Immatics Announces First Quarter 2025 Financial Results and Business Update
-- IMA203 PRAME Cell Therapy: Randomized-controlled Phase 3 trial, SUPRAME,
in previously treated advanced melanoma ongoing and expected to complete
enrollment in 2026
-- IMA203 PRAME Cell Therapy: Phase 1b clinical trial ongoing with updated
data in metastatic melanoma with substantially longer follow-up and
additional uveal melanoma patients to be presented in an oral
presentation at the 2025 ASCO Annual Meeting
-- IMA203CD8 PRAME Cell Therapy (GEN2): Phase 1a clinical trial in solid
tumors ongoing with next data update, including dose escalation and
ovarian cancer data, planned in 2025
-- IMA402 PRAME Bispecific: Phase 1a clinical trial in solid tumors ongoing
with next data update at relevant dose levels planned in 2025
-- Combination of IMA203 PRAME cell therapy and Moderna's PRAME adaptive
immune modulating therapy: FDA granted IND clearance for a Phase 1 trial
-- IMA401 MAGEA4/8 Bispecific: Phase 1a clinical trial, including a
checkpoint inhibitor combination, ongoing with next data update with a
focus on head and neck cancer planned in 2025
-- Cash and cash equivalents as well as other financial assets of $588.1
million1 (EUR543.8 million) as of March 31, 2025; cash reach into 2H 2027
Houston, Texas and Tuebingen, Germany, May 13, 2025 -- 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 provided a business update and reported financial results for the quarter ended March 31, 2025.
"Our focus in the first quarter of 2025 was led by the execution of our SUPRAME Phase 3 clinical trial in melanoma as well as our other clinical-stage PRAME product candidates," said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. "At the upcoming ASCO Annual Meeting, we will present another Phase 1b clinical update on our PRAME cell therapy, IMA203, in melanoma with substantially longer follow-up. We also look forward to providing clinical trial updates for our cell therapy and bispecific programs later this year, highlighting the potential of our therapies in and beyond melanoma. We maintain a strong cash position, enabling us to rapidly advance the development of all our clinical programs, with a specific focus on progressing IMA203 toward commercialization and delivering this highly differentiated PRAME therapy to cutaneous and uveal melanoma patients with unmet medical needs as quickly as possible."
First Quarter 2025 and Subsequent Company Progress
PRAME Programs
IMA203 PRAME Cell Therapy
IMA203 is Immatics' lead PRAME cell therapy, currently being evaluated in a Phase 3 trial (SUPRAME) in patients with previously treated advanced melanoma. IMA203 has the potential to become the first PRAME therapy to enter the market. In parallel, Immatics is preparing its in-house, state-of-the-art cell therapy manufacturing facility to serve its planned commercial supply. As part of maximizing the PRAME cell therapy opportunity, Immatics plans to expand IMA203 into uveal melanoma through the ongoing Phase 1b clinical trial. The current addressable patient population of PRAME/HLA-A*02:01-positive 2L unresectable or metastatic cutaneous melanoma in the US and EU5(2) is 7,300 plus 1,300 uveal melanoma patients in the US and EU5.
Phase 3 trial, SUPRAME, for IMA203 in previously treated, advanced cutaneous melanoma
-- Based on the positive Phase 1b clinical data, Immatics has advanced its
PRAME cell therapy, IMA203, into a randomized-controlled Phase 3 clinical
trial, SUPRAME, evaluating the efficacy, safety and tolerability of
IMA203 TCR T-cell therapy vs. investigator's choice of treatment in
patients with unresectable or metastatic cutaneous melanoma who have
received prior treatment with a checkpoint inhibitor.
-- Primary endpoint for seeking full approval will be blinded independent
central review ("BICR")-assessed (RECIST v1.1) progression-free survival
$(PFS)$. Secondary endpoints for the trial include objective response rate
$(ORR.AU)$, safety, duration of response (DOR), overall survival (OS) and
patient-reported outcomes.
-- The trial will be conducted internationally with approximately 50 sites
in the US and Europe.
