by Marie Daghlian
GigaGen announced that it is developing a recombinant polyclonal antibody therapy for the treatment of COVID-19, the pandemic coronavirus that has been sweeping the world and for which humans have no innate immunity.
Based in South San Francisco, GigaGen spent the first seven years of its existence developing its single cell technology drug discovery and development platform, often raising money just on ideas during that period. It eventually came up with a powerful way to make recombinant polyclonal antibodies and now has a pipeline targeting infectious disease, transplant rejection, and checkpoint resistant cancers.
David Johnson, co-founder and CEO, says the company realized years ago that its platform could be useful for emerging pathogens. Although the company tried but couldn’t secure funding from the U.S. military, at least it already had plans in place if a pathogen should emerge.
“When we first saw the coronavirus coming up in China in January, we started making plans for building a product,” said Johnson. “Of course, the virus had to be sequenced and people had to go make the antigen—so there was a time gap of several weeks. But we looked at this as something we should be involved with very early in the process.”
GigaGen’s experimental therapy, rCIG (recombinant anti-coronavirus 19 hyperimmune gammaglobulin), reproduces whole antibody repertoires of recovered COVID-19 patients. A constant supply of donors to produce rCIG are not needed because its single cell technology can capture and recreate complete libraries of antibodies from COVID-19 convalescent patients, which can then directly translate into antibody therapies. The method is much more scalable than plasma-based methods currently in development that rely on a constant supply of recovered donors to provide plasma, since one person’s B cell repertoire can be used to generate a drug that treats millions of patients. Recombinant polyclonals have also been shown to have hundreds-fold higher potency than plasma-derived equivalents, which may result in better clinical outcomes.
GigaGen has already begun sample collections through its partner Access Biologicals and is expanding its manufacturing process with hopes to be able to dose the first patient before the end of the year. When asked about development timelines, Johnson said the situation is evolving with the U.S. Food and Drug Administration as it changes its ideas about how to deal with the pandemic, with one biotech developing a two-monoclonal antibody cocktail saying they will be in the clinic in July, compressing the normal manufacturing and toxicity work to three to four months.
“Clearly we will be asking FDA how we can bring product to patients faster,” said Johnson. “It’s unclear at this point what one would “skip” to get to clinic faster; if we followed normal guidance, then we are looking at this winter for starting dosing.”
Of course all research and production has been exacerbated by state and county mandated shutdowns and “shelter-in-place” edicts, which have been disruptive. Johnson said it lost probably two to three weeks of work before it was clear they were allowed to operate.
Supply chains are also an issue, as the company doesn’t know what they might not get from one week to the next—the biotech’s “scientific toilet paper” similar to what people experienced from no toilet paper on warehouse and grocery shelves beginning in March. With limited staff in the lab to preserve social distancing and concern about getting enough material and reagents for its COVID-19 project, GigaGen has scaled back all of its other programs temporarily.
“We are leveraging our expertise in recombinant immunoglobulin development to create rCIG, which has the potential to provide a cure for hospitalized COVID-19 patients, and may also be used prophylactically to prevent disease development in high-risk individuals, such as health care workers, elderly or immune-compromised populations,” said Johnson.
Johnson emphasizes that drug development takes time and the only thing that can shorten the process is good science. “You can’t be saying something works before you test it in humans” he said. “Even if you’ve done it with only 30 patients and it looks good you still have to keep going.”
Johnson emphasized that rCIG is a therapeutic for COVID-19, not a vaccine, but it can play an important complementary role to a vaccine. “The medical system needs a good vaccine and a therapeutic, and hopefully, multiple therapeutics,” said Johnson. “There’s space for competing groups to be working on multiple methods for dealing with the pandemic.”
- GigaGen Press Release: GigaGen Initiates Development of Recombinant Polyclonal Antibody Therapy for COVID-19
- BioSpace: GigaGen Works to Develop Passive, Convalescent COVID-19 Therapy
- FierceBiotech: GigaGen jumps into COVID-19 arena with polyclonal antibodies
- San Francisco Business Times: Peninsula biotech readies attack on COVID-19 — all it needs now is more cash and recovered patients’ blood