January 23, 2018
BioLineRx Reports Data at ASCO-SITC Conference Showing Complete Tumor Regression by AGI-134 in Pre-Clinical Studies
AGI-134 on track to commence Phase 1/2a clinical study in H1 2018
Tel Aviv, Israel – January 23, 2018 - BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, announced today that AGI-134, an immunotherapy compound in development for the treatment of multiple solid tumors, demonstrated successful results in two pre-clinical melanoma studies. Results of these studies will be presented as a poster titled "Intratumoral Administration of the Alpha-Gal Glycolipid AGI-134 to Induce Tumor Regression in a Mouse Model of Melanoma” (Abstract 68) on January 25, 2018 at the ASCO-SITC Clinical Immuno-Oncology Symposium, being held January 25-27, 2018, in San Francisco, CA.
The ability of intratumorally injected AGI-134 to induce regression of established primary tumors was assessed in two murine melanoma models. In the two models, there was complete tumor regression in 50% and 67%, respectively, of mice treated with AGI-134. Moreover, treatment with AGI-134 showed a beneficial effect on survival, compared to the control group. In addition, the results show that injection of AGI-134 into the tumors induces activation of the complement system, an important component of the innate immune system. Activation of the complement system within tumors by AGI-134 is predicted to destroy tumor cells and create a pro-inflammatory tumor microenvironment that attracts and activates other immune cells, ultimately resulting in adaptive anti-tumor immunity. Previous studies with intratumoral administration of AGI-134 to primary tumors had shown that AGI-134 protects mice from the development of distant, untreated tumors.
"We are pleased to report these encouraging results for our second lead oncology project at the upcoming ASCO-SITC conference,” said Philip Serlin, Chief Executive Officer of BioLineRx. "Previous studies have demonstrated that intratumoral administration of AGI-134 induces a systemic anti-tumor response that protects mice from the development of distant tumors. These new studies now show direct regression of established primary tumors after injection with AGI-134, and that this regression is associated with activation of the innate immune system. These compelling pre-clinical data support investigating this approach in a Phase 1/2a study, and we are excited and on track to commence a first-in-man study with this promising novel oncology asset in patients with solid tumors in the first half of 2018.”