WINTER PARK, Fla., Aug. 20, 2020 /PRNewswire/ -- Cytocom, Inc. (Cytocom), a clinical-stage biopharmaceutical company developing novel immune modulating therapies based on proprietary platforms, today announced the company and Immune Therapeutics, Inc. (OTC: IMUN; Immune) have entered into an agreement to reacquire the emerging market rights to distribute and market its late-stage investigational drug candidates CYTO-201 and CYTO-401. The agreement contemplates the execution of certain additional documents and consents in order to complete the assumption of various liabilities from noteholders and other creditors. The company does not anticipate any issues with the closing of this transaction, which is expected by the end of the third quarter 2020.
As part of the 2014 spin off of Cytocom as a separate company, Immune licensed the rights to make and sell therapeutics containing CYTO-201 and CYTO-401 in over 80 countries, including Brazil and China. Cytocom is now reacquiring this license in exchange for the assumption of up to approximately $5 million of Immune liabilities.
"We are excited by this transaction and the opportunity to pursue the development of these products for indications such as cancer and HIV, not just in the U.S., but in other major markets such as Brazil and China," said Michael Handley, Cytocom CEO. "This agreement is consistent with our renewed strategic focus, and we look forward to advancing efforts to bring these potential new treatment options to patients as quickly as possible."
Cytocom's lead investigational drug candidate, CYTO-201, an immune modulator, is now being studied in late-stage clinical trials for Crohn's disease, fibromyalgia, multiple sclerosis and the human immunodeficiency virus (HIV), and is awaiting FDA clearance of an Investigational New Drug Application (IND) for a Phase 2 study in COVID-19. CYTO-401 is being developed as a cancer immunotherapy and antiviral therapy targeting HIV, as well as the H1N1 virus.
More information on the assignment of the license to Cytocom is available in a Form 8-K filing with the SEC by Immune Therapeutics, which can be viewed at www.sec.gov.
About Cytocom, Inc.
Cytocom, Inc. is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, inflammatory, infectious diseases and cancers based on a proprietary platform that is designed to rebalance body's immune system. The company is developing therapies designed to elicit a powerful and durable response of antigen-specific killer T cells and antibodies directly within patients, thereby activating essential immune defenses against autoimmune, inflammatory, infectious diseases and cancers. Cytocom believes that its technologies can meaningfully leverage the human immune system for prophylactic and therapeutic purposes by eliciting killer T cell response levels not achieved by other published immunotherapy approaches. The company's immunomodulatory platform technology seeks to restore a balance between the cellular (Th1) and the humoral (Th2) immune systems. Immune balance is regulated through T-helper cells that produce cytokines. The Th1 lymphocytes help fight pathogens that are within cells like cancer and viruses through activation of interferon-gamma and macrophages. The Th2 lymphocytes target external pathogens, such as cytotoxic parasites, allergens, and toxins, through the activation of B-cells and antibody production to effect to dendritic cells, which are natural activators of killer T cells, also known as cytotoxic T cells, or CD8+ T cells.
This release contains forward-looking statements that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties inherent in research and development; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Cytocom's business and prospects, adverse developments in Cytocom's markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment or economies generally; the impact of COVID-19 on our business, operations and financial results; and competitive developments. The Company assumes no obligation to update forward-looking statements contained in this release as a result of new information or future events or developments.