Profile: Cleveland BioLabs Inc (CBLI.O)

Cleveland BioLabs, Inc., incorporated on June 5, 2003, is a clinical-stage biotechnology company with a focus on oncology drug development. The Company’s lead drug candidate CBLB502 is developed for dual indications under the United States Food & Drug Administration's (FDA's) Animal Efficacy Rule, commonly referred to as the Animal Rule, as a radiation countermeasure, and under the FDA's traditional drug approval pathway as an anti-cancer agent and an oncology supportive care therapy. As of December 31, 2011, the Company had nine product candidates in its pipeline that are developed directly by the Company and its majority owned subsidiaries. The products include CBLB502, CBLB502, CBLB502, CBLB612, CBLC102, CBLC137, Revercom, Mobilan, Arkil, Antimycon, and Xenomycins. As of December 31, 2011, the Company had an approximately 75.8% ownership interest in Incuron, LLC (Incuron).As of December 31, 2011, the Company had an ownership stake of approximately 54.6% in Panacela Labs, Inc. (Panacela).

The Company proposed to develop pharmacological agents capable of temporarily and reversibly suppressing apoptotic cell death under such stress conditions in order to reduce tissue damage and improve organism survival. The Company's is focused on two classes of these compounds, which the Company refers to as Protectans: CBLB500 and CBLB600. CBLB500 and CBLB600 series compounds are injectable biologics that act through stimulation of specific mammalian cell surface receptors that regulate innate immunity, Toll-like receptors 5 and 2 (TLR5 and TLR2).TLRs act as molecular sensors to detect the presence of pathogens and induce an appropriate innate immune response. CBLB500 series compounds are pharmacologically optimized derivatives of the Salmonella flagellin protein and CBLB600s are synthetic lipopeptides that mimic properties of mycoplasma products.

CBLB502

The Company’s CBLB502 is lead compound in the CBLB500 series of Protectans. CBLB502 is an engineered derivative of the Salmonella flagellin protein that is designed to retain its specific TLR5-activating capacity while increasing its stability, reducing its immunogenicity and enabling high-yield production. The Company's studies have shown that CBLB502 has in vivo tissue protective effects in animal models of a number of tested scenarios, including protection against death following acute high-dose radiation exposure, protection of healthy tissues (but not tumors) from radiation and chemotherapy in cancer treatment models, and alleviation of ischemia-reperfusion-induced acute kidney injury. CBLB502 may be used as a targeted anti-cancer agent. CBLB502 may also be used as an adjuvant to standard anti-cancer radiation and chemotherapy. The Company has conducted multiple in vitro and in vivo experiments that showed CBLB502-mediated protection is limited to normal, non-cancerous cells.

CBLB612

The Company's second lead Protectan, CBLB612, is a compound based upon a natural activator of another tissue-specific component of the innate immune system, the TLR2/TLR6 heterodimeric receptor. CBLB612 is a pharmacologically optimized synthetic molecule that structurally mimics naturally occurring lipopeptides of Mycoplasma. Like Mycoplasma lipopeptides, CBLB612 activates NF-kB pro-survival and immunoregulatory signaling pathways through specific binding to TLR2 on a subset of body tissues and cell types that express this receptor. As of December 31, 2011, CBLB612 is undergoing formal pre-clinical safety assessment and cGMP-manufacturing development. The Company's Curaxin program has already brought two molecules to advanced stages of development.

CBLC102

The Company’s CBLC102 is a member of a class of Curaxins that includes relatives of 9-aminoacridine, a compound that is the core structure of many existing drugs. CBLC102 is a Quinacrine, a compound with a long history of use in humans as a treatment for malaria, osteoarthritis and autoimmune disorders.

CBLC137

Based on the Company's research relating to CBLC102 and other first generation Curaxins, the Company set out to identify related compounds with similar activities and mechanisms of action, but potentially improved efficacy and other characteristics. CBLC137 has emerged as the Company's lead second generation Curaxin, demonstrating reproducible anti-tumor effects in animal models of colon, breast, renal and prostate cancers. The Company's tests indicate that CBLC137 may have favorable pharmacological characteristics, including suitability for oral and intravenous administrations and the lack of genotoxicity damaging or mutagenic activity (DNA). CBLC137 is at an early stage of its development.

Revercom

The Company’s Revercom is an anti-cancer drug candidate consisting of a liposome-packaged small molecule named Reversan. Reversan is a small molecule inhibitor of the multi-drug transporter MRP1, which is associated with development of tumor resistance to chemotherapy. Early studies have shown that Reversan sensitizes tumor cells to conventional chemotherapeutic drugs. Therefore, Reversan is being developed as an adjuvant to conventional chemotherapy for use in treatment of a range of cancers. Revercom is in the pre-clinical stage of development.

Mobilan

The Company Mobilan is a nanoparticle-formulated recombinant non-replicating adenovirus that directs expression of TLR5 and its agonistic ligand, flagellin. Mobilan is in the pre-clinical stage of development as a universal anti-cancer therapy.

Arkil

The Company’s Arkil is a treatment for prostate cancer. This small molecule compound has been shown to cause selective degradation of androgen receptor, thereby eliminating the constant AR signaling pathway activity that is essential for growth and viability of the majority of prostate cancers, including those that have lost their dependence on androgen. Arkil is in the pre-clinical stage of research and development, undergoing hit-to-lead optimization.

Antimycon

The Company’s Antimycon is a small molecule lead compound generated to selectively target and inactivate oncoproteins of the Myc family, which are frequently upregulated in tumor cells. Potential indications for Antimycon include treatment of a range of solid tumors and hematological malignancies. Antimycon is in the pre-clinical stage of development, undergoing hit-to-lead optimization.

Xenomycins

The Company’s Xenomycin family of compounds has a range of potential applications as antimicrobial and, particularly, anti-fungal agents. Xenomycins are in the pre-clinical stage of development, undergoing hit-to-lead optimization.