Immutep Quarterly Activities Report Q1 FY24

Media Release

• Excellent survival benefit in 1st line non-small cell lung cancer (1L NSCLC) in TACTI-002 trial: median Overall Survival of 35.5 months (TPS ≥1% patients) providing additional 12-18 months survival compared to historical data, reported post period
• Late-stage & registrational trial progress:
  • 1st line head & neck squamous cell carcinoma (1L HNSCC) - Phase IIb TACTI-003 trial recruitment progressing and expected to be complete in November 2023
  • 1L NSCLC - Preparations ongoing to commence Phase III TACTI-004 registrational trial in CY2024
  • Metastatic breast cancer (MBC) - Patient recruitment ongoing for Phase II/III AIPAC-003 trial, first safety data from the open-label safety lead-in portion expected to be reported in Q4 CY2023
• Strong Overall Response Rate in INSIGHT-003 of 71.4%, plus encouraging response rate of 70.6% for low or negative PD-L1 expressors in NSCLC comparing favourably to historical data, reported post period
• Efti trial expansion: First patient enrolled in EFTISARC-NEO Phase II trial in soft tissue sarcoma
• Well financed: Strong cash position of $110.1m, with cash runway to early CY2026

SYDNEY, AUSTRALIA, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, provides an update on the ongoing development of its product candidates, eftilagimod alpha (efti) and IMP761 for the quarter ended 30 September 2023 (Q1 FY24).

EFTI DEVELOPMENT PROGRAM FOR CANCER
In August 2023, Immutep received positive scientific advice from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the continued development of efti. The CHMP advised further toxicology studies are not needed for a future Marketing Authorisation Application (MAA) for efti in Europe. Similar advice was received from the US Food and Drug Administration (FDA) for a potential future Biologics License Application (BLA).

The Company also received regulatory authorisation in September 2023 for efti manufactured at commercial 2,000L scale for use in clinical trials across multiple European countries including Germany, Belgium, Denmark and the United Kingdom. This followed the successful scale up of the manufacturing process of efti (from the 200L process) to commercial scale at WuXi Biologics. Immutep will introduce efti manufactured by the 2,000L scale process into current and future clinical trials.