Immune Therapeutics, Inc. d/b/a Biostax Corp. announced the signing of a research collaboration agreement with Immgenuity, Inc. The joint research will focus on using Immgenuity's IMTV014 and Biostax's Lodonal(TM) and JKB-122 both independently and together to determine if the immune modulatory effects of Biostax's drug therapies combined with Immgenuity's IMTV013 can achieve remission with HIV patients. Under the terms of the agreement, Immgenuity and Biostax will collaborate to advance the development of novel immunotherapies for the treatment of HIV and other diseases.

The collaboration will leverage Immgenuity's expertise in developing cutting-edge technologies for the identification and characterization of immune cell populations, mechanisms of immune escape, and Biostax's deep knowledge and experience in using naltrexone as an immune enhancing and anti-inflammatory agent. Immgenuity's IMTVO14 vaccine platform is an immunotherapy, comprising a genetically modified HIV virus which is unable to block immune signaling like the natural HIV does. By restoring immune signaling, IMTVOI4 is expected to restore a normal, viable, and robust immune response to HIV and likely lead to clearing the virus even from the sanctuary areas where the virus persists despite aggressive anti-HIV drug treatment.

Clinical Program JKB-122 and Lodonal Biostax will also look to fast track a Phase 2b trial with the FDA: " effects of JKB-122 and Lodon(TM) on T-Cell Immgenuity Activation and Inflammation in Non-Responders or who are Failing their CAR-T therapy with HIV." The primary end point is to show a decrease in comorbidities and opportunistic infection and clinical symptoms such as diarrhea, fatigue, pain, upper respiratory infections, skin disorders, and confirm changes of T-cell immune activation and reduction inflammation biomarkers. Prior clinical trials have shown Lodonal(TM) andJKB-122 can modulate the immune system by increasing NK cells, CD4, improve the CD4/CD8 and reduce opportunistic infection and pain in HIV patients while reducing inflammation. The success in these trials will provide evidence for the use of Lodonal(TM) and/or JKB-122 as part of combined therapy for remission and immune restoration in HIV patients.

Biostax has developed a rapid release oral formulation of the drug substance "low dose naltrexone", known as Lodonal(TM), for use as an active immunotherapy drug with anti-inflammatory properties. Lodonal(TM) is one of the first drugs approved to be taken once-a-day as an immune system regulator for the management of HIV/AIDS. The approval by NFDAC was based on the results of a bridging trial that resulted in a 44% increase in CD4 Count versus an 11% increase for standard of care patients.

Unlike "single target" and the trial is expected to be used to be taken as an active immunotherapy Drug with anti-inflammatory properties.