GigaGen Inc, a biotechnology company focused on innovative antibody therapies, has been awarded a significant contract by the Biomedical Advanced Research and Development Authority (BARDA), a Department of Health and Human Services, to develop recombinant polyclonal antibody therapies targeting botulinum neurotoxins (BoNT) and an additional biothreat yet to be determined. The contract starts with an initial commitment of $19.6 million, with the potential to reach up to $135.2 million over a six-year period.
In our interview with Carter Keller, senior vice president of Grifols and head of GigaGen, he expressed enthusiasm about the collaboration: “We were excited to announce we were awarded a contract with BARDA to create two therapeutics together. One is a therapeutic to protect US citizens against botulinum toxin poisoning, which could be used as a bioweapon or a biothreat. The US government is worried about that and wants to replace current options, and then one additional potential biothreat or pandemic, and we’re working with BARDA to figure out what that one will be.”
The funding will support drug manufacturing and Phase 1 clinical trials for these programs. BoNT, produced by the bacterium Clostridium botulinum, is one of the most toxic biological substances known, capable of causing progressive muscle paralysis and potentially fatal outcomes if untreated.
Keller also noted that GigaGen sees exciting opportunities soon for developing polyclonal antibody therapies and plans to leverage them strategically, “We believe that we have the ideal platform for a rapid response to any type of biothreat or pandemic. We have a platform that can take an immune response from a human that’s been exposed to a biothreat or an animal that’s been immunized with a biothreat and recreate a great immune system response as a drug very quickly. You can imagine this could be used against any type of future biothreat. This is our chance to prove that to the world, show the potential and further show the promise of this recombinant antibody platform to quickly protect people against any future threat that might arise.”
This project builds upon a prior contract awarded by the US Department of Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) in 2022, which confirmed the platform’s effectiveness against two BoNT variants. The new BARDA project will extend this research to develop treatments targeting all seven known BoNT variants.
Furthermore, GigaGen plans to utilize this platform for infectious and autoimmune diseases. Keller emphasized, “This is further validation that this is a great new way to treat patients. We’re the only company that can make recombinant polyclonal antibody therapeutics. Everybody’s aware of monoclonals. These are thousands of antibodies all directed towards the disease. We are excited to bring this new method of treating disease to patients in as many different ways as possible, and we’ll be doing that with partnerships with the government, with partnerships with other pharmaceutical firms, and within Grifols and GigaGen for all of the opportunities that we see fit. This is one more step on the path to using this platform to transform human disease.”
In addition to this advancement, GigaGen recently received clearance from the US FDA for its Investigational New Drug (IND) application to begin a Phase 1 clinical trial evaluating GIGA-2339, its first recombinant polyclonal antibody for hepatitis B virus (HBV) infection. The trial is expected to commence in the fourth quarter of 2024.
GigaGen’s next-generation recombinant polyclonal platform utilizes high-throughput, single-cell genomic, and protein engineering technologies to create a diverse array of synthetic polyclonal antibodies, more potent than traditional plasma-derived therapies. This innovative approach allows for continuous manufacturing of antibody products tailored to specific pathogens, providing a robust defense against evolving biological threats.
