Abstract
4754 Background: FolateImmune is a novel immunotherapy comprised of a vaccine EC90 with GP-0100 adjuvant and a folate-conjugated vaccine( EC-17) that targets folate receptor (FR) positive tumor cells to enhance tumor cell removal by cytokine stimulated immune cells. The over-expression of the FR occurs in a number of malignancies, including kidney, & ovarian. Methods: FolateImmune treatment begins with a series of subcutaneous inoculations of EC90 (0.2mg/dose), a KLH-FITC conjugate adjuvanted with GP-0100 (3.0mg/dose) to stimulate the production of antibodies to FITC. The patient then receives a subcutaneous injection of EC17, a folate FITC conjugate, that binds to cells over-expressing the FR and promotes their opsonization with the previously induced endogenous anti-FITC IgG. This process effectively marks the tumor cells for subsequent immune recognition. EC17 forms a molecular bridge between the tumor cell and the endogenous circulating anti-FITC IgG. This marking initiates an Fc-mediated immune response leading to the removal of the antibody-coated tumor cells. Eligibility included positive immunohistochemical confirmation of folate receptors on tumor tissue, ECOG score of ≤ 1, life expectancy >3 months, any prior chemotherapy or immunotherapy, normal organ/marrow function, measurable disease, and no active CNS disease. Results: 6 patients have been enrolled in dose level 0 of EC 17 (0.031mg/kg). 5 patients had RCC (4 patients clear cell, 1 patients papillary) and 1 patient had ovarian carcinoma. All patients had one or more prior treatments. No toxicities were seen at dose level 0. 6 RCC patients are preparing to begin dose level plus 1 (0.92mg/kg) 3 of the renal cell patients by RECIST criteria are stable and beginning a second cycle of therapy. No significant toxicity has been observed. Laboratory correlates are presently being analyzed. Conclusions: FolateImmune therapy is well tolerated with a suggestion of biologic activity reflected in that three patients are continuing therapy. Additional results will be updated at the meeting. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Endocyte
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