Clinical Research Papers:

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

Dmitry M. Ponomarenko, Irina D. Klimova, Yulia A. Chapygina, Viktoria V. Dvornichenko, 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 _ and Alexander M. Shneider

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Oncotarget. 2017; 8:53730-53739. https://doi.org/10.18632/oncotarget.16574

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Dmitry M. Ponomarenko1, Irina D. Klimova1, Yulia A. Chapygina1, Viktoria V. Dvornichenko1, Natalia V. Zhukova2, Rashida V. Orlova2,3, Georgy M. Manikhas2,4, Alexandr V. Zyryanov5, Lilya A. Burkhanova5, Irina I. Badrtdinova5, Basile N. Oshchepkov5, Elena V. Filippova4, Sergei V. Orlov4, Sergei I. Kolesnikov6, Albert A. Sufianov7,8, Svetlana R. Baum9, Olga Y. Zaitzeva9, Andrey B. Komissarov10, Mikhail P. Grudinin10, Oleg I. Kiselev10,*, Anatoly F. Tsyb11,*, Franco Venanzi12, Vita Shcherbinina13, Andrey Chursov13,14,Vladimir L. Gabai13,14,15 and Alexander M. Shneider8,14,16

1 Irkutsk State Medical Academy of Postgraduate Education, Irkutsk Regional Cancer Dispensary, Irkutsk, Russian Federation

2 Saint-Petersburg City Clinical Oncology Dispensary, Saint-Petersburg, Russian Federation

3 Saint-Petersburg University, Saint-Petersburg, Russian Federation

4 Pavlov First Saint Petersburg State Medical University, Saint- Petersburg, Russian Federation

5 Multidisciplinary Clinical Medical Center "Medical City", Tyumen, Russian Federation

6 Russian Academy of Sciences, Moscow, Russian Federation

7 Federal Center of Neurosurgery, Tyumen, Russian Federation

8 Sechenov First Moscow State Medical University, Moscow, Russian Federation

9 Synergy Research Group, Moscow, Russian Federation

10 Research Institute of Influenza, Saint-Petersburg, Russian Federation

11 A. Tsyb Medical Radiological Research Center, Obninsk, Russian Federation

12 Department of Biology MCA, University of Camerino, Italy

13 CL Oncology, LLC, Moscow, Russian Federation

14 CureLab Oncology, Inc, Dedham, MA, USA

15 Department of Biochem, Boston University School of Medicine, Boston, MA, USA

16 Department of Molecular Biology, Ariel University, Ariel, Israel

* deceased

Correspondence to:

Vladimir L. Gabai, email:

Alexander M. Shneider , email:

Keywords: cancer immunotherapy; chemotherapy; cancer vaccine; breast cancer; ovary cancer

Received: February 14, 2017 Accepted: March 16, 2017 Published: March 25, 2017


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.

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