Full Press Release Details
Reports Interim Clinical Data from Ongoing Phase 1b Cohort A
Monotherapy with ACTengine IMA203 TCR-T Targeting PRAME
Company to host conference call today,
May 2, at 8:30 am EDT / 2:30 pm CEST
Texas and Tuebingen, Germany, May 2, 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 an interim clinical data update for 11 patients with recurrent and/or refractory
solid cancers treated with ACTengine IMA203 TCR-T monotherapy in the ongoing Phase 1b dose expansion Cohort A. IMA203 TCR-T cells
are directed against an HLA-A*02-presented peptide derived from PRAME, a broadly expressed solid cancer target with clinical proof-of-concept
for IMA203 demonstrated by
Immatics in 2022. Overall, IMA203 showed a high
rate of deep and durable objective responses, with a confirmed objective response rate of 67% (6/9), across multiple tumor types, including
two confirmed partial responses (cPR) ongoing at more than 9 months after treatment and three additional partial responses ongoing at
data cut-off. IMA203 monotherapy continues to be well tolerated in heavily pre-treated patients at doses of up to approximately 9 billion
CD8+ TCR-T cells. No high-grade cytokine release syndrome (CRS) and no immune effector cell associated neurotoxicity syndrome (ICANS)
were observed in Cohort A at data cut-off.
The data will be presented by Martin Wermke, MD,
Professor at the University Hospital Dresden and Coordinating Investigator of the ACTengine IMA203 TCR-T trial during a conference
call today, May 2, at 8:30 am EDT / 2:30 pm CEST.
"The treatment of solid cancer patients who
have exhausted all available standard of care options remains a significant challenge. These patients typically show fast progressing
disease with very poor prognosis," said Martin Wermke, MD, Coordinating Investigator of the ACTengine IMA203 TCR-T trial. "It
is therefore very encouraging to see that IMA203 is able to provide durable, clinically relevant responses in a variety of solid cancer
"Today marks a significant step in our efforts
towards bringing our ACTengine IMA203 monotherapy to patients with solid tumors, as we present for the first time longer-term clinical
data demonstrating deep and durable responses, some of them ongoing beyond 9 months after treatment," commented Cedrik
Britten, MD, Chief Medical Officer at Immatics. "Furthermore, we show that these responses are agnostic of tumor type and
that ACTengine IMA203 achieved objective responses at widely differing PRAME expression levels. These data further increase our confidence
in the success and broad potential of targeting PRAME, and our product candidate IMA203. We continue executing and anticipate announcing
a potential fast-to-market pathway for the first 1-2 indications by the end of the year."
Safety data for IMA203 TCR-T monotherapy
in Phase 1b Cohort A: Treatment with IMA203 monotherapy continues to show manageable tolerability at doses as high as ~9x109
Clinical activity for IMA203 TCR-T monotherapy
in Phase 1b Cohort A: IMA203 monotherapy demonstrates a high rate of deep objective responses with ongoing durability of
more than 9 months after treatment in some patients.
Best Overall Response - Phase 1b Cohort
1 Ovarian cancer patient A-DL5-04 erroneously
received one dose of nivolumab and is part of intent-to-treat population (shown here) but not per-protocol population; NET: Neuroendocrine
Tumor; PD: Progressive disease; SD: Stable disease; PR: Partial response; cPR: Confirmed partial response; BL: Baseline; BOR: Best Overall
Response over Time - Phase 1b Cohort A
Manufacturing of IMA203 TCR-T cells
Development strategy to realize the multi-cancer
Immatics believes, the results presented today
further validate PRAME as one of the most promising solid tumor targets for TCR-based therapies. Immatics' IMA203 development strategy
is based on two pillars aimed initially at a (1) fast-to-market approach and, later at a (2) broad development.
The first objective is to deliver the PRAME-targeted
TCR-T cell therapy in 1-2 last-line solid cancer types as fast as possible with a focus on indications with PRAME prevalence above 80%
and where clinical proof-of-concept has been demonstrated, such as cutaneous melanoma (potentially bundled with uveal melanoma) and/or
ovarian cancer. The buildout of the manufacturing facility will support Immatics' efforts to maximize speed to market. Immatics
plans to start a first Phase 2 trial in 1H 2024, which is intended to be designed as a registration-directed trial.
As a second step, Immatics plans to also expand
development to other cancer types, such as uterine cancer, lung cancer, breast cancer, head and neck cancer and other tumor types having
a broad patient reach.
An update on all three IMA203 Phase 1b Cohorts
and clinical development path for PRAME TCR-T monotherapy towards registration-directed trials and potential commercialization is planned
In addition to ACTengine TCR-T, Immatics is
addressing PRAME-positive cancers with a second therapeutic modality, TCR Bispecifics (TCER ), to leverage the full potential of the
multi-cancer opportunity PRAME. Immatics' TCER IMA402 is a next-generation, half-life extended TCR Bispecific for which Immatics
submitted a clinical trial application (CTA4) to the Paul-Ehrlich-Institute
(PEI) on April 14, 2023, to initiate the Phase 1/2 trial. The trial is expected to commence in 2H 2023 with first clinical data planned
Both approaches, ACTengine and TCER ,
are distinct therapeutic modalities that have the potential to provide innovative treatment options for a variety of cancer patient populations
with different medical needs. Immatics will continue to evaluate which of these therapeutic modalities (ACTengine vs. TCER or
both) is best suited for each cancer type.
Immatics conference call
Immatics will host a conference call today, May
2nd, 2023, at 8:30 am EDT / 2:30 pm CEST to discuss the clinical data. The webcast and presentation can be accessed directly
through this link. Participants may also access the slides presented in the webcast on the Immatics website in the Investors section
under "Presentations" at www.investors.immatics.com/events-presentations. A replay
of the webcast will be made available shortly after the conclusion of the call and archived on 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 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.
ACTengine IMA203 TCR-T is currently being
evaluated in three ongoing Phase 1b dose expansion cohorts in last-line patients: Cohort A IMA203 TCR-T monotherapy, Cohort B IMA203 in
combination with an immune checkpoint inhibitor; Cohort B is focused on generating safety data for potential further investigation of
a combination approach as a front-line therapy, and Cohort C IMA203CD8 TCR-T monotherapy, where IMA203 engineered T cells are co-transduced
with a CD8 co-receptor. IMA203CD8 is currently being explored in DL4a (up to 0.8x109 TCR-T cells/m2
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
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).
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.
intends to use its website www.immatics.com as a means of disclosing material non-public information.
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'