BioLineRx is expanding the Phase 1/2 clinical trial of its investigational AGI-134 to include the U.S., now that regulatory officials there have approved the company’s request to test the treatment. The new sites are expected to open by mid-2020.
The U.S. Food and Drug Administration’s favorable decision regarding its Investigational New Drug (IND) application enlarges the trial from its current sites in the U.K. and Israel, Philip Serlin, chief executive officer of BioLineRx, said in a press release.
The open-label study (NCT03593226) is testing AGI-134 alone and in combination with the immune checkpoint inhibitor Keytruda (pembrolizumab) in patients with solid tumors. It will recruit about 70 people who have not responded to other therapies.
Divided in two parts, study researchers will first evaluate the safety and tolerability of escalating doses of AGI-134 and determine a recommended dose for further testing.
Then, in a second part, the recommended dose will be tested alone in a group of patients with multiple solid tumor types, and in combination with Keytruda in patients with metastatic colorectal cancer and head and neck squamous cell carcinoma.
Early efficacy results are planned to be released late next year.
AGI-134 is a man-made fatty molecule called alpha-Gal that uses the body’s defense mechanisms against bacteria to kill cancer cells.
Alpha-Gal is produced by bacteria and certain mammals but not by humans. This means that our immune system identifies alpha-Gal as foreign, and reacts to the molecule by producing anti-alpha-Gal antibodies.
AGI-134 is designed to bind to cancer cells, and label these cells with alpha-Gal to promote an anti-cancer immune response.
Despite being injected directly into the tumor site, AGI-134 may also induce durable responses against cancer cells that have spread to distant organs. This happens because immune cells become primed against the cancer’s own molecules.
In mice with melanoma, AGI-134 completely eliminated tumors in more than half of the animals. The anti-cancer effect was even more pronounced when the treatment was given in combination with medicines that boost the immune system, like Keytruda.
“Pre-clinical studies have demonstrated that treatment with AGI-134 leads to complete regression of primary tumors, prevents growth of untreated distal secondary tumors, and triggers a vaccine effect that may prevent the development of future metastases,” Serlin said.
“Furthermore … the combination of AGI-134 with an anti-PD-1 immune checkpoint inhibitor demonstrates a synergistic effect in protection from secondary tumor growth,” he added.
AGI-134 a received biological product designation from the FDA in December 2018, making the company eligible for a 12-year market exclusivity should it be approved to treat cancer patients in the U.S.