GigaGen Receives NIH Grant to Develop Production Technology for Recombinant Intravenous Immunoglobulin
Natural Repertoire Antibody Protein Expression System Will Form the Basis of rIVIG Therapeutic Product for Primary Immunodeficiency
Jan 16, 2018, 08:00 ET
SOUTH SAN FRANCISCO, Calif., Jan. 16, 2018 /PRNewswire/ -- GigaGen Inc., a biopharmaceutical company developing novel antibody therapies, has been awarded a $3 million grant from the National Institutes of Health (NIH) to advance its next-generation plasma therapy for patients with immune deficiencies. GigaGen will use the funds to develop a natural repertoire antibody protein expression system, laying the foundation for a recombinant immunoglobulin (rIVIG) therapy for patients with primary immunodeficiency diseases (PI) that overcomes many of the limitations of current plasma-based IVIG options.
"Immunoglobulin replacement therapy has, for decades, been a critical treatment for patients with primary immunodeficiency," said Dave Johnson, Ph.D., CEO of GigaGen. "In line with our mission to create antibody therapeutics that improve long-term outcomes for patients with severe diseases of immune dysregulation, we aim to significantly improve upon today's standard plasma therapy with a product that is safer, more consistent and unconstrained by donor supply. This NIH grant will enable us to continue to move swiftly toward our goal."
GigaGen is committed to the development of high-potential therapeutic candidates for diseases characterized by dysregulation of the immune system. In addition to the company's polyclonal antibody work to create rIVIG therapeutics, GigaGen has an internal monoclonal antibody discovery pipeline against 17 distinct immuno-oncology targets.
About PI
PI are a group of more than 300 rare, chronic disorders in which part of the body's immune system is missing or functions improperly. Although PI will be the primary indication for clinical study, GigaGen's product candidate could eventually be evaluated as a treatment for other diseases including autoimmune and infectious diseases.
Intravenous immunoglobulin therapy, or IVIG, is used to treat a number of hematologic, neurologic and dermatologic conditions, as well as PI. Today, the therapy is derived from pooled antibodies collected from thousands of plasma donors. However, while IVIG demand is increasing at an annual rate of 8-10 percent due to an aging population and growing therapeutic indications, conventional production methods present challenges that threaten continued expansion of the therapy. For example, IVIG production is dependent on limited human plasma supply and requires investment in expensive, large-scale purification facilities. Protein impurities and viral contamination are a threat, and batch-to-batch variability is common.
Recombinant IVIG could potentially solve these problems. However, until recently, there has been no technology that could capture highly diverse native immune repertoires and recreate them in vitro. Using its proprietary molecular genomics technology, GigaGen has built DNA libraries of natively paired Ig, which it expresses using recombinant techniques to produce the world's first rIVIG product. The company is now taking steps to further develop the therapeutic product: GigaGen is building a library that meets FDA guidelines, scaling protein production and benchmarking the product against conventional IVIG. At the conclusion of this work, GigaGen expects to have sufficient data to begin clinical studies, with the ultimate goal of bringing its rIVIG therapeutics to market.
About GigaGen
GigaGen is a privately-held, preclinical biopharmaceutical company developing novel antibody therapies to treat diseases of immune dysregulation. GigaGen's deep understanding of immune dysregulation is enabled by industry-leading technology that quickly captures the genetic makeup of entire immune repertoires to analyze B cells at a rate of millions per hour, while simultaneously identifying their antigen and protein binders. GigaGen has a robust internal pipeline consisting of novel antibodies against immuno-oncology targets, in addition to the first recombinant intravenous immunoglobulin (IVIG) for patients with immune deficiency. For more information visit www.GigaGen.com.
SOURCE GigaGen Inc.