GT Biopharma, Inc. issued the following announcement on Oct. 3.
GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA), an immuno-oncology company focused on innovative treatments based on the Company's patent pending TriKE™ technology, announced today that Tim Schacker, M.D., Jeffrey S. Miller, M.D., and their colleagues at the University of Minnesota presented data during a poster session held at the 18th meeting of the Society for Natural Immunity in Luxembourg discussing their design of an HIV-TriKE™ containing an antigen binding fragment (Fab) from a broadly-neutralizing antibody targeting the HIV-Env protein. The HIV-TriKE™ is designed to target HIV while redirecting NK cell killing specifically to actively replicating HIV infected cells.
While the use of anti-retroviral drugs have substantially improved the health and increased the longevity of individuals infected with the human immunodeficiency virus (HIV), these drugs are designed to suppress virus replication to help modulate progression to AIDS and to limit further transmission of the virus. Despite the use of anti-retroviral drugs, infected individuals retain reservoirs of latent HIV-infected cells that, upon cessation of anti-retroviral drug therapy, can reactivate and re-establish an active HIV infection. For a curative therapy, destruction of these latent HIV infected cells must take place.
Research findings from Dr. Schacker's and Dr. Miller's laboratories show enhanced NK cell cytokine production and killing of infected targets expressing HIV-Env when incubated with the HIV-TriKE™. Peripheral blood mononuclear cells (T-cells, B-cells, NK cells and monocytes) from healthy donors incubated with the HIV-TriKE™ showed marked increases in immune cell activation in NK cell, CD4 T-cell and CD8 T-cell population subsets. The HIV-TriKE™ also induced NK cell proliferation, and demonstrated the ability in vitro to reactivate and kill HIV-infected T-cells.
These findings indicate a potential role for the HIV-TriKE™ in the reactivation and elimination of the latently infected HIV reservoir cells by harnessing the NK cell's ability to mediate the antibody-directed cellular cytotoxicity (ADCC).
Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma, commented, "We are pleased to see how the TriKE™ technology is able to be extended to the treatment of infectious disease, and is able to kill HIV in the reservoir." Mr. Cataldo further stated, "We believe the HIV-TriKE™ will become part of a scalable and curative therapeutic strategy."
HIV (human immunodeficiency virus) harms the immune system by destroying white blood cells which fight infection. Infected individual are at risk for serious infections and certain cancers. The virus can be transmitted through contact with infected blood, semen, or vaginal fluids. The disease is usually asymptomatic until it progresses to AIDS (acquired immunodeficiency syndrome). No cure exists, but strict adherence to expensive antiretroviral therapy can dramatically slow the disease's progress and prolong life. According to the World Health Organization, there are over 36 million people currently infected with HIV. Current drugs only treat the symptoms of HIV at a significant economic cost. HIV infected individuals remain infected for the rest of their lives. The challenge in the HIV field is to kill virus infecting a patient's T-cells, and destroy virus hiding in sanctuary reservoir sites within the body.
About GTB-3550 TriKE™ and GTB-3550 TriKE™ Phase I/II Clinical Trial
GTB-3550 is the Company's first TriKE™ product candidate which is a single-chain, tri-specific recombinant fusion protein construct composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The GTB-3550 Phase I/II clinical trial for treatment of patients with CD33-expressing, high risk myelodysplastic syndromes, refractory/relapsed acute myeloid leukemia or advanced systemic mastocytosis opened for patient enrollment September 2019. The clinical trial is being conducted at the University of Minnesota's Masonic Cancer Center in Minneapolis, Minnesota under the direction of Dr. Erica Warlick.
About GT Biopharma, Inc.
GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology products based off our proprietary Tri-specific Killer Engager (TriKE™) and Multi-Target Directed Bispecific Drug Conjugate technology platforms. Our TriKE platform is designed to harness and enhance the cancer killing abilities of a patient's immune system natural killer cells (NK cells). GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize cancer therapies using proprietary TriKE technology developed by researchers at the university to target NK cells to cancer. Our Multi-Target Directed Bispecific Drug Conjugate platform can generate product candidates that are bi-specific, ligand-directed single-chain fusion proteins that, we believe, represent the next generation of targeted therapy.
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