Australian biotech developer Immutep (ASX: IMM) has provided an update on the ongoing clinical development of its immunotherapy product efti, as well as its partnered clinical programs.
The company today announced it has recruited the final patient for Part B f its ongoing TACTI-mel Phase I clinical trial in Australia.
The TACTI-mel trial is evaluating the combination of the drugs eftilagimod alpha, referred to as “efti”, and pembrolizumab in metastatic melanoma patients.
The total number of patients participating in the study now stands at 24. These patients will be treated by the drug combination for a 12-month period.
According to Immutep, interim data reported from the first three cohorts indicated the treatment was delivering “long-lasting and durable responses in a subset of patients”.
The company said it was continuing to progress the relevant regulatory and ethics approvals required to commence its TACTI-002 Phase II clinical study, which is scheduled for the second half of this year.
Immutep announced its plans to conduct this trial in collaboration with US pharma giant Merck & Co back in March.
The study is expected to evaluate the efti-pembrolizumab combination in up to 120 patients with head and neck squamous cell carcinoma or non-small lung cancer. The trial will be conducted in up to 15 clinics across Australia, Europe and the US.
In addition, patient recruitment is continuing for Immutep’s AIPAC Phase IIb clinic trial, which will study the combination of efti with the drug paclitaxel on a planned 226 patients across Europe and the UK with hormone receptor-positive metastatic breast cancer.
A similar study is scheduled to begin in September in China, being conducted by Immutep’s Chinese partner EOC China.
Meanwhile, Immutep’s alliance partner GlaxoSmithKline has been developing GSK’781, which is a fully humanised monoclonal antibody derived from Immutep’s IMP731 antibody.
GlaxoSmithKline recently announced ulcerative colitis as the lead indication for GSK’781 and anticipates proof of concept data to become available in 2020.
Another partner, Novartis, has commenced one of two new Phase II clinical trials for LAG525, which has been derived from Immutep’s IMP701 antibody and will be tested in the treatment of triple-negative breast cancer and metastatic melanoma.
In a second announcement today, Immutep said it has been granted a patent in Canada covering its IMP731 antibody and its use in the treatment or prevention of organ transplant rejection and autoimmune disease.
This patent, which expires in April 2028, joins corresponding patents from the same family previously granted in Europe, Japan and the US.
The IMP731 antibody, developed by the company’s French subsidiary Immutep SAS, has been designed to specifically deplete potentially pathogenic, recently activated, LAG-3 expressing T cells that are enriched at the disease site in T-cell driven immune-inflammatory disorders.
LAG-3, or Lymphocyte Activation Gene-3, is a protein that is involved in regulating the immune system by controlling the signalling between specific immune cells.
Immutep shares slid 2.78% to A$0.035 following the double announcement but recovered back to A$0.036 by early afternoon trade.