Oncostar: A drug for the treatment of breast cancer

The main articles are:

• Breast cancer (BC)
• Cancer treatment
• Drugs to treat cancer

2022: Preliminary drug trials. Raising 64 million rubles for clinical trials

The resident company OncostarSkolkovo conducted preliminary tests of the drug for breast cancer human therapy and attracted 64 million rubles from private investors. The funds will allow the completion of the first phase of clinical trials by mid-2023. The product is developed on the basis of a genetically modified oncolytic, virus officially authorized for clinical trials. The Skolkovo Foundation announced this on December 14, 2022.

The purpose of the first phase of the Oncostar clinical trial is to assess the safety, tolerability and pharmacokinetic parameters of a VV-GMCSF-Lact-based drug product in patients with recurrent or refractory metastatic breast cancer. The recombinant strain of this vaccinia virus was developed at the Institute of Chemical Biology and Fundamental Medicine of the SB RAS together with the FBUN SSC WB "Vector" of Rospotrebnadzor.

{{quote 'author = said Kirill Kayem, Senior Vice President for Innovation, Skolkovo Foundation.|The development of Oncostar is certainly important and innovative. The developed drug allows to obtain high efficiency of tumour therapy with minimal toxicity for healthy tissues. A feature of oncolytic virus therapy is not only a direct effect on cancer cells, but also involvement in the fight against a tumor of a cancer patient's own immune system. We see a great potential for this drug in oncology, due to the peculiarity of the mechanism of action and the lack of analogues of Russian production. We hope that the results of clinical studies will confirm preliminary data and therapy will be available to patients in the coming years, }}

Previous preclinical studies have proven the safety and antitumor effectiveness of the drug Onkostar, which allowed it to obtain permission from the Russian Ministry of Health to conduct the first phase of clinical trials. The company began to join them in May 2022. As of December 2022, they are held in 5 medical centers in Moscow and St. Petersburg.

The tests are carried out in 2 stages: single administration of the drug in increasing doses and repeated administration of the drug in doses determined in the first stage. Clinical stages of patients of the 1st, 2nd and 3rd and 4th dose levels were completed. No dose-limiting toxicity events were reported.

The funds raised will be used to finance the first phase of clinical trials, which will intensify the conduct of trials and complete them by mid-2023. Attracting investment was made possible by the encouraging results of the first stages of the study. In 2024, we plan to move to the second phase of clinical trials, noted Vladimir Richter, co-founder of Onkostar.

The main objectives of the study: to determine the maximum tolerated dose of the drug; determining the frequency, nature, intensity and duration of adverse reactions associated with the use of the investigational drug when administered at increasing doses; detection of dose-limiting toxicity, degree of its severity, duration and reversibility; determination of the pharmacokinetic profile of the virus and its antibodies; assessment of objective response to the treatment; assessment of tumour size change dynamics.