-- Patient enrollment and randomization for the trial was initiated in early
2025 and is expected to be completed in 2026. In April 2025, Immatics
received regulatory approval from the German regulatory authority,
Paul-Ehrlich-Institute (PEI), to commence the IMA203 SUPRAME Phase 3
trial in Germany.
-- A pre-specified interim data analysis will be triggered upon the
occurrence of a defined number of events for PFS (progressive disease or
death)3, anticipated to occur after approximately 200 patients. Immatics
aims to submit a Biologics License Application $(BLA.AU)$ in 1Q 2027 for full
approval.
-- IMA203 PRAME cell therapy development is supported by the FDA RMAT
designation. Advantages of the RMAT designation (which includes all
benefits of Breakthrough Therapy designation) include potential priority
review of the BLA and frequent interactions with the US FDA as an
opportunity to expedite development and review.
-- A trial-in-progress poster on SUPRAME will be presented in a poster
presentation by the SUPRAME lead principal investigator, Jason Luke, MD,
FACP, FASCO, at the 2025 ASCO Annual Meeting on June 2, 2025.
Phase 1b trial for IMA203 PRAME cell therapy in solid tumors with a focus on uveal melanoma
-- In addition to cutaneous melanoma, Immatics intends to expand the IMA203
opportunity to treat uveal melanoma patients and will continue to
evaluate IMA203 in this patient population through the ongoing trial.
-- Updated data from the Phase 1b trial of IMA203 in metastatic melanoma
with substantially longer follow-up compared to the last presentation in
October 2024, and including data from additional uveal melanoma patients
enrolled since then, will be highlighted by Martin Wermke, MD, in an oral
presentation at the 2025 ASCO Annual Meeting on May 31, 2025.
-- In April 2025, Nature Medicine published a manuscript covering prior
clinical results on IMA203. The publication includes data from 40 heavily
pretreated patients with PRAME cancers, mostly treated during the Phase
1a dose escalation part of the trial.
Cell therapy manufacturing capabilities
-- The IMA203 PRAME cell therapy products are manufactured from a patient's
leukapheresis (with no surgery required) within 7-8 days, followed by
7-day QC release testing at >95% success rate4 to achieve the target dose
(1-10x109 TCR T cells).
-- Immatics' proprietary manufacturing process, timeline, capabilities and
facility support late-stage clinical development and commercial cell
therapy supply.
IMA203CD8 PRAME Cell Therapy (GEN2)
IMA203CD8 is the Company's second-generation cell therapy product candidate targeting PRAME. Given its pharmacology profile, once the target dose is reached, the Company intends to pursue the clinical development of this product in multiple PRAME cancers, starting with gynecologic cancers.
-- Clinical data demonstrated enhanced pharmacology of IMA203CD8, which
opens the possibility of addressing hard-to-treat solid tumor indications
with both high- and medium-level PRAME copy numbers, such as ovarian
cancer, uterine cancer, squamous non-small cell lung carcinoma, triple
negative breast cancer and others.
-- Phase 1a dose escalation in solid tumors is ongoing to evaluate higher
doses of IMA203CD8 with and without IL-2. As of today, patients are being
treated with up to 8 billion total GEN2 TCR T cells.
-- The next clinical trial update, which will report on the continued dose
escalation in multiple PRAME cancers, including ovarian cancer patients
treated at relevant doses, is planned in 2025.
IMA402 PRAME Bispecific
To expand the PRAME opportunity to additional solid cancer types and earlier lines of treatment, the Company is developing its half-life extended TCR Bispecific, IMA402. Upon delivering clinical proof-of-concept ("PoC") in last-line melanoma, Immatics plans to explore its potential in gynecologic cancers, NSCLC, breast cancer, and other solid tumor indications as well as earlier treatment lines of solid cancers, such as first-line (1L) cutaneous melanoma.
-- First clinical data from the early Phase 1a dose escalation trial
demonstrated initial signs of dose-dependent and PRAME target
expression-dependent clinical activity.
-- Phase 1a dose escalation at higher dose levels to determine the optimal
therapeutic dose is advancing and currently ongoing at dose level 11 (12
mg).
-- The next Phase 1a clinical trial update with clinical data at relevant
dose levels in second-line or later (2L) melanoma is planned in 2025.
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