https://transkript.de/artikel/2024/gute-datenlage-immatics-kann-direkt-in-phase-iii-gehen/ Good data situation: immatics can go directly into Phase III Tübingen-based Immatics NV published updated Phase Ib clinical data on ACTengine® IMA203, which allow for a more in-depth analysis compared to the last data update in May 2024. The data on progression-free survival (PFS) and overall survival (OS) are so convincing that the company can proceed directly with an approval-ready Phase III study on this basis. And Immatics is using the tailwind to place new shares for $150 million.
The data from the ongoing Phase 1b study have been eagerly awaited and will only be presented tomorrow by Dr. Martin Wermke at the Society for Melanoma Research Congress 2024. However, the Tübingen-based company Immatics NV is making it public earlier. The observation of significant tumor shrinkage and a lasting response in combination with meaningful results on progression-free survival and overall survival after a single treatment with ACTengine® IMA203, which Dr. Martin Wermke, coordinating investigator of the TCR-T study, will present there, are simply too impressive to keep quiet any longer.
"These results now confirm the therapeutic potential of IMA203 in this patient population, all of whom have exhausted multiple lines of systemic treatment. They demonstrate the impact IMA203 can have in patients with metastatic melanoma and provide a strong rationale for accelerating late-stage clinical development of this product candidate," said Wermke.
And that is the second important part of the advance announcement before the congress presentation: With the complete study data from Phase I, Immatics can go straight into a phase III study that is relevant for approval after consultation with the FDA. Recruitment will start soon, but the company expects that it will take around a year until enough study participants have been found, and then another year until the crucial data packages can be viewed in an interim analysis.
The Type D meeting with the US Food and Drug Administration (FDA) took place at the end of September. The study design for SUPRAME (Phase III) was discussed, in which IMA203, which targets PRAME, will be investigated in 360 HLA-A*02:01-positive patients with inoperable or metastatic melanoma in the second line or later (2L+) who were previously treated with a checkpoint inhibitor.
"We are excited about the clinical data as they confirm our belief in the durability and long-term efficacy of ACTengine® IMA203, as demonstrated by the favorable median progression-free survival of patients in the dose expansion cohort. I would like to highlight that a subset of 12 of the 26 patients had a reduction in tumor lesion size of more than 50% and a median PFS of 13.4 months," said Dr. Cedrik Britten, Chief Medical Officer at Immatics. "We believe that the presentation of this data set, coupled with our recent meeting with the FDA, which resulted in a pivotal study design with progression-free survival as the primary endpoint for full approval, positions us to significantly advance the development of IMA203."
The Tübingen-based cell therapy company is taking advantage of the tailwind and today announced the start of a subscribed public offering for its common shares. The volume is planned to reach 150 million US dollars, but this also depends a little on the current stock market situation. However, the data could also lead to increased interest.
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