SERB Pharmaceuticals has signed a worldwide exclusive license to use an antigen from Soligenix [NSDQ: SNGX] to develop a novel therapeutic treatment for ricin poisoning. There is an unmet need for protection against this highly potent toxin for which there is no vaccine or therapeutic intervention available.
To develop the ricin antidote, SERB will leverage its unique broad spectrum polyclonal antibody platform, gained in its acquisition of BTG Specialty Pharmaceuticals. This specialized manufacturing process generates binding fragments from antibodies that are specific to a given antigen, helping to ensure potency and purity. This platform is currently used to manufacture two of the company’s currently marketed products, CroFab® and DigiFab®.
The antibodies will be generated using a modified form of the ricin toxin, developed by Soligenix. The modifications have removed the biological activity of the protein so that it is not toxic, while still retaining its shape to trigger an effective antibody response.
“With no current therapeutic options, the threat of ricin represents a significant unmet need in the field of biodefense and medical countermeasures,” said Anthony Higham, CEO of SERB Pharmaceuticals. “Our expertise in antibody development and the commercial scale manufacturing capabilities acquired with BTG together with SERB’s track record of reliably providing a portfolio of high quality CBRN antidotes, uniquely position us to successfully deliver a solution.”
SERB is an expert and leader in the field of medical countermeasures to protect the public and military forces. Their current portfolio includes 14 critical care medicines that counter Chemical, Biological, Radiological, and Nuclear (CBRN) risks. SERB has been a long-standing partner of health authorities, militaries, and other governmental and non-governmental agencies in the US, Europe, Latin America, the Middle East, and North Africa.
SERB will conduct studies to assess the efficacy and safety of the product with initial results expected by the end of 2022. The company is scheduled to discuss the development pathway with the FDA and EMA in the coming months, which will determine the overall development timeline.
The polyclonal antibody platform
To produce antibodies, animals are immunized with an antigen to produce a range of antibodies specific to that antigen. These proteins are extracted from the serum and purified, then cleaved to separate the fragment that binds to the antigen (known as the fragment antigen-binding, or Fab) from the Fc, or fragment crystallizable region. These smaller Fabs can access difficult-to-reach therapeutic targets and are less likely to cause unwanted downstream effects on the immune system. Additional filtration and viral clearance stages help to ensure purity and avoid adverse reactions.
The Ricin threat
Ricin is a source of concern because it is a relatively easy to obtain, easy to weaponize and highly potent toxin. Ricin can be extracted from the seeds of the castor oil plant, Ricinus communis. Ricin is one of the most toxic biological agents known—a Category B bioterrorism agent and a Schedule number 1 chemical warfare agent.
Ricin has been a threat since governments began experimenting with it during World War I. Most famously used in the assassination of Bulgarian writer Georgi Markov in 1978, ricin has been developed and deployed with alarming frequency. Several ricin attacks have been prevented in Europe and the United States in recent years, ranging from a militant group in Germany prevented from launching a ricin attack by police in 2017 to the 2020 delivery of letters laced with ricin to the White House.
About SERB Pharmaceuticals
SERB is a growing pharmaceutical company and a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. For over 30 years we have made treating these complex and life-threatening conditions possible, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. As a fully integrated company, we have the experience and capabilities to acquire, develop, and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain.
Learn more about SERB: https://serb.eu/
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Chris Sampson, Corporate Communications Director
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