Cleveland BioLabs
Encyclopedia
Cleveland BioLabs, Inc. (Nasdaq:CBLI) is a biotechnology
company leveraging its proprietary discoveries around programmed cell death (apoptosis
) to develop a pipeline of drugs for multiple medical and defense applications.
The Company was founded in partnership with the Cleveland Clinic
in 2003. The Cleveland Clinic retains a board seat and significant shareholding in the company. The company has also a strategic alliance with Roswell Park Cancer Institute
, in Buffalo, NY, where the company is currently headquartered. Other strategic alliances or partnerships include ChemBridge Corporation and the Armed Forces Radiobiology Research Institute.
, chemotherapy
and ischemias (pathologies developed as a result of blocking blood flow to a part of the body). Curaxins are being developed as anticancer agents that could act as monotherapy drugs or in combination with other existing anticancer agents.
It's most advanced product candidate is Protectan CBLB502, a microbial
protein derivative, which has demonstrated the capacity to reduce injury from acute stresses, such as radiation and chemotherapy, in animal models. It mobilizes several cell protective mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration-promoting cytokines.
It is in active development under the U.S. Food and Drug Administration (FDA) Animal Efficacy Rule to treat Acute Radiation Syndrome (ARS)
or radiation poisoning
from any exposure to radiation such as a nuclear
or radiological weapon
or dirty bomb
, or from a nuclear accident. This pathway requires demonstration of efficacy
in representative animal models and safety and drug metabolism
testing in healthy human volunteers.
Evidence of its mechanism of action
and activity in animal models was published in Science Magazine in April 2008. Data from 50 subjects in an initial Phase I safety and tolerability study indicated that CBLB502 was well tolerated and that normalized biomarker results corresponded to previously demonstrated activity in animal models of ARS. This will be followed by a second, larger safety study in healthy human volunteers. There is currently no FDA approved medical countermeasure to treat ARS.
The substance is also being developed as a supportive care measure to reduce and prevent occurrence of side effects of radiotherapy or chemotherapy in cancer treatment.
Another compound in the Protectan family, CBLB612, is a modified lipopeptide
of mycoplasma
, which has demonstrated the ability to induce hematopoietic stem cells in bone marrow
and mobilize them into peripheral blood in animal studies. Potential applications include accelerated hematopoietic recovery during chemotherapy, and during donor preparation for bone marrow transplantation.
The company's Curaxin family of anticancer compounds includes CBLC102, a member of the aminoacridine
family, and CBLC137, a new chemical entity belonging to a class of molecules known as Carbazole
. CBLC102 demonstrated safety and activity in a Phase II trial in hormone-refractory prostate cancer, which was concluded in 2008. Insights into the mechanism of action of CBLC102 were published in Oncogene in January 2009.
Fonstein is Chief Executive Officer and President. He served as Director of the DNA Sequencing Center at the University of Chicago from its creation in 1994 to 1998, when he left to found Integrated Genomics, Inc. located in Chicago, Illinois. He served as CEO and President of Integrated Genomics from 1997 to 2003.He has won several awards, including the Incubator of the Year Award from the Association of University Related Research Parks and a KPMG Illinois High Tech Award.
Gudkov is Chief Scientific Officer. Prior to 1990, he led a broad research program on virology and cancer drug resistance at The National Cancer Research Center in Moscow (USSR). In 1990, he moved to the University of Illinois at Chicago where he became a tenured faculty member in the Department of Molecular Genetics. His lab concentrated on the development of new functional gene discovery methodologies and the identification of candidate cancer treatment targets. In 1999, he defined p53
as a major determinant of cancer treatment side effects and suggested this protein as a target for therapeutic suppression. In 2001, he moved to the Lerner Research Institute
at the Cleveland Clinic as Chairman of the Department of Molecular Biology and Professor of Biochemistry at Case Western Reserve University. In 2007, he accepted the position of Senior VP Basic Science and Chair, Department of Cell Stress Biology at Roswell Park Cancer Institute in Buffalo, NY. Gudkov divides time between work for CBLI and for Roswell Park.
Kogan is Chief Operating Officer. From 2001 to 2003, he was Director for Business Development at Integrated Genomics,Previously, he worked as a Group Leader/Senior Scientist at Integrated Genomics and ThermoGen, Inc. and as Research Associate at the University of Chicago. He holds a Ph.D. degree in Molecular Biology from VNII Genetica, as well as an M.S. degree in Biology from Moscow State University and an MBA from the University of Chicago.
