OncoImmune

OncoImmune is a clinical-stage biopharmaceutical company engaging in drug discovery and drug development for treating autoimmune disease and cancer that is headquartered in Rockville, Maryland and was founded in 2000 by Kun-Liang Guan, Ming You, Pan Zheng, and Yang Liu.

CD24Fc (GVHD) is a recombinant fusion protein targeting novel immune pathways with efficacy for treating multiple sclerosis and rheumatoid arthritis in animal models and phase I clinical trials in healthy humans. OncoImmune has also completed a phase II clinical trial using CD24Fc (GVHD) for prophylactically treating graft-versus-host disease (GVHD) in human leukemia patients receiving hematopoietic stem cell transplantation that are developing indications such as metabolic disorders and adverse immunotherapy related effects in multiple planned clinical trials. CD24Fc works through two mechanisms of action acting together to modulate immune responses.

1. Binding of Danger-Associated Molecular Patterns (DAMPs), associated with components of injured cells, by trapping inflammatory stimuli preventing DAMP interaction with a set of pattern recognition receptors called toll-like receptors (TLRs)
2. Binding of Siglec G/10 and regulating responses to Siglec G/10-associated SHP1 inhibitory signalling due to tissue injury

The United States and Europe have given OncoImmune orphan drug designations for CD24Fc (GVHD). The Food and Drug Administration (FDA) granted orphan drug approval for CD24Fc for humanized fusion protein consisting of extracellular domain of CD24 linked to IgG1 Fc domain (CD24Fc) for the prevention of graft-versus-host disease on June 9, 2015.

On September 16, 2016 OncoImmune announced dosing their first human patient with CD24Fc at the University of Michigan Medical Center in its phase II clinical trial for testing the efficacy and safety of treating leukemia patients undergoing hematopoietic stem cell transplantation. Medical centers participating in this phase II clinical trial for CD24Fc are the James Cancer Hospital at the Ohio State University, Karmanos Cancer Center at the Wayne State University, and Indiana University Medical Center.

On September 19, 2017 OncoImmune received a $2 million SBIT grant from the Nationa Cancer Institute for help with running a Phase IIA clinical trial for testing the efficacy of CD24Fc for treating leukemia patients undergoing hematopoietic stem cell transplantation. The clinical trial enrolled 24 patients and was a randomized, double blind, placebo controlled, dose-escalation trial.

On July 30, 2018 OncoImmune received a $2 million grant from the Food and Drug Administration's Orphan Products Clinical Trials Program for helping to run the company's phase IIB study for using CD24Fc for preventing graft-versus-host disease in leukemia patients going through hematopoietic stem cells. The phase IIB study is a randomized double blind clinical trial.

On April 20, 2020 OncoImmune initiated a phase III clinical trial for testing the efficacy and safety of using CD24Fc to treat hospitalized COVID-19 patients at 10 medical centers across the United States. The phase III trial is being done out of University of Maryland Baltimore Medical Center. Researchers are expecting CD24Fc to lower the amount of inflammation caused by virus-induced cellular injuries suspected to be the underlying cuase of immune dysfunction, pneumonia, and cytokine storms experienced in severe COVID-19 patients. Due to the novel mechanism of action exhibited by CD24Fc it is suspected to have a synergistic effect when used in combination with other drugs such as chlorquine and Remdesivir, or other immune modulators targeting cytokines or their receptors. The phase III clinical trials will accept patients undergoing or intending to

ONC-392 is an antibody targeting CTLA-4 by selectively eliminating tumor-infiltrating regulatory T-cells (Treg) without affecting peripheral T cell activation. OncoImmune claims that ONC-391 has a more robust cancer immunotherapeutic effect (CITE) and a significantly lower amount of immunotherapy-related adverse events (irAE) compared to other commercial and clincal stage anti-CLTA4 antibodies.

OncoImmune is investing Echinomycin for treating patients with haematological malignancies. The company is working to develop new Echinomycin formulation to improve its half life and therapeutic index with support of the Nanotechology Characterization Laboratory of the National CancerInstitute. OncoImmune has received an orphan drug designation for using Echinomycin to treat acute myeloid leukemia (AML).

ONC-781is based on a novel monoclonal bispecific antibody capable of binding of binding an antigenic glyco-epitope broadly expressed in all major types of cancer but not expressed in normal tissues. ONC-781-based immunotherapy used a novel anti-body to target bispecific antibodies and CAR-T cells with broad reactivity to hepatocellular carcinoma, breast cancer, ovarian cancer, cervical cancer, neuroblastoma, prostate cancer, lung cancer, and all types of malignant brain tumors.