Full Press Release Details
Reports Interim Clinical Data Update on ACTengine IMA203 TCR-T Monotherapy Targeting PRAME
to host conference call today,
October 10, at 8:30 am EDT / 2:30 pm CEST
Texas and Tuebingen, Germany, October 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 clinical data update for the IMA203 monotherapy covering the completed
Phase 1a dose escalation part of the trial and initial data from the first 5 patients in the ongoing Phase 1b dose expansion cohort A
(monotherapy). In the Phase 1 trial with ACTengine IMA203, Immatics is treating recurrent and/or refractory solid cancer
patients utilizing TCR-T cells directed against an HLA-A*02-presented peptide derived from PRAME, which is frequently expressed across
several solid cancer indications. Overall, IMA203 continues to be well tolerated and achieved confirmed
objective responses across multiple solid cancers
such as cutaneous melanoma, ovarian cancer, head and neck cancer, uveal melanoma, and synovial sarcoma. Encouraging early signs of improved
durability were seen with a 50% (6/12) confirmed objective response rate, when patients were infused at the target dose or above with
more than 1 billion TCR-T cells.
Key clinical findings from IMA203 TCR-T monotherapy
The data obtained during the Phase 1a and Phase
1b cohort A trial provide clinical validation of PRAME as a highly promising T cell target for solid cancers. Confirmed clinical responses
were observed at high and low PRAME-expression levels above threshold, indicating IMA203's potential to provide clinical benefit
for all PRAME biomarker-positive cancer patients. The predicted high PRAME prevalence across key indications has so far been supported
by prevalence rates obtained during the clinical screening of patients.
Moving from Phase 1a to Phase 1b, Immatics
has continued to introduce planned improvements that may influence clinical outcomes including (1) applying higher cell doses (DL4 and
exploratory DL5), (2) optimizing the cell product through manufacturing enhancements and (3) working with disease area experts to gradually
reduce the fraction of very heavily pre-treated patients with extreme tumor burden who have exhausted standard of care and have undergone
multiple clinical trials. In addition, the focus in Phase 1b is also shifting from initial objective response rate (ORR) determined at
the ~6-week scan to confirmed ORR determined at the ~12-week scan.
Preliminary Objective Response Rates (ORR; RECIST
1.1) in Phase 1a and Phase 1b Cohort A
| Phase 1a | Phase 1a + Phase 1b | Phase 1b only | ||
| All pts (DL1-4) | DL4 pts only 1 | DL4/DL5 pts only 1 | All pts (DL4/DL5) 1 | |
| Patients Treated | 27 | 7 | 12 | 5 |
| ORR (~week 6) | 48% (13/27) | 57% (4/7) | 67% (8/12) | 80% (4/5) |
| cORR (~week 12) 2 | 19% (5/27) | 29% (2/7) | 50% (6/12)* | 80% (4/5)* |
1 All patients received >1 billion
total TCR-T cells; 2 confirmed ORR (cORR), * 1 patient with SD at ~6-week
scan with pending ~12-week scan considered as non-responder for cORR; DL - dose level
Positively evolving durability profile for
IMA203 was observed at higher doses: 6 of 12 patients (50%) treated with more than 1 billion infused TCR-T cells (DL4 and DL5) in the
Phase 1a and Phase 1b cohort A part of the trial experienced a confirmed objective response (partial response according to RECIST 1.1).
In the Phase 1b part of the trial alone, 4 of 5 patients (80%) had a confirmed objective response which were all ongoing at the timepoint
"The data presented today highlight the clinical
potential of PRAME as one of the most promising multi-tumor targets to achieve meaningful benefits for a large cancer patient population,"
commented Cedrik Britten, MD, Chief Medical Officer at Immatics. "In addition to this
first data from IMA203 monotherapy today, we are awaiting data from two additional dose expansion cohorts: IMA203 together with an immune
checkpoint inhibitor and our 2nd generation product candidate IMA203CD8. As we continue to shift our focus from Phase 1a to
Phase 1b, we look forward to reporting meaningful data throughout 2023, including safety and response rates, as well as durability of
response with a longer follow-up time. In addition, we are excited to start a first-in-human trial with our half-life extended Bispecific
against PRAME, TCER IMA402, also in 2023."
Safety data for IMA203 monotherapy across
Phase 1a and Phase 1b: Treatment with IMA203 continues to show manageable tolerability profile.
Phase 1a - Clinical activity:
IMA203 demonstrated a high initial objective response rate in several solid tumor types.
Phase 1b Cohort A - Clinical activity:
IMA203 monotherapy demonstrates high confirmed objective response rate of 80% with early signs of prolonged durability.
ACTengine IMA203 is currently being evaluated
in an ongoing Phase 1b study including three expansion cohorts: (A) IMA203 as a monotherapy, (B) IMA203 in combination with an immune
checkpoint inhibitor and (C) IMA203CD8, a next-generation cell therapy where IMA203 engineered T cells are co-transduced with a CD8ab
co-receptor. Further data read-outs on the individual cohorts are planned throughout 2023. In addition to the ACTengine programs,
Immatics is addressing PRAME-positive cancers with a second therapeutic modality: TCR Bispecifics. The company's TCER IMA402
is a next-generation, half-life extended TCR Bispecific which will enter the clinic in 2023. 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 conference call
Immatics will host a conference call today, October
10, 2022, at 8:30 am EDT / 2:30pm CEST to discuss these clinical data. The webcast and presentation can be accessed directly through
this link. Participants may also access the slides and 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 the Company's website for
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 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.
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.
For regular updates about Immatics, visit www.immatics.com.
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