Phase I Clinical Trial Begins for COVID-19 Immunity Agent
Posted on October 29th, 2020
Phase I Clinical Trial Begins in Australia for Temporary Immunity Agent for COVID-19
Nasal drops containing antibodies are the result of an international collaboration between academic institutions, Perth’s Linear Clinical Research and industry expert volunteers
PERTH, WA and STANFORD, CA, — Linear Clinical Research and SPARK GLOBAL have announced that the first human subjects in a Phase I clinical trial in Perth have been dosed with an agent that aims to provide temporary immunity to SARS-CoV-2, the coronavirus that causes COVID-19.
The immunity agent contains antibodies that aim to protect against SARS-CoV-2. The antibodies are produced in chicken egg yolks and formulated into nasal drops that can be self-administered at home or on the go, potentially providing immediate immunity for approximately four hours.
The trial is expected to be completed in December 2020 and is a major milestone in the development of the agent that, if proven effective, could be available early next year.
“As has now been reported by the WHO, realistically it will be well into 2022 before safe, effective COVID-19 vaccines are available in sufficient quantities around the world,” said Daria Mochly-Rosen, PhD, President and Founder of SPARK GLOBAL, Co-Director and Founder of SPARK at Stanford, and a professor of chemical and systems biology at Stanford University School of Medicine.
“In the absence of vaccines or proven-effective treatments for COVID-19, an affordable temporary immunity agent that can be self-administered would enable people to safely resume their normal daily life and work activities while we wait for vaccines and treatments.”
The approach was the idea of Dr. Michael Wallach, Professor and Associate Head of the School of Life Sciences at University of Technology, Sydney and SPARK Sydney director and was developed by an international team, led by SPARK at Stanford. Antibody-based treatments are considered to be one of the best defences against COVID-19 with multiple trials being planned or underway across the world.
The development, manufacturing, and distribution of the nasal drops is being coordinated by SPARK GLOBAL, a translational research partnership that originated at Stanford. The clinical trial is being run by Linear Clinical Research at its Perth facility.
Said Linear CEO Jayden Rogers, “We have established a unique partnering model to fast-track this COVID-19 project with the potential to help millions of people worldwide. Western Australia could be helping Dr. Mochly-Rosen and her team find a COVID-19 solution for the world, especially in regions that might have limited or delayed access to things we take for granted in developed nations, including vaccines.”
Linear will enrol 48 healthy men and women in a randomized, double-blind study for the COVID-19 temporary immunity agent. The Phase I trial is a single dose study in 24 participants, followed by multiple doses in an additional 24 participants, who will be dosed daily in Linear’s clinic and through self-administration at home.
“The immunity agent we are testing is not a traditional vaccine, which works by stimulating a person’s immune system to permanently recognise and fight a virus by producing its own antibodies against it,” said Dr. Mochly-Rosen. “Instead, the nasal drops provide protection by capturing and neutralizing the coronavirus that causes COVID-19 before it enters the body.
“The nasal drops will not replace vaccines and measures such as wearing face masks, social distancing and washing hands,” said Dr. Mochly-Rosen. “But they could play a vital role in keeping people safe while the medical community and governments around the world pursue all options for ending the pandemic.”
Added Mr. Rogers, “This project is an out-of-the-box collaboration that could serve as a model for others in the global scientific community, not just for the current COVID-19 pandemic but for future pandemics as well.”
Other players in the effort include Charles River Avian Vaccine Services, which is handling chicken immunization and antibody production, and Bravado Pharmaceutical LLC, which is formulating and producing the nasal drops, including for the clinical trial.
More about the antibodies:
- To produce the antibodies, egg-laying hens are first immunized with a key SARS-CoV-2 protein.
- The antibodies are passed to the hens’ eggs as IgY antibodies, extracted from the egg yolks, and formulated into nasal drops.
- When administered, antibodies in the drops coat the surfaces inside the nose and throat as a barrier against SARS-CoV-2.
- The use of chicken IgY antibodies has been shown to be safe and effective for multiple diseases. IgY are considered safe for humans when ingested, and the hens are never exposed to the actual virus.
- Because hens are widely available around the world, when immunized they provide a plentiful, inexpensive, and safe source of antibodies against the virus.
Linear Clinical Research
Linear Clinical Research is a global leader in early stage clinical trials and subsidiary of the Harry Perkins Institute of Medical Research. Linear operates one of Australia’s most active early phase trial centres and is considered a leader in clinical trial innovation and data systems. It has conducted over 300 early phase trials which includes one of the most active cancer trial teams in the Asia-Pacific. For more information visit Linear.
SPARK GLOBAL is a network of academic institutions around the globe that utilize a translational research model pioneered by SPARK at Stanford, which was founded by Dr. Mochly-Rosen at Stanford University in 2006. SPARK at Stanford is a cost-effective program that relies on a large network of volunteer industry advisors to help translate breakthrough academic discoveries into products that benefit patients and society. For more information visit sparkmed.stanford.edu.