Immutep Quarterly Activities Report - Seite 3

Phase II Clinical Trial in Head and Neck Cancer
The encouraging results reported by Immutep at SITC in patients with 2nd line HNSCC prompted the Company to announce its intention to run a new randomised, controlled phase II clinical study in approximately 160 1st line HNSCC patients which is a more commercially relevant indication. Patients will be 1:1 randomised to receive efti in combination with an anti-PD-1 treatment, or anti-PD-1 monotherapy. The trial is intended to take place across clinical trial sites in the United States, Australia and Europe.

Immutep is continuing planning for this new trial and will announce further details in due course.

TACTI-mel - Phase I clinical trial
The results of Immutep’s phase I TACTI-mel trial were recently published in the peer-reviewed Journal for ImmunoTherapy of Cancer. TACTI-mel evaluated efti in combination with pembrolizumab in metastatic melanoma patients.

EAT COVID – Phase II clinical trial
The University Hospital Pilsen in the Czech Republic has commenced an investigator-initiated randomised phase II clinical trial evaluating efti in up to 110 hospitalised patients with COVID-19. Recruitment of patients commenced in October 2020.

Initial results from the safety run in of the trial are expected to be reported in early 2021 with initial interim efficacy results in 2021.

IMP761 Update

IMP761, a LAG-3 agonist antibody, is Immutep’s preclinical candidate for autoimmune disease. The Company is continuing cell line and other preclinical development for IMP761 in preparation for clinical trials.

Partner Updates

EOC Pharma - Phase II clinical trial
EOC Pharma announced its plans to conduct a new trial in December 2020, following Immutep’s announcement of encouraging first OS data from its Phase IIb study, AIPAC (see above).

Approximately 152 patients will participate in EOC Pharma’s clinical trial which evaluates efti in combination with chemotherapy and is fully funded by EOC.  EOC Pharma is the exclusive licensee of efti for the Chinese market. The ethics committee of the leading clinical site has already approved the study.

GlaxoSmithKline 
As announced today, GSK has stopped its phase II clinical trial evaluating GSK2831781 (derived from Immutep’s IMP731 antibody) in ulcerative colitis based on the assessment of clinical data as part of a planned interim  analysis  conducted in consultation with the trial’s Data Review Committee. GSK is conducting further reporting, assessment and analyses of the efficacy and safety data and evaluating the biology to determine next steps for the GSK2831781 development program. Immutep’s collaboration with GSK remains in place and GSK2831781 continues to be under an exclusive license with GSK. The discontinuation of the GSK trial has no impact on Immutep’s three other product candidates all of which have different mechanisms of action, including its lead product candidate eftilagimod alpha. Immutep’s cash runway is also unimpacted.