Alkermes has entered into a clinical research collaboration with Fred Hutchinson Cancer Research Center (Fred Hutch) for ALKS 4230, Alkermes' immuno-oncology drug candidate. ALKS 4230 is a novel, 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.
The planned phase 2 multi-site trial, ION-01, is designed to estimate the response rate to ALKS 4230 in combination with the anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced or recurrent head and neck squamous cell cancer who did not achieve complete remission with an anti-PD-(L)1 antibody treatment. Secondary objectives include evaluation of the duration of response, progression-free survival, time to progression and overall survival of patients with advanced or recurrent head and neck squamous cell cancer receiving treatment with ALKS 4230 in combination with pembrolizumab. As an exploratory objective, the ION-01 study will assess the tumor microenvironment using paired tumor biopsies to evaluate potential predictive biomarkers for response to the addition of ALKS 4230. This multi-site study is designed to leverage the scientific, clinical and management resources of the Immune Oncology Network (ION), a network of foremost academic immunologists at top North American universities and cancer centers. The study is expected to initiate in the fourth quarter of 2019.
"We are honored to collaborate with Fred Hutch, given its commitment to improving outcomes and advancing care for people living with cancer," said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. "We're encouraged by the profile emerging from the preclinical and initial clinical data for ALKS 4230 and are eager to explore whether this novel investigational drug may improve the therapeutic benefit of checkpoint inhibition with pembrolizumab, in patients with head and neck cancers. The ION-01 study, along with our ongoing ARTISTRY clinical development program, offers the opportunity to strengthen and advance our scientific and clinical understanding of ALKS 4230 and its potential role in treating cancer patients with high unmet needs."
ALKS 4230 is a novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.