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Immutep Advances Towards Phase III Trial for Lung Cancer Treatment with Positive Regulatory Feedback

New York, December 27, 2023 – Immutep Limited (ASX: IMM; NASDAQ: IMMP), a trailblazing clinical-stage biotechnology company, has announced encouraging news from the Paul-Ehrlich-Institut (PEI), part of the Committee for Medicinal Products for Human Use (CHMP). This announcement marks a significant step forward in the company’s development of novel LAG-3 immunotherapies for cancer and autoimmune diseases.

Marc Voigt, CEO of Immutep stated, “We appreciate the valuable feedback from the PEI and look forward to additional discussions with other regulatory agencies in the coming months. Immutep is uniquely positioned to address multiple patient populations within non-small cell lung cancer as defined by their level of PD-L1 expression, including high, low, and negative expressors, with either efti combined with anti-PD-1 therapy or a triple combination approach including chemotherapy. Our confidence in efti’s ability in this important indication stems from the mature data in the large TACTI-002 Phase II trial, and the emerging data from the triple combination INSIGHT-003 study.”

Highlights:

Efti is being considered for use in combination with anti-PD-1 therapy, either as part of a chemotherapy-free regimen or in a triple combination that includes chemotherapy.

The PEI acknowledged efti’s good safety profile in combination with anti-PD-1 therapy.

Ongoing interactions with the U.S. Food and Drug Administration (FDA) and other European regulators are in process, with final trial design expected to be announced in Q1 of CY2024.

Efti, Immutep’s proprietary soluble LAG-3 protein, is recognized as a first-in-class antigen presenting cell (APC) activator and has received Fast Track designation from the FDA for first line treatment in HNSCC and NSCLC.

Earlier this month the company announced that it had received a €1,595,475 (~ A$2,628,354 ) research and development (R&D) tax incentive payment in cash from the French Government under its Crédit d’Impôt Recherche scheme (CIR).

About Immutep

Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune diseases. Pioneering the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), Immutep’s diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response.

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