CBLI --Here's the rest. Charts didn't copy. Go to link.
John
Lead Compounds
Protectan CBLB502
Protectan CBLB502 is a rationally designed recombinant derivative of the bacterial protein, flagellin, which binds and activates the mammalian TLR5 cell surface receptor. CBLI initially chose to explore flagellin as a potential radioprotectant since its signaling through TLR5 is known to activate the anti-apoptotic NF-kappaB pathway. Moreover, TLR5 is expressed on the endothelial cells of the small intestine lamina propria, the most radiosensitive part of the GI tract.
Extensive preclinical studies have demonstrated that CBLB502 is an effective and non-toxic anti-radiation treatment. The compound rescues both mice and non-human primates (Macaca mulatta) from lethal doses of total body gamma radiation, whether injected prior to, or after, radiation exposure. CBLB502 is non-toxic at therapeutic doses in both mice and monkeys. Importantly, CBLB502 protects cells of both the HP system and the GI tract. GI protection is a unique advantage of CBLB502 over any currently known radioprotectant or radiomitigator. CBLB502 is highly stable and is effective when administered through intramuscular injection, characteristics important for practical application as an emergency or military field treatment.
CBLB502 Development Status:CBLI is currently focused on expedited development of the drug for “non-medical” biodefense applications. The “Animal Efficacy“ rule developed by the U.S. Food and Drug Administration (FDA) in 2002 eliminates the requirement for Phase II and Phase III clinical trials for investigational drugs that address situations such as acute radiation injury, since it would be infeasible and/or unethical to conduct efficacy studies in humans. In such cases, drugs are considered for approval based upon efficacy studies in representative animal species and only extended Phase I safety, pharmacokinetic, pharmacodynamic and biomarker testing in healthy human volunteers. Development of CBLB502 under this rule has been supported in part by millions of dollars in contracts from the Department of Defense (DoD) and the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), as well as other federal agencies. Most animal efficacy studies, two human safety studies and cGMP manufacturing have been completed. CBLI has been granted fast track and orphan drug status for CBLB502 from the FDA and expects to complete necessary studies and submit a Biologic License Application (BLA) for FDA licensure. CBLI is also initiating clinical studies of CBLB502 as a radioprotectant for medical applications, such as Supportive Care in Cancer Treatment.
View Product Pipeline
CBLB600 Series Protectans
In addition to CBLB502, CBLI initially investigated the radioprotective potential of a series (CBLB600 Series Protectans) of pharmacologically improved synthetic derivatives of mycoplasma lipopeptide. Mycoplasma lipopeptide is the natural agonist of heterodimeric TLR2/TLR6 receptors expressed on mammalian cells. Signaling through this receptor results in activation of the anti-apoptotic NF-kappaB pathway.
Preclinical investigation of CBLB600 Series compounds as radioprotectants has demonstrated that they protect mice and non-human primates from death due to HP acute radiation syndrome when administered either before or after radiation exposure. The compounds are non-toxic at therapeutic doses in mice, are highly stable, and can be effectively delivered by intramuscular or subcutaneous injection. A striking feature of CBLB600 Series Protectans is that, in the absence of irradiation, their administration stimulates proliferation of bone marrow hematopoietic stem cells and induces their migration to the peripheral blood. Given the advanced nature of Protectan CBLB502’s development as an antidote for radiation exposure, CBLI has redirected the clinical development of the CBLB600 Series Protectans to other potential medical applications, such as Stem Cell Induction and Mobilization in the context of recovery from chemotherapy-induced myelosuppression, or bone marrow transplant.
View Product Pipeline
Market Data 
Markets 
AI
