Positive Initial Clinical Data Reported from Immutep’s Efti Combined with Radiotherapy and Checkpoint Inhibitor from Phase II Trial in Soft Tissue Sarcoma - Seite 2

Frédéric Triebel, M.D., Ph.D, Immutep’s Chief Scientific Officer, added: “We are pleased to see these early results from EFTISARC-NEO, which has allowed efti for the first time to be clinically evaluated in a non-metastatic cancer setting. The ability to evaluate tumour specimens is helping elucidate the significant anti-cancer immune response efti drives through its direct maturation and activation of antigen-presenting cells as an MHC Class II agonist. If the positive trend of strong pathological responses continues in this rare orphan disease, we will pursue all available avenues to bring this innovative therapy to soft tissue sarcoma patients in need of new, effective therapies in an expeditious manner.”

Efti’s targeting and unique activation of dendritic cells, the most potent professional antigen-presenting cells, as a MHC Class II agonist leads to broad adaptive and innate immunity to fight cancer, including proliferation of CD8+ cytotoxic T cells that can be armed with radiotherapy-induced tumour antigens. The combination of efti with radiotherapy and anti-PD-1 therapy has the potential to generate a robust anti-tumour immune response in the immunosuppressed tumour microenvironment of soft tissue sarcoma.

The open-label EFTISARC-NEO Phase II study will treat up to 40 patients and is being conducted by the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw. The trial is primarily funded with an approved grant from the Polish government awarded by the Polish Medical Research Agency program. The study’s primary endpoint is the pathologic response rate (defined as percentage of tumor hyalinization/fibrosis) to the treatment assessed at the time of surgical resection. The lower the number of viable tumor cells and the higher the extent of hyalinization/fibrosis observed in patients’ tumor specimens will determine the therapy’s effectiveness. For more information, visit clinicaltrials.gov (NCT06128863).

The trial is ongoing with 14 patients now enrolled and additional clinical data is planned to be presented at a medical conference in H2 CY2024.

About Soft Tissue Sarcoma
Soft tissue sarcoma (STS), an orphan disease, represents a high unmet medical need with a poor prognosis. The incidence of STS varies in different regions, with approximately 23,400 cases annually and a crude incidence of 4.7 per 100,000 in Europe, according to the RARECARE project. In the United States, the number of new cases is estimated to be 13,400 annually with 5,140 deaths, according to the American Cancer Society.