Sotio Biotech has decided to halt ongoing studies of its IL-15 superagonist, nanrilkefusp alfa, due to insufficient efficacy in clinical trials, dealing another setback to efforts to establish cytokines as a cornerstone in cancer care.
In late 2021, the Czech biotech secured 280 million euros ($295 million) to advance nanrilkefusp alfa, also known as SOT101. However, the recent interim data analysis has shown that the drug lacks the efficacy required to justify further development in larger randomized trials within the targeted clinical settings. Consequently, Sotio has immediately ceased enrollment in three ongoing studies.
These clinical trials were investigating nanrilkefusp alfa in combination with Eli Lilly’s Erbitux and Merck & Co.’s Keytruda in solid tumor patients. Although these combinations are no longer viable for market development, Sotio remains open to the possibility of pairing its IL-15 drug candidate with other treatment modalities, particularly cell therapies. The biotech has expressed optimism about promising preclinical data related to a cell therapy combination.
“While we are disappointed with this outcome, we will continue to gather and analyze the full body of data from these studies to inform our future development plans for nanrilkefusp alfa, especially its potential utility in combination with other cancer immunotherapies. We are grateful to the patients, families and investigators that participated in these trials and whose contributions are essential to improving the standard of care for solid tumor cancers.”
– Richard Sachse, M.D., Ph.D., chief medical officer of Sotio
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Sotio is not alone in exploring IL-15 candidates. ImmunityBio previously filed for approval of its antibody cytokine fusion protein but faced FDA rejection on manufacturing grounds. Nektar Therapeutics is conducting a phase 2/3 clinical trial of an IL-15 receptor agonist, NKTR-255. Novartis, meanwhile, is nearing the conclusion of a phase 1 trial for its IL-15 prospect, NIZ985, though it stopped enrollment before reaching its intended goal.
Sotio still maintains an interest in cytokines and anticipates that its next-generation PD-1-inhibiting candidate will enter clinical trials in the second quarter of the coming year. However, the company’s research and development focus is now shifting more toward antibody-drug conjugates, a modality that has gained prominence as enthusiasm for cytokines has waned.
“Sotio remains committed to developing immuno-oncology therapies that can improve outcomes for patients with solid tumors. With SOT201 we are advancing an even more differentiated program toward the clinic, combining checkpoint inhibition with IL-15 activation to produce a dual-acting therapy of great potential. We will continue to actively advance current and additional programs across our three platforms, and as such we believe Sotio to be well-positioned for success with our diversified pipeline of next-generation immunotherapies.”
– Radek Spisek, M.D., Ph.D., chief executive officer of Sotio
