Immutep Limited (ASX:IMM; NASDAQ:IMMP), a biotechnology firm specialising in novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases, announced its Quarterly Activities Report and Appendix 4C for Q4 FY23. The report highlights significant progress in late-stage and registrational trials, along with positive clinical results for eftilagimod alpha (efti) in various trials.
Late-stage & Registrational Trial Progress:
TACTI-004 Phase III: The US FDA provided positive feedback for the planned registrational trial in 1st line non-small cell lung cancer (1L NSCLC).
TACTI-003 Phase IIb: The randomised study in 1st line head & neck squamous cell carcinoma (1L HNSCC) achieved approximately 91% patient recruitment, and top-line results are expected in the second half of CY2023.
AIPAC-003 Phase II/III: The first patient was dosed in the metastatic breast cancer trial.
Positive Eftilagimod Alpha Clinical Results:
TACTI-002 Phase II: The trial evaluating efti + KEYTRUDA® (pembrolizumab) in 1L NSCLC patients with >1% PD-L1 TPS showed an initial Overall Survival (OS) benefit of 25 months. More mature data will be presented in the second half of CY2023.
TACTI-002 Phase II (2L HNSCC): Final results presented at ASCO 2023 exhibited promising response rates, overall survival, and durable responses, including a Complete Response in a patient with negative PD-L1.
INSIGHT-003 Phase I: Evaluating efti + KEYTRUDA® + doublet chemo in 1L NSCLC, despite 81% of patients having low or negative PD-L1 expression, achieved a 67% response rate and 91% disease control rate.
Efti Trial Expansion:
INSIGHT-005: Regulatory approval granted to initiate the investigator-initiated trial in urothelial carcinoma.
EFTISARC-NEO: Investigator-initiated trial commenced in soft tissue sarcoma.
Immutep maintains a strong cash position of $123.4 million, following an A$80 million capital raise. The funds will be utilised for registrational and late-stage trials of efti and potentially a first-in-human trial for IMP761, extending the cash runway to early CY2026.
Immutep’s CEO, stated, “Our late-stage and registrational trial programs continue to progress well, and we are pleased to see positive clinical results for efti in various trials. Our strong financial position enables us to advance our development programs and bring promising immunotherapy treatments closer to patients in need.”
Immutep remains committed to advancing its product candidates and developing innovative immunotherapies to address unmet medical needs in cancer and autoimmune diseases.