Cleveland BioLabs Releases Entolimod Phase 1 Study Findings at ASCO

BUFFALO, NY--(Marketwired - Jun 1, 2015) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced the release of results from a Phase 1 open-label, dose-escalation trial of entolimod in patients with advanced cancer at the 2015 annual meeting of the American Society of Clinical Oncology (ASCO), held from May 29 - June 2 in Chicago, Illinois.

Entolimod is a specific, 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 that have high TLR5 expression. These organs include liver and lung (common sites of metastases for many tumors) as well as bladder uroepithelium, which undergoes malignant transformation during the development of bladder cancers.

The study was undertaken to evaluate entolimod's safety, tolerability, pharmacokinetics, immunoactivity and preliminary antitumor activity. Twenty-six patients ranging in age from 46 to 82 years were enrolled in the study. All had previously treated metastatic cancers, including colorectal, non-small cell lung, anal and urothelial bladder tumors. The study evaluated an 8-fold range of subcutaneous dose levels from 5 to 40 µg/dose administered as 4 or 5 injections within a 2-week period. Pharmacokinetic and pharmacodynamic measurements and immune function samples were obtained pre- and post-dosing. 

Stable disease for more than 6 weeks was observed in 8 patients with various cancer types; among these, 3 patients (with anal, colorectal and urothelial cancers) had maintenance of stable disease for more than 12 weeks. Patients exhibited CD8⁺ T-cell activation with stable or decreased levels of myeloid-derived suppressive cells, accompanied by increased immunostimulatory cytokines (G-CSF, IL-6, and IL-8). 

The tolerability profile in patients with advanced cancer was similar to that observed in two previously conducted studies in 150 healthy volunteers receiving entolimod. As expected with activation of innate immune pathways, common adverse events were flu-like symptoms and fever, with some patients having transient, spontaneously resolving tachycardia, hypotension, and hyperglycemia. Overall, treatment with entolimod was well tolerated. 

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. Drug-related side effects consistent with intended TLR agonism were transient and manageable, even in this very ill population with multiple comorbidities. The safety and immunological data suggest that entolimod can be combined with chemotherapeutic, targeted, or other immunotherapeutic anticancer agents or vaccines."

Langdon Miller, M.D., President and Chief Medical Officer of CBLI, noted: "Observations made during this trial corroborate preclinical findings and strongly support the hypothesis that entolimod has potential as an immunotherapeutic agent. We are performing a follow-on study in Moscow, Russia, to extend the clinical observations from the higher entolimod dose levels evaluated in this trial. Additionally, given the safety and immunological data acquired in this completed entolimod study, we are evaluating combinations with immune checkpoint inhibitors in preclinical models of breast, colon and bladder cancer and continuing to explore the potential for entolimod as a local (intravesical) therapy for non-invasive bladder cancer."

The poster, "A Phase I Study of the Toll-Like Receptor 5 (TLR5) Agonist, Entolimod in Patients (Pts) With Advanced Cancers," is abstract no. 3063 and was presented on board no. 389 by Hatoon Bakhribah, MD, a Drug Development Fellow at Roswell Park Cancer Institute during the Developmental Therapeutics-Immunotherapy poster session on Saturday May 30, 2015.

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 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 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 "plan," "potential," "will," "support," "potential," "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.