14 November 2022 - - US-based biotech company Ankyra Therapeutics has presented new, preclinical data highlighting the potential of the company's lead program, ANK-101, an IL-12-based treatment, to deliver potent anti-tumor responses following intratumoral administration at the Society for Immunotherapy of Cancer 37th annual meeting, the company said.

IL-12 is a potent cytokine that can promote innate and adaptive anti-cancer immunity, but its clinical development has been limited by toxicity when delivered systemically.

Intratumoral administration can expand the therapeutic window of IL-12; however, it is limited by rapid drug clearance from the tumor, thereby reducing efficacy, necessitating frequent administration, and increasing systemic accumulation.

To overcome the limitations of traditional cytokine therapeutics, Ankyra has leveraged its Anchored Immunotherapy Platform to develop ANK-101, a stable complex of a modified IL-12 cytokine with aluminum hydroxide (Alhydrogel).

Alhydrogel, an FDA-approved adjuvant for use in human and veterinary vaccines, acts as a scaffold to locally retain the potent activity of IL-12 following intratumoral administration in order to improve its therapeutic window.

The data to be presented TODAY are from several preclinical studies in mouse models and non-human primates.

Administration of mANK-101 (murine surrogate) led to enhanced tumor retention and reduced systemic exposure compared to un-anchored IL-12

Administration of mANK-101 was efficacious in diverse syngeneic tumor models, including large tumors, leading to substantial reductions in tumor volume after one or two injections

mANK-101 treatment induced a profound remodeling of the tumor microenvironment with increased T- and NK-cell infiltration and activation, shifts to pro-inflammatory myeloid cell phenotypes, and increased markers of antigen presentation and co-stimulation as measured by Nanostring, IHC, and scRNA-seq

ANK-101 administration in NHPs was well tolerated across all dose levels evaluated
Ankyra is currently advancing ANK-101 through Investigational New Drug enabling studies and plans to submit an IND to the US Food and Drug Administration in the second quarter of 2023.

Ankyra Therapeutics is a biotechnology company developing a novel approach to treating cancer, designed to expand the therapeutic window of cytokine drugs.

Cytokine treatments have shown to be effective in treating cancer, but systemic dosing is limited by broad immune activation and toxicity.

Using its proprietary Anchored Immunotherapy Platform, Ankyra has developed methods to localize cytokines specifically and persistently in tumor tissue, creating intense hot spots of inflammation that awaken an anti-tumor immune response.

Using its platform, the company is building a pipeline of therapeutics designed to provide prolonged immune activation and potent local and systemic immunity with reduced systemic toxicity.