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Viraj Mane, co-founder of Lactiga, a Toronto-based biotherapeutics company, with a sample of donated breast milk used to extract antibodies, in Toronto.

Christopher Katsarov/(Christopher Katsarov/The Globe

When Viraj Mane became a parent in 2012, he was struck by the packets of excess breast milk that started to pile up in his freezer. He began to wonder about the global supply of unused human milk.

Dr. Mane’s observations as a parent, combined with the knowledge he’d gained pursuing his PhD in molecular and human genetics and working in immunology, virology and nanotechnology, led him to think about ways to repurpose excess donations to milk banks, which stockpile breast milk for use in emergency neonatal care. In 2017, he co-founded Lactiga, a Toronto-based biotech company that has since developed and patented methods of extracting antibodies from human breast milk, with the aim of developing new treatments for immunodeficient patients.

Now, like many researchers and biotech companies, Lactiga’s focus has shifted in response to the pandemic. The company is currently developing an airway treatment for COVID-19 infected patients, using donated milk sourced from mothers who have been vaccinated against COVID-19 or recovered from natural infection. This type of milk has been found by researchers to contain COVID-19 antibodies.

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The final goal of Lactiga’s work is a COVID-19 treatment – not prevention – that reduces the viral load of SARS-CoV-2 in the airways. As the antibodies are absorbed through the respiratory tract, they would mitigate the severity of COVID-19 infection. The treatment would look like a liquid in a small cartridge. Using an already-available device with a mask that covers the mouth and nose, patients would inhale a mist.

Lactiga is working in collaboration with Rebecca Powell, a researcher at Mount Sinai Icahn School of Medicine in New York. Last year, they jointly received US$2-million in funding from the National Institutes of Health (NIH) Emergency Award Fund, which includes a three-year project commitment from the NIH for the research and development of this COVID-19-specific treatment.

If ultimately approved by Health Canada and the U.S. Food and Drug Administration, Lactiga’s treatment could be used at home or in hospital – a key differentiator from other clinical treatments, Dr. Mane said, as offering patients opportunities to recover at home is important given global shortages of hospital equipment, beds and staffing.

The treatment is in the preclinical phase of development, but Dr. Powell said it will likely be tested on hamsters by the end of the summer. Dr. Mane expects human clinical trials to take place in 2022.

The use of antibody treatments for COVID-19 gained attention last year when former president Donald Trump was treated with Regeneron, which uses monoclonal antibodies – laboratory-made proteins to which viral variants are resistant.

Richard Bozzato, a senior health adviser at MaRS Discovery District, said that compared with monoclonal antibody treatments, Lactiga’s treatment, which relies on polyclonal antibodies, would have a “broader spectrum of potential effectiveness” in the fight against COVID variants. Polyclonal antibodies found in human milk are naturally adaptable and can target many sites on a virus – like a spike protein – even if it has mutated. They are also believed to be highly stable.

“This material can be stockpiled for months, possibly even years, and used in acute situations,” Mr. Bozzato said.

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Viraj Mane, co-founder of Lactiga, holds a vial of antibodies extracted from breast milk.

Christopher Katsarov/(Christopher Katsarov/The Globe

Similar to other COVID-19 treatments, Dr. Powell said, Lactiga would primarily target patients who are at higher risk for developing serious disease or who haven’t yet developed severe infection.

This and other antibody treatments could help mitigate the harm from COVID-19 cases that aren’t prevented by vaccines or other measures. “Most countries are now in their third or fourth COVID wave. So, the unfortunate truth is that these key public-health initiatives, like mask wearing, just have not been sufficiently observed,” Dr. Mane said.

Dr. Powell, who at the start of the pandemic had been studying breast-milk antibodies from donors who had recovered from natural COVID-19 infection, believes the overall stability of those antibodies supports the global feasibility of the treatment. Antibody levels in human milk remain high for 10 months or longer following vaccination, she said, which would mean a large pool of potential donors.

Lactiga has signed commitments from milk banks in Canada, the U.S. and Britain, and samples through Dr. Powell’s lab. If a firm supply chain is established, it would be the first time non-profit milk banks have partnered with a for-profit biotech company. As research and development of the treatment progressed, milk donors would be offered a consent framework to clarify the way their milk samples would be used.

In an interview, Andrea Edlow, a maternal fetal medicine specialist at Massachusetts General Hospital and assistant professor of obstetrics and gynecology at Harvard Medical School, emphasized the importance of including pregnant and lactating women in research.

“Because [they] have been an under-studied group, the potential for any kind of bodily fluid of a pregnant or lactating woman for therapeutic potential probably hasn’t been adequately explored,” she said.

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“We’re going to really need a lot of different strategies to protect people for a long time,” Dr. Powell said. “Outside of COVID, what we learn from these studies could be impactful for other for other sensitive infections, because this could pave the way for using milk antibody in that way.”

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