DEVELOPMENT OF NOVEL ANTICANCER AGENT TO POTENTIATE SENSITIVITY TO ANTI-ESTROGEN THERAPY

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Our Phase I Contract demonstrated that AG1, an anti-GP88 (Progranulin) recombinant antibody potentiated the efficacy of anti-estrogen (AE) based therapy to inhibit tumor growth in breast cancer xenografts. Additionally we have demonstrated that AG1 is efficacious as a single agent in lung cancer xenografts. The significant: >50% of estrogen positive (ER+) breast cancer patients are, or become insensitive to AE therapy and ~50% lung cancer patients die even when disease is detected at an early stage. Thus potentiating efficacy of AE in ER+ breast cancer potentially offers a treatment solution for AE resistant patients and improving treatment options for early stage lung cancer may reduce the number of deaths. These biological data, together with the complete manufacturing process and stability studies that we have developed for AG1, supports moving AG1 into final pre-clinical studies. The PI is requesting support in form of a Phase II contract to enable the production of a batch of AG1, complete dosing studies, and perform repeat-dose in life toxicology (Acute dose previously performed), pharmacokinetics and dose assessment in non-human primates and file an IND with the US FDA for first in human safety and efficacy studies for indications of breast and lung cancer.