On June 13, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported that 17 patients have been enrolled into the first cohort of the first line non-small cell lung cancer (NSCLC) arm (Part A) of the Phase II TACTI-002 clinical trial (Press release, Immutep, JUN 13, 2019, View Source [SID1234537060]). This completes patient recruitment of the initial cohort of the study Part A. TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Patient enrollment for TACTI-002 commenced in early 2019, with the first patient being dosed in March 2019.
Under the Simon’s two-stage design, the initial cohort of first line NSCLC patients may be enlarged by a further 19 patients, if a pre-defined number of responses are observed. Ten study centers are now recruiting patients into the trial across the U.S., Europe and Australia, with three additional sites expected to commence recruitment in the coming months.
Dr Frederic Triebel, Immutep CSO and CMO, commented, "Efti has a unique mode of action. As an antigen presenting cell activator, it is successful in activating dendritic cells that process and present antigens for recognition by the T cell receptor on T lymphocytes. Efti is the only antigen presenting cell activator targeting MHC class II molecules currently in clinical development, setting it apart from other immuno-oncology therapies in the landscape.
It is very encouraging that we are achieving such positive traction with recruitment for our TACTI-002 study of efti, which commenced dosing patients just over three months ago. We expect to report the first data from this trial in mid-2019."
Recruitment is ongoing for the initial cohorts of the 2nd line NSCLC and 2nd line HNSCC of the Phase II TACTI-002 clinical trial. These cohorts may also be enlarged if a pre-defined number of responses are observed.
About TACTI-002 Phase II Trial
TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of Immutep’s lead product candidate eftilagimod alpha ("efti" or "IMP321") with MSD’s KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line. The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multi centre clinical study that is taking place in up to 13 study centres across the U.S., Europe and Australia.