Cleveland BioLabs Announces Oncology Clinical Development Update for Entolimod

BUFFALO, NY--(Marketwired - Jan 29, 2015) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced updates on oncology clinical development of entolimod (previously known as CBLB502).

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 Cancer Institute (RPCI) in the United States. The study was designed to evaluate the safety, pharmacokinetic, and immunoactivation profiles of entolimod. Assessments for evidence of anticancer activity were also performed.

Preliminary evaluations of the study indicate that the tolerability profile in patients with advanced cancer was similar to that observed in two previously conducted studies in 150 healthy volunteers. Initial assessments of immunological response were consistent with TLR5 activation. Early analyses indicate that stable disease was observed in several patients with heavily pretreated cancers.

Alex Adjei, M.D., Ph.D., F.A.C.P., Chairman of the Department of Medicine and Senior Vice President of Clinical Research at Roswell Park Cancer Institute, and principal investigator for the trial, stated: "Entolimod offers a novel immunotherapeutic approach to cancer that is distinct from other methods currently in development. Based on the observations from this clinical study, we plan to submit the findings for presentation at the annual meeting of the American Society of Clinical Oncology (ASCO), which will be held from May 29 - June 2 in Chicago, Illinois. We look forward to sharing the final trial results at ASCO."

Langdon Miller, M.D., Strategic Medical Advisor to CBLI, noted: "Observations made during this trial corroborate preclinical findings and strongly support the hypothesis that entolimod has potential as an immunotherapeutic agent. We wish to extend the clinical observations from the higher entolimod dose levels evaluated in this trial. We have initiated a follow-on study in Moscow, Russia, where we have received financial support through a matching-funds development contract from the Ministry of Industry and Trade of the Russian Federation. Additionally, when considered together with encouraging preclinical data, the systemic clinical safety data from this study also supports exploration of entolimod as a local (intravesical) therapy for bladder cancer. We are assessing the toxicology, regulatory, and clinical steps necessary to move entolimod forward in a non-invasive bladder cancer indication."

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 lead product candidates are entolimod, which is being developed as radiation countermeasure and a potential cancer treatment, and Curaxin CBL0137, our lead oncology product candidate. The company conducts business in the United States and in the Russian Federation through our three operating subsidiaries, Incuron, LLC, BioLabs 612, LLC and Panacela Labs, Inc. The Company maintains strategic relationships with the Cleveland Clinic, Roswell Park Cancer Institute, and the Children's Cancer Institute Australia. 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 "plan," "potential," "will," "look forward" 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; 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.