Cancer Immunotherapy Targets Patient-Specific Tumor Neoantigens

BioLineRx AGI-134 is a synthetic alpha-Gal glycolipid in development for treating solid tumors

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An Israel based biopharmaceutical company focused on oncology, announced that it has successfully completed the dose-escalation part of the Phase 1/2a clinical study for AGI-134, a novel compound that targets patient-specific tumor neoantigens. 

AGI-134 is a synthetic alpha-Gal glycolipid in development for solid tumors that are highly differentiated from other cancer immunotherapies. 

In a September 3, 2019, press release, BioLineRx said ‘AGI-134 was found to be safe and well-tolerated, with no serious drug-related adverse events or dose-limiting toxicities reported.’ 

The ongoing Phase 1/2a study’s objectives are to evaluate the safety and tolerability of AGI-134 at the recommended dose in multiple solid tumor types, to evaluate a wide array of biomarkers, and to validate AGI-134's mechanism of action.

Furthermore, efficacy will be assessed by clinical and pharmacodynamic parameters. The dose-expansion part 2 of the study is expected to commence shortly.

Prof. Mark Middleton of the University of Oxford, the study's principal investigator, stated in a press release, "AGI-134 represents a new mechanistic class of cancer immunotherapies, with a unique and highly differentiated mode of action, harnessing pre-existing immune machinery to trigger a systemic anti-tumor response and create a pro-inflammatory tumor microenvironment.” 

“We expect the mechanistic assessments performed during the study to further elucidate and confirm AGI-134's activity. These assessments are ongoing and will be extended during part 2 of the study."

Philip Serlin, Chief Executive Officer of BioLineRx, said: “Following the FDA's recent IND approval for AGI-134, we are looking forward to initiating part 2 of the study shortly, with initial results expected by year-end 2020."

AGI-134 is designed to label cancer cells with alpha-Gal via intra-tumoral administration, thereby targeting the body's pre-existing, highly abundant anti-alpha-Gal (anti-Gal) antibodies and redirecting them to treated tumors. 

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Binding of anti-Gal antibodies to the treated tumors results in inactivation of the complement cascade, which destroys the tumor cells and creates a pro-inflammatory tumor microenvironment that also induces a systemic, specific anti-tumor (vaccine) response to the patient's own tumor neo-antigens.

AGI-134 has been evaluated in numerous pre-clinical studies. 

In a mouse melanoma model, treatment with AGI-134 led to the regression of established primary tumors and suppression of secondary tumor (metastases) development. 

Synergy has also been demonstrated in additional pre-clinical studies when combined with an anti-PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. 

AGI-134 was obtained by BioLineRx through the acquisition of Agalimmune Ltd.

BioLineRx is a clinical-stage biopharmaceutical company focused on oncology. For additional information on BioLineRx.

Published by Vax Before Cancer