rCIG (recombinant anti-coronavirus 19 hyperimmune gammaglobulin) in development to treat high-risk and severely ill individuals infected with COVID-19
Overcomes limitations of plasma-based polyclonal antibody therapies, offering controlled volume production, consistency across batches and purity
SOUTH SAN FRANCISCO, Calif., March 30, 2020 (GLOBE NEWSWIRE) -- GigaGen Inc., a biotechnology company advancing transformative antibody drugs for infectious diseases, transplant rejection and checkpoint resistant cancers, announced today it has been developing a recombinant polyclonal antibody therapy for the treatment of COVID-19.
The therapy in development, rCIG (recombinant anti-coronavirus 19 hyperimmune gammaglobulin), reproduces whole antibody repertoires of recovered COVID-19 patients, including high concentrations of those antibodies that target and prevent further replication of the COVID-19 virus. rCIG will be administered to the patients intravenously to provide passive immunity to help them fight infection and facilitate recovery.
GigaGen’s unique approach for the treatment of infectious diseases in high-risk and immunocompromised patients is centered around a unique method for producing recombinant polyclonal antibodies. Unlike plasma-based polyclonal antibodies, such as convalescent serum therapies in development for COVID-19, rCIG does not rely on the constant supply of plasma from recovered COVID-19 donors to provide a regular source of the therapy to patients in need. GigaGen uses its leading single cell technology to capture and recreate complete libraries of antibodies from COVID-19 convalescent patients that can directly translate into antibody therapies. This method is much more scalable than plasma-based methods, since one person’s B cell repertoire can be used to generate a drug that treats millions of patients. Additionally, due to their recombinant nature, GigaGen’s recombinant polyclonal therapies have a decreased risk of contamination and are consistent from batch to batch, enabling a controlled dosing protocol. GigaGen has also shown that recombinant polyclonals have hundreds-fold higher potency than plasma-derived equivalents, which may result in better clinical outcomes.
GigaGen is currently recruiting patients who have recovered from COVID-19 to donate blood for the development of rCIG. The company has signed a collaboration agreement with Access Biologicals, an industry leader in the collection and manufacturing of plasma products, to expedite patient identification and assist with sample collection. The company has already discussed the manufacturing method with the U.S. Food and Drug Administration (FDA) and will be having further discussions to find ways to expedite development.
“At GigaGen, 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 immunocompromised populations,” said David Johnson, Ph.D., co-founder and chief executive officer of GigaGen. “We are working expeditiously to recruit COVID-19 recovered blood donors in the New Orleans and San Diego areas, which will help us further develop this drug. In parallel, we are expanding our manufacturing process to enable GMP production and scalability to expedite time to IND filing. Our goal is to reach the clinic in early 2021.”
“GigaGen has taken a unique and powerful approach for the development of polyclonal antibody therapies,” commented Everett Meyer, M.D., Ph.D., physician scientist at Stanford University and GigaGen co-founder and medical advisor. “The ability of their platform to capture and replicate complete antibody libraries from recovered patients not only has the potential to provide a highly efficacious therapy, but overcomes challenges related to supply shortages, which are an ongoing problem for plasma-based therapies in regular conditions and which are exacerbated in high-demand scenarios, such as in a global pandemic.”
GigaGen’s purified recombinant polyclonal antibodies have already been validated in mouse models and its platform has successfully created recombinant polyclonal antibodies against a number of pathogens, including Zika virus, Haemophilus influenzae b, Influenza A virus and Hepatitis B virus. In addition to rCIG, GigaGen is currently advancing a pipeline of recombinant polyclonal antibody therapies, including a recombinant IVIG therapy for primary immune deficiency and a recombinant immunoglobulin against an undisclosed infectious pathogen in partnership with Grifols, a global leader in the production of plasma-based immunoglobulin products.
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2), first identified in 2019 in Wuhan, China. The disease has since spread globally, reaching pandemic levels. While most cases result in mild symptoms, including fever, cough and shortness of breath, some can progress into severe pneumonia and multi-organ failure.
GigaGen is advancing transformative antibody drugs for infectious diseases, transplant rejection and checkpoint resistant cancers by leveraging industry-leading, single-cell technologies. Our technology uniquely captures and recreates complete immune repertoires as functional antibody libraries. This approach has enabled the creation of the first recombinant polyclonal immunoglobulin therapies, which overcome current limitations of plasma-based products. GigaGen’s technology has also filled a pipeline of monoclonal antibodies with unique properties against known and novel oncology targets with the potential to translate into therapies with improved efficacy and safety profiles.
Monica Rouco Molina, Ph.D.