Immatics N.V., a clinical-stage biopharmaceutical company, has provided an update on its ongoing Phase 1 clinical trial involving its lead cell therapy candidate, ACTengine®
IMA203. This therapy targets
PRAME, a protein frequently expressed in various
solid cancers, and is being tested on patients with
metastatic melanoma who have undergone multiple prior treatments. The company has reported encouraging results from the trial.
As of April 25, 2024, the data indicate that IMA203 has demonstrated a confirmed objective response rate (cORR) of 55% among the 30 heavily pre-treated metastatic melanoma patients.
Tumor shrinkage was observed in 87% of the patients, showcasing the therapy's potential efficacy. The median duration of response (mDOR) was identified as 13.5 months, with 11 of the 16 confirmed responses still ongoing at the time of the data cut-off. The longest duration of response recorded exceeded 21 months post-infusion. The response rates remained consistent across different
melanoma subtypes, including
cutaneous and uveal melanoma.
IMA203 continues to maintain a favorable safety profile with no treatment-related grade 5 events reported among the 65 patients across all dose levels and tumor types. The therapy is currently being evaluated at the recommended Phase 2 dose (RP2D), which ranges from 1 to 10 billion total TCR-T cells.
Looking ahead, Immatics plans to commence a registration-enabling randomized Phase 2/3 trial for ACTengine® IMA203 in second-line or later (2L+) melanoma patients in 2024. This trial will target HLA-A*02:01-positive
cutaneous melanoma patients and potentially include those with uveal melanoma. The trial design is being developed in alignment with the FDA’s guidance and aims to streamline patient enrollment by not requiring PRAME pre-testing.
The company also provided updates on its second-generation product candidate,
IMA203CD8 (GEN2). This therapy involves co-transduction of PRAME-specific CD8+ and CD4+ cells, aiming to enhance pharmacological outcomes. Preliminary data from November 2023 showed a 56% cORR in nine patients, with a manageable tolerability profile. Immatics plans to continue dose escalation to determine the optimal dose for further development, expanding its clinical applications to
ovarian and uterine cancers.
Moreover, Immatics is advancing its T cell engaging receptor (TCER®) bispecific programs. These next-generation molecules are designed for an optimized dosing schedule and enhanced efficacy. Initial clinical data for TCER® candidates
IMA401 (targeting
MAGEA4/8) and
IMA402 (targeting PRAME) are expected in the second half of 2024. The IMA401 trial targets multiple solid tumors, including lung and ovarian cancers, while IMA402 is focused on melanoma and other solid tumors. Both programs aim to demonstrate tolerability, optimize dosing schedules, and show initial clinical anti-tumor activity.
On the financial front, Immatics completed a public offering in January 2024, raising approximately $201.5 million. As of March 31, 2024, the company reported cash and financial assets totaling $609.7 million, projected to fund operations into 2027. In the first quarter of 2024, Immatics reported revenue of €30.3 million, primarily due to the termination of a collaboration with
Genmab, and a net loss of €3.1 million, significantly reduced from the previous year’s €19.7 million loss.
Immatics continues to make progress in its clinical and corporate developments, positioning itself as a significant player in the field of T cell-redirecting cancer immunotherapies. The upcoming trials and data readouts are anticipated to further validate the efficacy and safety of their innovative therapies, potentially providing new treatment options for patients with challenging cancer types.
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