ALKS 4230, which was formerly referred to as RDB 1450, a novel selective effector cell activator protein designed to preferentially bind and signal through the intermediate affinity interleukin-2 (IL-2) receptor complex.
It selectively activates and increases the number of immunostimulatory tumor-killing immune cells and prevents the expansion of immunosuppressive cells that interfere with anti-tumor response.
Under the multi-center phase 1 study, Alkermes will assess the safety, tolerability and immunological-pharmacodynamic effects of ALKS 4230 in the treatment of patients with solid tumors.
The company will carry out the in two stages that include a dose-escalation stage and a dose-expansion stage.
The first stage of the trial is designed to identify a maximum tolerated dose, and the maximum dose range of ALKS 4230 depending on measures of immunological-pharmacodynamic effects.
The dose-eexpansion stage would assess ALKS 4230 in patients with selected solid tumor types.
First results from the initial stage of the phase 1 trial are anticipated in 2017.
Alkermes chief medical officer Elliot Ehrich said: "ALKS 4230 is a unique immuno-oncology candidate that is designed to harness the IL-2 mechanism in a selective way that enhances tumor-killing immune cells, so that a patient’s own immune system can be activated in order to fight cancer more effectively.
"We have designed this initial clinical study of ALKS 4230 to be highly informative and to position us for phase 2 studies, including those that may include ALKS 4230 in combination with other immuno-oncology therapies.
Image: Alkermes Corporate Headquarters at Connaught House in Dublin, Ireland. Photo: courtesy of Alkermes.