Global biopharmaceutical company Alkermes has begun a Phase l clinical trial of its immuno-oncology drug candidate, ALKS 4230, to treat patients with solid tumours.
ALKS 4230 is a new selective effector cell activator (SECA) protein designed to preferentially bind and signal through the intermediate affinity interleukin-2 (IL-2) receptor complex.
The drug then selectively activates and increases the number of immunostimulatory tumour-killing immune cells and avoids the expansion of immunosuppressive cells that interfere with anti-tumour responses.
The Phase l trial will be performed in two phases, firstly a dose-escalation stage, followed by a dose-expansion stage.
In the first phase of the trial, ALKS 4230 will be given as an intermittent intravenous infusion with increasing doses in patients with solid tumours who are refractory or intolerant to established therapies.
The first stage is designed to find out a maximum tolerated dose, and to recognise the optimal dose range of ALKS 4230 based on measures of immunological-pharmacodynamic effects.
After the identification of the optimal dose range of ALKS 4230 in the first phase of the trial, the dose-expansion stage of the trial will assess ALKS 4230 in patients with selected solid tumour types.
Initial results from the first stage of the Phase l trial are expected by next year.
Alkermes chief medical officer Dr Elliot Ehrich said: "ALKS 4230 is a unique immuno-oncology candidate designed to harness the IL-2 mechanism in a selective way that enhances tumour-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 ll studies, including those that may include ALKS 4230 in combination with other immuno-oncology therapies."