
TACTI-003 - Phase IIb clinical trial
Recruitment of 1st line head and neck squamous cell carcinoma (HNSCC) patients into the TACTI-003 trial continued in Q3 FY22. 21 patients out of approximately 154 have been enrolled into the trial. To date, 21 sites have been activated out of 30 sites. TACTI-003 is a Phase IIb multicentre, open label, randomised and controlled trial. It was granted fast track designation for 1st line HNSCC by the US FDA in 2021.
TACTI-002 (also designated KEYNOTE-PN798) - Phase II clinical trial
Immutep reported new interim data from patients with 2nd line metastatic NSCLC from the Phase II TACTI-002 trial in a poster presentation at ESMO’s European Lung Cancer Congress (ELCC) in March 2022. Efti, in combination with pembrolizumab, is showing an encouraging early overall survival rate of 73.7% at the six-month landmark, along with promising interim disease control and tumour growth kinetics. These early signs are supportive that efti may boost the body’s immune system to enable pembrolizumab to work more effectively in NSCLC patients that have progressive disease after 1st line treatment with anti-PD-1 or anti-PD-1 plus chemotherapy.
As announced yesterday, new interim data for 1st line NSCLC patients from TACTI-002 has been selected for a prestigious Oral Presentation at the American Society of Clinical Oncology’s (ASCO) 2022 Annual Meeting.
In addition, the Phase IIb TACTI-003 trial design will be presented in a Trial-in-Progress Poster Presentation. ASCO’s 2022 Annual Meeting will take place in-person and online from 3-7 June 2022 in Chicago, United States.
INSIGHT-003 - triple combination
Patient recruitment is ongoing for INSIGHT-003 which is an investigator-initiated Phase I trial taking place at the Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF), Germany. Already 10 out of a total of 20 patients with various solid tumours are now participating in the trial. The study is evaluating a triple combination therapy consisting of efti and an existing approved standard of care combination of chemotherapy (carboplatin) and an anti-PD-1 therapy. Interim results from the study are expected to be reported in 2022.
IMP761 Development Program for Autoimmune Disease
Immutep is continuing the required preclinical development evaluations of IMP761 prior to entering clinical trials. In addition, the Company’s contract development and manufacturing organisation partner, Northway Biotech is progressing development of a GMP-compliant manufacturing process of IMP761 to prepare the materials needed for the clinical trials.
Intellectual Property
In February 2022, Immutep was granted a new Australian patent protecting its intellectual property for therapeutic preparations comprising efti and an anti-PD-1 or anti-PD-L1 antibody, such as pembrolizumab, nivolumab, avelumab, durvalumab or atezolizumab.
The Company and its out-licensing partner for IMP701, Novartis, were granted a new patent by the Japanese Patent Office for LAG525 (IMP701) for the treatment of cancer. The new patent protects pharmaceutical
Immutep Limited, Level 33, Australia Square
264 George Street, Sydney NSW 2000
ABN: 90 009 237 889