Alkermes Initiates Phase 1 Clinical Trial Of Immuno-Oncology Drug Candidate ALKS 4230

Alkermes Plc (NASDAQ: ALKS) revealed Wednesday that it initiated a phase 1 clinical trial of its immuno-oncology drug candidate, ALKS 4230, which was formerly referred to as RDB 1450, a novel Selective Effector Cell Activator protein designed for targeted interleukin-2 (IL-2) receptor activation. The company expects the initial results from the first stage of the phase 1 trial next year.

According to the company, the multi-center phase 1 study is meant to assess the safety, tolerability and immunological-pharmacodynamic effects of ALKS 4230 in the treatment of patients with solid tumors.

Alkermes Chief Medical Officer Elliot Ehrich commented about the initiation of the trial stating, "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."

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He added, "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."

The company stated that the first stage trial would be conducted in two stages: a dose-escalation stage followed by a dose-expansion stage. This first stage of the trial is designed to establish a maximum tolerated dose, and to identify the maximum dose range of ALKS 4230 based on measures of immunological-pharmacodynamic effects.

Alkermes said that following the identification of the optimal dose range in the first stage of the trial, the dose-expansion stage of the trial would assess ALKS 4230 in patients with selected solid tumor types.

At time of writing, the stock was down 0.76 percent at $43.09.