Tonix Pharmaceuticals (NASDAQ:TNXP) Holding Corp. said it has exercised an option to obtain an exclusive license from Columbia University for the development of a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies (mAbs) for the treatment or prophylaxis of SARS-CoV-2 infection.
SARS-CoV-2 is the cause of COVID-19. The licensed mAbs were developed as part of a research collaboration and option agreement between Tonix and Columbia University, originally announced in 2020, the clinical-stage biopharmaceutical company said.
“The licensing of these mAbs strengthens our expanding pipeline of next-generation therapeutics to treat and prevent COVID-19,” said Tonix chief executive officer Seth Lederman, MD, in a statement.
“Immunocompromised individuals, including organ transplant recipients, are at increased risk of severe COVID-19 and poor clinical outcomes. We believe there is a need for second-generation mAb treatments and prophylactics to protect this population.”
Although five mAb products containing seven distinct mAbs received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for either treatment or prophylaxis of COVID-19, none remain useful or available since January 26, 2023, when the FDA announced that the last remaining mAb, Evusheld, is no longer authorized.
Previously, either the National Institutes of Health COVID Treatment Guidelines Panel or FDA had removed recommendations or approvals for the other mAbs.
Ilya Trakht, PhD, associate research scientist at Columbia University Vagelos College of Physicians and Surgeons commented: “We are excited to work with Tonix because of its commitment to developing therapeutics for COVID-19. Our antibody platform has proven robust and capable of rapidly making therapeutically relevant fully human mAbs to SARS-CoV-2.
“We have also generated murine mAbs, which represent a new approach. Murine mAbs have the potential for neutralizing a broader spectrum of SARS-CoV-2 variants and may be harder for SARS-CoV-2 to evade as we face a multitude of variants.”
To date, the formerly EUA-approved products were derived from the blood of COVID-convalescent patients or humanized mice. The fully human mAbs generated by Columbia University, TNX-3600, have been isolated using a proprietary system involving a human hybridoma fusion partner.
Tonix said it believes that murine mAbs, such as TNX-4100, have the potential to generate high affinity antibodies that recognize different epitopes on the SARS-CoV-2 spike protein. This is because mice have a different repertoire of antibodies than humans and the technology for generating antibodies optimizes the selection of appropriate B cells by the timing of immunization, harvesting approach and screening platform.
“The potential therapeutic antibodies licensed from Columbia University leverage our expanding internal development and manufacturing capabilities for biologics. These fully human and murine mAbs and their humanized counterparts build on a base of knowledge from a distinct murine mAb platform in development, TNX-3800, from which we have licensed three humanized mAbs from Curia Global,” added Dr Lederman.
Contact the author at jon.hopkins@proactiveinvestors.com