Affinity’s COVID-19 antibodies ready for manufacture for clinical trials

30 July 2020, Melbourne, Australia

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: Antibodies that potently inhibit or enhance SARS-CoV-2 spike protein-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.

“An effective antibody therapy would help our healthcare system to better manage COVID-19 outbreaks, hopefully resulting in fewer patients requiring hospitalisation and enabling a quicker resumption of normal life as we await a vaccine.”

“It is imperative that all parties involved in this process move quickly to provide a solution for Australians. The quicker we do, the quicker our economy can recover.”

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.

Whilst considerable hope continues to be placed in the ability of the pharmaceutical industry to test and supply effective protective vaccines for COVID-19, the timing, effectiveness, and duration of protection are still uncertain. It is well known that the elderly, who are most at risk from COVID-19, generally show weaker immune responses to vaccines.

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. For more information, please visit www.affinity.bio/covid19.


Affinity discovers potent SARS-CoV-2 antibodies

Melbourne-based Affinity Biosciences Pty Ltd (Affinity), a privately held company focused on antibody discovery for cancer therapeutics, today announces the discovery of potent antibodies with therapeutic potential against COVID-19.

In March, Affinity commenced screening its proprietary library of one hundred billion human antibodies to discover those that might neutralise SARS-CoV-2, the virus that causes COVID-19. After discovering a number of candidate antibodies that block the virus spike protein from binding to its human receptor, Affinity engaged The Peter Doherty Institute for Infection and Immunity (Doherty Institute) in April to conduct testing using the virus in the laboratory. The Doherty Institute has confirmed that Affinity’s antibodies can completely neutralise the infectivity of SARS-CoV-2 at a single digit microgram/ml concentration in a five-day virus neutralisation assay. The antibodies have high affinity for the SARS-CoV-2 spike protein at around 20 picomolar, driven by an exceptionally slow off-rate, a measure of how long the antibody remains bound to its target.

“Our antibodies latch onto the virus spike protein and block its activity,” said Affinity CEO, Dr Peter Smith. “These antibodies may be protective in humans by preventing the virus from gaining a foothold in healthy people exposed to the virus, and may be useful in arresting the progress of the virus in an infected person by blocking its ability to infect new cells and replicate.”

A highly effective therapy would allow a faster resumption of normal life by reducing the threat of infected individuals needing hospitalisation.

The next steps in the development of Affinity’s COVID-19 therapy are:

  • Manufacturing Affinity’s antibodies for studies. Affinity will seek an expedited process to enable antibodies to be rapidly manufactured to the standards of Good Manufacturing Practice (GMP) for clinical studies.
  • Identification of expedited clinical development/approvals pathways with regulatory agencies such as TGA, FDA, and EMA.
  • Discussions with governments, NGOs, and pharmaceutical companies for accelerated development and commercial distribution. Affinity’s antibodies are currently in a comparative study being conducted by the La Jolla Institute for Immunology (the CoVIC program) funded by the COVID-19 Therapeutics Accelerator launched in March by the Bill & Melinda Gates Foundation, Wellcome Trust, Mastercard, and philanthropists (covic.lji.org).

Affinity is also part of a consortium headed by the Walter and Eliza Hall Institute for the development of biologics against SARS-CoV-2 which recently received funding from the Victorian Government and the Medical Research Future Fund (MRFF).

Further information about Affinity’s antibodies can be found at affinity.bio/covid-19.

Download this announcement here.


Affinity part of COVID-19 ‘biologics’ medicine consortium awarded grant funding from MRFF

On 2 June 2020 the Australian government announced that Melbourne-based Affinity Biosciences Pty Ltd (Affinity) would receive funding from the Australian Medical Research Futures Fund (MRFF) as part of a ‘biologics’ medicine consortium to discover potential antibody therapies for COVID-19.

Affinity is an antibody discovery business normally focussed on discovering novel cancer therapeutics.  In March, with the COVID-19 pandemic gaining momentum Affinity pivoted to screen its proprietary library of one hundred billion human antibodies to discover those that might neutralise SARS-CoV-2, the virus that causes COVID-19. After a number of successful campaigns conducted in parallel, Affinity discovered a number of antibodies that are highly effective in neutralising the infectivity of SARS-CoV-2 in the laboratory.

Affinity is working with renowned international and Australian academics and institutes to move the program forward as rapidly as possible.

As part of those efforts, Affinity will participate in a consortium of leading Australian biotech businesses and institutes to assist the Australian consortium to evaluate antibodies that block the SARS-CoV-2 virus from infecting human cells.

The successful MRFF bid was led by the Walter and Eliza Hall Institute and includes several collaborators such as the Peter Doherty Institute, CSL, CSIRO, Burnet Institute, Kirby Institute as well as Affinity, with each contributing its unique expertise.

This Australian consortium has been granted funding from the Australian federal government’s MRFF, which augments earlier grant funding from the Victorian Government.

Further releases will be provided as Affinity advances its COVID-19 therapy.  For more information, visit affinity.bio/covid-19.

Media contact: WE-AUAffinityBio@we-worldwide.com