Cleveland BioLabs and Roswell Park Cancer Institute Announce Award of Department of Defense Breast Cancer Research Program Breakthrough Grant for Entolimod

BUFFALO, NY--(Marketwired - Apr 27, 2015) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) and Roswell Park Cancer Institute (RPCI) today announced the award of a three-year, $1.2 million Breast Cancer Research Program Breakthrough Award to Roswell Park from the Department of Defense Congressionally Directed Medical Research Program for research into the immunotherapy of metastatic breast cancer with entolimod, a toll-like receptor 5 (TLR5) agonist. The intent of the Breakthrough Award is to support promising research that has potential to lead to or make breakthroughs in breast cancer therapy.

Breast cancer is one of the most common cancers in women worldwide.¹ Nearly 50% of women diagnosed with breast cancer will progress to liver and lung metastatic disease.² The 5-year survival rate for metastatic breast cancer is currently estimated at less than 25%.³ Current anti-cancer therapies show limited efficacy against metastatic breast cancer and often display significant toxicities. Entolimod, a proprietary investigational drug being developed by CBLI, has shown preclinical potential in the immunotherapy of cancer, including models of liver metastases. Entolimod administration activates innate and adaptive immune responses and mobilizes immunocytes to organs and tumors that express entolimod's target, TLR5.

A Phase 1 open-label, dose-escalation trial of entolimod in patients with advanced cancer was completed in September 2014 at Roswell Park Cancer Institute. Findings will be presented during the Developmental Therapeutics - Immunotherapy poster session at the 2015 annual meeting of the American Society of Clinical Oncology (ASCO) on May 30, 2015. A second Phase 1 study of entolimod in patients with advanced cancer is enrolling in the Russian Federation to expand upon clinical observations made at the higher dose levels in the RPCI study and to gather further statistics on immune response to administrations of entolimod.

Andrei Gudkov, Ph.D., D.Sci., Senior Vice President of Basic Science at Roswell Park Cancer Institute, Chief Scientific Officer of Cleveland BioLabs, and Principal Investigator on the grant, stated, "We are honored to be among less than 5% of the highest scored applications awarded with this very competitive grant and are excited to further our research into the potential utility of entolimod in treating breast cancer. We expect that the Breakthrough Award will support several avenues of research, including characterization of the immune response elicited by administrations of entolimod in a pre-clinical model of metastatic breast cancer and in patients with metastatic breast cancer being enrolled in an ongoing clinical study in the Russian Federation. We also plan to explore entolimod's ability to improve the therapeutic efficacy of a tumor-specific dendritic cell vaccine in animal models."

References
¹ Society, A. C. Cancer Facts & Figures 2014. (American Cancer Society, Atlanta, 2014).
² Berkowitz, N., Gupta, S. & Silberman, G. Estimates of the lifetime direct costs of treatment for metastatic breast cancer. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research 3, 23-30, doi:10.1046/j.1524-4733.2000.31003.x (2000).
³ National Cancer Institute. SEER Stat Fact Sheets: Breast. http://seer.cancer.gov/statfacts/html/breast.html.

About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is an innovative biopharmaceutical company seeking to develop first-in-class pharmaceuticals designed to address diseases with significant medical need. The company's most advanced product candidate is entolimod, which is being developed for a biodefense indication and as a potential cancer treatment. The company conducts business in the United States and in the Russian Federation through a wholly-owned subsidiary, BioLab 612, LLC and through two joint ventures, Panacela Labs, Inc. and Incuron, LLC. 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 "plan," "potential," "will," "expect" 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; subsequent changes in the agreement with the Russian Ministry of Industry and Trade; 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; and 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.