Immutep Strikes Deal with Merck to Pair Product With Keytruda in Phase II Trial

Shares of Australia-based Immutep Limited jumped more than 22 percent this morning after the company announced it will pair its lead immunotherapy productwith Merck & Company’s blockbuster PD-1 inhibitor Keytruda to treat three solid tumor types in a single trial.

Immutep (Formerly known as Prima Biomed) and Merck struck a collaborative clinical trial and supply agreement to initiate a Phase II study of Immutep’s lead immunotherapy product candidate eftilagimod alpha (IMP321) with Keytruda to target multiple cancer types. The drugs will be paired to treat non-small cell lung cancer ("NSCLC"), head and neck cancer and ovarian cancer in the mid-stage trial.

The Phase II trial, dubbed TACTI-002 (Two ACTive Immunotherapies), will evaluate the safety and efficacy of the combination treatment. The trial, which will include up to 120 patients across the three indications, is expected to begin in the second half of 2018.

IMP321 and Keytruda have two complementary mechanisms of action that will push body’s immune response at two different points in the cancer immunity cycle, according to the release. Immutep’s efti is a first-in-class antigen presenting cell activator that stimulates cancer-fighting T-Cells. Keytruda, an anti-PD-1 therapy, works by increasing the ability of the body’s immune system to help detect and fight tumor cells.

Marc Voigt, chief executive officer of Immutep, said company leadership is "extremely pleased" to be working with Merck.

"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," Voigt said in a statement.

Data from Immutep’s ongoing TACTI-mel clinical trial has supported the company’s hypothesis that "there is a compelling therapeutic synergy in administering efti in combination with another immuno-oncology treatment," Voigt added.

In February Immutep said the Database Safety Monitoring Board confirmed that the combination of the two drugs is safe and well tolerated at doses up to 30 mg per injection in a Phase I TACTI-mel trial in unresectable or metastatic melanoma patients.

"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," he said.

On its own, Immutep is studying IMP321 in a Phase IIb trial in treating metastatic breast cancer. The trial is assessing the efficacy of the drug in combination with chemotherapy treatment paclitaxel.

In addition to its deal with Merck, Immutep announced Sunday that is raised $6.85 million through an institutional stock placement to Australian investors. The funds raised will be used to drive the company’s immuno-oncology development programs.

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