Cleveland Biolabs Inc. Announces Acceptance Of Entolimod Phase 1 Study Findings For Poster Presentation At ASCO

BUFFALO, NY--(Marketwired - April 22, 2015) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that findings from a Phase 1 clinical study of entolimod (previously known as CBLB502) have been accepted for poster presentation at the 2015 annual meeting of the American Society of Clinical Oncology (ASCO), which will be held from May 29 - June 2 in Chicago, Illinois.

The poster, titled: “A phase I study of the toll-like receptor 5 (TLR5) agonist, entolimod in patients with advanced cancers,” will be presented by Hatoon Bakhribah, MD, a Drug Development Fellow at Roswell Park Cancer Institute, during the Developmental Therapeutics - Immunotherapy poster session on May 30, 2015, between 8 a.m. and 11:30 a.m. CDT.

Entolimod is a toll-like receptor 5 (TLR5) agonist that has shown preclinical potential in the immunotherapy of cancer. Entolimod administration activates innate and adaptive immune responses and mobilizes immunocytes to organs -- such as the liver, intestine, and bladder -- that have high TLR5 expression. Enrollment in a Phase 1 open-label, dose-escalation trial of entolimod in patients with advanced cancer was completed in September 2014 at Roswell Park in the United States. The study, led by Alex Adjei, M.D., Ph.D., F.A.C.P., Chair of the Department of Medicine and Senior Vice President of Clinical Research at Roswell Park Cancer Institute, was designed to evaluate the safety, pharmacokinetic, and immunoactivation profiles of entolimod. Assessments for evidence of anticancer activity were also performed.

Dosing is ongoing in a follow-on study in Moscow, Russia intended to extend the clinical observations from the higher entolimod dose levels evaluated in the Roswell Park trial.

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.

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,” “will,” “ongoing” 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; and the Company’s need for substantial additional financing to meet its business objectives. 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.