Immutep's Groundbreaking FDA Update on Eftilagimod Alfa for Cancer

Immutep's Positive Path Forward with Eftilagimod Alfa

In an exciting development for cancer treatment, Immutep Limited (ASX: IMM; NASDAQ: IMMP) has recently received encouraging feedback from the U.S. Food and Drug Administration (FDA). This feedback pertains to the clinical development of their leading immunotherapy candidate, Eftilagimod Alfa, particularly aimed at addressing the needs of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose PD-L1 expression is below the threshold level of one.

FDA's Support for the Combination Treatment

The FDA has expressed its support for the ongoing clinical trials of Eftilagimod Alfa in combination with KEYTRUDA, the well-known anti-PD-1 therapy developed by Merck & Co., Inc. This is particularly significant as it underscores the high unmet medical need in the patient cohort expressing low PD-L1 levels. Immutep's Phase IIb trial, TACTI-003, has shown promising results, and this new affirmation from the FDA is a crucial step toward improving treatment options for these patients.

Paths for Future Clinical Development

Looking ahead, Immutep is set to explore various paths for clinical development. The combination therapy could either proceed with a robust randomized trial to evaluate its effectiveness against existing standard treatments or follow a more streamlined approach with a smaller single-arm study. This could include 70 to 90 patients, focusing on key outcomes such as safety, response rates, and the duration of the therapeutic effects.

CEO's Optimistic Outlook

Marc Voigt, CEO of Immutep, shared his excitement regarding the FDA's feedback. He stated that the recognition of the high unmet need for effective treatments in patients with low PD-L1 levels validates their work and mission. Immutep is now poised to strategize around collaborative clinical development initiatives that could yield significant benefits for patients.

Focus on Non-Small Cell Lung Cancer

While this is a thrilling update for head and neck cancer patients, Immutep remains committed to its ongoing TACTI-004 Phase III trial, which is focusing on Eftilagimod Alfa as a first-line therapy for non-small cell lung cancer. The consistent positive feedback from physicians regarding this trial has been encouraging, showing Immutep’s dedication to expanding its therapeutic impact.

Understanding Project FrontRunner

The FDA's Project FrontRunner initiative is an important backdrop to this development. This program aims to support earlier-stage clinical proposals for advanced and metastatic cancer drugs, encouraging sponsors to pursue approvals in a more timely manner. The focus is on delivering new therapies that can significantly enhance patients' overall quality and quantity of life, particularly for those who have limited options remaining.

High Unmet Need in Head and Neck Cancer

The cancer population represented by HNSCC patients with a Combined Positive Score (CPS) below one is considerably underserved. Research indicates that nearly 20% of first-line HNSCC patients fall into this category, and current treatments typically involve chemotherapy. Immunotherapy has catalyzed significant advancements in cancer treatment, but options remain scarce for this particular patient group.

About Immutep

Immutep is a prominent biotechnology company dedicated to pioneering novel immunotherapy treatments for patients grappling with cancer and autoimmune diseases. Their expertise in Lymphocyte Activation Gene-3 (LAG-3) forms the cornerstone of their innovative approach, which aims to harness the immune system more effectively. By continually seeking developments in therapeutic potentials, Immutep strives to offer new hope to patients in need while maximizing value for its shareholders.

Contact Information for Investors

For inquiries related to Australian investments, please reach out to Eleanor Pearson at Sodali & Co. via phone at +61 2 9066 4071 or email at eleanor.pearson@sodali.com. For U.S. investor inquiries, contact Chris Basta, VP of Investor Relations, at +1 (631) 318 4000 or chris.basta@immutep.com.

Frequently Asked Questions

What is Eftilagimod Alfa?

Eftilagimod Alfa is an immunotherapy developed by Immutep which targets specific cancer types, enhancing the body's immune response to fight cancer cells.

How does Immutep plan to use FDA feedback?

The FDA's feedback will shape Immutep's strategy in the clinical development of Eftilagimod Alfa, especially regarding further testing protocols and pathways toward possible approval.

What is the significance of CPS levels in cancer treatment?

CPS levels indicate the expression of PD-L1, a protein that plays a crucial role in immune response. Lower CPS levels are associated with high unmet medical needs.

What is KEYTRUDA?

KEYTRUDA is a PD-1 inhibitor used in cancer therapy developed by Merck & Co. It has shown effectiveness but is mainly approved for patients with high PD-L1 expression.

How is Immutep expanding its research?

Immutep is planning various clinical trials to develop Eftilagimod Alfa for both head and neck cancer and non-small cell lung cancer, enhancing their therapeutic spectrum.

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