Immutep enters clinical trial collaboration, raises $6.85m

Biotechnology company Immutep has entered into a clinical trial collaboration and supply agreement with Merck & Co (known as MSD outside the US and Canada), through a subsidiary, to evaluate the combination of Immutep’s lead immunotherapy product candidate, eftilagimod alpha (‘efti’ or ‘IMP321’), with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in several different solid tumours.

The trial will combine two immuno-oncology (IO) treatments with complementary mechanisms of action, analogous to releasing the brakes and pushing the accelerator of the body’s immune system at two different positions in the cancer immunity cycle. Immutep’s efti is an antigen-presenting cell (APC) activator which stimulates cancer-fighting T cells, while KEYTRUDA works by increasing the ability of the body’s immune system to help detect and fight tumour cells.

The Phase II clinical trial, referred to as TACTI-002 (Two ACTive Immunotherapies), will evaluate the safety and efficacy of this novel immunotherapy combination in patients with non-small cell lung cancer (NSCLC), head and neck cancer, or ovarian cancer. The clinical trial will be a Phase II, Simon two-stage, non-comparative, open-label, single-arm, multicentre clinical study. Up to 120 patients across the three indications are planned to be treated in medical centres in Europe and the US, with the trial expected to commence in the second half of 2018.

“This clinical trial will evaluate a novel combination of two complementary immuno-oncology treatments in three cancer indications simultaneously, which could lead to more rapid drug development subject to successful outcomes,” said Immutep CEO Marc Voigt. “The data generated thus far from our ongoing TACTI-mel clinical trial has supported our hypothesis that there is a compelling therapeutic synergy in administering efti in combination with another immuno-oncology treatment. This new Phase II clinical trial significantly builds on the momentum we are delivering in the evaluation of efti in cancer, with two Phase I clinical trials and now two Phase II clinical trials in our program for 2018.”

Immutep has separately announced a successful capital raise involving the placement of 326,192,381 new fully paid ordinary shares in the company to Platinum Investment Management Limited (trading as Platinum Asset Management) and Australian Ethical Investment Limited, former Immutep Chairman Lucy Turnbull AO and US healthcare institutional investors, including Ridgeback Capital Investments, at an issue price of $0.021 per new share, raising a total of $6,850,040 before transaction-related expenses.

The proceeds from the placement will be used to support Immutep’s ongoing and planned IO clinical development programs, its preclinical program in autoimmune disease and for general working capital purposes.

“It’s great to have the participation of leading Australian healthcare institutional investors Platinum and Australian Ethical in the capital raising, and we are pleased to welcome them to our share register,” said Voigt. “We are also encouraged by the continued support of our former chairman, Lucy Turnbull, and existing shareholder Ridgeback Capital Investments.

“The capital raising will help support our new combinatory IO-IO clinical trial, which we also announced earlier today, of efti in additional indications.”

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