Cleveland BioLabs Announces Expanded U.S. Patent Protection for Entolimod

BUFFALO, NY--(Marketwired - Nov 30, 2015) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced the allowance of two new patent applications by the U.S. Patent Office with claims that provide further protection for the Company's lead candidate, entolimod, as both a medical radiation countermeasure and an oncology therapeutic.

The allowed claims of U.S. Patent Application No. 14/828,111 expand coverage of the Company's lead agent, the flagellin-derived entolimod, as well as various other flagellin-derived agents, by providing composition of matter protection, which covers use of these various flagellin-derived agents to treat, for example, apoptosis related to radiation exposure or cancer. The allowed claims of U.S. Patent Application No. 13/979,104 focus on the entolimod oncology program and provide protection for uses of flagellin and flagellin-derived agents in the treatment of various cancers. 

CBLI now has 14 issued or allowed U.S. patents with composition of matter and method of use claims relating to entolimod's biodefense and oncology indications, as well as chemotherapy adjuvant and reperfusion injury indications. Additional pending U.S. and foreign patent claims include those covering other oncology and biodefense uses, as well as various compositions that expand the scope of the Company's Toll-like receptor (TLR) agonist platform. 

Yakov Kogan, Ph.D., Chief Executive Officer of Cleveland BioLabs, commented, "We believe the continued expansion of our patent claims for entolimod and its related derivatives strengthen our market position as a leader in the Toll-like receptor 5 (TLR5) space. With the market's increasing focus on immunotherapies for multiple indications, including oncology, CBLI has a strong and varied patent estate that underpins the Company's value."

About Cleveland BioLabs
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.

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 "pending," "believe," and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding our ability to expand our patent portfolio; our ability to successfully develop and commercialize our therapeutic products; our ability to successfully submit and receive approval of our pre-EUA application for entolimod; the conduct and results of our various clinical trials; our ability to obtain approval from the U.S. Food and Drug Administration of our product candidates; and future performance. 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 risks and uncertainties include, among others, our ability to obtain, maintain and protect intellectual property rights (including for entolimod and other pipeline candidates); the Company's failure to successfully and timely develop existing and new products; the Company's collaborative relationships and the financial risks related thereto; the risks inherent in the early stages of drug development and in conducting clinical trials; 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; subsequent changes in the agreement with the Russian Ministry of Industry and Trade; and 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. 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.