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Affinity's COVID-19 antibodies ready for manufacture for clinical trials - BSA bureau
The neutralizing antibodies under trial are potentially useful for vaccine development for an apid therapy or to protect people in high-risk situations such as healthcare workers or people in direct contact with COVID patients.
The neutralizing antibodies under trial are potentially useful for vaccine development for an apid therapy or to protect people in high-risk situations such as healthcare workers or people in direct contact with COVID patients. Melbourne-based Affinity Biosciences Pty Ltd (Affinity) has lodged a pre-publication submission to the scientific journal, ‘mAbs’, detailing its results and observations relating to the discovery of potent antibodies against COVID-19. This can be found at the link,'Antibodies that potently inhibit or enhance SARS-CoV-2 spikeprotein-ACE2 interaction isolated from synthetic single-chain antibody libraries’. Affinity’s lead antibodies have been shown to be capable of completely neutralising SARS-CoV-2, the virus that causes COVID-19, and are amongst the most potent reported to date. The virus neutralisation data generated under contract by The Peter Doherty Institute for Infection and Immunity in Melbourne have been previously announced by Affinity. Affinity is now aiming to have its COVID-19 antibody therapy available to the public as fast as possible. Affinity has requested proposals for the manufacture of their antibody for clinical trials from Australian and overseas contract manufacturing organisations and is in discussions with regulatory consultants to establish an expedited path for manufacturing, trials, and approval of the antibody therapy. Affinity’s CEO, Dr Peter Smith, said that material for clinical trials can be manufactured in as little as three to four months, which will provide an opportunity to initiate clinical trials before the end of the year. Securing funding for manufacturing will also ensure local supply. This will be especially important if access to overseas supplies of vaccines or therapeutics are limited or products take longer to develop than expected. Vaccines generally work by inducing the production of antibodies that neutralise the virus. Affinity’s antibodies, when injected into patients, should achieve the same effect of neutralising the virus for a short period, likely to be measured in weeks. It will therefore be potentially useful as a short-term therapy or to protect people in high risk situations such as healthcare workers or people in direct contact with COVID patients. Another observation detailed in the pre-publication submission is the discovery of antibodies that increase binding of the virus spike-protein to human ACE2. This observation may be important for vaccine development because if a vaccine induces similar antibodies, it could potentially reduce its effectiveness. Affinity is now investigating how these antibodies function to inform vaccine design moving forward. Affinity is currently engaging with government agencies and other sources of funding to enable the start of manufacturing and clinical trials for their antibody therapy.
MP Biomedicals and A*STAR co-develop rapid antibody test kit for SARS-COV-2 - BSA bureau
ASSURE® antibody test kit rapidly (15 minutes) identifies individuals who are asymptomatic, have mild symptoms or those who are previously exposed to SARS-CoV-2 virus
ASSURE® antibody test kit rapidly (15 minutes) identifies individuals who are asymptomatic, have mild symptoms or those who are previously exposed to SARS-CoV-2 virus MP Biomedicals Asia Pacific Pte Ltd in collaboration with Singapore's A*STAR has developed ASSURE® SARS-CoV-2 IgG/IgM rapid antibody test kit to detect IgG and IgM antibodies in an individual infected by SARS-CoV-2. The kit produces accurate results in as little as 15 minutes and employs a lateral flow format similar to those used in home pregnancy tests. ASSURE® was developed and manufactured in Singapore. It can be deployed at or near the point of patient care and has been distributed to regions such as Europe, Africa and South America. MP Biomedicals intends to file for Emergency Use Authorization (EUA) from the US FDA for this product as well. Studies have shown that levels of IgG and IgM appear to be correlated with the severity of COVID-19. By detecting IgG and IgM antibodies ASSURE® proves to be a good biomarker in samples such as human blood, plasma or serum for confirming positive or past infection. Aligned with the current recommendation by the World Health Organization, point-of-care or rapid serology tests including ASSURE® rapid antibody test kit should not be used in the clinical diagnosis of COVID-19 infections or in the evaluation of persons with acute respiratory symptoms, especially within the first 14 days of illness. This is to avoid giving patients false reassurance that they do not have the infection, arising from a negative result. However, ASSURE® rapid antibody test kit can help to determine whether an individual has been previously exposed to the virus and generated antibodies as a result. This can help identify asymptomatic individuals or those with only mild symptoms who were not subjected to RT-PCR testing. The technology behind the ASSURE® rapid antibody test kit utilizes proprietary synthetic SARS-CoV-2 proteins. These proteins bind to the IgG and IgM antibodies if the antibodies are present in the specimen samples. MP Biomedicals used it to develop the product based on their lateral flow platform. The Diagnostics Development (DxD) Hub, a national platform hosted by A*STAR's commercialization arm, A*ccelerate, co-developed the validation protocols and quality controls. The ASSURE® rapid antibody test kit was evaluated by the National University Hospital’s (NUH) Department of Laboratory Medicine, and demonstrated good results for both serum and whole blood. The sensitivity of the kit performed well as compared to commercial immunoassays, when tested with convalescent blood from recovered COVID-19 patients in the clinic. The ASSURE® rapid antibody test kit has been granted Provisional Authorisation by the Health Sciences Authority (HSA) for its intended use in Singapore.