Immutep expands clinical trial for lead drug candidate efti

Immutep ASX IMM clinical trial lead drug candidate eftilagimod alpha
Immutep’s immunotherapy research builds momentum with key read-outs expected in March.

Biotech company Immutep (ASX: IMM) intends to expand ongoing development of its lead drug candidate eftilagimod alpha, otherwise known as “efti”, after welcoming positive clinical data from its TACTI-002 and AIPAC studies.

The company said it plans to increase the number of patients included in the studies with recruitment already completed for the third stage of TACTI-002.

Efti is a soluble fusion protein based on a key immune control mechanism that is known to play a vital role in the regulation of the T-cell immune response.

Immutep is hopeful it can develop an effective drug or treatment that can successfully boost the immune system and impact solid tumours.

The company wields a series of drugs in its development pipeline but is focusing on efti within two distinctive studies looking into how the drug can be best deployed, as a supplement to other drugs and treatments.

Development in collaboration

Immutep is currently conducting a phase 2 clinical study in collaboration with US pharma giant Merck, evaluating the outcome of combining efti with Merck’s Keytruda product (alternatively known as pembrolizumab) in up to 109 patients with second-line head and neck squamous cell carcinoma or non-small cell lung cancer.

According to Immutep, its TACTI-002 study is seeking to combine the effects of two active immunotherapies as part of a two-stage, non-comparative, open-label, single-arm, multi-centre clinical study, taking place in 13 locations across the US, Europe and Australia.

In a statement earlier today, Immutep said that following a Data Monitoring Committee (DMC) decision, the biotech company is now keen to advance towards recruiting an additional 19 patients, thereby forming stage 2 of part C of the study, having already completed recruitment of 18 patients for stage 1.

The news follows on from Immutep expanding stage 1 of part A of the TACTI-002 study in September last year.

With developmental momentum growing as a result of confirmed partial responses, Immutep claims the study is “progressing well” with further trial data expected to be published before the end of March.

“The study is progressing well as the expansion of part C to include 19 additional patients with second-line HNSCC marks the second out of three parts of our TACTI-002 study to be expanded, having already observed the pre-determined number of partial responses in parts A and C patients,” said Immutep’s chief strategy and marketing officer Dr Frederic Triebel.

AIPAC on course to report

In parallel to its development of efti and ongoing trial with Merck, Immutep is also advancing its AIPAC clinical trial evaluating efti in combination with chemotherapy in 227 metastatic breast cancer patients in a randomised, double-blinded, placebo-controlled phase 2 clinical trial.

Immutep has reported that the first progression-free survival read-out is on track to be published by the end of the current quarter with March the most likely time for the company to inform the market of how efti performs with respect to treating breast cancer.

Following this morning’s company update, Immutep shares recorded gains of almost 4% after market open and was trading at $0.275.