Immutep Receives Major Regulatory Boost from European Medicines Agency: Positive Scientific Advice Given

Immutep, formerly known as Prima Biomed, is ecstatic to announce a major milestone today in the development of eftilagimod alpha (efti). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given the green light for the continued development of the Company’s soluble LAG-3 protein and first-in-class MHC Class II agonist, offering a glimmer of hope to those with cancer and autoimmune diseases. This is a triumph for Immutep, which is committed to developing novel, breakthrough immunotherapies.

In May 2023, Immutep sought the sage advice of the EMA regarding the future development of their novel drug, efti. Both the EMA and FDA agreed, based on the available clinical data and the acknowledgement that additional studies in animal models were unlikely to be useful, that no further toxicology studies were required in order to submit a future Marketing Authorization Application (MAA) in Europe or a Biologics License Application (BLA) in the United States.

Immutep remains encouraged by the ongoing dialogue it is having with the regulatory authorities regarding its ever-expanding late-stage clinical pipeline, which recently received very positive feedback from the FDA. Notably, Immutep is readying the TACTI-004 Phase III trial for first line non-small cell lung cancer and has already initiated dosing in the AIPAC-003 Phase II/III trial for metastatic breast cancer in the second quarter of this year, providing a great boost in confidence.

About Scientific Advice

The European Medicines Agency (EMA) offers a valuable service to medicine makers: the Scientific Advice Procedure. This procedure provides clarification and guidance to expedite the development of effective, safe and quality medicines – all for the benefit of patients. While its advice is not legally binding, it offers sound advice based on the present scientific knowledge that could contribute to successful and timely market authorizations.

About Eftilagimod Alpha (Efti)

Immutep’s Efti is revolutionizing cancer therapy by its transformative ability to stimulate both innate and adaptive immunity. Acting as an antigen-presenting cell (APC) activator, it binds to the major histocompatibility complex (MHC) Class II molecules on the APC, triggering the proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. This remarkable protein also upregulates the expression of key biological molecules such as IFN-γ and CXCL10 to further enhance the body’s cancer-fighting power. Efti provides a new hope and potential for cancer sufferers, globally.

Efti is an exciting new therapeutic option for many solid tumours, such as NSCLC, HNSCC, and metastatic breast cancer. Its impressive safety profile and the potential to combine it with anti-PD-[L]1 immunotherapy and/or chemotherapy has earned it Fast Track Designation from the FDA in both 1st line HNSCC and NSCLC. This new treatment can offer hope to those battling cancer.

About Immutep

Immutep is at the cutting-edge of biotechnology, pioneering the development of novel LAG-3 immunotherapy for treating cancer and autoimmune diseases. Our unique product portfolio is designed to take advantage of the powerful immune-modulating properties of Lymphocyte Activation Gene-3 (LAG-3), enabling us to stimulate an immune response or suppress it as needed. We are committed to providing life-changing treatments to those who need it, as well as delivering value to our shareholders.

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