Key Developments: Cleveland BioLabs Inc (CBLI.PH)
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6 Jun 2013
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Latest Key Developments (Source: Significant Developments)
Cleveland BioLabs Inc And Incuron Announce Notice Of Allowance From FDA To Commence Clinical Testing With Cbl0137
Cleveland BioLabs Inc and Incuron, LLC, a joint venture between the Company and Bioprocess Capital Ventures, announced the receipt of a Notice of Allowance from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application for CBL0137. A multi-center, Phase 1, single agent, dose escalation trial evaluating intravenous administration of CBL0137 in patients with metastatic or unresectable advanced solid cancers is being finalized with the FDA. The primary objective of the study is to determine the maximally tolerated dose and recommend a Phase 2 dose for CBL0137 in these patients. Secondary objectives include describing the dose limiting toxicity, adverse event and pharmacokinetic profile of CBL0137, as well as documenting any objective responses. Exploratory objectives for the study include examining the relationship between tumor expression of Facilitates Chromatin Transcription (FACT), the molecular target of CBL0137, tumor response and the effect of CBL0137 on FACT expression in peripheral blood mononuclear cells and on soluble factors in serum. A Phase 1, single agent, dose escalation study of oral administration of CBL0137 in patients with advanced solid tumors that are resistant or refractory to standard of care treatment is ongoing in the Russian Federation. Full Article
Cleveland BioLabs Incs' Panacela Labs Inc Signs Contract With Russian Ministry of Industry and Trade for Development of Xenomycins
Cleveland BioLabs Inc's Panacela Labs Inc announced an award of a contract valued at 146 million rubles, or approximately $4.6 million (based on current exchange rates), with the Ministry of Industry and Trade of the Russian Federation for development of Xenomycins, a family of compounds in development as anti-infective agents. The contract, issued under the Russian Federation's Pharma 2020 development initiative, provides matching funding over a period of approximately three years, which will be used to support preclinical and clinical studies. Full Article
Cleveland BioLabs Inc Prices $15 Million Public Offering Of Common Stock And Warrants
Cleveland BioLabs Inc announced that it has priced an underwritten public offering of 7,500,000 units at a price to the public of $2.00 per unit, resulting in gross proceeds of $15.0 million. Each unit consists of one share of common stock and one warrant to purchase 0.5 shares of common stock at an exercise price of $3.00 per whole share. The offering is expected to close on or about October 24, 2012, subject to satisfaction of customary closing conditions. Cleveland BioLabs has granted the underwriters a thirty (30) day option to purchase up to 1,125,000 additional shares and/or additional warrants to purchase up to 562,500 shares to cover over-allotments, if any. Oppenheimer & Co. Inc. is acting as the sole bookrunner for the proposed offering and Cantor Fitzgerald & Co. and Ladenburg Thalmann & Co. Inc. are acting as co-managers. Burrill Merchant Banking acted as the financial advisor in connection with the offering. Full Article
Cleveland BioLabs Inc Proposes Public Offering of Common Stock and Warrants
Cleveland BioLabs Inc announced that it intends to offer shares of its common stock and warrants to purchase shares of its common stock in an underwritten public offering. The shares of common stock and warrants to purchase common stock are being offered as units. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Oppenheimer & Co. Inc. is acting as the sole bookrunner for the proposed offering and Cantor Fitzgerald & Co. and Ladenburg Thalmann & Co. Inc. are acting as co-managers. Full Article
Cleveland BioLabs Inc And Incuron Announces CBL0102 Orphan Drug Status For Hepatocellular Carcinoma
Cleveland BioLabs Inc and Incuron, LLC, a joint venture between the Company and Bioprocess Capital Ventures, announced that curaxin CBL0102 (quinacrine) has been granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for treatment of hepatocellular carcinoma. Full Article
Cleveland BioLabs, Inc. Signs Contract With Russian Ministry Of Industry And Trade For Development Of CBLB612 Through Subsidiary
Cleveland BioLabs, Inc. announced that, through a wholly owned Russian subsidiary, it has signed a contract valued at RUB139 million, or approximately $4 million (based on current exchange rates), with the Ministry of Industry and Trade of the Russian Federation for development of CBLB612, a drug in development for stimulation of hematopoietic stem cell proliferation and mobilization. The contract, issued under Russia's Pharma 2020 development initiative, provides funding over a period of approximately three years, which will be used to support completion of preclinical studies, filing of an IND and Phase I and II clinical studies. Full Article
Cleveland BioLabs, Inc. Appoints Yakov Kogan As Chief Executive Officer
Cleveland BioLabs, Inc. announced that the Company's Board of Directors appointed Yakov Kogan, CBLI's Chief Executive Officer. Dr. Kogan had served as interim Chief Executive Officer since January 2012. Full Article
Cleveland BioLabs, Inc. Reports Strong Survival Results Which Met The Primary Endpoint Of Its GLP Efficacy Study With Radiation Countermeasure CBLB502
Cleveland BioLabs, Inc. announced strong survival results for its randomized, blinded, placebo-controlled efficacy study of CBLB502 in 179 non-human primates (NHPs) conducted under Good Laboratory Practice (GLP) with elements of Good Clinical Practice (GCP), as required by the U.S. Food and Drug Administration’s (FDA) Animal Rule. The study demonstrated with a high degree of statistical significance the dose-response relationship between the administration of CBLB502 and the survival of lethally irradiated animals, the study’s primary endpoint. Animals in the study received a 70% lethal dose of total body irradiation (TBI) followed by a single injection of a range of doses of CBLB502 or a placebo, in each case, 25 hours after irradiation. In addition to determination of 60-day survival, the study measured multiple pharmacodynamic parameters which the Company believes are essential for animal-to-human dose conversion. A minimal efficacious dose of CBLB502 was determined and doses above the minimal efficacious dose formed a plateau at approximately 75% survival, compared to 27.5% survival in the placebo treated group. These results demonstrated with a high degree of statistical significance (p < 0.0001 for the trend up to the 40 ug/kg dose and p = 0.0021 for the trend up to the 10 ug/kg dose) that a single administration of CBLB502 given 25 hours after TBI led to a nearly three-fold increase in overall survival in the subject animals. Full Article
Cleveland BioLabs, Inc. Announces Start Of Advanced Cancer Trial For CBLB502
Cleveland BioLabs, Inc. announced that the first patient completed an initial series of five doses in a Phase I trial evaluating CBLB502 in advanced cancer patients. The study will evaluate the safety and pharmacokinetic profile of CBLB502 in patients with advanced cancers. Up to forty-eight patients are expected to be enrolled in multiple cohorts to determine the safety, tolerability, and maximum tolerated dose of repeated administrations of CBLB502. Evaluations for evidence of anticancer activity of CBLB502 in advanced cancer patients will also be performed. Full Article
Cleveland BioLabs, Inc. Announces Management Reorganization
Cleveland BioLabs, Inc. announced that Michael Fonstein, Ph.D., has stepped down from his position as Chief Executive Officer of the Company. He will continue to serve as the President of CBLI with a primary focus on advancing the CBLB502 program towards FDA licensure as a countermeasure for Acute Radiation Syndrome, guiding promising business development opportunities and supporting recently established joint ventures. Yakov Kogan, Ph.D., MBA, the current Chief Operating Officer of the Company, has also been appointed interim Chief Executive Officer and will lead and coordinate all of the Company's strategic and operational activities. C. Neil Lyons, CPA, the current Chief Financial Officer, will add to his duties oversight of investor and public relations activities. Andrei Gudkov, Ph.D., D.Sci., will continue serving as Chief Scientific Officer. Full Article
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