis including IMA203 GEN1 in
Phase 1a and Cohort A as well as deprioritized Cohort B (IMA203 in combination with a checkpoint inhibitor), is available as part of
the presentation on the company's website.
Development path for IMA203 GEN1 and IMA203CD8
The goal of Immatics' development strategy
is to make its cell therapies targeting PRAME available to the broadest possible solid cancer patient population with an initial focus
on the US market. To achieve this, Immatics has announced a three-step development strategy for leveraging the full breadth of PRAME,
a target that is highly expressed in various solid cancers.
last-line patients per year in the US. A next update on the clinical development plan is expected in the first quarter of 2024.
Immatics conference call and webcast
Immatics will host a conference
call and webcast today, November 8, 2023, at 8:30 am EST/2:30 pm CET to discuss the clinical data. The presentation can be
accessed directly through this link. A replay of the webcast will be made available shortly after
the conclusion of the call and archived on the Immatics website for at least 90 days.
About IMA203 and target PRAME
ACTengine 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 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 Phase 1 Cohort A IMA203 GEN1 monotherapy, and Cohort C IMA203CD8 GEN2 monotherapy, where IMA203 engineered T cells are co-transduced
with a CD8 co-receptor. As previously reported, Cohort B IMA203 in combination with an immune checkpoint inhibitor has been
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
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 are 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.
Immatics 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
Forward-Looking Statements:
Certain statements in
this presentation may be considered forward-looking statements. Forward-looking statements generally relate to future events or the Company's
future financial or operating performance. For example, statements concerning timing of data read-outs for product candidates, the timing
Last updated: Nov 8, 2023