Immutep's Q4 FY24 Clinical Milestones and Corporate Progress

Immutep Limited, a clinical-stage biotechnology company, announced significant developments in its quarterly update for Q4 FY24. The company has been making strides in the development of its novel LAG-3 immunotherapies for cancer and autoimmune diseases. Below are some key highlights from their recent activities and clinical trials:

TACTI-004 Phase III Trial in Non-Small Cell Lung Cancer (NSCLC)

In June 2024, Immutep entered into a pivotal clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc.). This agreement will evaluate eftilagimod alfa (efti) in combination with MSD’s KEYTRUDA® (pembrolizumab) and chemotherapy for the first-line treatment of metastatic non-small cell lung cancer (1L NSCLC). The TACTI-004 Phase III trial will include approximately 750 patients and aims to address the entire 1L NSCLC market eligible for anti-PD-1 therapy. Notably, Immutep retains commercial rights to efti while MSD supplies KEYTRUDA.

Positive Clinical Data from Other Trials

1. TACTI-003 Phase IIb in Head and Neck Squamous Cell Carcinoma (HNSCC):
During the quarter, positive topline results were reported from the TACTI-003 Phase IIb trial. Efti combined with KEYTRUDA showed higher overall response rates compared to KEYTRUDA monotherapy, across all levels of PD-L1 expression. In particular, patients with high PD-L1 expression (CPS ≥20) exhibited a 31.0% objective response rate (ORR) and a 75.9% disease control rate (DCR).

2. AIPAC-003 Phase II/III in Metastatic Breast Cancer:
Immutep presented encouraging efficacy and safety data from the AIPAC-003 trial at the ESMO Breast Cancer 2024 conference. The trial's safety lead-in phase, which included the first-ever 90mg dosing of efti combined with paclitaxel, showed a 50% overall response rate and a 100% disease control rate in six metastatic breast cancer patients.

3. INSIGHT-003 Trial in Non-Squamous NSCLC:
The INSIGHT-003 trial continues to enrol patients, with 43 out of 50 enrolled to date. This trial evaluates a triple combination therapy of efti, chemotherapy (carboplatin and pemetrexed), and pembrolizumab.

4. EFTISARC-NEO Phase II in Soft Tissue Sarcoma:
Initial data from the EFTISARC-NEO trial, which combines efti with radiotherapy and KEYTRUDA, demonstrated no new safety concerns and encouraging efficacy. Four out of six patients showed near-complete pathological responses.

Regulatory and Corporate Developments

Immutep received positive regulatory feedback from both the Spanish Agency for Medicines and Health Products (AEMPS) and the U.S. Food and Drug Administration (FDA) regarding the TACTI-004 trial. Additionally, an exclusive license agreement was signed with Cardiff University for the development of an orally available small molecule anti-LAG-3 therapy for cancer treatment.

Financial Overview

Immutep successfully completed an A$100.2 million equity underwritten financing in the quarter, extending its cash runway to the end of 2026. The company's cash, cash equivalents, and term deposits total approximately A$181.8 million. Operating expenses included $7.4 million in net cash outflows, with significant allocations for advancing clinical trial programs.

Immutep’s Mission

As pioneers in the understanding and development of LAG-3 immunotherapies, Immutep aims to leverage its expertise to bring innovative treatment options to patients. The company continues to focus on expanding its clinical programs and delivering value to shareholders.

Overall, Immutep's recent activities highlight its commitment to advancing its pipeline of LAG-3 therapies, with significant progress in various clinical trials and strong financial positioning to support its future endeavors.

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