iLeukon Therapeutics Inc, a clinical-stage biotechnology company developing next-generation mRNA-based immunotherapies, announced on Tuesday that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application and a phase II protocol evaluating ILKN421H in combination with pembrolizumab for first line and post-IO treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC).

ILKN421H is a novel LNP-formulated mRNA therapy encoding a non-alpha HSA–IL-2v fusion protein for the treatment of cancer. It is administered intravenously every three weeks and is claimed to achieve efficient and preferential mRNA expression in lymphoid organs with an extended half-life of IL-2v around 20 hours.

According to the company, ILKN421H has demonstrated antitumour activity and a favourable safety profile, with no cases of vascular-leak syndrome or hypotension in a first-in-human, open-label Phase I study.

Haining Huang, iLeukon Therapeutics chief executive officer, said: "Next-generation IL-2 agents have been a major focus of the immuno-oncology field for the past decade. ILKN421H expands cytotoxic lymphocytes -- CD8 T cells and NK cells -- by up to five- and twenty-five-folds respectively, the first IL-2 based treatment that achieved this level of immune promotion safely. We believe ILKN421H can enhance the efficacy of checkpoint inhibitors, such as pembrolizumab, and may also support future modalities including TIL and in vivo CAR-T therapies. With FDA clearance to proceed to phase II, we look forward to advancing ILKN421H globally to meet the significant unmet needs and to improve the outcomes for patients with NSCLC and potentially other types of cancers in the future."