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Hans Grossniklaus in research lab surgery
Hans E. Grossniklaus MD, MBA (left) at the operating microscope with John Morgan Micheletti MD, first year resident, in the experimental ocular oncology/pathology laboratory.

 

December 16, 2015

Entolimod Shown to Suppress Liver Metastases in Model of Ocular Melanoma in Collaborative Study by Cleveland BioLabs, Emory University and Roswell Park Cancer Institute

Media contact:  Joy Bell, 404-778-3711, jbell@emory.edu

 

Buffalo, NY – Cleveland BioLabs, Inc. (NASDAQ:CBLI), Emory University and Roswell Park Cancer Institute (RPCI) today announced the publication of a study in Oncotarget demonstrating the ability of entolimod to suppress liver metastases in a preclinical model of uveal melanoma (UM). The study was led by Hans Grossniklaus MD, Professor of Ophthalmology, Director of the L.F. Montgomery Pathology Laboratory and Director of the Section of Ocular Oncology and Pathology at Emory Eye Center, Emory University, and Lyudmila Burdelya, PhD, Assistant Professor of Oncology in the Department of Cell Stress Biology at RPCI.

Uveal melanoma is the most common primary cancer of the eye in adults, with 2,000-2,500 new diagnoses per year in the United States. Primary UM tumors are usually treated with surgery, radiation therapy and/or thermotherapy. Despite these treatments, about 50% of all UM cases progress to metastatic disease. Most metastasis of UM (80-90%) occurs in the liver, and UM patients with a “class 2” gene expression signature have an extremely poor survival prognosis due to development of detectable metastases in the liver within three years of primary tumor diagnosis. There are currently no effective treatments for metastatic UM, and there is an average life expectancy of nine months from the time of detection of metastases.

Entolimod is a Toll-like receptor 5 (TLR5) agonist currently under development by Cleveland BioLabs as both a medical radiation countermeasure and an oncology immunotherapy. Entolimod rapidly activates TLR5-NF-kappaB signaling in hepatocytes and suppresses growth of both TLR5-expressing and non-expressing tumors in the liver through mobilization and activation of innate and adaptive immune mechanisms.

The goal was to explore the potential of entolimod as an immunotherapeutic agent against liver metastasis of UM using the TLR5-expressing B16LS9 animal model in which orthotopic intraocular tumors spontaneously metastasize to the liver. Reported results indicated that systemic entolimod treatment led to a significant reduction in the number of metastatic liver nodules in the laboratory models. This entolimod-mediated antimetastatic effect was associated with increased blood-borne homing, maturation and activation of natural killer (NK) cells in the liver, and was abrogated when mice were depleted of NK cells before entolimod treatment.

Dr. Grossniklaus commented, “Our previous research has determined that NK cells are necessary for melanoma elimination in the liver. These findings, combined with entolimod’s demonstrated ability to reduce the number of metastatic nodules in the liver by boosting NK activity, makes entolimod a very exciting potential therapy to address the challenge of liver metastases in this group of patients.”

Dr. Burdelya stated, “This study further advances our knowledge regarding the role of particular immune cells in entolimod’s stimulation of the body’s natural immune response. Confirmation of the drug’s stimulation of NK cell development and maturation in the liver may have broader implications for future development of entolimod as an immunotherapeutic drug in indications where tumors have a propensity to metastasize to the liver.”

Andrei Gudkov, Ph.D., D.Sc., Chief Scientific Officer of Cleveland BioLabs, Senior Vice President of Basic Science at RPCI and one of the co-authors of the study, said, “We are very excited to partner with Dr. Grossniklaus, a globally recognized leader in ophthalmology and UM, to explore entolimod’s potential utility in this indication. Following up on data reported from a Phase 1 trial of entolimod in patients with advanced cancer at the 2015 annual meeting of the American Society of Clinical Oncology, we are gathering additional clinical data and evaluating future directions for development of entolimod as a cancer immunotherapy.”

This work was supported by grants from the National Institutes of Health (awards R01CA176001 and P30EY06360), Research to Prevent Blindness Inc. and Cleveland BioLabs Inc. The publication can be found online.

Part of this work was done by Vanessa Morales-Tirado PhD and Matthew Wilson MD at the University of Tennessee at Memphis.

About Cleveland BioLabs, Inc.

Cleveland BioLabs, Inc. is an innovative biopharmaceutical company developing novel approaches to activate the immune system and address serious medical needs. The company’s proprietary platform of Toll-like immune receptor activators has applications in radiation mitigation, oncology immunotherapy, and vaccines. The company’s most advanced product candidate is entolimod, which is being developed for a biodefense indication and as an immunotherapy for oncology and other indications. The company conducts business in the United States and in the Russian Federation through a wholly-owned subsidiary, BioLab 612, LLC and a joint venture with OJSC Rusnano, Panacela Labs, Inc. The company maintains strategic relationships with the Cleveland Clinic and Roswell Park Cancer Institute. To learn more about Cleveland BioLabs, Inc., please visit the Company's website at http://www.cbiolabs.com.

About Roswell Park Cancer Institute

The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. Founded in 1898, RPCI is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs.

For more information, visit www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org. Follow Roswell Park on Facebook and Twitter.

This press release contains certain forward-looking information about Cleveland BioLabs that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words and phrases such as “potential,” “may,” “future” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding the conduct and results of our various clinical trials; the efficacy of our therapeutic products; our ability to successfully complete planned clinical studies; and our ability to obtain regulatory approval for our therapeutic products. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.

These factors include, among others, the risks inherent in the early stages of drug development and in conducting clinical trials; the Company’s collaborative relationships and the financial risks related thereto; the Company’s ability to comply with its obligations under license agreements; the Company’s inability to obtain regulatory approval in a timely manner or at all; the Company’s history of operating losses and the potential for future losses, which may lead the Company to not be able to continue as a going concern; the Company’s need for substantial additional financing to meet its business objectives; the potential for the loss of funding from the Company’s R&D grants and contracts and its ability to win additional funding under such grants and contracts. Some of these factors could cause future results to materially differ from the recent results or those projected in forward-looking statements. See also the “Risk Factors” and “Forward-Looking Statements” described in the Company’s periodic filings with the Securities and Exchange Commission.

Contacts:

Cleveland BioLabs, Inc.
Rachel Levine, Vice President, Investor Relations
T: 917-375-2935 E: rlevine@cbiolabs.com

Roswell Park Cancer Institute
Annie Deck-Miller, Senior Media Relations Manager
T: 716-845-8593 E: annie.deck-miller@roswellpark.org

Emory Eye Center
Joy H. Bell, Director of Public Relations
T: 404-778-3711 E: jbell@emory.edu

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