Immune Therapeutics, Inc., (a Biostax Corp.) a hub-and-spoke biotech development engine, signed a research collaboration agreement with Immgenuity, Inc. The joint research will focus on using Immgenuity’s IMTV014 and Biostax’s Lodonal and JKB-122 to determine if the immune modulatory effects of Biostax’s drug therapies combined with Immgenuity’s IMTV014 can achieve remission with HIV patients.

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 technologies for the identification and characterization of immune cell populations, mechanisms of immune escape, and Biostax’s 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 aims 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.

“Based upon existing HIV data surrounding both JKB-122 and Lodonal we believe that by performing combined research we will generate additional compelling data, that complements our existing clinical data,” said Noreen Griffin, Biostax’s CEO. “We are delighted to enter into this partnership that will further develop our product candidates for the treatment of patients with HIV.”

Biostax will also look to fast track a Phase 2b trial with the FDA: “Effects of JKB-122 and Lodonal on T-Cell Immune 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 and JKB-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 and/or JKB-122 as part of combined therapy for remission and immune restoration in HIV patients.