Safety and efficacy of p62 DNA vaccine ELENAGEN in a first-in-human trial in patients with advanced solid tumors.

Safety and efficacy of p62 DNA vaccine ELENAGEN in a first-in-human trial in patients with advanced solid tumors.

Oncotarget. 2017 Mar 25;:

Authors: Ponomarenko DM, Klimova ID, Chapygina YA, Dvornichenko VV, Zhukova NV, Orlova RV, Manikhas GM, Zyryanov AV, Burkhanova LA, Badrtdinova II, Oshchepkov BN, Filippova EV, Orlov SV, Kolesnikov SI, Sufianov AA, Baum SR, Zaitzeva OY, Komissarov AB, Grudinin MP, Kiselev OI, Tsyb AF, Venanzi F, Shcherbinina V, Chursov A, Gabai VL, Shneider AM

Abstract
Elenagen is a plasmid encoding p62/SQSTM1, the first DNA vaccine possessing two mutually complementing mechanisms of action: it elicits immune response against p62 and mitigates systemic chronic inflammation. Previously, Elenagen demonstrated anti-tumor efficacy and safety in rodent tumor models and spontaneous tumors in dogs. This multicenter I/IIa trial evaluated safety and clinical activity of Elenagen in patients with advanced solid tumors. Fifteen patients were treated with escalating doses of Elenagen (1- 5 mg per doses, 5 times weekly) and additional 12 patients received 1 mg dose. Ten patients with breast and ovary cancers that progressed after Elenagen were then treated with conventional chemotherapy. Adverse events (AE) were of Grade 1; no severe AE were observed. Cumulatively twelve patients (44%) with breast, ovary, lung, renal cancer and melanoma achieved stable disease for at least 8 wks, with 4 of them (15%) had tumor control for more than 24 wks, with a maximum of 32 wks. The patients with breast and ovary cancers achieved additional tumor stabilization for 12-28 wks when treated with chemotherapy following Elenagen treatment. Therefore, Elenagen demonstrated good safety profile and antitumor activity in advanced solid tumors. Especially encouraging is its ability to restore tumor sensitivity to chemotherapy.

PMID: 28388548 [PubMed - as supplied by publisher]

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