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

• DOI: 10.18632/oncotarget.16574
• Publication Date: 2017-03-26T04:28:14Z
• Authors: Dmitry M. Ponomar...; Irina D. Klimova; Yulia A. Chapygina; Viktoria V. Dvorn...; Natalia V. Zhukova; Rashida V. Orlova; Georgy M. Manikhas; Alexandr V. Zyryanov; Lilya A. Burkhanova; Irina I. Badrtdinova; Basile N. Oshchepkov; Elena V. Filippova; Sergei V. Orlov; Sergei I. Kolesnikov; Albert A. Sufianov; Svetlana R. Baum; Olga Y. Zaitzeva; Andrey B. Komissarov; Mikhail P. Grudinin; Oleg I. Kiselev; Anatoly F. Tsyb; Franco Venanzi; Vita Shcherbinina; Andrey Chursov; Vladimir L. Gabai; Alexander M. Shne...
• Keywords: Solid tumor

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, demonstrated anti-tumor efficacy safety in rodent tumor models spontaneous tumors dogs. This multicenter I/IIa trial evaluated clinical activity patients with advanced solid tumors. Fifteen were treated escalating doses (1- 5 mg per doses, times weekly) additional 12 received 1 dose. Ten breast ovary cancers that progressed after then conventional chemotherapy. Adverse events (AE) Grade 1; no severe AE observed. Cumulatively twelve (44%) breast, ovary, lung, renal cancer melanoma achieved stable disease for at least 8 wks, 4 them (15%) had control more than 24 maximum 32 wks. The stabilization 12-28 wks when chemotherapy following treatment. Therefore, good profile antitumor Especially encouraging its ability to restore sensitivity