Tonix Pharmaceuticals Holding Corp. products

TNX-102 SL is a small, rapidly-disintegrating, under the tongue (sublingual) product candidate containing 2.8 mg of cyclobenzaprine HCl. The unique patented formulation has been designed to optimize the delivery and absorption of cyclobenzaprine for the therapeutic benefit of improving sleep quality, while minimizing the potential residual effects of oral formulations of cyclobenzaprine. TNX-102 SL is a centrally acting analgesic that helps in relieving pain by improving sleep.

TNX-601 ER is a novel oral formulation of tianeptine hemioxalate that is being developed as a potential treatment for major depressive disorder (MDD), posttraumatic stress disorder (PTSD) and neurocognitive dysfunction associated with corticosteroid use. Tonix’s TNX-601 ER includes tianeptine hemioxalate in an extended-release formulation.

TNX-1300 (recombinant T172R/G173Q double-mutant cocaine esterase 200 mg, IV solution) is being developed under an Investigational New Drug application (IND) for the treatment of cocaine intoxication. It has been designated a Breakthrough Therapy by the FDA. Currently there is no specific pharmacotherapy indicated for cocaine intoxication, a state characterized by acute agitation, hyperthermia, tachycardia, arrhythmias, and hypertension, with the potential life-threatening sequalae of myocardial infarction, cerebrovascular accident, rhabdomyolysis, respiratory failure, and seizures. Patients are currently managed only by supportive care for the adverse effects of cocaine overdose on the cardiovascular and central nervous systems.

TNX-1900, Tonix’s proprietary potentiated intranasal oxytocin is in the pre-Investigational New Drug (IND) stage and is currently being studied as a candidate for prophylaxis of chronic migraine.

TNX-1500 is a humanized monoclonal antibody (mAb) directed against CD40-ligand, which is also known as CD154, T-BAM, 5c8 antigen, TRAP and gp39. TNX-1500 incorporates the antigen binding fragment (Fab) region of hu5c8 (recombinant monoclonal antibody to CD40-ligand), that has been extensively characterized at the molecular level in complex with the CD40-ligand. TNX-1500 is being studied and evaluated for its role in preventing or treating organ transplant rejection and for treating autoimmune disorders.

TNX-1700 is a stabilized recombinant version of Trefoil Factor 2 (TFF2) and is being developed by Tonix as a biologic to treat gastric and colorectal cancers. TFF2 is a small, secreted protein, encoded by the TFF2 gene in humans that is expressed in gastrointestinal mucosa where it functions to protect and repair mucosa. TFF2 is also expressed at low levels in splenic immune cells and is now appreciated to have intravascular roles in spleen and in the tumor microenvironment. In gastric cancer, TFF2 is epigenetically silenced, and TFF2 is suggested to be protective against cancer development through several mechanisms.

TNX-102 SL is a small, rapidly-disintegrating, under the tongue (sublingual) product candidate containing 2.8 mg of cyclobenzaprine HCl. The unique patented formulation has been designed to optimize the delivery and absorption of cyclobenzaprine for the therapeutic benefit of improving sleep quality, while minimizing the potential residual effects of oral formulations of cyclobenzaprine. TNX-102 SL is a centrally acting analgesic that helps in relieving pain by improving sleep.

TNX-1850 is the planned new version of the TNX-1800 vaccine that encodes spike protein from SARS-CoV-2 BA.2 strain.

TNX-801 is a novel, live virus vaccine based on synthesized horsepox (sHPXV). It is being developed as a potential smallpox preventing vaccine for widespread immunization and national stockpile. Though it shares structural characteristics with vaccinia-based vaccines, TNX-801 has unique properties that Tonix believes it may lower toxicity and offer potential safety advantages over existing vaccinia-based vaccines, which have been associated with adverse side effects such as myocarditis/pericarditis².

TNX-2900, Tonix’s proprietary potentiated intranasal oxytocin is in the pre-Investigational New Drug (IND) stage as a candidate for the treatment of Prader-Willi syndrome (PWS) and non-organic failure to thrive disease. TNX-2900 has been granted Orphan Drug Designation (ODD) in the US by the FDA for the treatment of PWS.