Immutep Quarterly Activities Report Q2 FY24

Media Release

• Excellent clinical data reported from TACTI-002 Phase II trial, including median Overall Survival of 35.5 months in first line non-small cell lung cancer (1L NSCLC) patients expressing PD-L1 (TPS ≥1%)
• Promising efficacy and tolerability data reported from INSIGHT-003 Phase I trial, including a strong Overall Response Rate of 71.4% in 1L NSCLC patients
• Late-stage & registrational trial progress:
  • 1L NSCLC: constructive regulatory feedback received for registrational TACTI-004 Phase III trial
  • First line head and neck squamous cell carcinoma: enrolment completed for TACTI-003 Phase IIb trial, and first data expected in H1 CY2024
  • Metastatic breast cancer: safety lead-in portion of AIPAC-003 Phase II/III trial completed early, with no safety or tolerability issues reported enabling the randomized portion of trial to commence
• Preclinical studies of IMP761, the world’s first LAG-3 agonist to treat the underlying cause of autoimmune diseases, continued. The Company is planning to begin first-in-human trials by mid-CY2024.
• Well financed with a cash balance of A$103.7 million, providing cash runway to early CY 2026

SYDNEY, AUSTRALIA, Jan. 30, 2024 (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 31 December 2023 (Q2 FY24).

EFTI DEVELOPMENT PROGRAM FOR CANCER

TACTI-002 (KEYNOTE-PN798) – Phase II clinical trial in first line NSCLC
Immutep reported excellent new clinical data from the TACTI-002 trial evaluating efti in combination with KEYTRUDA (pembrolizumab) at the ESMO Congress in October 2023. A median Overall Survival (OS) of 35.5 months was reported in first line NSCLC patients expressing PD-L1 (TPS ≥1%). Encouragingly, for patients with low PD-L1 expression (TPS 1-49%) median OS was 23.4 months, for patients with negative expression (TPS<1%) median OS was 15.5 months, and a median OS has not yet been reached in patients with high PD-L1 expression (TPS ≥50%).