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Immutep Announces Investigator-Initiated Phase II Trial Evaluating LAG-3 Candidate Eftilagimod Alpha (Efti) in Soft Tissue Sarcoma
SYDNEY, AUSTRALIA, Sept. 06, 2022 (GLOBE NEWSWIRE) -- 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 Sklodowska-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). Subject to the necessary approvals from the Polish State Institute for Drug Control and ethics committee, the dosing of the first patient is anticipated in the first half of calendar year 2023, with initial interim data expected in the fourth quarter of CY 2024. Under the Agreement, the Maria Sklodowska-Curie National Research Institute of Oncology will primarily fund the study with an approved grant from the Polish government of €1.5M (~A$2.2M) awarded by the Polish Medical Research Agency program. Immutep will provide efti at no cost to the Maria Sklodowska-Curie National Research Institute of Oncology and will technically support the trial. The trial will be led by Principal Investigators, Dr. Katarzyna Kozak, M.D. PhD., and Pawel Sobczuk, M.D., medical oncologists at the Department of Soft Tissue/Bone Sarcoma and Melanoma at the Maria Sklodowska-Curie National Research Institute of Oncology. Immutep CEO, Marc Voigt, said: “We were delighted to be approached by Dr Pawel Sobczuk and Dr. Katarzyna Kozak to form this collaboration with the Maria Sklodowska-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 governmentfor 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 Sklodowska-Curie National Research Institute of Oncology.” Maria Sklodowska-Curie National Research Institute of Oncology, Medical Oncology Fellow and Co-Principal Investigator, Dr. Pawel 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.” Efti’s Mechanism of Action About The Maria Sklodowska-Curie National Research Institute of Oncology About Immutep Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 fusion protein (LAG-3Ig), which is a first-in-class antigen presenting cell (APC) activator being explored in cancer. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease. Additional LAG-3 products, including antibodies for immune response modulation, are being developed by Immutep’s large pharmaceutical partners. Further information can be found on the Company’s website www.immutep.com or by contacting: Australian Investors/Media: U.S. Media: 
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