On May 25, 2016 Alkermes plc (NASDAQ: ALKS) reported the initiation of a phase 1 clinical study of the company’s immuno-oncology drug candidate, ALKS 4230 (formerly referred to as RDB 1450), a novel Selective Effector Cell Activator (SECA) protein designed for targeted interleukin-2 (IL-2) receptor activation (Press release, Alkermes, MAY 25, 2016, View Source [SID:1234512770]). Schedule your 30 min Free 1stOncology Demo! The multi-center phase 1 study is designed to evaluate the safety, tolerability and immunological-pharmacodynamic effects of ALKS 4230 in the treatment of patients with solid tumors.
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The phase 1 study will be conducted in two stages: a dose-escalation stage followed by a dose-expansion stage. In the first stage of the study, ALKS 4230 will be administered as an intermittent intravenous infusion with ascending doses in patients with solid tumors who are refractory or intolerant to established therapies. This first stage of the study is designed to determine a maximum tolerated dose, and to identify the optimal dose range of ALKS 4230 based on measures of immunological-pharmacodynamic effects. Following the identification of the optimal dose range of ALKS 4230 in the first stage of the study, the dose-expansion stage of the study will evaluate ALKS 4230 in patients with selected solid tumor types. Initial results from the first stage of the phase 1 study are expected 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 Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. "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."
About ALKS 4230 and the SECA Immuno-Oncology Program
ALKS 4230 is a novel selective effector cell activator (SECA) protein designed to preferentially bind and signal through the intermediate affinity interleukin-2 (IL-2) receptor complex, thereby selectively activating and increasing the number of immunostimulatory tumor-killing immune cells while avoiding the expansion of immunosuppressive cells that interfere with anti-tumor response. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects while overcoming limitations of existing IL-2 therapy which activates both immunostimulatory and immunosuppressive receptors.
SECA proteins are engineered using Alkermes’ proprietary PICASSOTM circular permutation technology leveraging human protein biology to achieve their unique mechanism of action.