Immutep reveals commencement of vital phase 2 trial

Efti’s targeting activation of antigen-presenting cells delivers an adaptive immunity to fight cancer

Immutep – a company concentrating on novel LAG-3 immunotherapies for cancer and autoimmune conditions – has announced the beginning of an open-label phase 2 trial researching eftilagimod alpha (efti).

The therapy is a soluble LAG-3 protein and MHC Class 2 agonist used in tandem with pembrolizumab and radiotherapy in up to 40 soft tissue sarcoma (STS) patients within the pre-surgery setting.

The investigator-initiated study – EFTISARC-NEO – will be largely financed by the Maria Skłodowska-Curie National Research Institute of Oncology, with an approved grant from the Polish government awarded by the Polish Medical Research Agency programme. Meanwhile, Immutep will provide efti and wider technical support at no cost.

Efti’s targeting activation of antigen-presenting cells, via MHC Class 2 molecules, delivers an adaptive and innate immunity to fight cancer. Combining efti with radiotherapy and the anti-PD-1 therapy pembrolizumab has the potential to deliver a robust anti-tumour immune response in the immunosuppressed tumour microenvironment of STS.

Immutep chief executive officer, Marc Voigt, was confident that the trial will yield positive results: “Efti’s unique potential to help safely drive superior clinical efficacy for cancer patients, with and without the use of chemotherapy, is attracting increasing attention from industry and academia.”

He added: “We are delighted to see efti and pembrolizumab, which together have led to deep and durable responses in several difficult-to-treat advanced solid tumours, being combined with radiotherapy for the first time and hope this approach can make a difference for soft tissue sarcoma patients who have limited treatment options.”

Dr Paweł Sobczuk, part of the team leading the study, concluded: “We are excited to begin this chemotherapy-free study combining radiotherapy with the novel immunotherapy, eftilagimod alpha, and pembrolizumab.

“Given efti’s synergistic effects with immune checkpoint inhibitors and its ability to arm, activate, and proliferate cytotoxic T cells with radiotherapy-induced cancer antigens, this combination has a strong foundation to drive effective immunity against soft tissue sarcoma, a rare and aggressive disease in immense need of new therapeutic approaches.”

The prevalence of STS varies in different regions, with approximately 23,400 cases annually and a crude incidence of 4.7 per 100,000. Across the US. The number of new STS cases is estimated to be 13,400 annually.