Tonix Pharmaceuticals Holding Corp. has received FDA clearance of its IND application to support a phase I trial with TNX-1500, an anti-CD40L monoclonal antibody. The first indication Tonix is seeking for TNX-1500 is the prevention of organ rejection in patients receiving a kidney transplant. Enrollment in the phase I study is expected to open in the third quarter of this year.
Researchers from Tonix Pharmaceuticals have presented preclinical data for mTNX-1700 (mTTF2-MSA), a novel recombinant fusion protein with an extended half-life, in anti-PD-1 treated colorectal cancer (CRC) models.
Tonix Pharmaceuticals Holding Corp. 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 for the treatment or prophylaxis of SARS-CoV-2 infection.
Tonix Pharmaceuticals Holding Corp. has announced it plans to develop the TNX-3900 series of oral antivirals as monotherapy or in combination with other antivirals, following an agreement whereby it has acquired all of the assets of Healion Bio Inc., including its entire portfolio of next-generation antiviral technology assets.
Tonix Pharmaceuticals Holding Corp. has entered into a sponsored research agreement with Boston Children's Hospital to study TNX-1500, an Fc-modified anti-CD40L monoclonal antibody, for the prevention of graft-vs.-host disease (GVHD) after hematopoietic stem cell transplant (HSCT) in animals.
Now that the U.S. Department of Health and Human Services (HHS) has declared monkeypox a public health emergency, nearly two weeks after a similar declaration from the World Health Organization, the way is cleared for a coordinated response and emergency use authorizations to address supply challenges that could limit the availability of currently approved vaccines. It also has several companies ready to leap into the fray if their preclinical studies show a path to approval. HHS said it just shipped more than 602,000 doses of the Jynneos vaccine to states and jurisdictions, an increase of 266,000 in the past week.
Tonix Pharmaceuticals Holding Corp. is looking to lessons from tuberculosis and smallpox to guide its future in infectious diseases. The company is developing an intradermal skin test like that used for TB to measure T-cell immunity to SARS-CoV-2, the virus that causes COVID-19. It also has three vaccines in development for COVID-19 that rely on horsepox, likely the form of vaccinia used by Edward Jenner to create the smallpox vaccine.
Tonix Pharmaceuticals Holding Corp.’s failure last December in the phase III study called Recovery with TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg dented hopes for patients with civilian and military-related post-traumatic stress disorder (PTSD), but other developers remain in the game.
An interim analysis of the phase III Recovery study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for treating post-traumatic stress disorder (PTSD) compelled Tonix Pharmaceuticals Holding Corp. to halt enrollment in the clinical trial.