Biotechnology
Biotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts. Biotechnology also utilizes these products for manufacturing purpose...
company leveraging its proprietary discoveries around programmed cell death (apoptosis
Apoptosis
Apoptosis is the process of programmed cell death that may occur in multicellular organisms. Biochemical events lead to characteristic cell changes and death. These changes include blebbing, cell shrinkage, nuclear fragmentation, chromatin condensation, and chromosomal DNA fragmentation...
) to develop a pipeline of drugs for multiple medical and defense applications.
The Company was founded in partnership with the Cleveland Clinic
Cleveland Clinic
The Cleveland Clinic is a multispecialty academic medical center located in Cleveland, Ohio, United States. The Cleveland Clinic is currently regarded as one of the top 4 hospitals in the United States as rated by U.S. News & World Report...
in 2003. The Cleveland Clinic retains a board seat and significant shareholding in the company. The company has also a strategic alliance with Roswell Park Cancer Institute
Roswell Park Cancer Institute
The Roswell Park Cancer Institute is a comprehensive cancer research and treatment center located in Buffalo, New York. Founded in 1898 by Dr. Roswell Park, it was the first dedicated medical facility for cancer treatment and research in the United States. The facility is involved in drug...
, in Buffalo, NY, where the company is currently headquartered. Other strategic alliances or partnerships include ChemBridge Corporation and the Armed Forces Radiobiology Research Institute.
Products
The company's pipeline includes products from two primary families of compounds: Protectans and Curaxins. Protectans are being developed as drug candidates that protect normal tissues from acute stresses such as radiationRadiation
In physics, radiation is a process in which energetic particles or energetic waves travel through a medium or space. There are two distinct types of radiation; ionizing and non-ionizing...
, chemotherapy
Chemotherapy
Chemotherapy is the treatment of cancer with an antineoplastic drug or with a combination of such drugs into a standardized treatment regimen....
and ischemias (pathologies developed as a result of blocking blood flow to a part of the body). Curaxins are being developed as anticancer agents that could act as monotherapy drugs or in combination with other existing anticancer agents.
It's most advanced product candidate is Protectan CBLB502, a microbial
Microorganism
A microorganism or microbe is a microscopic organism that comprises either a single cell , cell clusters, or no cell at all...
protein derivative, which has demonstrated the capacity to reduce injury from acute stresses, such as radiation and chemotherapy, in animal models. It mobilizes several cell protective mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration-promoting cytokines.
It is in active development under the U.S. Food and Drug Administration (FDA) Animal Efficacy Rule to treat Acute Radiation Syndrome (ARS)
Radiation poisoning
Acute radiation syndrome also known as radiation poisoning, radiation sickness or radiation toxicity, is a constellation of health effects which occur within several months of exposure to high amounts of ionizing radiation...
or radiation poisoning
Radiation poisoning
Acute radiation syndrome also known as radiation poisoning, radiation sickness or radiation toxicity, is a constellation of health effects which occur within several months of exposure to high amounts of ionizing radiation...
from any exposure to radiation such as a nuclear
Nuclear weapon
A nuclear weapon is an explosive device that derives its destructive force from nuclear reactions, either fission or a combination of fission and fusion. Both reactions release vast quantities of energy from relatively small amounts of matter. The first fission bomb test released the same amount...
or radiological weapon
Radiological weapon
A radiological weapon or radiological dispersion device is any weapon that is designed to spread radioactive material with the intent to kill, and cause disruption upon a city or nation....
or dirty bomb
Dirty bomb
A dirty bomb is a speculative radiological weapon that combines radioactive material with conventional explosives. The purpose of the weapon is to contaminate the area around the explosion with radioactive material, hence the attribute "dirty"....
, or from a nuclear accident. This pathway requires demonstration of efficacy
Efficacy
Efficacy is the capacity to produce an effect. It has different specific meanings in different fields. In medicine, it is the ability of an intervention or drug to reproduce a desired effect in expert hands and under ideal circumstances.- Healthcare :...
in representative animal models and safety and drug metabolism
Drug metabolism
Drug metabolism is the biochemical modification of pharmaceutical substances by living organisms, usually through specialized enzymatic systems. This is a form of xenobiotic metabolism. Drug metabolism often converts lipophilic chemical compounds into more readily excreted polar products...
testing in healthy human volunteers.
Evidence of its mechanism of action
Mechanism of action
In pharmacology, the term mechanism of action refers to the specific biochemical interaction through which a drug substance produces its pharmacological effect...
and activity in animal models was published in Science Magazine in April 2008. Data from 50 subjects in an initial Phase I safety and tolerability study indicated that CBLB502 was well tolerated and that normalized biomarker results corresponded to previously demonstrated activity in animal models of ARS. This will be followed by a second, larger safety study in healthy human volunteers. There is currently no FDA approved medical countermeasure to treat ARS.
