On July 25, 2022 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that it has signed a worldwide exclusive license to supply its ricin antigen to SERB Pharmaceuticals (SERB), for development of a novel therapeutic treatment against ricin toxin poisoning (Press release, Soligenix, JUL 25, 2022, View Source [SID1234616897]). There is an unmet need for protection against this highly potent toxin for which there is no vaccine or therapeutic intervention available.
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"We are pleased to be partnering with Soligenix on the use of their antigen to accelerate our ricin therapeutic program. 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 Chemical, Biological, Radiological, and Nuclear (CBRN) antidotes, uniquely positions us to successfully deliver a solution."
"Beyond our own development of a heat stable ricin vaccine (RiVax) to protect against lethal ricin poisoning, which has been supported with more than $30 million dollars to date by the U.S. government, we felt it important to also partner with SERB in the development of its ricin therapeutic drug candidate," stated Christopher J. Schaber, PhD, President and CEO of Soligenix. "SERB is a leader in the field of medical countermeasures to protect the public and military forces. By supplying our novel ricin antigen as an important component of their formulation, we are hopeful that it will assist in accelerating development of this early-stage program."
In pursuit of a 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.
The specific licensing terms have not been disclosed at this time, but consist of a manufacturing supply agreement and small royalty percentage upon commercialization.
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.