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Immatics Presents Clinical Proof-of-Concept Data from Ongoing Phase 1 Dose Escalation Trial with TCR Bispecific Molecule TCER IMA401 Targeting MAGEA4/8 at ESMO 2024 and Provides Development Update TCER IMA4

Key Takeaway: Immatics Presents Clinical Proof-of-Concept Data Phase 1 Dose Escalation Trial with TCR Bispecific Molecule TCER IMA401 Targeting MAGEA4/8 at ESMO 2024 and Provides Texas and Tuebingen, Germany, September 16, 2024 - Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a

Full Press Release Details

Immatics Presents Clinical Proof-of-Concept Data
Phase 1 Dose Escalation Trial with TCR Bispecific Molecule TCER IMA401
Targeting MAGEA4/8 at ESMO 2024 and Provides
Texas and Tuebingen, Germany, September 16, 2024 - Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"),
a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today
in this analysis had received IMA401 infusions 1 mg and showed MAGEA4/8 target expression higher than the MAGEA4/8high
qPCR threshold (n=17).
proof-of-concept clinical data for the first candidate
of its next-generation, half-life extended TCR Bispecifics platform, TCER IMA401 (MAGEA4/8), during an oral presentation
at the European Society for Medical Oncology (ESMO) Congress 2024.
Initial data from the IMA401 Phase 1a first-in-human
dose escalation basket trial in a broad range of heavily pretreated patients with recurrent and/or refractory solid tumors showed initial
anti-tumor activity, durable objective responses, including confirmed responses ongoing at 13+ months,
and a manageable tolerability profile.
The data from the ongoing Phase 1 trial will be
presented today by Martin Wermke, M.D. during the Investigational Immunotherapy oral presentation session at the ESMO Congress 2024.
The IMA401 data slides are accessible in the Events & Presentations' section
of the Investor & Media section of the Company's website.
"Today marks the achievement of a major milestone
for Immatics as the data presented confirm clinical proof-of-concept for our proprietary TCER therapeutic approach and
IMA401, our next-generation, half-life extended TCR-based bispecific targeting a novel tumor-specific peptide derived from MAGEA4/8. We
are very pleased to observe initial anti-tumor activity, including durable objective responses, during dose escalation in a heavily pre-treated
patient population and across several solid tumor types," said Carsten Reinhardt, M.D., Ph.D., Chief Development Officer at Immatics.
"As the clinical trial progresses, our goal will be to further leverage the potential of this product candidate by focusing on the
enrollment of indications with high MAGEA4/8 target expression, such as lung and head and neck cancer patients, seeking to optimize the
treatment schedule and also exploring the incremental clinical benefit available to patients through combining IMA401 with a checkpoint
collaboration with Bristol Myers Squibb (NYSE:BMY) for the co-development of IMA401 has ended
due to ongoing portfolio prioritization efforts within Bristol Myers Squibb. The existing collaboration and license agreement signed
in December 2021 will terminate effective December 12, 2024. Thereafter, all IMA401 development and commercialization rights will be reverted
to Immatics. Immatics is not obligated to refund Bristol Myers Squibb any part of the $150 million upfront received under the collaboration
and is not required to make any future milestone payments to Bristol Myers Squibb; the parties will engage in a wind-down period as stipulated
under the collaboration agreement.
Based on the terms of the agreement with Bristol
Myers Squibb, Immatics has been responsible for conducting the ongoing Phase 1 clinical trial. Immatics intends to advance IMA401 further
through clinical development. The next data update is expected in 2025.
"Building on the initial anti-tumor activity
observed in heavily pretreated patients with solid tumors, we are delighted to bring this highly promising drug candidate back into our
pipeline as a wholly owned asset," said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. "We see tremendous potential
in going after cancers that express MAGEA4 and MAGEA8, complementing our PRAME franchise and strengthening our ability to deliver a meaningful
impact on the lives of solid cancer patients."
Key Clinical Findings from TCER IMA401 Monotherapy
baseline characteristics: Heavily pretreated patients with a broad range of tumor types
