Post by highskier on Jun 1, 2022 13:01:29 GMT
The stk is up 44% in pre-market trading this and share buyback news .
Tonix Pharmaceuticals Announces Issuance of U.S. Patent for TNX-801 Smallpox and Monkeypox Vaccine and Recombinant Pox Virus (RPV) Platform Technology
Tonix Pharmaceuticals Holding Corp.
Wed, June 1, 2022, 7:00 AM
Strengthens Patent Portfolio Protecting Horsepox-Based Live Virus Vaccines
TNX-1840 and TNX-1850 are Potential RPV Vaccines Designed to Protect Against COVID-19
Confirms Leadership Position in Synthetic Biology
Statutory Term of New Patent Expected to Provide Exclusivity Until 2037
CHATHAM, N.J., June 01, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,345,896 to the Company on May 31, 2022. This patent, entitled "Synthetic Chimeric Poxviruses," includes claims covering synthetic horsepox virus, the basis for the Company’s TNX-8011 vaccine in development to protect against monkeypox and smallpox and for the Company’s Recombinant Pox Virus (RPV) platform to protect against other pathogens, including SARS-CoV-2. This patent is expected to provide Tonix with U.S. market exclusivity until 2037, excluding any possible patent term extensions or patent term adjustments.
“This patent is an important milestone in protecting our expanding pipeline of vaccines that address known and potentially novel pathogens,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-801 is a horsepox-based live virus vaccine currently in development to protect against monkeypox and smallpox. TNX-18401 and TNX-18501 are designed to express the spike proteins from the SARS-CoV-2 omicron and BA.2 variants, respectively. Horsepox was one of the first few viruses ever generated by synthetic biology and remains among the largest. As we prepare to advance horsepox-based live virus vaccines into clinical development, we are excited to have this new patent as an important element of our patent estate.”
About TNX-801, TNX-1840 and TNX-1850
TNX-801 is a live virus vaccine based on synthesized horsepox2,3. Tonix is developing TNX-801 for percutaneous administration as a vaccine to protect against monkeypox and smallpox. Tonix has previously reported positive data from a monkeypox challenge study in non-human primates4. Tonix is also developing TNX-1840 and TNX-1850 (horsepox-based live virus vaccines) for the prevention of COVID-19. TNX-1840 and TNX-1850 are designed to express the spike protein from the omicron and BA.2 variants of SARS-CoV-2, respectively. Tonix has previously reported positive data from a SARS-CoV-2 challenge study in non-human primates in which animals were vaccinated with TNX-1800, a horsepox-based vaccine expressing spike protein from the Wuhan strain5. Tonix’s TNX-801 was synthesized2 based on the sequence of the 1976 natural isolate Mongolian horsepox clone MNR-763. Molecular analysis of DNA sequences suggests that TNX-801 is closer than modern smallpox vaccines to the vaccine discovered and disseminated by Dr. Edward Jenner in 17986-8. For example, recent studies9,10 have shown approximately 99.7% colinear identity between TNX-801 and the circa 1860 U.S. smallpox vaccine VK05.11 The small plaque size in culture of TNX-801 appears identical to the U.S. Centers for Disease Control publication of the natural isolate12. Relative to vaccinia, horsepox has substantially decreased virulence in mice2. Dr. Edward Jenner invented vaccination in 1798 and the procedure was called “vaccination” because ‘cow’ is ‘vacca’ in Latin and the inoculum material was initially obtained from lesions on the udders of cows affected by a mild disease known as cowpox. However, Dr. Jenner suspected that cowpox originated from horses.8 Subsequently, Dr. Jenner and others immunized against smallpox using material directly obtained from horses. The use of vaccines from horses was sometimes called ‘equination’ from the Latin ‘equus’ which means ‘horse’13. Equination and vaccination were practiced side-by-side in Europe13,14.
About the Recombinant Pox Virus (RPV) Platform
Horsepox virus and vaccines based on its use as a vector are live replicating viruses that elicit strong immune responses. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been exploited as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice2. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, that can be manufactured using conventional cell culture systems, with the potential for mass scale production and packaging in multi-dose vials. Tonix’s TNX-801 and RPV vaccine candidates are administered percutaneously using a two-pronged, or “bifurcated” needle. The major cutaneous reaction or “take” to vaccinia vaccine was described by Dr. Edward Jenner in 1796 and has been used since then as a biomarker for protective immunity to smallpox, including in the World Health Organization’s (WHO) accelerated smallpox eradication program that successfully eradicated smallpox in the 1960’s. The “take” is a measure of functional T cell immunity validated by the eradication of smallpox, a respiratory-transmitted disease caused by variola.
About Monkeypox and Smallpox
Monkeypox15 and smallpox16 are diseases in humans called by the monkeypox and smallpox (or variola) viruses, respectively. Monkeypox and variola are closely related orthopox viruses. Vaccination against smallpox with live virus vaccines based on horsepox or vaccinia protects against monkeypox. After routine smallpox vaccination was stopped in about 1970, monkeypox has become a growing problem in Africa. Recently approximately 300 cases have been identified outside of Africa.17 Smallpox is considered eradicated, but there are concerns about malicious reintroduction.
