BioLineRx : Phase 1/2a Study Of AGI-134 In Metastatic Solid Tumors Meets Primary Endpoint

(RTTNews) - BioLineRx Ltd. (BLRX) said that phase 1/2a Study of investigational anti-tumor vaccine AGI-134 in unresectable metastatic solid tumors met its primary endpoint of safety and tolerability.

In Tuesday pre-market trade, BLRX was trading at $0.64 up $0.03 or 5.41%.

In the first-in-human trial, a total of 38 patients were treated with AGI-134: 5 patients in part 1, the accelerated dose-escalation part of the study; and 33 patients in part 2, the dose expansion part of the study.

Part 1 demonstrated that AGI-134 was safe and well tolerated, with no dose-limiting toxicities reported. The maximum tolerated dose was not reached and the recommended dose for part 2 of the study (RP2D) was determined to be up to 200mg.

In the dose expansion part 2 of the study, AGI-134 was generally well-tolerated, with treatment-related adverse events being transient and mostly mild to moderate.

Generation of an immune response and markers of clinical efficacy were assessed as secondary endpoints. Most patients analyzed showed an increase in Alpha-Gal antibodies, indicating increased overall immune activity.

Additionally, increases in antigen presenting cells were observed in most tissue samples analyzed, and T cell and macrophage tumor infiltration was seen in approximately one-third of evaluable patients' injected tumors, and in approximately half of evaluable patients' un-injected lesions.

Radiological assessments found that 29 percent of patients in the trial achieved best overall response of stable disease. Seven of the 11 patients who achieved stable disease had previously failed checkpoint-inhibitor therapy.

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