Biopharmaceutical company Alkermes, announced a research collaboration with the Fred Hutchinson Cancer Research Center, aiming to advance its immuno-oncology candidate, ALKS 4230, to Phase II clinical trials.
ALKS 4230 is an engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex.
Alkermes will work collaboratively with the research center on ION-O1, a multi-site Phase II clinical trial, expected to begin in the fourth quarter of 2019.
During the project, the candidate will be tested in combination with Keytruda (pembrolizumab), owned by Merck (known as MSD outside of North America and Mexico), as a treatment for advanced or recurrent head and neck squamous cell cancer in patients who did not achieve complete remission with an anti-PD-(L)1 antibody treatment.
According to Alkermes, the study aims to estimate the response rate to the treatment, as well as to evaluate the duration of the response, the disease progression and the patients’ survival rate.
The development company already runs Artistry, a Phase I/II clinical study evaluating the candidate as a treatment for patients with advanced solid tumors.
Craig Hopkinson, the chief medical officer and SVP of medicines development at Alkermes, commented that the initial preclinical and clinical data for ALKS 4230 are encouraging, adding that the upcoming clinical development program is expected to advance the scientific understanding of the candidate.