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Ref Type Journal Article
PMID (28881846)
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
Title Safety and efficacy of p62 DNA vaccine ELENAGEN in a first-in-human trial in patients with advanced solid tumors.
Journal Oncotarget
Vol 8
Issue 32
Date 2017 Aug 08
URL
Abstract Text 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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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Elenagen Elenagen 1 0
Drug Name Trade Name Synonyms Drug Classes Drug Description
Elenagen Elenagen is a DNA vaccine comprising a plasmid that contains SQSTM1, which encodes for p62, resulting in the prevention of tumor growth and enhancement of chemotherapeutic sensitivity (PMID: 28881846).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown breast cancer not applicable Elenagen + Tamoxifen Phase Ib/II Actionable In a Phase Ib/II trial, a chemorefractory patient with breast cancer demonstrated restored chemotherapeutic sensitivity upon sequential treatment of Elenagen and Nolvadex (tamoxifen), which resulted in stable disease (PMID: 28881846). 28881846
Unknown unknown Advanced Solid Tumor not applicable Elenagen Phase Ib/II Actionable In a Phase I/IIa trial, Elenagen treatment resulted in a best response of stable disease in 44% (12/27) of patients with advanced solid tumors (PMID: 28881846). 28881846
Unknown unknown triple-receptor negative breast cancer not applicable Cyclophosphamide + Doxorubicin + Elenagen Phase Ib/II Actionable In a Phase Ib/II trial, chemorefractory patients with triple-receptor negative breast cancer demonstrated restored chemotherapeutic sensitivity upon sequential treatment of Elenagen and the combined therapy, Cytoxan (cyclophosphamide) and Adriamycin (doxorubicin), which resulted in stable disease (PMID: 28881846). 28881846