Immutep Quarterly Activities Report Q3 FY24

Media Release

• First clinical data from the safety lead-in of AIPAC-003 in metastatic breast cancer shows 90mg dosing of efti safe and well tolerated: 50% overall response rate, including one patient reporting a complete response (complete disappearance of all lesions), and a 100% disease control rate
• Subsequent to quarter end announced a positive preliminary response rate of 26.9% in first line metastatic head and neck squamous cell carcinoma patients with negative PD-L1 expression
• Preclinical studies of IMP761 progressing to clinical trials mid-CY2024
• Anne Anderson joins as independent non-executive director on Immutep’s Board

SYDNEY, AUSTRALIA, April 29, 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 March 2024 (Q3 FY24).

EFTI DEVELOPMENT PROGRAM FOR CANCER

TACTI-002 (KEYNOTE-PN798) – Phase II clinical trial in 1L NSCLC
The TACTI-002 trial is ongoing with Immutep continuing to follow patients with 1L NSCLC (Part A) where, encouragingly, a median Overall Survival has not yet been reached in patients with high PD-L1 expression (TPS ≥50%). As previously reported at ESMO 2023, excellent median Overall Survival rates were seen across all levels of PD-L1 expression, including in patients expressing any PD-L1 (patients with a Tumor Proportion Score [TPS] of >1%) and patients with low PD-L1 expression (TPS 1-49%), with 35.5 months and 23.4 months reported respectively. Immutep has previously reported final data from Parts B and C of the TACTI-002 trial.

TACTI-003 (KEYNOTE-PNC34) – Phase IIb clinical trial in 1L HNSCC
The TACTI-003 multicenter Phase IIb trial evaluating efti in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) is ongoing with a total of 171 first line head and neck squamous cell carcinoma (1L HNSCC) patients enrolled. Cohort A evaluating efti in combination with KEYTRUDA as compared to KEYTRUDA monotherapy (randomised) involves 138 patients with PD-L1 positive (Combined Positive Score [CPS] ≥1) tumours and Cohort B (non-randomised) includes 33 patients with PD-L1 negative tumours.