Entolimod (CBLB502) Oncology
Entolimod is a clinical-stage investigational drug with potential application as a cancer treatment. This recombinant protein is an agonist of toll-like receptor 5 (TLR5), an innate immunity receptor. Entolimod activation of TLR5 triggers NF-kB signaling, mobilizing an innate immune response that drives expression of numerous genes. Unlike activation of some other TLRs, activation of TLR5 does not induce a septic shock-like syndrome or a “cytokine storm.”
In preclinical models, administration of entolimod shows a direct cytotoxic effect on tumors expressing TLR5. In addition, entolimod activation of an innate immune response can induce potent antitumor activity in animal models of liver metastasis, regardless of TLR5 expression. Additionally, a supportive care benefit has been demonstrated in preclinical studies of entolimod when the drug has been administered in combination with radiation or cytotoxic agents with adverse hematopoietic or gastrointestinal effects. Preclinical studies suggest that the tissue protective effects of entolimod do not extend to tumors.
In two completed clinical studies in 150 healthy subjects, administration of entolimod was associated with a transient mild to moderate flu-like syndrome, which is consistent with the mechanism of action of the compound. Transient decreases in blood pressure and elevation of liver enzymes were also observed.
A Phase 1 study of entolimod in patients with advanced solid tumors at Roswell Park Cancer Institute was completed and results were presented at the 2015 annual meeting of the American Society of Clinical Oncology (ASCO) (see press release dated June 1, 2015).
A second Phase 1 study of entolimod in patients with advanced cancer was initiated in the Russian Federation to expand upon clinical observations made at the higher dose levels in the Roswell Park study and to gather further statistics on immune response to administrations of entolimod.
A Phase 2, single-blind, randomized, placebo-controlled clinical study of the safety and tolerability of entolimod as a neo-adjuvant therapy in treatment-naïve patients with primary colorectal cancer who are recommended for surgery was initiated in the Russian Federation.
Cleveland BioLabs, Inc.
73 High Street
Buffalo, NY 14203
Permission to Use
Intellectual Property Rights
Certain Site Content
Any health or medical information included on the Site is for informational purposes only and is not, and is not intended to be, a medical diagnosis or a replacement for advice given by a physician or other healthcare professional, and none of the information included on the Site constitutes, or is intended to constitute, investment advice. Product candidates in development described on the Site have not been found safe or effective by any regulatory agency and are not approved for any use other than in certain clinical trials. Information included on the Site regarding any product approved for marketing is qualified in its entirety by reference to the full prescribing information for such product.
The Site may include certain third-party information or content. This third-party information or content does not represent the views, opinions or beliefs of Cleveland BioLabs, and Cleveland BioLabs disclaims any responsibility for any such third-party information or content.
This Site contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors.
These factors include, among others, 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; the Company’s failure to successfully and timely develop new products; the risks inherent in the early stages of drug development and in conducting clinical trials; the Company’s inability to obtain regulatory approval in a timely manner or at all; the Company’s collaborative relationships and the financial risks related thereto; the Company’s ability to comply with its obligations under license agreements; the potential for significant product liability claims; and the Company’s ability to comply with various safety, environmental and other governmental regulations. 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.
You may use the Site to contact Cleveland BioLabs with inquiries about information included on the Site. When you provide any information to Cleveland BioLabs, you agree to provide true, accurate, complete and current information and not to use a false or misleading name or a name that you are not authorized to use. You shall not transmit information to or through the Site that: (i) infringes or violates any intellectual property right or privacy right of any third party; or (ii) contains confidential information or trade secrets belonging to you or any third party. Cleveland BioLabs does not want to receive any such information. Any ideas, suggestions, information, know-how, material or other content transmitted to or through the Site will be deemed to include a royalty-free, perpetual, irrevocable, transferable, worldwide, nonexclusive right and license for Cleveland BioLabs to adopt, publish, reproduce, disseminate, transmit, distribute, copy, use, create derivative works, display, (in whole or part), or act thereon without any approval or consideration from you, in any form, medium, or technology now known or later developed for the full term of any rights that may exist therein. Cleveland BioLabs makes no promise, express or implied, that it will not use any such idea, suggestion, information, know-how, material or other content for its own purposes, which may include reproduction, publication, broadcast and posting.
The Site may provide hypertext links to other web sites that are not owned or controlled by Cleveland BioLabs. These links are provided for your convenience only. These web sites are controlled by third parties that Cleveland BioLabs does not control. Accordingly, Cleveland BioLabs expressly disclaims any responsibility for the content of such web sites, for the accuracy or reliability of the information thereon and for the quality of products or services provided thereby or advertised thereon. No link included on the Site constitutes an endorsement of Cleveland BioLabs of any content of, information on or product or service provided by, or advertised on, any such web site. If you choose to hyperlink to another web site, you do so at your own risk. Cleveland BioLabs reserves the right to terminate any hypertext link without notice.
