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• W2259401693 abstract "3006 Background: Effective immunization requires efficient antigen delivery to antigen presenting cells (APCs). Antigens attached to the human antibody B11, targeting mannose receptors on APCs, have been shown to be processed and presented efficiently, and generate robust immune responses when combined with toll-like receptor (TLR) agonists. The CDX-1307 vaccine is composed of B11 fused with hCGβ, a tumor antigen correlated with advanced stage of disease and poor prognosis in a number of common epithelial cancers, but reported at variable rates of expression. Methods: Two phase I studies investigate intradermal (id) vs. systemic (iv) administration of CDX-1307. Patients with advanced epithelial cancers known to frequently express hCGβ receive 4 biweekly vaccinations of CDX-1307, alone or in combination with immunostimulants including GM-CSF (GM), the TLR3 agonist Poly-ICLC, and the TLR7/8 agonist resiquimod. Results: Dose-escalation is complete. In the id study, 37 patients received CDX-1307 at doses of 0.3, 1.0, and 2.5 mg, then 2.5 mg + GM, 2.5 mg + GM + Poly-ICLC, and 2.5 mg + GM + resiquimod. 2.5 mg + GM + Poly-ICLC + resiquimod is planned. In the iv study, 24 patients were treated at 1, 3, 10, and 30 mg, as well as 10 mg + GM and 30 mg + GM. 30 mg + GM + Poly-ICLC is enrolling. Treatment-related toxicities were generally mild to moderate with no dose-limiting toxicities, most frequently injection site reactions and fatigue in the id study, and fatigue, myalgia, and flu-like illness in the iv study. Humoral responses to hCGβ were increased in 56% of the analyzed patients receiving adjuvants. Serum hCGβ was frequently elevated at study entry or during treatment (males = 88%, females = 53%, pancreatic = 89%, colorectal = 78%, breast = 47%). hCGβ decreases were seen in some patients with immune responses. To date, a significant mixed response was seen in one patient with pancreatic cancer (id), while stable disease has been seen in 4 patients (2 with breast cancer = 25, 27 weeks and 2 with colorectal cancer = 9+ weeks). Conclusions: CDX-1307 is well tolerated and results in immune responses that are enhanced by immunostimulants. Elevated hCGβ was detected at a higher than expected frequency in these tumors. [Table: see text]" @default.
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• W2259401693 date "2009-05-20" @default.
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• W2259401693 title "Phase I clinical results of an APC-targeted hCGβ vaccine (CDX-1307) with TLR agonists" @default.
• W2259401693 doi "https://doi.org/10.1200/jco.2009.27.15_suppl.3006" @default.
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