BioLineRx Highlights Early-Stage Trial Data From Cancer Vaccine Candidate

BioLineRx Ltd BLRX announced results from the Phase 1/2a study of the intratumoral cancer vaccine candidate AGI-134 in patients with unresectable metastatic solid tumors.
The study met its primary endpoint of AGI-134's safety and tolerability.
In this first-in-human trial, 38 patients were treated with AGI-134.
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 primarily mild to moderate.
Most patients analyzed showed an increase in Alpha-Gal antibodies, indicating increased overall immune activity.
Additionally, increases in antigen-presenting cells (APCs) were observed in most tissue samples analyzed.
T cell and macrophage tumor infiltration was seen in approximately one-third of evaluable patients' injected tumors and approximately half of evaluable patients' un-injected lesions.
Radiological assessments found that 29% of patients in the trial achieved the best overall response of the stable disease. Seven of the 11 patients who achieved stable disease had previously failed checkpoint-inhibitor therapy.
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