Full Press Release Details
Immatics Announces Full Year 2024 Financial Results
Texas and Tuebingen, Germany, March 27, 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
All amounts translated using the exchange rate published by
the European Central Bank in effect as of Month 31, 2024 (1 EUR = 1.0389 USD).
business update and reported financial results
for the quarter and full year ended December 31, 2024.
"2025 will be marked by milestones across
our TCR-T and TCR Bispecifics clinical portfolio, including advancing two of our main objectives for this year: firstly, reporting data
on solid cancer types beyond melanoma, such as ovarian cancer, head and neck cancer and others and secondly, demonstrating that our next-generation,
half-life extended TCR Bispecifics can deliver meaningful response rates in advanced solid cancer patients," said Harpreet Singh,
Ph.D., CEO and Co-Founder of Immatics. "Additionally, the initiation of SUPRAME, the Phase 3 trial for our lead TCR-T cell therapy,
IMA203, represents a transformative step in Immatics' journey towards becoming a commercial-stage enterprise. We believe IMA203 offers
patients and their treating physicians a cell therapy with impressive response rates and favorable tolerability in advanced melanoma.
Notably, it requires no surgery or biopsy, has a fast turnaround time and a high manufacturing success rate. We are committed to rapidly
delivering the first TCR therapeutic targeting PRAME to the market and to cancer patients, serving their unmet medical needs."
Full Year 2024 and Subsequent Company Progress
Cell Therapy Programs
ACTengine IMA203 (PRAME)
IMA203 is Immatics' lead TCR-T 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 TCR therapeutic targeting PRAME to enter the market. In parallel, Immatics is priming its in-house, state-of-the-art
TCR-T manufacturing facility to serve its planned commercial supply. In addition to 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 EU52 is ~7,300 plus ~1,300 uveal
melanoma patients in the US and EU5.
Clinical and commercial development plan
for ACTengine IMA203 TCR-T
Based on the positive
Phase 1b clinical data presented in 2024 and supported by the FDA
RMAT designation3, Immatics has advanced its lead TCR-T product candidate,
IMA203 targeting PRAME, into a randomized-controlled Phase 3 trial, called "SUPRAME" (NCT06743126).
The trial commenced in December 2024. The first patient was randomized in the United States and enrollment continues as planned.
France, Germany, Italy, Spain, United Kingdom.
3 Includes all benefits of
Breakthrough Therapy Designation.
SUPRAME is a prospective, multicenter, open-label,
randomized-controlled Phase 3 clinical trial evaluating the efficacy, safety and tolerability of IMA203 TCR-T in patients with unresectable
or metastatic cutaneous melanoma who have received prior treatment with a checkpoint inhibitor. 360 HLA-A*02:01-positive patients will
be randomized 1:1 to treatment with IMA203 or investigator's choice of selected approved treatments in the 2L setting (nivolumab/relatlimab,
nivolumab, ipilimumab, pembrolizumab, lifileucel (US), chemotherapy). Based on the Company's discussions with the FDA, the primary
endpoint for seeking full approval will be blinded independent central review ("BICR")-assessed (RECIST v1.1) progression-free
survival (PFS). Given the expected median PFS of 2-3 months in this patient population4, as well as the median PFS of
6 months (> 1 year in patients with deep responses) observed in the data from the IMA203 Phase 1b trial, the Company has determined
that utilizing PFS as the primary endpoint is the fastest pathway to seeking full approval and presents a more attractive commercial
positioning as compared to objective response rate (ORR). Secondary endpoints for the trial include ORR, safety, DOR, OS and patient-reported
The trial is planned to run internationally with
approximately 50 sites in the United States and Europe.
Patient enrollment for SUPRAME is forecasted to
be completed in 2026. A pre-specified interim data analysis will be triggered upon the occurrence of a defined number of events for PFS
(progressive disease or death)5 anticipated to occur after approximately 200 patients are enrolled in 1Q 2026. The final analysis
is planned for 4Q 2026. Immatics aims to submit a Biologics License Application (BLA) in 1Q 2027 for full approval and to launch IMA203
In addition to cutaneous melanoma, Immatics intends
to expand the IMA203 TCR-T opportunity to treat uveal melanoma patients and will continue to evaluate IMA203 in this patient population
through the ongoing Phase 1b trial.
2023, Diab et al., 2024
5 Centrally assessed by BICR
Manufacturing capabilities
Immatics' proprietary manufacturing process,
timeline, capabilities and facility support late-stage clinical and commercial cell therapy development and supply.
IMA203 products are manufactured from a patient's
leukapheresis (with no surgery required) within 7 days, followed by 7-day QC release testing at >95% success rate6 to achieve
the target dose (1-10x109 TCR-T cells). The Company's state-of-the-art ~100,000 sq. ft. R&D and GMP manufacturing
facility in the Houston Metropolitan Area was built with a modular design for efficient and cost-effective scalability (total of 8 manufacturing
suites, plus further expansion space) to serve early-stage and registration-directed clinical trials as well as planned commercial supply.
Through in-house manufacturing and QC testing, Immatics aims to better control the manufacturing process, shorten the turnaround time,
ensure the manufacturing success rate and quality of the product and realize potential cost efficiencies, including manufacturing capacity
optimization through scalability for a competitive and profitable commercial cell therapy product.
Clinical data on ACTengine
IMA203 TCR-T as of October 2024
On October 10, 2024,
Immatics provided a data update on IMA203 monotherapy in 28 heavily pretreated metastatic melanoma patients from the ongoing Phase 1b
dose expansion part of the clinical trial in which patients were treated at the recommended Phase 2 dose (RP2D, 1 to 10 billion total
As of the data cut-off on August 23, 2024, treatment
with IMA203 monotherapy in this melanoma patient population has demonstrated:
IMA203 monotherapy has maintained a favorable tolerability
profile with no treatment-related Grade 5 events in the entire safety population (N=70 Phase 1a and Phase 1b patients across all dose
levels and all tumor types).
Immatics plans to present updated clinical data
from the Phase 1b trial, including patients reported previously with longer follow-up and additional uveal melanoma patients, in 2025.
ACTengine IMA203CD8 TCR-T (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 PRAME-positive solid cancers beyond melanoma, starting with gynecologic cancers.
On November 8, 2024,
Immatics announced updated Phase 1 dose escalation clinical data on its next-generation ACTengine IMA203CD8 TCR-T cell
therapy in 44 heavily pretreated HLA-A*02:01 and PRAME-positive patients with solid tumors, thereof 41 patients being evaluable for efficacy.
Of note, these patients had been treated at substantially lower doses than IMA203 (GEN1), i.e. in a range of 0.2-0.48x109
TCR-T cells/m2 BSA (dose level 3) to 0.801-1.2x109 TCR-T cells/m2 BSA (dose level 4c) T cells infused.
As of the data cut-off on September 30, 2024, treatment
with IMA203CD8 monotherapy demonstrated:
IMA203CD8 monotherapy has maintained a manageable
tolerability profile in the 44 patients treated.
Based on the enhanced pharmacology of IMA203CD8
demonstrated in this trial, the evaluation of higher doses of IMA203CD8 in the ongoing dose escalation trial 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.
The next clinical data update including dose escalation
and ovarian cancer is planned in 2025.