cut-off on July 23, 2024, 35 heavily pretreated patients with recurrent and/or refractory solid tumors have been treated with IMA401 monotherapy
across nine escalating dose levels. The treated patient population is composed of patients with 16 different solid tumor indications who
are both HLA-A*02:01 and MAGEA4/8-positive, had received a median of four and up to eight lines of prior systemic treatments and the majority
have an ECOG performance status of 1. The safety population includes all
35 patients treated with IMA401. 29 patients were evaluable for efficacy analysis, of which 17 patients were treated at relevant dose
Safety: Treatment with IMA401 demonstrates a manageable tolerability
IMA401 demonstrated an overall manageable tolerability
profile in the 35 patients treated. The most frequent treatment-related adverse events (AEs) were transient lymphopenia and mild to moderate
cytokine release syndrome (CRS) with the majority of CRS occurring at the first dose. Both AEs are consistent with the proposed mechanism
of action and reported for other bispecific T cell engagers. Neutropenia was also observed at high dose levels and occurred mostly at
the initial target dose in patients with and without dexamethasone pre-medication. High-grade neutropenia was fully resolved in all cases
Dose escalation for the trial is ongoing and the
maximum tolerated dose has not yet been determined.
Pharmacokinetics: Next-generation TCER
format shows extended half-life in solid cancer patients
IMA401 demonstrated an "antibody-like"
median half-life of over two weeks (16.9 days). This supported the switch to q2w dosing (once every two weeks) during dose escalation.
In addition, the data support pursuing increased
dosing intervals of up to q4w (once every four weeks), which could further offer an ideal dosing interval for potential combination with
checkpoint inhibitors.
Initial anti-tumor activity: IMA401 demonstrates
initial anti-tumor activity in multiple tumor types
of data cut-off on July 23, 2024, three of four confirmed responses were ongoing at 13+, 8+ and 3+ months. Deep responses (tumor shrinkage
of 50%) were observed in four patients (head and neck squamous cell carcinoma, neuroendocrine tumor of unknown primary, cutaneous
and mucosal melanoma).
obtained also indicate that objective responses are associated with MAGEA4/8 target expression level.
Patients with relevant IMA401 doses and MAGEA4/8 high levels 1 (N=17) Overall efficacy-evaluable population across all dose and target levels (N=29)
Objective Response Rate 29% (5/17) 21% (6/29)
Confirmed Objective Response Rate 25% (4/16) 14% (4/28)
Disease Control Rate 53% (9/17) 55% (16/29)
Tumor Shrinkage 53% (8/15) 44% (12/27)
in this analysis had received IMA401 infusions 1 mg and showed MAGEA4/8 target expression higher than the MAGEA4/8high
qPCR threshold (n=17).
TCER IMA401 is Immatics'
most advanced TCER molecule from the Bispecifics pipeline that targets an HLA-A*02-presented (human leukocyte antigen)
peptide derived from two different cancer-associated proteins, melanoma-associated antigen 4 and/or 8 ("MAGEA4/8"). The MAGEA4/8
peptide has been identified and validated by Immatics' proprietary mass spectrometry-based target discovery platform XPRESIDENT
and is presented at a 5-fold higher copy number per tumor cell than the MAGEA4 peptide targeted in other clinical trials.
TCER IMA401 is currently being
evaluated in a Phase 1 basket trial in patients with solid tumors expressing MAGEA4/8. The MAGEA4/8 peptide has a high prevalence in several
solid tumor indications such as head and neck squamous cell carcinoma (HNSCC), small cell lung cancer (SCLC), as well as melanoma, sarcoma
subtypes and other solid cancer types.
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 press release 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,
outcome and design of clinical trials, the nature of clinical trials (including whether such clinical trials will be registration-enabling),
the timing of IND or CTA filing for pre-clinical stage product candidates, estimated market opportunities of product candidates, the Company's
focus on partnerships to advance its strategy, and other metrics are forward-looking statements. In some cases, you can identify forward-looking
statements by terminology such as "may", "should", "expect", "plan", "target",
"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
Last updated: Sep 16, 2024