BioSpectrum Asia|July 2020
Since the start of the outbreak; researchers, pharma firms, governments all over the world are scrambling to find a treatment. From herbal medications to repurposing older drugs as potential COVID-19 therapies, anything which could possibly save lives is being tested and of course the hunt for a vaccine is on. There are 16 vaccine candidates in clinical evaluations and 125 candidates in preclinical evaluation around the world. (As of June 24, 2020. Source: WHO)
Developing a vaccine is a time-consuming process. Vaccines, on an average, take 10 years to develop. The fastest vaccine ever developed till date was approved for the mumps in 1967, took four years. The latest vaccine developed for an epidemic, Ebola vaccine, also took five years,was approved in 2019. Both the vaccines were developed by Merck.
Though the vaccine is touted as the fastest to develop, developing a vaccine that is safe, effective and producing it in large quantities that the world needs to fight a pandemic is a surmountable challenge. It is interesting to note that there is still no licensed vaccine for an earlier Coronavirus, Severe acute respiratory syndrome (SARS). Studies showed that some preliminary SARS vaccines enhanced the disease in model experiments.
That’s why the hunt is on to find the alternative treatment to save people’s lives till the vaccine arrives. And the antibody-based treatments offer an excellent hope. That’s what companies like Regeneron, Eli Lilly, Vir Biotechnology and many more from USA, Europe and Asia Pacific are working on antibodies for COVID-19.
Firms are racing to develop antibody-based treatments because this approach has proven effective against an infectious disease before. During the Ebola epidemic in Africa, a cocktail of antibodies developed by Regeneron were superior to other drugs in reducing mortality from Ebola, according to a study done in the Democratic Republic of the Congo. No other treatments had worked against Ebola. Researchers are hoping that this turns the same way for Coronavirus.
Since April 2020, about 14 organisations across Asia, Europe and the USA are working on antibodies for COVID-19. Seven projects are still in research phase and while others are under clinical trial. The companies that have taken the research to the trial phase include Eli Lilly, USA (Phase I trial), Regeneron, USA (Phase I trial), Celltrion, South Korea (Completed preclinical studies; Phase I trial to start in July), Roviant Sciences, Switzerland (Trial ongoing), Antibody Therapy Against Coronavirus (ATAC) project funded by the European Commission and led by Sweden’s Karolinska Research Institute (Human testing in Germany/ animal testing in Switzerland) and Institute for Biological Research Institute (IIBRI), Israel (Human clinical trials to start). In the Asia Pacific, South Korea’s Celltrion is leading the way. Singapore’s Tychan is also initiating Phase I clinical trials to evaluate TY027, the first novel mAb.
Leading the way
Celltrion in partnership with Korea Centers for Disease Control and Prevention (KCDC), has identified 14 neutralising monoclonal antibodies (mAbs) from a pool of 300 antibodies that bind to SARS-CoV-2’s surface proteins. Following the selection of antibody candidates which demonstrate high potency in neutralising SARS-CoV-2, Celltrion will begin cell-line development. Once this is completed, Celltrion aims to roll out mass production of the therapeutic antibody and, together with the KCDC, Celltrion will conduct efficacy and toxicity testing in mice and non-human primates. The company announced positive results on May 31.
Celltrion Group announced positive preclinical results for its COVID-19 antiviral antibody treatment, with data demonstrating a 100-fold reduction in the viral load of SARSCoV-2, the virus causing COVID-19. The treatment was also able to show improvement in lung lesions to a normal activity level in animal models.
The pre-clinical study was conducted in an animal model in collaboration with one of the Korean National Universities, Chungbuk National University College of Medicine. The trial set out to assess the efficacy of two dosage amounts (low and high) for the antiviral antibody treatment. In comparison to the placebo-controlled group, the research team observed improved recovery in terms of clinical symptom scores such as runny nose, cough and body aches, after the first day of treatment. From the fifth day, significant clinical remission was observed. This announcement follows the identification of antibody candidates for an antiviral treatment which Celltrion completed in April. In response to these positive results, Celltrion will now conduct additional efficacy and toxicity testing in preclinical settings and anticipates starting first-in-human clinical trials in July.
Besides Celltrion, with approval from the Health Sciences Authority (HSA), Tychan, a Singapore based clinical-stage biotechnology company, has completed recruiting healthy volunteers for Phase I clinical trials to evaluate TY027, a monoclonal antibody (mAb) that specifically targets SARS-CoV-2, the virus that causes COVID-19.
Tychan developed TY027 in partnership with the Ministry of Defence, Ministry of Health, the Economic Development Board and other government agencies. TY027 is being explored for the treatment of patients with COVID-19 to slow the progression of the disease and accelerate recovery, as well as for its potential to provide temporary protection against infection with SARS-CoV-2.
On June 10 it announced that the Phase I trial, to be conducted by Sing Health Investigational Medicine Unit, will take about six weeks to evaluate the safety, tolerability and pharmacokinetics of TY027. Upon reaching the key milestones of the Phase I trial, Tychan will seek approval from HSA for TY027 to be administered to a larger population of volunteer patients in subsequent trials to establish the efficacy of the mAb.
The US-based Eli Lilly, on June 1, became the first company to begin world’s first study of a potential COVID-19 antibody treatment in humans. This investigational medicine, referred to as LY-CoV555, is the first to emerge from the collaboration between Lilly and Canada’s AbCellera to create antibody therapies for the prevention and treatment of COVID-19.
Lilly scientists rapidly developed the antibody in just three months after AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) identified it from a blood sample taken from one of the first U.S. patients who recovered from COVID-19. LY-CoV555 is the first potential new medicine specifically designed to attack SARS-CoV-2, the virus that causes COVID-19. The first patients in the study were dosed at major medical centers in the U.S., including NYU Grossman School of Medicine and Cedars-Sinai in Los Angeles.
Should Phase I results show the antibody can be safely administered, Lilly expects to move into the next phase of testing, studying LY-CoV555 in nonhospitalized COVID-19 patients. The company also plans to study the drug in a preventative setting, focusing on vulnerable patient populations who historically are not optimal candidates for vaccines.
Lilly is researching multiple approaches to treating COVID-19. Existing Lilly medicines are now being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with two biotech companies to discover novel antibody treatments for COVID-19.
On June 8, Eli Lilly and Company announced that its partner Junshi Biosciences has dosed the first healthy volunteer in a study of a potential neutralizing antibody treatment designed to fight COVID-19. The investigational medicine, referred to as JS016, is being co-developed by Junshi Biosciences and Lilly, with Junshi Biosciences leading development in Greater China. Lilly has exclusive rights in the rest of the world and will begin dosing patients in a complementary Phase I study in the United States in the coming days. Both Phase I studies aim to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of JS016 in healthy participants who have not been diagnosed with COVID-19. This is Lilly’s second neutralizing antibody to start clinical trials, following LY-CoV555 that recently entered Phase I and is currently being tested in hospitalized COVID-19 patients.
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