Cytocom Updates Investigational New Drug Application for Phase 2 Clinical Trial of CYTO-205 for the Treatment of COVID-19

FORT COLLINS, Colo., Feb. 16, 2021 /PRNewswire/ -- Cytocom, Inc., a leading biopharmaceutical company creating first second-generation immune therapies, today provided an update regarding its CYTO-200 portfolio of clinical programs.

Cytocom has submitted an Investigational New Drug (IND) application with updated protocols to the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial, to evaluate the safety and efficacy of CYTO-205 to slow or halt the progression of the SARS-CoV-2, the virus that causes COVID-19. Preclinical in vitro studies using coronavirus strain 229E have demonstrated the potential of CYTO-205 to inhibit the replication of a coronavirus (strain 229E) in human lung cells. The trial, titled, "A Randomized, Placebo-Controlled, Phase 2 Study to Evaluate Safety and Efficacy of CYTO-205 in Adult Patients With Mild COVID-19 Infection Who Are at High Risk for Disease Progression," is expected to begin in the second quarter of 2021 upon FDA clearance of the IND. In preparation for the start of the trial, Cytocom has invested in manufacturing clinical supplies of CYTO-205.

Michael K. Handley, President and CEO of Cytocom, stated, "Despite the recent launch of several COVID-19 vaccines, there remains a tremendous need for effective therapies for those infected with SARS-CoV-2, especially in light of the emergence of highly contagious new variants of the virus. To date, research has provided compelling rationale for the potential CYTO-205 could have as both a therapeutic intervention and as a prophylactic agent to reduce the spread of the disease, and we look forward to working with the FDA to advance the drug's development and bring a therapeutic to patients suffering from the potentially life-threatening consequences of COVID-19."

In separate news, Cytocom has entered into an agreement with ICON plc (NASDAQ: ICLR), a global contract research organization (CRO), to manage its upcoming Phase 3 clinical trial for its lead drug candidate, CYTO-201, as a treatment for Crohn's disease.

"We are pleased with the progress we are making in our CYTO-200 clinical program, which includes Phase 3-ready assets in Crohn's disease, fibromyalgia and multiple sclerosis, as well as our COVID-19 therapy, CYTO-205," stated Mr. Handley. "CYTO-201 is the program's lead clinical asset and we are pleased to have ICON as our CRO partner given the company's proven expertise and track record of clinical excellence. Meanwhile, with the filing of the Phase 2 IND for CYTO-205 in COVID-19 and corresponding manufacturing, we are steadily advancing our efforts to address the significant need for COVID-19 therapies."

CYTO-200 Clinical Programs

The goals of the CYTO-200 programs are to treat patients by restoring immune homeostasis. Our clinical programs include CYTO-205 in COVID-19, and three Phase 3-ready development programs for the treatment of Crohn's disease (CYTO-201), fibromyalgia (CYTO-202) and multiple sclerosis (CYTO-203).

CYTO-205 and COVID-19

CYTO-205 is designed to modulate immune system function by decreasing elevated inflammatory responses associated with viral infection. Preclinical in vitro studies have demonstrated the potential of CYTO-205 to inhibit the replication of a Corona virus (strain 229E) in human lung cells. Further, early-stage clinical data suggest that CYTO-205 could prevent or dampen the potentially life-threatening lung inflammation caused by COVID-19 and possibly promote protection from reinfection. These are particularly important features in the fight to reduce the global spread of COVID-19.

CYTO-201 and Crohn's Disease

As Cytocom's lead investigational drug candidate, CYTO-201, is being studied in Crohn's disease, an inflammatory bowel disease that causes chronic inflammation of the gastrointestinal (or digestive) tract, causing symptoms such as persistent diarrhea, abdominal pain and rectal bleeding. Crohn's is a progressive disease, meaning it gets worse over time. Studies show that because the signs and symptoms of the disease are unpredictable patients living with the disease endure significant burdens, not only physical, but also motional and economic.

About Cytocom

Cytocom, Inc. is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, inflammatory, infectious diseases and cancers based on a proprietary platform designed to rebalance the body's immune system and restore homeostasis. Cytocom is developing therapies designed to elicit directly within patients a robust and durable response of antigen-specific killer T-cells and antibodies, thereby activating essential immune defenses against autoimmune, inflammatory, infectious diseases, and cancers. Specifically, Cytocom has four programs in late-stage clinical development in Crohn's disease, fibromyalgia, multiple sclerosis and pancreatic cancer. 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. Cytocom's immunomodulatory technology restores the 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 within cells like cancer and viruses through interferon-gamma and macrophages. The Th2 lymphocytes target external pathogens like cytotoxic parasites, allergens, 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. Furthermore, the Cytocom technology antagonizes the toll-like receptors to inhibit pro-inflammatory cytokines. To learn more about Cytocom, Inc., please visit www.cytocom.com .

Forward-Looking Statements:

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.

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SOURCE Cytocom, Inc.

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