ALKS 4230 is a novel selective effector cell activator (SECA) protein developed to specially bind and signal through the intermediate affinity interleukin-2 (IL-2) receptor complex. These proteins harness a patient’s immune system to preferentially activate and increase the number of tumor killing immune cells.
The SECA proteins are developed using the company’s proprietary circular permutation technology called PICASSO, which uses human protein biology to reach exclusive mechanism of action. ALKS 4230’s selectivity leverages anti-tumor effects and overcomes the limitations of currently available IL-2 therapy which triggers immunosuppressive and immunostimulatory receptors.
The Phase 1 clinical trial will assess the immunological-pharmacodynamic effects, the safety, and the tolerability of ALKS 4230 in two stages.
In the first stage, patients with solid tumors who are refractory or intolerant to conventional treatments will be given ALKS 4230 in an intermittent intravenous infusion, in ascending doses. This stage of the trial aims to established the maximum dose that patients tolerate and to determine the ideal dose rage of the drug agent based on the assessment of its immunological-pharmacodynamic effects.
In the second stage of the trial, the dose-expansion stage, ALKS 4230 will be evaluated in patients with selected solid tumor types.
The company expects to report the initial data in 2017.
“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,” said Dr. Elliot Ehrich, chief medical officer of Alkermes in a press release. “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. We are excited about the start of the clinical program and the potential for ALKS 4230 to make an impact for patients with cancer.”