The Ministry of Health of the Russian Federation has authorized the conduct of phase 1 clinical trials of AntioncoRAN-M (produced at the facilities of the Gamalei Center) for cancer gene therapy with a non-viral delivery system. This is evidenced by the data of the state register of medicines (GRLS) of the department.
The aim of the clinical trial was to evaluate the safety, tolerability and pharmacokinetics of various doses of AntioncoRAN-M against the background of infusions of tSimeven® in patients with advanced solid tumors.
The trials will be held in the following medical institutions: NMRC of Radiology of the Ministry of Health, Lapino Clinical Hospital, NMRC of Oncology named after N.N. Blokhin, MCRC named after A.S. Loginov, NMRC of Oncology named after N. N. Petrov, and NMRC of OGP named after V.I. Kulakov.
As Izvestia wrote in April with reference to the press service of the NTI Platform, AntioncoRAN-M has successfully passed preclinical tests: its safety and efficiency on animals have been proven. The participants of the trials of the novel drug will be patients with advanced cancer.
Maxim Koksharov, one of the founders of OOO Gennaya Khirurgiia, the company that is developing the drug, earlier said that this is a non-viral antitumor drug, which is potentially safer compared to viral drugs of this class. No drugs like that are currently registered in the world.
“This allows Russia to take a leading position in the global cancer gene therapy market and further strengthen its leadership in the market of genetic technologies,” Maxim Koksharov noted.
AntioncoRAN-M is based on the method of delivery of the so-called cancer-killing gene and the gene that activates the antitumor immune response. Cancer cells are destroyed inside the tumor, which reduces the harm to other tissues.
This drug is expected to enter the market by 2027, but this may happen earlier if the drug shows efficacy on certain types of tumors. It will be cheaper than its counterparts currently available on the market.
In an interview for Sekret Firmy (“The Secret of the Firm”) publication, the head of the AntioncoRAN-M project Irina Alekseenko said that the team, which brought together scientists from three institutes of the Russian Academy of Sciences, began working on this drug for the treatment of cancer in 2007.
“We took two genes: a human gene and a gene of herpes simplex virus, we processed them in a test tube, connected them with a special linker, added the necessary elements for the genes to work in cells, and obtained a gene structure (a DNA molecule closed in a ring that contains the necessary genes),” Alekseenko explained.
The working group of the National Technological Initiative (NTI), as reported by Vademecum, supported the project of OOO Gennaya Khirurgiia by sending 125 million rubles in the form of a grant for clinical trials of phases 1-3.