CLINICAL AND REGULATORY
Synthekine dosed first patient in Phase 1 trial of its STK-012 for treatment of solid tumors
Synthekine announced the dosing of the first patient in a Phase 1a/1b clinical trial of its IL-2 partial agonist, STK-012, for the treatment of solid tumors. STK-012 is designed as an alpha/beta-biased IL-2 partial agonist to selectively stimulate antigen-activated T cells, which are associated with potent anti-tumor activity, and avoid stimulation of toxicity causing immune cells, such as natural killer cells. Aldesleukin (recombinant IL-2) has shown to be active in certain cancers, but its use is limited due to life threatening toxicities. Synthekine presented preclinical data at AACR 2021 demonstrating a mouse surrogate of STK-012 achieved superior tumor regression compared to both wild-type mouse IL-2 and a non-alpha-IL-2 agent, representing a different approach to biasing IL-2. In toxicity models, the mouse surrogate of STK-012, unlike these same comparators, was well tolerated and did not induce CLS. In non-human primate studies, STK-012 avoided lymphopenia, NK cell activation and CLS induction, which was observed with both aldesleukin and a non-alpha-IL-2 agent. The Phase 1a/1b clinical trial is an open-label, multi-center study enrolling patients with advanced solid tumors. The dose escalation portion of the study will evaluate STK-012 both as a monotherapy and in combination with pembrolizumab. Following completion of the dose escalation, Synthekine will initiate expansion cohorts with STK-012.
Alkermes presented new nemvaleukin alfa monotherapy data at ASCO GU
Alkermes presented new data from the ongoing phase 1/2 ARTISTRY-1 clinical trial for nemvaleukin alfa, the company's novel, investigational, engineered IL-2 variant immunotherapy. The data were presented at ASCO GU Cancers Symposium. The presentation included updated efficacy and safety data from the monotherapy arm of ARTISTRY-1, in which single-agent, anti-tumor activity of intravenous nemvaleukin was observed in patients with advanced renal cell carcinoma, including patients who were checkpoint inhibitor-pretreated. Nemvaleukin monotherapy induced robust expansion of CD8+ T and NK cells, with minimal effect on Tregs. Among 23 evaluable patients, four patients, all of whom were CPI-pretreated, achieved a partial response (one unconfirmed) and three of these patients continued monotherapy. Decreases in target lesions of up to 60% were observed. Stable disease was observed in 10 patients. Safety among these patients with advanced RCC was consistent with that which was previously reported for the IV nemvaleukin monotherapy-treated population in the ARTISTRY-1 study. Fever, chills, nausea, and anemia were the most frequently reported adverse events (AEs), regardless of causality. Chills and anemia were the most reported treatment-related AEs of grade ≥3.