Biopharmaceutical company BioLineRx Ltd (NASDAQ: BLRX) (TASE: BLRX) said on Tuesday that it has successfully filed its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for the novel immunotherapy AGI-134 anti-cancer vaccine.

The company added that AGI-134 is a synthetic alpha-Gal glycolipid in development for solid tumours. AGI-134 is designed to label cancer cells with alpha-Gal via intratumoral administration, targeting the body's pre-existing, highly abundant anti-alpha-Gal (anti-Gal) antibodies and redirecting them to treated tumours.

This ongoing Phase 1/2a multicentre, open-label study is expected to take place at 15 sites in the US, UK and Israel in two parts to evaluate the safety and tolerability of AGI-134, given both as monotherapy and in combination with an immune checkpoint inhibitor, in solid tumours. The initial safety results is expected in H2 2019 and the initial efficacy results is expected by year-end 2020.

Under the ongoing accelerated dose-escalation part, the company will assess the safety and tolerability of intratumorally injected AGI-134 as a monotherapy, as well as to determine the maximum tolerated dose and the recommended dose for part two of the study.

As part of the recommended dose part, the study is comprised of three cohorts and designed to assess the safety, tolerability and anti-tumour activity of AGI-134 as a monotherapy in a basket cohort of multiple solid tumour types, as well as in two additional cohorts in combination with an immune checkpoint inhibitor – in metastatic colorectal cancer and in head and neck squamous cell carcinoma, concluded the company.