The Institute of Human Virology (IHV) at the University of Maryland School of Medicine (UMSOM) recently announced the launch of a Phase II clinical trial called CALIBER, which will test an experimental product called CD24Fc presently being commercialized by Oncolmmune, Inc. The study will assess if CD24Fc can reduce late effects of HIV infection, such as inflammatory abnormalities including cardiovascular disease. The therapy is intended for use in HIV patients who have received the traditional antiretroviral therapies that control, but do not cure, HIV infection.

Challenge

With about 36.7 million people afflicted with HIV worldwide, in America about 1.1 million people are infected. With increased access to antiretroviral treatment (ART) actual life expectancy with people with HIV increases. But this comes with new prospective health issues as people living longer with HIV start encountering new health challenges from increased cardiovascular disease to other metabolic disorders contributes to an increased risk of morbidity and mortality.

What is CD24Fc?

An experimental drug, it consists of two parts including 1) a form of cell surface protein called CD24 and 2) derived from region of an antibody called Fc. CD24 inhibits inflammation triggered by accidental cell death, while Fc helps the drug stay in the body for weeks. Early stage research (preclinical animal studies and Phase I studies with healthy volunteers) demonstrates the experimental product’s ability to reduce inflammation as well as “bad” cholesterol known s LDL-C, by stimulating a family of immunoregulatory molecules called Siglec.

The Study: CALIBER

The new trial, called CALIBER, will test the drug for its ability to tone down chronic inflammation and metabolic abnormalities in HIV patients. The study started January 2020 and concludes October 2022. The Phase II, randomized, double-blind, placebo-controlled clinical trial involves a cohort of 64 patients with HIV on antiretroviral therapy randomized in a 1:1 fashion. They will receive CD24Fc or placebo during a 4-week window followed by a 24-week follow-up period to assess safety and efficacy in normalizing lipid profiles, reducing inflammation in the cardiovascular system and liver, as well as reducing immune abnormalities found in HIV patients.

Sponsored by biotech firm Oncolmmune, Inc. study collaborators include University of Maryland and support from the National Heart, Lung, and Blood Institute (NHLBI)—part of the NIH. The Institute of Human Virology (IHV) at University of Maryland will serve as clinical investigational site.

The Institute of Human Virology (IHV)

IHV was formed in 1996 as a partnership between the State of Maryland, the City of Baltimore, the University System of Maryland and the University of Maryland Medical System. An institute of the University of Maryland School of Medicine, IHV is home to some of the most globally recognized and world-renowned experts in all of virology. The IHV combines the disciplines of basic research, epidemiology and clinical research in a concerted effort to accelerate the discovery of diagnostics and therapeutics for w wide variety of chronic and deadly viral immune disorders—most notably HIV.

Oncolmmune

Oncolmmune is a privately-held, clinical-stage biopharma venture actively engaged in the discovery and development of novel immunotherapies for cancer, inflammation and autoimmune disease. Based in Rockville, MD, the company was founded two decades ago 2000 by researchers out of the University of Maryland. Their leading experimental drug candidate in the pipeline is CD24Fc, a novel therapeutic that regulates host inflammatory response to tissue injuries and which has broad implications in the pathogenesis of cancer, autoimmune disease, metabolic syndrome and graft-versus-host disease (GvHD). According to Crunchbase the firm has raised a total of $15 million since its inception two decades ago. It appears that the firm is very small—under 10 employees. In 2017 the Rockville, based firm raised $.5.5 million falling $10 million short of the management’s goals. The funds originated from China-based Bioventures Capital, a venture investment fund focused on healthcare. 

Lead Research/Investigators

Shyamasundaran Kottilil, Institute of Human Virology, University of Maryland, Baltimore

Source: Institute of Human Virology

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