Immatics NV (IMTX)

[FACT-MASTER]

IMTX: Form 6-k

https://ih.advfn.com/stock-market/NASDAQ/immatics-nv-IMTX/stock-news/92498872/form-6-k-report-of-foreign-issuer-rules-13a-16

EXCERPT 1:


Development path for IMA203 GEN1 and IMA203CD8 GEN2 monotherapies



The goal of Immatics’ development strategy is to make its cell therapies targeting PRAME available to the broadest possible solid cancer patient population with an initial focus on the US market. To achieve this, Immatics has announced a three-step development strategy for leveraging the full breadth of PRAME, a target that is highly expressed in various solid cancers.



1. Focus on IMA203 GEN1 in cutaneous melanoma (potentially bundled with uveal melanoma), targeted to enter a registration-enabling Phase 2 clinical trial in 2024. Discussions with FDA to align on patient population, clinical trial design and CMC aspects are ongoing under the RMAT designation achieved for IMA203 GEN1 in multiple cancer types including cutaneous and uveal melanoma. There are up to 3,300 HLA-A*02 and PRAME-positive cutaneous and


Immatics Press Release November 8, 2023 5 | 8


uveal melanoma last-line patients per year in the US. A next update on the clinical development plan is expected in the first quarter of 2024.



2. In parallel, commence dedicated dose expansion cohorts for signal finding in ovarian and uterine cancer, preferentially with IMA203CD8 GEN2. Enrollment of patients with these cancer types is already ongoing. There are up to 9,000 HLA-A*02 and PRAME-positive ovarian and uterine last-line cancer patients per year in the US.


3. The development of a broader tumor-agnostic label in PRAME+ solid cancers, including in NSCLC, triple-negative breast cancer, and others. This could leverage the full potential of PRAME across multiple solid cancer types.