Post by highskier on Dec 12, 2022 14:44:47 GMT
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CHATHAM, N.J., Dec. 12, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that it has obtained an exclusive license from Curia Global, Inc., a leading contract research, development and manufacturing organization, for the development of three humanized murine monoclonal antibodies (mAbs) for the treatment or prophylaxis of SARS-CoV-2 infection. SARS-CoV-2 is the cause of COVID-19.
âWe believe that the licensing of these mAbs strengthens our pipeline of next-generation therapeutics to treat COVID-19,â said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. âImmunocompromised individuals, including organ transplant recipients, are at increased risk of severe COVID-19 and poor clinical outcomes1. Although five monoclonal antibody products, containing seven distinct monoclonal antibodies, have received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for either treatment or prophylaxis of COVID-19, only a single product, EvusheldÂŽ, is still recommended for use as a prophylaxis by the National Institutes of Health COVID-19 Treatment Guidelines Panel or FDA2,3. Moreover, concerns have been raised about the ongoing ability of EvusheldÂŽ to prophylax in the face of new variants4. We believe there is a need for second generation mAb treatments and prophylactics for COVID-195. To date, the EUA-approved products have been derived from the blood of COVID-convalescent patients or a humanized mouse6,7. The Company believes that humanized murine monoclonal antibodies discovered by Curia and licensed by Tonix represent a potential new approach to treating SARS-CoV-2 infection. The Company believes that murine monoclonal antibodies 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 âvariant soupâ from both convergent and divergent evolution.â8
Brian Zabel, Ph.D., Senior Director at Curia said, âWe are excited to work with Tonix because of their commitment to developing therapeutics to COVID-19. Murine monoclonal antibodies represent a different approach and one that has the potential to generate high affinity antibodies that recognize different epitopes on the SARS-CoV-2 spike protein. Mice have a different repertoire of antibodies and the Curia technology for generating antibodies optimizes the selection of appropriate B cells by the timing of immunization, harvesting approach and screening platform.â
Seth Lederman added, âThe potential therapeutic antibodies licensed leverage our expanding internal development and manufacturing capabilities for biologics. These murine monoclonal antibodies and their humanized counterparts build on a base of knowledge from the fully human monoclonal antibody platform, TNX-3600, which we are developing with Columbia University.â
1Haidar G, Mellors JW. Improving the Outcomes of Immunocompromised Patients With Coronavirus Disease 2019. Clin Infect Dis. 2021;73(6):e1397-e1401. Doi:10.1093/cid/ciab397
2https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/ - accessed Nov 3, 2022
3FDA Updates on Bebtelovimab www.fda.gov/drugs/drug-safety-and-availability/fda-updates-bebtelovimab- Accessed Nov 4, 2022
4Wu, K.J. October 29, 2022. The Atlantic. âThe End of Evusheld: If youâre immunocompromised, this ⌠isnât great.â www.theatlantic.com/health/archive/2022/10/covid-variants-antibody-treatments-immunocompromised/671929/
5Madison Muller, M. November 16, 2022. Bloomberg. âDoctors Are Running Out of Antibody Drugs to Treat Covid as Virus Mutates.â www.bloomberg.com/news/articles/2022-11-16/covid-s-mutations-leave-doctors-with-far-fewer-antibody-drugs-to-treat-virus?
6Hansen J et al. Science. 2020 Aug 21;369(6506):1010-1014. Doi: 10.1126/science.abd0827
7 Asdaq, S.M.B. et al. A Patent Review on the Therapeutic Application of Monoclonal Antibodies in COVID-19. Int. J. Mol. Sci. 2021, 22, 11953. doi.org/10.3390/ijms222111953
8Callaway, E. Oct 28 2022. Nature (News). COVID âvariant soupâ is making winter surges hard to predict: Descendants of Omicron are proliferating worldwide â and the same mutations are coming up again and again. www.nature.com/articles/d41586-022-03445-6
Brian Zabel, Ph.D., Senior Director at Curia said, âWe are excited to work with Tonix because of their commitment to developing therapeutics to COVID-19. Murine monoclonal antibodies represent a different approach and one that has the potential to generate high affinity antibodies that recognize different epitopes on the SARS-CoV-2 spike protein. Mice have a different repertoire of antibodies and the Curia technology for generating antibodies optimizes the selection of appropriate B cells by the timing of immunization, harvesting approach and screening platform.â
Seth Lederman added, âThe potential therapeutic antibodies licensed leverage our expanding internal development and manufacturing capabilities for biologics. These murine monoclonal antibodies and their humanized counterparts build on a base of knowledge from the fully human monoclonal antibody platform, TNX-3600, which we are developing with Columbia University.â
1Haidar G, Mellors JW. Improving the Outcomes of Immunocompromised Patients With Coronavirus Disease 2019. Clin Infect Dis. 2021;73(6):e1397-e1401. Doi:10.1093/cid/ciab397
2https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/ - accessed Nov 3, 2022
3FDA Updates on Bebtelovimab www.fda.gov/drugs/drug-safety-and-availability/fda-updates-bebtelovimab- Accessed Nov 4, 2022
4Wu, K.J. October 29, 2022. The Atlantic. âThe End of Evusheld: If youâre immunocompromised, this ⌠isnât great.â www.theatlantic.com/health/archive/2022/10/covid-variants-antibody-treatments-immunocompromised/671929/
5Madison Muller, M. November 16, 2022. Bloomberg. âDoctors Are Running Out of Antibody Drugs to Treat Covid as Virus Mutates.â www.bloomberg.com/news/articles/2022-11-16/covid-s-mutations-leave-doctors-with-far-fewer-antibody-drugs-to-treat-virus?
6Hansen J et al. Science. 2020 Aug 21;369(6506):1010-1014. Doi: 10.1126/science.abd0827
7 Asdaq, S.M.B. et al. A Patent Review on the Therapeutic Application of Monoclonal Antibodies in COVID-19. Int. J. Mol. Sci. 2021, 22, 11953. doi.org/10.3390/ijms222111953
8Callaway, E. Oct 28 2022. Nature (News). COVID âvariant soupâ is making winter surges hard to predict: Descendants of Omicron are proliferating worldwide â and the same mutations are coming up again and again. www.nature.com/articles/d41586-022-03445-6