Fred Hutchinson Cancer Research Center (Fred Hutch) and Alkermes plc (ALKS) inked a collaborative deal where the parties will conduct a Phase II multi-site trial for ALKS 4230, 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 clinical trial, known as 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. The study will commence in the fourth quarter of 2019.
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.
The sponsors and site 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, a network of foremost academic immunologists at top North American Universities and cancer centers.
Craig Hopkinson, MD Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs with Alkermes noted, “The ION-01 stud, along with our 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.”
What is ALKS 4230?
ALKS 4320 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.
ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating ALKS 4230 in patients with advanced solid tumors. ARTISTRY-1 is an ongoing phase 1/2 study in which ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. ARTISTRY-1 has three distinct stages: an ongoing monotherapy dose-escalation stage, a recently-initiated monotherapy expansion stage and an ongoing combination therapy stage with the PD-1 inhibitor KEYTRUDA® (pembrolizumab) in patients with select advanced solid tumors. ARTISTRY-2 is an ongoing phase 1/2 study of ALKS 4230 administered subcutaneously as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. ARTISTRY-2 is designed to explore the safety, tolerability and efficacy of ALKS 4230 administered subcutaneously and assess once-weekly and once-every-three-week dosing schedules
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases and oncology. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction, multiple sclerosis and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website.
Call to Action: Do you or a loved one know of someone with advanced or recurrent head and neck squamous cell cancer who did not achieve complete remission with anti-PD(L)1 antibody treatment? Consider connecting with this study.