SL Onkolodzhi, a Skolkovo resident startup working on a cancer vaccine, has successfully completed phase I/IIa clinical trials together with its U.S. partner, CureLab Oncology, Inc.
The two companies have developed a cancer vaccine called Elenagen™ that is effective against a broad spectrum of primary tumours and metastatic processes. In the clinical trials conducted in four clinical centres in Russia, Elenagen™ was able to cease disease progression in patients with breast, ovary, lung and renal cancer, as well as melanoma.
The vaccine both stopped the disease progressing and restored tumours' sensitivity to chemotherapy. Photo: Wikimedia Commons.
“Patients admitted into our trial were ‘salvage patients’ who have failed all other available treatment protocols and were in the active disease progression stage. The main goal was to stop the disease progression, which we have achieved,” the Boston-based CureLab Oncology said on its website.
The vaccine was also shown to restore tumor sensitivity to chemotherapy.
“All patients admitted to the clinical trials have already failed multiple lines of chemotherapy. However, after treatment with Elenagen™, the patients were able to successfully respond to new rounds of chemotherapy,” CureLab said.
Three groups of five patients each were administered escalating doses of Elenagen™ in the trials. Most cancer drugs that stimulate the immune system are highly toxic, but Elenagen™ demonstrated a high level of safety, with only minimal Grade I side effects observed in some patients. The research results were published in the international oncology journal Oncotarget.
CureLab Oncology, Inc. now plans to conduct phase II clinical trials in ovarian and breast cancer in the U.S., as well as international trials in eight kinds of cancer, including pancreatic and stomach cancer.
Vera Rybko, a project manager within the Skolkovo Foundation’s biomed cluster, said the cluster was eagerly awaiting the results of future trials of Elenagen™.
“The results we have seen so far are very encouraging, both in terms of safety and side effects, and in terms of the clinical response of tumours to the treatment,” she said. “We hope that the CureLab Oncology team and our biomed cluster resident SL Onkolodzhi will get their treatment registered not only in Russia, but around the world, and we are ready to support them in that complex procedure.”
Elenagen™ is an anti-cancer DNA vaccine, meaning it activates the patient’s immune system to fight against cancer cells. Inhibition of malignant tumour growth by activating the patient's immune system is one of the most promising areas of modern oncology. The drug was invented in Boston, before being tested on mice and dogs in the U.S., Italy, Russia and Ukraine. The vaccine’s efficacy in the spontaneous tumours of dogs and cats has been demonstrated in comparative medicine pilot studies.
With the help of the Skolkovo Foundation and the Pharma-2020 programme, the Russian company SL Onkolodzhi obtained the exclusive licensing rights for Russia, where the first phase of clinical trials took place.
“We’re pleased to continue our international research: at a time when irresponsible politicians and self-interested influence groups are dividing countries and peoples, science and medicine should bring us together,” said Professor Alexander Schneider, the founder of CureLab Oncology and inventor of Elenagen™.