Orlando, FL, Aug. 29, 2023 (GLOBE NEWSWIRE) — Immune Therapeutics, Inc. d/b/a Biostax Corp. (OTC Pink: IMUN) (“Biostax”), a hub-and-spoke biotech development engine, announces the signing of a research collaboration agreement with Immgenuity, Inc. The joint research will focus on using Immgenuity’s IMTV014 and Biostax’s Lodonal™ and JKB-122 both independently and together to determine if the immune modulatory effects of Biostax’s drug therapies combined with Immgenuity’s IMTV014 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.
“While HIV treatment has advanced dramatically over the past three decades, people living with HIV still face a lifetime of therapy and chronic illness,” said Sateesh Apte, MD. “Remission in HIV remains the ultimate aspiration for both Biostax’s and Immgenuity’s research and development efforts.”
“Patients are required to be off all anti-viral medications before Immgenuity’s vaccine platform can be administered and we expect Biostax’s naltrexone-based drug candidates to work synergistically during the period when patients stop taking their anti-viral medications and before the vaccine’s immune response takes effect, ” said Dr. Apte. “This, along with Biostax’s immune-modulating therapy and our other partnerships and internal programs, reflects our commitment to finding a therapy that will achieve remission for HIV and bring about an end to the HIV epidemic.”
“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.”
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 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.
About Lodonal and JKB-122
Biostax has developed a rapid release oral formulation of the drug substance “low dose naltrexone”, known as Lodonal™, for use as an active immunotherapy drug with anti-inflammatory properties. Lodonal™ 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 NAFDAC 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” immune suppressors, or drugs that require a specific cell receptor to act, Lodonal™ and JKB-122’s molecular structure allows it to be a promiscuous antagonist of various classes of receptors/proteins (multiple targets), eliciting multiple complimentary effects. Beyond modulation of the cell cycle by way of growth factor-like activities downstream of opioid receptors, clinical trials indicated that it reduces the overall activation state (metabolic shift) of cells responsive to pathogen signals, damage signals, or both (drivers of inflammation).
Our recent research shows that Lodonal™ and JKB-122’s molecular shape allows it to bind to a variety of cellular receptors and proteins beyond the surface and nuclear opioid receptors. Because noroxymorphone at low dose can bind surface receptors as well as diffuse rapidly into the cell and its nucleus, several parallel mechanisms of action combine.
Biostax is an innovative biopharmaceutical company that acquires and develops immune restoration pharmaceutical and medical technology (MedTech) products with a well -defined path to market. We use a hub-and-spoke business model, where the parent company (hub) holds a centralized management and administrative team, and each subsidiary (spoke) operates a specialized development team focused on individual product pipelines.
Where Biostax has a diversity of product pipelines that will provide revenue while reducing risk, our goal is to develop new therapies that provide disease remission by restoring immune balance for patients with autoimmune, inflammatory, and infectious diseases without suppressing their immune system. Restoring homeostasis or balance to the immune system is the first step to a cure by improving patients’ lives in chronic illness caused by immune dysfunction and inflammation. www.biostaxcorp.com
About Immgenuity, Inc.
Immgenuity, Inc. is a biotechnology company dedicated to developing innovative immunotherapy solutions to improve the lives of patients suffering from HIV. The company’s lead product candidate is IMTV014, a novel immunotherapy for HIV and NeuroAIDS, which has shown to be safe in preclinical studies. Immgenuity, Inc. is headquartered in Dover, Delaware and is led by a team of experienced biotech professionals with deep expertise in infectious diseases, immunology, virology, and drug development. For more information, visit https://immgenuity.com
Forward Looking Statement
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Noreen M. Griffin
Chief Executive Officer