TNX-1840 and TNX-1850 are Potential RPV Vaccines Designed to Protect Against COVID-19
Confirms Leadership Position in Synthetic Biology
Statutory Term of New Patent Expected to Provide Exclusivity Until 2037
CHATHAM, N.J., June 01, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,345,896 to the Company on May 31, 2022. This patent, entitled "Synthetic Chimeric Poxviruses," includes claims covering synthetic horsepox virus, the basis for the Company’s TNX-8011 vaccine in development to protect against monkeypox and smallpox and for the Company’s Recombinant Pox Virus (RPV) platform to protect against other pathogens, including SARS-CoV-2. This patent is expected to provide Tonix with U.S. market exclusivity until 2037, excluding any possible patent term extensions or patent term adjustments.
“This patent is an important milestone in protecting our expanding pipeline of vaccines that address known and potentially novel pathogens,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-801 is a horsepox-based live virus vaccine currently in development to protect against monkeypox and smallpox. TNX-18401 and TNX-18501 are designed to express the spike proteins from the SARS-CoV-2 omicron and BA.2 variants, respectively. Horsepox was one of the first few viruses ever generated by synthetic biology and remains among the largest. As we prepare to advance horsepox-based live virus vaccines into clinical development, we are excited to have this new patent as an important element of our patent estate.”
About TNX-801, TNX-1840 and TNX-1850
TNX-801 is a live virus vaccine based on synthesized horsepox2,3. Tonix is developing TNX-801 for percutaneous administration as a vaccine to protect against monkeypox and smallpox. Tonix has previously reported positive data from a monkeypox challenge study in non-human primates4. Tonix is also developing TNX-1840 and TNX-1850 (horsepox-based live virus vaccines) for the prevention of COVID-19. TNX-1840 and TNX-1850 are designed to express the spike protein from the omicron and BA.2 variants of SARS-CoV-2, respectively. Tonix has previously reported positive data from a SARS-CoV-2 challenge study in non-human primates in which animals were vaccinated with TNX-1800, a horsepox-based vaccine expressing spike protein from the Wuhan strain5. Tonix’s TNX-801 was synthesized2 based on the sequence of the 1976 natural isolate Mongolian horsepox clone MNR-763. Molecular analysis of DNA sequences suggests that TNX-801 is closer than modern smallpox vaccines to the vaccine discovered and disseminated by Dr. Edward Jenner in 17986-8. For example, recent studies9,10 have shown approximately 99.7% colinear identity between TNX-801 and the circa 1860 U.S. smallpox vaccine VK05.11 The small plaque size in culture of TNX-801 appears identical to the U.S. Centers for Disease Control publication of the natural isolate12. Relative to vaccinia, horsepox has substantially decreased virulence in mice2. Dr. Edward Jenner invented vaccination in 1798 and the procedure was called “vaccination” because ‘cow’ is ‘vacca’ in Latin and the inoculum material was initially obtained from lesions on the udders of cows affected by a mild disease known as cowpox. However, Dr. Jenner suspected that cowpox originated from horses.8 Subsequently, Dr. Jenner and others immunized against smallpox using material directly obtained from horses. The use of vaccines from horses was sometimes called ‘equination’ from the Latin ‘equus’ which means ‘horse’13. Equination and vaccination were practiced side-by-side in Europe13,14.
About the Recombinant Pox Virus (RPV) Platform
Horsepox virus and vaccines based on its use as a vector are live replicating viruses that elicit strong immune responses. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been exploited as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice2. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, that can be manufactured using conventional cell culture systems, with the potential for mass scale production and packaging in multi-dose vials. Tonix’s TNX-801 and RPV vaccine candidates are administered percutaneously using a two-pronged, or “bifurcated” needle. The major cutaneous reaction or “take” to vaccinia vaccine was described by Dr. Edward Jenner in 1796 and has been used since then as a biomarker for protective immunity to smallpox, including in the World Health Organization’s (WHO) accelerated smallpox eradication program that successfully eradicated smallpox in the 1960’s. The “take” is a measure of functional T cell immunity validated by the eradication of smallpox, a respiratory-transmitted disease caused by variola.
About Monkeypox and Smallpox
Monkeypox15 and smallpox16 are diseases in humans called by the monkeypox and smallpox (or variola) viruses, respectively. Monkeypox and variola are closely related orthopox viruses. Vaccination against smallpox with live virus vaccines based on horsepox or vaccinia protects against monkeypox. After routine smallpox vaccination was stopped in about 1970, monkeypox has become a growing problem in Africa. Recently approximately 300 cases have been identified outside of Africa.17 Smallpox is considered eradicated, but there are concerns about malicious reintroduction.