ELENAGEN DNA vaccine: an encouraging start
Anti-cancer DNA vaccine successfully passes clinical trials in Russia
The results of phase I/IIa clinical trials of the new therapeutic anti-cancer DNA vaccine Elenagen, demonstrating the clinical benefits of the drug for cancer patients, as well as an excellent safety profile, have been published in the form of a preprint by the largest international journal of oncology Oncotarget (Ponomarenko et al., Safety and efficacy of p62 DNA vaccine ELENAGEN in a first-in-human trial in patients with advanced solid tumors). The study was conducted by the resident of the biomedical technologies cluster of the Skolkovo Foundation, SL Onkolodzhi, and the American startup KureLab Onkolodzhi, Inc. (CureLab Oncology, Inc., Boston).
Elenagen was invented in Boston by Professor Alexander Schneider, the founder of KyurLab Onkolodzhi. Subsequently, the drug was tested on mice and dogs in the USA, Italy, Russia and Ukraine. Then, with the help of the Skolkovo Foundation and the Pharma 2020 program, the Russian company SL Onkolodzhi received an exclusive license for the Russian Federation, where the first phrase of the tests took place.
As has been shown in previous studies, Elenagen activates the immune system. And since most anti-cancer drugs that stimulate the immune system show a very high level of toxicity, the main goal of Phase I clinical trials was to test the safety of Elenagen. Clinical trials were conducted on 27 adult terminally ill patients with a progressive disease, in the treatment of which all available means were exhausted. During the trials described in the article, the level of discomfort that appeared in patients was characteristic of well-tolerated injectable drugs.
In addition, according to the protocol of phase I trials, Elenagen was used independently, which in theory should have led to worse results, since in practice doctors usually combine drugs, supplementing and enhancing their effect. "Even with self–administration, Elenagen stopped the progression of ovarian cancer in 4 out of 6 women and the progression of breast cancer in 4 out of 8 for a period of 2 to 6 months," Alexander Schneider emphasizes.
Also, 10 women (7 with breast cancer and 3 with ovarian cancer) whose tumor progressed after one or more courses of ElenagenomTM treatment were helped by chemotherapy after taking the tested drug. It is assumed that Elenagen may become the first drug that restores the sensitivity of the tumor to chemotherapy. In the next phase IIb/III clinical trials, the researchers plan to use Elenagen in combination with radiation therapy and chemotherapy.
The prospects of combining the drug with other means of fighting cancer notes Vlad Gabay, PhD, Head of the Research department at KyurLab Onkolodzhi, lecturer at the Department of Biochemistry at Boston University: "We do not believe that Elenagen competes with existing treatments. On the contrary, we believe that it will be combined with other treatment standards and interact with them with a synergetic effect."
Skolkovo is looking forward to the results of further clinical trials of the Elenagen vaccine, says Vera Rybko, project manager of the Biological and Medical Technologies cluster of the Foundation. "This project surprises with its apparent simplicity: the introduction of "naked" DNA into the patient's body. Many competitive solutions use additional means of targeted delivery directly to tumors or cells of the immune system. Nevertheless, the results obtained so far are encouraging, both in terms of the safety and tolerability of the drug, and in the clinical response of tumors to the treatment. We hope that the team of CureLab Oncology and the resident of the BMT SL Onkolodzhi cluster will bring their development to registration not only in the Russian Federation, but also in the world and are ready to support them on this difficult path," Vera Rybko emphasizes.
According to Alexander Schneider, the researchers plan to focus phase IIb/III clinical trials on ovarian cancer and breast cancer. The next phases of clinical trials are planned to be conducted in America, Europe, Israel, Russia and Asian countries.
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31.03.2017