You are prohibited from violating or attempting to violate the security of the Site. Without limiting the generality of the foregoing, you may not: (i) access data or materials that are not intended for you; (ii) log, or attempt to log, into a server or account that you are not authorized to access; or (iii) attempt to probe, scan or test the vulnerability of the Site. Violations of system or network security may result in civil or criminal liability. Cleveland BioLabs reserves the right to investigate any suspected violation of this section and to involve and cooperate with law enforcement authorities in prosecuting any party who participates in any such violation.
Compliance with Laws
You may use the Site only for lawful purposes. You agree that you will, at all times, comply with all applicable local, state, national and international laws, statutes, rules, regulations, ordinances and the like applicable to your use of the Site.
Disclaimers; Limitation of Liability
THE SITE IS PROVIDED “AS IS” AND “AS AVAILABLE,” WITHOUT WARRANTIES OF ANY KIND. TO THE FULLEST EXTENT PERMISSIBLE BY LAW, CLEVELAND BIOLABS DISCLAIMS ALL WARRANTIES, EXPRESS, IMPLIED OR STATUTORY (INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT).
Cleveland BioLabs does not warrant that the Site will be uninterrupted, secure or error-free, that defects will be corrected, or that the Site or the server that makes it available are or will be free of viruses or other harmful components. Information included on the Site may be incomplete, outdated or inaccurate and may contain typographical errors. Cleveland BioLabs makes no commitment to update the information included on the Site. YOUR USE OF THE SITE IS AT YOUR OWN RISK. UNDER NO CIRCUMSTANCES SHALL CLEVELAND BIOLABS OR ANY OF ITS DIRECTORS, OFFICERS, EMPLOYEES, OR AGENTS BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES (INCLUDING DAMAGES FOR LOSS OF BUSINESS, REVENUE OR PROFITS AND THE LIKE) ARISING OUT OF OR IN CONNECTION WITH YOUR USE OF THE SITE OR YOUR RELIANCE ON ANY INFORMATION CONTAINED ON THE SITE, WHETHER BASED ON CONTRACT, NEGLIGENCE, TORT, STRICT LIABILITY OR ANY OTHER BASIS, EVEN IF CLEVELAND BIOLABS HAS BEEN ADVISED OF, OR SHOULD HAVE KNOWN OF, THE POSSIBILITY OF SUCH DAMAGES. Because some jurisdictions do not permit the exclusion of certain warranties or the limitation of liability as set forth above, such exclusions and limitations may not apply to you.
The information provided on the Site is intended for United States audiences only. Cleveland BioLabs makes no representation that the information on the Site is appropriate or available for use in other locations, and access or use of the Site from territories in which the content of the Site may be illegal is prohibited. If you wish to access or use the Site from outside of the United States, you do so on your own initiative and you are responsible for complying with applicable laws and regulations. You should not construe anything on the Site as a promotion of, or solicitation for, any product or product candidate that is not authorized by the laws and regulations of the country in which you are located.
Collection of Personal Information
We collect Personal Information that you submit to us voluntarily through our website. The types of Information we collect are:
For visitors who email us directly via an email hyperlink:
- Email address
- Any content included in the email
For all visitors:
- As you navigate our website, certain passive information will also be collected, including Internet Protocol addresses, cookies and navigational data. This type of information will be used for the purposes of gathering data to provide improved administration of our website, and to improve the quality of your experience when interacting with our website.
Use of Personal Information
In general, Personal Information you submit to us is used either to respond to requests that you make, or to aid us in serving you better.
Disclosure of Personal Information
We do not sell your Personal Information or share your information with other companies or organizations without your consent. The content of any communications you send to us is non-confidential, and we are under no obligation to refrain from reproducing, publishing, or otherwise using such content in any way or for any purpose. We will not reproduce, publish, or otherwise use your Personal Information in connection with such content. We may, however, reproduce or use your Personal Information in connection with any resume you submit to us for employment recruiting purposes. We are free to use the content of any such communications (excluding any resume you submit to us), including any ideas, inventions, concepts, techniques, or know-how disclosed therein, for any purpose including developing, manufacturing, and/or marketing goods or services.
Our website is not designed for children under the age of 13. We will not deliberately gather Personal Information about visitors in this age group, and do not collect any information on this website with respect to age.
Links to Other Sites
Cleveland BioLabs, Inc.
73 High St.
Buffalo, NY 14203
This policy was last updated on June 15, 2012.