Cleveland Biolabs
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Controlling Cell Death To Protect Human Life iJ Cleveland BioLabs 2011 Annual Report company with focus for is being developed ue U.S Food Drug Administrations nal Efficac U-LC agent and an oncologic supportive care the FDAs traditional drug approval pathway We anticipate that CBLB5O2 upon nsure as radiation countermeasure will be sold to the U.S government for the national stockpile and other defense-related purposes friendly foreign governments and the nuclear energy industry and upon licensure as an anti-cancer agent will be sold to the public through traditional channels Since our inception we have pursued the research development and commercialization of products that have the potential to evidence direct anti-cancer activity prevent and treat acute radiation syndrome and counteract the toxic effects of radio and chemotherapies for oncology candidates in that patients Presently we have nine product our pipeline are being developed and Inc directly by us and our majority-owned subsidiaries Incuron LLC Panacela Labs Mission Statement CBLIs mission is to develop and commercialize innovative drugs to treat cancer and protect scientific healthy tissues from radiation chemotherapy or ischemic conditions using revolutionary concepts developed at CBLI and in collaboration with distinguished academic partners Talented scientists experienced drug development executives and innovative entrepreneurs comprise balanced CBLI team united by common goals to make difference in the lives of untreatable patients and to cure people suffering from previously diseases CBLI recognizes that our efforts would be impossible without our many loyal stakeholders who mission of support us The CBLI team is committed to creating long-term value by fulfilling its developing novel drugs for unmet medical conditions using the most pragmatic approach and highest ethical standards 2011 Annual Report in for stimu past year has been one of enormous challenge CBLB612 compound development cell and mobilization and opportunity for CBLI We have progressed hematopoietic stem proliferation ahead our scientific discoveries expanded the scope of our to peripheral blood continues to move through operations and significantly advanced both our defense formal preclinical development and oncology pipelines Incuron is actively developing the Curaxin line of anti that have and is forward towards We are proud to say we currently nine product cancer compounds moving in advanced candidates in our pipeline that are being developed by completion of the Phase lb trial of CBLC1O2 the us and our majority-owned subsidiaries lncuron LLC cancer patients with liver metastases in Russian and Panacela Labs Inc Three of these candidates are Federation Completion of this trial is anticipated in from currently in or about to commence clinical oncology 2012 Incuron was recently granted clearance the first in trials in addition to all of the activity we have ongoing the Russian regulatory authority to begin for CBLB5O2 defense human trial with the oral formulation of CBLC137 The opening of this IND is funding milestone for Incurons With all of these exciting developments we remain investment partner BioProcess Capital Partners focused on our primary business objective the full towards IND completion of CBLB5O2s development as radiation Panacela is moving ahead at speed countermeasure and its commercialization enabling preclinical work in the Russian Federation for its five pipeline candidates During the past year we conducted several face-to- face meetings and had additional exchanges with the Recognizing the potential of our expanding pipeline Division of Medical Imaging Products of the FDA the in the oncology field we have been preparing our division that is currently overseeing our IND for the organization to achieve significant milestones by defense in the bench of our CBLB5O2 program We are currently the midst methodically enhancing strength of formal discussions regarding the design of remaining team We made several key hires in 2011 including animal efficacy and human safety studies required for senior personnel in regulatory affairs quality assurance submission of Biologic License Application pre-clinical operations manufacturing project management business development and finance In In conjunction with our FDA negotiations we continue late 2011 we reorganized our internal teams in order to work with and solicit funds from several U.S to enhance operational efficiencies and in January Federal government agencies to help advance our 2012 we realigned senior managements roles and development efforts responsibilities These changes were made to better focus our management team on commercialization of Capitalizing on CBLB5O2s direct anti-cancer preclinical CBLB5O2 and on meeting our other strategic objectives data we are enrolling patients in an advanced cancer trial at Roswell Park Cancer Institute Up to forty-eight On the business development front we are pursuing in cohorts patients are expected to be enrolled multiple potential partnering opportunities for some of our to determine the safety tolerability and maximum oncology pipeline candidates Recent licensing trends in tolerated dose of repeated administrations of CBLB5O2 oncology are encouraging According to our research on Evaluations for evidence of anti-cancer activity in these therapeutic licenses announced in 2011 the oncology patients will also be performed sector represented over one third of all therapeutic 2011 Annual Report nsing of of multiple downstream signaling events triggered by represented CBLB5O2 including its activation of innate immune over 70% of all 2011 deals We cant predict what responses This new insight strengthens our leadership interest our compounds may garner but strategic position in the TLR5 field solidifies our intellectual and adds abilities further development partner could present very attractive property position to our to opportunity for CBLI explore this target for therapeutic benefit further few of our peer review publications made quite Our intellectual property position was with several splash in the scientific community this year In August enhanced this year the grants of patents and 2011 Science Translational Medicine published including grants of patents for CBLB5O2 CBLB612 breakthrough findings regarding the deciphered compositions of matter in the United States in August mechanism of action of Curaxins The paper showed 2011 and the grant of method of use patent for that Curaxins ability to inhibit tumor cell growth and CBLB5O2 in January 2012 division is mediated by functional inactivation of We believe CBLI is well positioned to advance our chromatin remodeling complex named Facilitates development programs and capitalize on opportunities Chromatin Transcription FACT which makes it novel in the coming year We remain committed to increasing cancer treatment target The paper was accompanied long-term shareholder value and greatly appreciate by perspective article co-authored by Ron DePinho your continued support M.D current president of the MD Anderson Cancer Center at The University of Texas Sincerely In October 2011 the International Journal of Radiation Oncology Biology and Physics published study demonstrating CBLB5O2s ability to both protect against local radiation toxicity and inhibittumor growth in mouse tumor models This work provided the first Yakov Kogan Ph.D MBA demonstration of CBLB5O2s radioprotective efficacy in Interim Chief Executive Officer Cleveland model of localized irradiation of cancer and showed BioLabs Inc that it has direct anti-cancer activity as well More recently we co-authored Science publication with the worlds leading experts in structural biology from Scripps Research Institute on the determination of structural mechanisms of the Toll-Like Receptor TLR5 interaction with bacterial flagellin the precursor of CBLB5O2 TLR5 is an innate immunity receptor expressed of on the surface mammalian cells that CBLB5O2 targets By elucidating three-dimensional interactions between TLR5 and CBLB5O2 at extremely high resolution it provided breakthrough in understanding the sequence 2011 Annual Report United States Securities and Exchange Commission WASHINGTON D.C 20549 FORM 10-K Mark One Act of 1934 EEl Annual Report Pursuant to Section 13 or 15d of the Securities Exchange December 2011 For the fiscal year ended 31 or Act Transition Report pursuant to Section 13 or 15d of the Securities Exchange from For the transition period ____________to ____________ Commission file number 001-32954 CLEVELANDBIOLABS INC Exact name of registrant as specified in its charter DELAWARE 20-0077155 State or other jurisdiction of incorporation I.R.S Employer Identification No or organization 73 High Street Buffalo NY 14203 716 849-6810 Address of principal executive offices Telephone No Securities Registered Pursuant to Section 12b of the Act Title of each class Name of each exchange which registered Common Stock par value $0.005 per share NASDAQ Capital Market Securities Registered Pursuant to Section 12g of the Act None Indicate by check mark if the registrant is well-known seasoned issuer as defined in Rule 405 of the Securities Act Yes 11 No Section of the Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15d Act Yes No 13 of the Securities Indicate by check mark whether the registrant has filed all reports required to be filed by Section or 15d file such Exchange Act of 1934 during the preceding 12 months or for such shorter period that