Full Press Release Details
ASX/Media Announcement
Immutep Announces Investigator-Initiated Phase II Trial Evaluating LAG3 Candidate Eftilagimod Alpha (Efti) in Soft Tissue Sarcoma
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 Sk odowska-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
Sk odowska-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 Sk odowska-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 Pawe Sobczuk, M.D., medical
oncologists at the Department of Soft Tissue/Bone Sarcoma and Melanoma at the Maria Sk odowska-Curie National Research Institute of Oncology.
Immutep CEO, Marc Voigt, said: We were delighted to be approached by Dr Pawe Sobczuk and Dr. Katarzyna Kozak to form this
collaboration with the Maria Sk odowska-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.
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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 Sk odowska-Curie National Research Institute of
Maria Sk odowska-Curie National Research Institute of Oncology, Medical Oncology Fellow and Co-Principal Investigator, Dr. Pawe 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
Efti is a first-in-class antigen presenting cell (APC) activator currently being developed by Immutep for the treatment of cancer. Efti binds to antigen presenting cells such as
dendritic cells, monocytes and macrophages via MHC II molecules. This activates the APCs causing them to become professional antigen presenting cells, thereby presenting antigen to the adaptive immune system. This leads to activation and
proliferation of CD4+ (helper) and CD8+ (cytotoxic) T cells. Thus, the aim of efti is to push the gas on the body s innate and adaptive immune systems making it a suitable candidate to evaluate not only for the treatment of cancer,
but also for the treatment of infectious diseases.
About The Maria Sk odowska-Curie National Research Institute of Oncology
The Maria Sk odowska Curie National Research Institute of Oncology is the leading Polish comprehensive cancer centre, as well as the primary government
research institution devoted solely to oncology. Founded in 1932 by Maria Sklodowska-Curie, it is currently divided into 28 specialised clinical departments responsible for the diagnostics and therapy of different tumour types such as: Breast Cancer
Clinic, Head and Neck Cancer Clinic, General and Visceral Surgery, Thoracic Surgery, Urology, Gynaecology, Haematology, Soft Tissue/Bone Sarcoma and Melanoma Clinic, Radiation Oncology, Brachytherapy and Diagnostic Radiology, Pathology and Molecular
Medicine and Cell Research. Oncology, Gastroenterology, Cancer Epidemiology and Prevention Division and others.
Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related
immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders.
Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.
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.
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264 George Street, Sydney NSW 2000
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:
Catherine Strong, Citadel-MAGNUS
McCarthy, LifeSci Advisors
+1 (212) 915.2564; tim@lifesciadvisors.com
This announcement was authorised for release by the Board of Immutep Limited.
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264 George Street, Sydney NSW 2000