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On October 12, 2020, the U.S. Patent Office received and registered Icosagen Cell Factory OÜ’s Patent Application No. 63090576 “SARS-CoV-2 Neutralizing Antibodies."
With this patent application, Icosagen will obtain intellectual property protection for the new antiviral antibodies in the USA. Next, the company intends to implement intellectual property protection around the world. Thereby, Icosagen has successfully completed the first phase of development of its next-generation virus-neutralizing antibodies as promising biological drug candidates against Covid-19.
The patent discloses antibodies against SARS-CoV-2 based on genetic sequences obtained from antibody secreting B-lymphocytes isolated from the blood of Covid-19 recovered donors in Estonia. Cells displaying anti-SARS-CoV-2 antibodies were screened and the genetic sequences encoding the antibodies were isolated using Icosagen's previously patented HybriFree technology. To increase the efficiency of the resulting antibodies, the amino acid sequences were optimized and used to generate IgG antibody isotype. Most potent variations were produced using Icosagen’s QMCF Technology. Based on the biochemical and biophysical parameters of the antibodies, it can be stated that Icosagen has been able to isolate high-affinity antibodies against the SARS-CoV-2 viral spike protein (S protein).
The ability of the antibodies to block virus replication was measured in cell culture under BSL3 laboratory conditions in collaboration with researchers from the University of Tartu and the Norwegian University of Science and Technology. These experiments showed that 19 different antibodies were able to block the proliferation of SARS-CoV-2 in a concentration-dependent manner, even at very low concentrations. The best antibody variants blocked the virus at concentrations of less than 50 picograms / ml, while a typical window of efficacy for therapeutic antibodies is in nano- or even micrograms per ml scale. Collectively, the data obtained suggest that we have succeeded in isolating highly potent and effective antiviral therapeutic antibody candidates.
"Candidates for therapeutic antibodies currently in clinical trials, including those administered to President Trump, can be considered first-generation molecules showing activity according to preliminary results. Although efficacious, the required doses indicate that broad-scale availability of such drugs may not be feasible. The next-generation drug candidates developed by Icosagen that have demonstrated efficacy at much lower doses should significantly increase the accessibility of such therapeutic antibodies to people infected with the virus,” said Mart Ustav Jr., Icosagen’s Chief Scientific Officer. "For industrial production of these antibodies (yields up to 10 grams per liter), we have created excellent production cell lines using IcoCell technology developed by Icosagen and we plan to use the IcoCell platform to produce the drug candidates at a partnering cGMP plant."
Furthermore, in collaboration with Dr. Denis Kainov from the Norwegian University of Science and Technology, Icosagen has identified a strong synergistic potential of viral neutralization with an already approved drug Nelfinavir. These findings provide further rationale for investigating combinatorial therapy approaches in clinical phase trials.
On November 16th, animal studies with antibodies developed by Icosagen will begin in France. The purpose of the experiments will be to determine their ability to prevent SARS-CoV-2 infection or to eliminate the virus after infection. Following these animal studies, Icosagen plans to start clinical trials and test the suitability of the antibodies for both prevention and treatment of viral infections in humans.
"It is still unclear how effective and long-lasting the immune response elicited by vaccines is, especially among the elderly or at-risk people. Neutralizing antibodies offer an opportunity to overcome SARS-CoV-2 virus infection and continue to live normally, even when the human immune system is weakened, " said the Founder and Chief Executive Officer of Icosagen, Prof. Mart Ustav. “We have started preparations for conducting clinical trials and are preparing a request to the Government of the Republic of Estonia in the amount of 12-15 million euros to support our efforts in both the production of antibodies and the conduct of Phase I and II clinical trials,“ he added.
Icosagen's core business and source of income has been contract research and development of biological drugs, providing high-quality service to pharmaceutical companies to support their drug development. The coronavirus pandemic has given Icosagen the opportunity to utilize expertise gained through years of research and service in the field. The antibodies developed and patented by Icosagen have the potential to make anti-coronavirus antibody therapy significantly cheaper and, thereby, much more accessible and widely available. These achievements have been driven by the great contributions, high qualification, and willingness of Icosagen's employees to overcome the challenges and reach new milestones,“ noted Prof. Ustav. He also emphasized the role of the patients and medical professionals in facilitating Icosagen’s research: „The development of Icosagen’s antibodies against coronavirus has been possible only thanks to volunteer donors who were willing to donate blood when we invited them to take part in our research and development project. We would like to thank all of the volunteers who joined our efforts. Many thanks as well to all the primary care and other doctors who spread the word and informed their patients of our study.“
Samples for study were collected in collaboration with Qvalitas, University of Tartu Hospital, Kuressaare Hospital, and North-Estonian Regional Hospital. In addition, Icosagen's developments have been supported by partners from the University of Toronto, the Norwegian University of Science and Technology (NTNU), and the University of Tartu. Icosagen has financed these developments from its own resources.
Development of coronavirus diagnostics is also underway at Icosagen, and the company is inviting the volunteer donors to participate again. This time, people who have been positively diagnosed with the coronavirus will be assessed using saliva samples to validate a novel antigen test that can diagnose the infection faster, more conveniently, and more extensively than the current RNA test. The Government of the Republic of Estonia has supported Icosagen in its development of diagnostics with 100,000 euros.