Immutep Announces Investigator-Initiated Phase II Trial Evaluating LAG3 Candidate Eftilagimod Alpha (Efti) in Soft Tissue Sarcoma

Posted: 6 September 2022

  • Expansion of the efti clinical development pipeline with a new Phase II setting
  • Efti Phase II trial awarded €1.5M (~A$2.2M) in funding as part of the Polish Medical Research Agency program funded by the Polish government
  • Collaboration with the Maria Skłodowska-Curie National Research Institute to evaluate efti in triple combination with Keytruda (pembrolizumab) and radiotherapy, followed by surgery
  • First patient dose anticipated by H1 2023

SYDNEY, AUSTRALIA – 6 September 2022 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), is pleased to announce it has signed a Material Transfer Agreement (“Agreement”) with the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland to enable an investigator-initiated open label Phase II clinical trial. The trial will evaluate Immutep’s lead product candidate efti in combination with pembrolizumab and radiotherapy in the neoadjuvant setting (prior to surgery) in up to 40 patients with select soft tissue sarcoma (STS).

Immutep CEO, Marc Voigt, said: “We were delighted to be approached by Dr Paweł Sobczuk and Dr. Katarzyna Kozak to form this collaboration with the Maria Skłodowska-Curie National Research Institute of Oncology to explore the potential of efti in combination with pembrolizumab and radiotherapy in soft tissue sarcoma. We thank the Polish government for granting €1.5M in non-dilutive cash funding for this trial. Recurrence and lack of deep and durable responses are challenges with the limited standards of care available for this rare and difficult-to-treat disease. Efti’s novel mechanism of action offers potential to enhance anti-tumour responses for these patients. This latest expansion of the efti pipeline is further evidence of the increased interest from a variety of interested parties to investigate the broad potential of efti to improve patient outcomes in yet another cancer indication and treatment regimen.”

Immutep CSO and CMO, Dr Frederic Triebel said: “Efti stimulates the immune system through a differentiated mechanism that targets LAG-3-driven activation of antigen-presenting cells. By working upstream of T cells, efti has potential to generate a broad and robust anti-tumour immune response even in the immunosuppressed tumour microenvironment of soft tissue sarcomas. Therefore, we are very pleased to be collaborating with our colleagues at the Maria Skłodowska-Curie National Research Institute of Oncology.”

Maria Skłodowska-Curie National Research Institute of Oncology, Medical Oncology Fellow and Co-Principal Investigator, Dr. Paweł Sobczuk said: “The need for new approaches in this rare and aggressive disease is evident by the still dismal responses with current standards of care including surgery, radiotherapy and chemotherapy. Clinical data in other solid tumours suggest that efti can synergize with radiotherapy and pembrolizumab for robust responses across PD-L1 status, supporting the potential of this combination to mount effective immunity against aggressive malignancies like soft tissue sarcoma and replace the need for chemotherapy.”

Full ASX announcement for further detail.


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