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™.
Half of all Russian-origin innovative pharmaceuticals are developed by Skolkovo Foundation startups, Kirill Kaem, head of the organisation’s biomed cluster, told a meeting of the foundation’s council on Monday evening.
Of about 1,400 pharmaceuticals approved by Russia’s Health Ministry in 2014-2016, most (1,258) were generics and biosimilars. The others were original brand name imported pharmaceuticals (119) or original Russian pharmaceuticals (21). Of four original newly developed innovative Russian pharmaceuticals, two were developed by Skolkovo residents: the anti-viral drug Triazaverin and the hypoglycemic drug Satarex, Kaem told the council members, presenting a status report on the cluster’s work.
Kirill Kaem presented a progress report on the biomed cluster at a meeting of the Skolkovo Foundation council held at the innovation city’s brand new Technopark building on Monday. Photo: Sk.ru.
Two innovative drugs may not sound like much to the general public, but there are only a few dozen innovative medicines being developed at any one time in the world, so Skolkovo’s input is a significant one, Kaem told the council in response to a question from another council member.
Eight more medical products developed by Skolkovo residents are expected to get approval from the Health Ministry this year, followed by seven in 2018 and eight in 2019, said Kaem.
The process of launching new medical drugs and devices is a lengthy one, as pre-clinical trials followed by three stages of clinical trials are required. Then an application to register the product must be submitted, and approval obtained by the Health Ministry before the product can be sold.
On Friday – World Tuberculosis Day – Skolkovo startup Infectex announced it had completed clinical trials in Russia of its new drug, SQ109, for treating multiple drug-resistant strains of the disease. The innovative drug is expected to be launched on the market in 2018.
Skolkovo’s biomed cluster is now home to 324 startups working in biomedicine, while another 69 belong to the cluster’s agrotech subdivision. Most of the startups – 81 percent – are early stage, meaning they have carried out scientific research and are now at the stage of clinical studies or prototyping, explained Kaem. Twelve percent are middle stage (meaning they have a working prototype), and 7 percent are late stage, meaning they are completing clinical studies.
One of the cluster’s agrotech startups, Artembryogen, is successfully working in partnership with the major Russian meat producer Cherkizovo Group, which believes the startup – which has developed a new technology that reduces the cost of producing valuable cattle embryos – is a potential unicorn.
The startups’ combined revenue and private investment exceeded an estimated 4.5 billion rubles ($79 million) in 2016, Kaem told the foundation council members present at the Skolkovo Technopark, who included Skolkovo Foundation president Victor Vekselberg and new member Dmitry Livanov, Russia’s former science and education minister. Taking part from abroad via video link were former Finnish prime minister Esko Aho and the retired CEO of Intel Corporation, Craig Barrett.