Grifols' GigaGen garners up to $135M from BARDA to tackle botulinum biothreat

Antibody aficionado GigaGen, a subsidiary of Spanish biopharma Grifols, is ramping up its tech to tackle botulinum neurotoxins, earning the chance to pocket up to $135 million over six years from the Biomedical Advanced Research and Development Authority (BARDA), an office of the Department of Health and Human Services dedicated to fighting bioterrorism and emerging diseases.

“Building on our successful collaboration with the Department of Defense (DOD), this project demonstrates the versatility of our recombinant polyclonal antibody platform, which is ideally suited for rapid responses to imminent biological threats,” Carter Keller, senior vice president of Grifols and head of GigaGen, said in an Oct. 3 release.

GigaGen’s prior work with the DOD produced polyclonal antibodies that can neutralize two botulinum neurotoxins, which are secreted by the bacterium Clostridium botulinum. With their new BARDA cash, which consists of an initial $20 million and the possibility of making $135 million total, the California-based biotech will manufacture and clinically develop antibodies that target the full suite of seven toxin variants made by the microbes.

The money will also be used to develop treatments for a second biothreat that has yet to be determined, the release said.

Botulinum prevents the neurotransmitter acetylcholine from being released at the junctions of nerves and muscles, which prevents muscles from contracting. Botulinum’s paralytic powers have made it popular as Botox, a cosmetic treatment for facial wrinkles. If the toxin hits the diaphragm, it can prevent breathing and cause suffocation. Most infections come from contaminated food or through open wounds, as C. botulinum is a relatively common bacterium.  

Grifols fully acquired GigaGen in 2021 for $80 million, after first investing $50 million in the biotech in 2017 for a deal to develop polyclonal antibodies. GigaGen first snagged the spotlight when they began testing antibodies for Covid-19 derived from the blood plasma of patients who had a naturally high ability to fight the virus. A phase 1 trial of GIGA-2050 was ultimately discontinued in 2022 due to poor recruitment, Keller told Fierce Biotech in an emailed statement, "as was the case with many studies investigating potential treatments during the pandemic prior to the spread of the Delta variant."

GigaGen’s leading candidate is a polyclonal antibody for hepatitis B, which they plan to begin testing in a phase 1 trial in the fourth quarter of 2024, the company said in the release.