BioLineRx announced a Notice of Allowance has been issued by the United States Patent and Trademark Office (USPTO) for a patent application claiming the use of AGI-134, a novel immunotherapy compound, for the treatment of solid cancer tumors.
This patent, when issued, will be valid until May 2035 with a possibility of up to five years patent term extension. Additional corresponding patent applications for AGI-134 are pending in Europe, Japan, China, Canada, Australia and Israel.
"We are extremely pleased at receiving this important notice of allowance from the USPTO for the patent application covering AGI-134, and believe this represents significant progress in the development of our second oncology asset," said Philip A. Serlin, Chief Executive Officer of BioLineRx. "We have recently presented very encouraging preclinical data demonstrating complete tumor regression of primary tumors following intratumoral injection of AGI-134, and are looking forward to commencing a Phase 1/2a study for this compound in several solid tumor indications in mid-2018."
AGI-134 is a synthetic alpha-Gal immunotherapy in development for solid tumors. AGI-134 harnesses the body's pre-existing, highly abundant anti-alpha-Gal antibodies to induce a systemic, specific anti-tumor response to the patient's own tumor neo-antigens. This response not only kills the tumor cells at the site of injection, but also brings about a durable, follow-on, anti-metastatic immune response. AGI-134 has completed numerous pre-clinical studies, demonstrating complete tumor regression of primary tumors following intratumoral injection, as well as robust protection against the development of secondary tumors in a model of melanoma with a single dose only. Synergy has also been demonstrated in additional pre-clinical studies when combined with a 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.