Frequently asked Questions.

We are a clinical-stage biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, with operations in Australia, Europe and the United States.

We are the global leaders in Lymphocyte Activation Gene-3 (“LAG-3”), a cell surface molecule which plays a vital role in regulating T cells. Our objective is to harness and strengthen the power of patients’ own immune systems.

We have a diversified portfolio of cutting-edge immuno-oncology and targeted LAG-3 immunotherapy including three clinical stage candidates, one pre-clinical candidate, and one candidate that is early-stage. We also continue to assess new LAG-3 opportunities.

Our lead product is eftilagimod alpha (efti or IMP321), a first-in-class soluble LAG-3 protein that is an antigen presenting cell (APC) activator currently in a number of clinical trials, including for non-small cell lung cancer, head and neck squamous cell carcinoma, and breast cancer (see Clinical Trials).

IMP731 is a depleting antibody intended to destroy LAG-3 expressing activated T cells involved in autoimmunity, being developed by partner GlaxoSmithKline (GSK).

IMP701 is an antagonist antibody targeting the LAG-3 molecule on T cells with potential applications in the treatment of cancer, under development by our partner Novartis.

Our newest product candidate, IMP761, is an antibody against highly active immune cells in autoimmune diseases, currently in preclinical development.  

Immutep, formerly Prima BioMed, was originally created as a mining company (Prima Resources) in Australia in 1987, and was first publicly traded in 1988 on the Australian Stock Exchange. The Company was repositioned as a biotechnology company in 2001 following the acquisition of the rights to develop technologies from the Austin Research Institute (now the Burnet Institute), including CVac™, an immunotherapeutic product candidate.

On 2 October 2014, Prima BioMed announced the acquisition of Immutep SA, a private French biotechnology company.

The transaction was formalised at the Annual General Meeting of shareholders on 14 November 2014 and completed on 17 December 2014. On 1 December 2017, Prima BioMed changed its name to Immutep Limited following shareholder approval at the Annual General Meeting on 17 November 2017.

Immutep’s corporate headquarters are in Sydney, Australia. Immutep also has operations in Germany, France and the United States.

Immutep Limited (Immutep) is listed on the Australian Securities Exchange (ASX) under the ticker, IMM. The ASX is the home market of Immutep and the exchange on which its ordinary shares can be traded.

Immutep has a secondary listing on the NASDAQ under the ticker, IMMP. Immutep’s American Depositary Receipts (ADRs) are listed on the NASDAQ.

For more information on ADRs please visit www.adrbnymellon.com/resources/dr-basics

Each ADR represents 10 Immutep Limited ordinary fully paid shares. For further details on Immutep’s ADRs please visit https://www.adrbnymellon.com/?cusip=45257L108

LAG-3 stands for Lymphocyte Activation Gene-3 (LAG-3 or CD223), a protein which in humans is encoded by the LAG-3 gene. It is a cell surface molecule, which is involved in the regulation of T cells.

The LAG-3 protein controls the signaling between T cells and antigen presenting cells (APC’s). It has a unique dual mechanism of action, as an APC activator to stimulate the immune response and, in other applications, as a negative regulator of T cells to switch off the immune response.

In total, we have three clinical stage candidates, one pre-clinical candidate, and one candidate that is early-stage.

Our lead product candidate eftilagimod alpha (efti) is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

Our partnered product candidates include depleting and antagonist LAG-3 antibodies which are undergoing Phase I/II clinical trials. The newest product candidate IMP761 is under preclinical development, and we also have an early-stage small molecule anti-LAG-3 candidate.

We operate as a global company, and therefore, perform R&D in different countries. Clinical research is conducted in Australia, Europe and the United States, and we have a laboratory facility in Paris.

Our current development strategy is to focus on our LAG-3 programs in order to bring our product candidates to commercialisation, either through our own clinical trials or through our various commercial partnerships. This requires ongoing funding and as a clinical stage biotechnology company we continually assess opportunities for supporting our product pipeline and R&D activities.

We are a globally active biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. Active collaborations are an integral part of our business and we have a number of collaborations underway with various corporations and academic institutions including:

• Clinical trial collaboration and supply agreements with MSD (Merck US) and Merck KGaA (Darmstadt, Germany)
• License agreements with Novartis (LAG525), GlaxoSmithKline (GSK’781) and EOC Pharma (eftilagimod alpha in Greater China). The clinical-stage asset GSK’781 is being transitioned back to Immutep as the licensing agreement has been terminated with an effective date of 30 May 2024.
• Additional collaborations or agreements with Labcorp, Maria Skłodowska-Curie National Research Institute, Cardiff University, and Monash University.

Immutep owns or co-owns a total of 13 patent families covering its pipeline of product candidates. In particular, Immutep owns seven families covering eftilagimod alpha (efti).  Three of these families are directed to methods of treating cancer and infectious disease with efti alone, or in combination with chemotherapy, a therapeutic antibody acting via ADCC or a PD-1 / PD-L1 inhibitor. Another family is directed to triple combination with efti, chemotherapy and a PD-1/PD-L1 inhibitor, and two families are drawn to teh aspects of the AIPAC clinical trials. One further family is directed to a release assay associated with the manufacture of efti.

In addition, Immutep owns three patent families covering IMP761, and co-owns with Novartis two families covering LAG525. The two families covering LAG525 are exclusively licensed to Novartis. Immutep also co-owns a patent family covering GSK'781. This family is co-owned with the National Institute for Health and Medical Research (INSERM) and has been exclusively licensed to GSK.

Efti is Immutep’s proprietary soluble LAG-3 clinical stage candidate that is a first-in-class antigen-presenting cell (APC) activator that stimulates both innate and adaptive immunity for the treatment of cancer. Efti binds to and activates antigen presenting cells via MHC II molecules leading to expansion and proliferation of CD8+ (cytotoxic) T cells, CD4+ (helper) T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

• Eftiagimod alpha, known as efti or IMP321, is a soluble LAG-3 protein targeting a subset of major histocompatibility complex class II (MHC class II) on antigen presenting cells. It is potentially synergistic with other therapeutic agents, e.g. immuno-oncology agents or chemotherapies.

• The combination of efti and chemotherapy amplifies the immune system response using the antigens released by dying tumour cells induced by chemotherapy.
• The chemotherapy causes the so called “immunogenic” death of tumour cells which results in the release of tumour specific proteins (antigens). These antigens can be taken up by a specific type of immune cells (called antigen presenting cells) and presented to cytotoxic T cells leading to an immune response in the body against other cancer cells.