The substance is also being developed as a supportive care measure to reduce and prevent occurrence of side effects of radiotherapy or chemotherapy in cancer treatment.
Another compound in the Protectan family, CBLB612, is a modified lipopeptide
Lipopeptide
A lipopeptide is a molecule consisting of a lipid connected to a peptide. Bacteria express these molecules. They are bound by TLR 1, and other, Toll-like receptors.Certain lipopeptides are used as antibiotics....
of mycoplasma
Mycoplasma
Mycoplasma refers to a genus of bacteria that lack a cell wall. Without a cell wall, they are unaffected by many common antibiotics such as penicillin or other beta-lactam antibiotics that target cell wall synthesis. They can be parasitic or saprotrophic. Several species are pathogenic in humans,...
, which has demonstrated the ability to induce hematopoietic stem cells in bone marrow
Bone marrow
Bone marrow is the flexible tissue found in the interior of bones. In humans, bone marrow in large bones produces new blood cells. On average, bone marrow constitutes 4% of the total body mass of humans; in adults weighing 65 kg , bone marrow accounts for approximately 2.6 kg...
and mobilize them into peripheral blood in animal studies. Potential applications include accelerated hematopoietic recovery during chemotherapy, and during donor preparation for bone marrow transplantation.
The company's Curaxin family of anticancer compounds includes CBLC102, a member of the aminoacridine
Aminoacridine
Aminoacridine may refer to any of several chemical compounds:* 2-Aminoacridine* 3-Aminoacridine* 4-Aminoacridine* 9-Aminoacridine...
family, and CBLC137, a new chemical entity belonging to a class of molecules known as Carbazole
Carbazole
Carbazole is an aromatic heterocyclic organic compound. It has a tricyclic structure, consisting of two six-membered benzene ring fused on either side of a five-membered nitrogen-containing ring...
. CBLC102 demonstrated safety and activity in a Phase II trial in hormone-refractory prostate cancer, which was concluded in 2008. Insights into the mechanism of action of CBLC102 were published in Oncogene in January 2009.
Senior management
Cleveland BioLabs was founded by Michael Fonstein, Andrei Gudkov, and Yakov Kogan.Fonstein is Chief Executive Officer and President. He served as Director of the DNA Sequencing Center at the University of Chicago from its creation in 1994 to 1998, when he left to found Integrated Genomics, Inc. located in Chicago, Illinois. He served as CEO and President of Integrated Genomics from 1997 to 2003.He has won several awards, including the Incubator of the Year Award from the Association of University Related Research Parks and a KPMG Illinois High Tech Award.
Gudkov is Chief Scientific Officer. Prior to 1990, he led a broad research program on virology and cancer drug resistance at The National Cancer Research Center in Moscow (USSR). In 1990, he moved to the University of Illinois at Chicago where he became a tenured faculty member in the Department of Molecular Genetics. His lab concentrated on the development of new functional gene discovery methodologies and the identification of candidate cancer treatment targets. In 1999, he defined p53
P53
p53 , is a tumor suppressor protein that in humans is encoded by the TP53 gene. p53 is crucial in multicellular organisms, where it regulates the cell cycle and, thus, functions as a tumor suppressor that is involved in preventing cancer...
as a major determinant of cancer treatment side effects and suggested this protein as a target for therapeutic suppression. In 2001, he moved to the Lerner Research Institute
Lerner Research Institute
Cleveland Clinic Lerner Research Institute is home to all laboratory-based, translational and clinical research at the Clinic.The Institute comprises 11 Departments: Biomedical Engineering, Cancer Biology, Cell Biology, Genomic Medicine Institute, Immunology, Molecular Cardiology, Molecular...
at the Cleveland Clinic as Chairman of the Department of Molecular Biology and Professor of Biochemistry at Case Western Reserve University. In 2007, he accepted the position of Senior VP Basic Science and Chair, Department of Cell Stress Biology at Roswell Park Cancer Institute in Buffalo, NY. Gudkov divides time between work for CBLI and for Roswell Park.
Kogan is Chief Operating Officer. From 2001 to 2003, he was Director for Business Development at Integrated Genomics,Previously, he worked as a Group Leader/Senior Scientist at Integrated Genomics and ThermoGen, Inc. and as Research Associate at the University of Chicago. He holds a Ph.D. degree in Molecular Biology from VNII Genetica, as well as an M.S. degree in Biology from Moscow State University and an MBA from the University of Chicago.