In this interview, Carter Keller, Head of GigaGen and SVP at Grifols, discusses the company’s groundbreaking work in developing recombinant polyclonal antibody therapies for its recent contract awarded by BARDA. These therapies aim to address biothreats like botulinum neurotoxin. Keller shares insights into their technology’s unique challenges and advantages, the implications for future treatments, and their strategic partnership with the US government to enhance national biosecurity.
Moe Alsumidaie: How does GigaGen’s recombinant polyclonal therapeutic differ from current botulinum treatments?
Carter Keller: Our approach to botulinum neurotoxin at GigaGen is unique due to its ability to address all seven serotypes, unlike current therapies focusing on only two. Existing treatments rely on human or horse plasma, which has limited supply and longevity. For instance, the human antibody product is derived from vaccinated plasma, limited to two serotypes, and requires continuous vaccination to maintain supply. Although the horse-derived product covers all seven serotypes, it has a short half-life and can induce anti-horse antibodies, limiting its use.
Our recombinant method allows us to produce highly potent, human antibodies against all seven serotypes without continuous immunization. This method provides a stable, scalable solution that can be used repeatedly prophylactically or for treatment, addressing a significant gap in current treatments. We work closely with the US government to ensure our product meets national security needs.
Moe Alsumidaie: What safety concerns might arise in the first human trials of your therapies?
Carter Keller: We have extensive experience with recombinant human antibodies, which have shown to be safe. Our platform captures a wide diversity of antibodies, similar to plasma-derived products. Our parent company Grifols, a leader in plasma-derived therapies, provides a strong foundation in handling diverse human antibodies, ensuring safety. Our initial trials for botulinum neurotoxin will take place in a control setting, such as using small doses of botulinum toxin to assess efficacy. We are also evaluating our recombinant polyclonals for other indications, including an upcoming trial for hepatitis B, which will provide additional safety validation of our approach. We are confident in the safety profile of our products, given our extensive background and the rigorous testing protocols we employ.
Moe Alsumidaie: How significant is the scalability of your antibody production for emergencies?
Carter Keller: Our recombinant manufacturing process allows us to produce large quantities of antibodies, which are crucial for stockpiling and addressing large-scale biothreats. Unlike plasma-derived products for botulinum toxins, we can create stable, high-quality stockpiles that do not expire quickly, ensuring readiness for any potential threat. For instance, our ability to produce our product from a single cell line means we can meet the needs of a full country or military force, providing both prophylactic protection and acute treatment. This scalability is vital for national preparedness against biothreats. The ability to rapidly scale production ensures that we can respond effectively to emergencies, providing a reliable supply of therapeutics when needed.
Moe Alsumidaie: How do you plan to design your clinical trial protocol for rare biothreat exposures?
Carter Keller: We have to do all of the same safety studies that you would do for any new therapeutic and demonstrate that the product is efficacious in well controlled studies at government facilities. Thankfully we will be able to leverage all of the earlier work done to support the approval of the equine product in developing and establishing studies. Real-world data will be collected from actual exposure cases to validate our product further, ensuring it is safe and effective in practical scenarios. This approach allows us to gather comprehensive data before moving into later-stage human trials, ensuring our products are ready for real-world application.
Moe Alsumidaie: What are the implications of using your platform for multiple infectious agents?
Carter Keller: Our platform at GigaGen is ideal for rapid response to diverse biothreats. We expect to start phase one trials for the botulinum therapeutic in late 2029. We’re also working with BARDA to identify and address other significant biothreats, with the contract covering six years to develop these solutions. This flexibility allows us to adapt to emerging threats, whether pandemic-related or potential bioweapons, ensuring we can provide timely and effective responses. The versatility of our platform means we can quickly pivot to address new challenges, making it a valuable tool in the fight against a wide range of infectious agents.
Moe Alsumidaie: Is there anything else you’d like to add about your work?
Carter Keller: This contract validates our unique industry-pioneering platform. Our recombinant polyclonal method is versatile and applicable to infectious diseases, autoimmune disorders, and more. We’re eager to partner with others to expand this technology’s impact across various medical fields. The upcoming clinical trials for our hepatitis B product will further demonstrate the potential of our approach, paving the way for new collaborations and applications. We believe this technology represents a significant advancement in therapeutic development, offering new possibilities for treating complex diseases.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
