Kode™ Technology licensee, BiolineRx successful in dose-escalation

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AGI-134 was found to be safe and well tolerated with no dose-limiting toxicities observed
Dose expansion part of study expected to commence shortly, with initial results expected by year-end 2020

BioLineRx Successfully Completes Dose-Escalation Part of Phase 1/2a Clinical Study for AGI-134, a Novel Immunotherapy for Treatment of Solid Tumors

TEL AVIV, Israel, Sept. 3, 2019 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, announced today that it has successfully completed the dose-escalation part of the Phase 1/2a clinical study for AGI-134, a novel compound that evokes a direct anti-tumor response, as well as a vaccine effect, via a unique, multi-arm mechanism that targets patient-specific tumor neoantigens. AGI-134 was found to be safe and well tolerated, with no serious drug-related adverse events or dose-limiting toxicities reported. The maximal tolerated dose was not reached and the recommended dose for part 2 of the study was determined.

The ongoing Phase 1/2a study is a multicenter, open-label study expected to take place at approximately 15 sites in the US, UK and Israel. The objectives of the study 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, "We are pleased with these initial safety results of the first-in-human clinical trial assessing AGI-134 for the treatment of solid tumors. 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."

"We are excited with the positive results of the first part of the Phase 1/2a of our second lead oncology asset," said Philip Serlin, Chief Executive Officer of BioLineRx. "Numerous pre-clinical studies to date have demonstrated that treatment with AGI-134 leads to regression of established primary tumors, prevents growth of untreated distal secondary tumors, and triggers a vaccine effect that may prevent the development of future metastases. Following the FDA's recent IND approval for AGI-134, we plan to add sites in the US to the study, which is currently being conducted in the UK and Israel, by the first half of 2020. We are looking forward to initiating part 2 of the study shortly, with initial results expected by year-end 2020."

"In addition, we are also waiting with great anticipation for the upcoming top-line data for BL-8040's COMBAT/KEYNOTE-202 trial in pancreatic cancer, which is running according to schedule and is expected to read out by the end of the year," added Mr. Serlin.