Bionovo
Encyclopedia
Bionovo is an American
biotechnology
company
focused on the discovery and development of botanically derived treatments for women's health and cancer based in Emeryville
, California
. The company currently has two drug candidates in U.S. Food and Drug Administration
(FDA) clinical trials- Menerba (formerly known as MF101) an selective estrogen receptor beta
agonist for hot flashes associated with menopause
and Bezielle (formerly BZL101) for advanced breast cancer
.
(TCM) as its discovery engine, isolating, purifying and testing potent active ingredients from herbs and other botanicals, then formulating them into products which can be packaged as powders or pills for easy use by patients.
The company has identified the active chemical components underpinning the mechanism of action for all of their lead drug candidates, and in some cases, has developed synthetic methods of production
. They are developing their drugs in accordance with the U.S. FDA's botanical drug guidelines.
currently has two drug candidates in clinical trials and several additional candidates positioned to enter clinical trials upon the receipt of funding or partnership.
(ERβ) agonist designed to treat vasomotor symptoms (hot flashes) associated with menopause
.
Although Menerba is a selective estrogen receptor modulator
(SERM), it is distinct from the other FDA-approved SERMs, such as tamoxifen
and raloxifene
, since these drugs have mixed agonist/antagonist activity and are not selective in transcriptional regulation to one of the two known estrogen receptor
subtypes.
Menerba completed its Phase II clinical trial, showing the drug to be safe, clinically efficacious and well tolerated. The drug will begin its Phase III clinical trial pending FDA approval.
. The drug is derived from the herb, Scutellaria Barbata, which is used in traditional Chinese medicine
to treat cancer
. Bezielle is selectively cytotoxic to most of twelve breast cancer cell lines examined as well as to a number of cancer cell lines of different tissue origins such as prostate, lung, colon, ovarian and pancreatic cancers. At the same dose, Bezielle does not induce appreciable cell death in normal cells such as fibroblasts and normal mammary epithelial cells and lines.
Bezielle’s mechanism of action
targets diseased cells while leaving normal cells healthy and intact by inhibiting glycolysis
production. Normal cells depend primarily on the citric acid cycle
(>85%) and very little on glycolysis
(<7%) for energy production. In contrast, cancer cells depend largely on glycolysis
(>85%) for energy production. Bezielle induces strong oxidative stress
in cancer cells leading to severe DNA damage, but in normal cells the effect is blunted due to their different metabolic profile. Cancer cells attempt but ultimately fail to repair DNA damage that results in the inhibition of glycolysis and cancer cell death while normal cells remain unharmed. Bezielle has completed Phase 1A and 1B clinical trials for advanced metastatic breast cancer.
upon receipt of funding.
BN107 and BN108, both designed to treat advanced breast cancer, are slated to begin Phase I/II clinical trials upon funding.
Bezielle is scheduled to begin a Phase I/II clinical trial
for the treatment of pancreatic cancer
upon funding.
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
biotechnology
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
Company
A company is a form of business organization. It is an association or collection of individual real persons and/or other companies, who each provide some form of capital. This group has a common purpose or focus and an aim of gaining profits. This collection, group or association of persons can be...
focused on the discovery and development of botanically derived treatments for women's health and cancer based in Emeryville
Emeryville, California
Emeryville is a small city located in Alameda County, California, in the United States. It is located in a corridor between the cities of Berkeley and Oakland, extending to the shore of San Francisco Bay. Its proximity to San Francisco, the Bay Bridge, the University of California, Berkeley, and...
, California
California
California is a state located on the West Coast of the United States. It is by far the most populous U.S. state, and the third-largest by land area...
. The company currently has two drug candidates in U.S. Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) clinical trials- Menerba (formerly known as MF101) an selective estrogen receptor beta
Estrogen receptor beta
Estrogen receptor beta , also known as NR3A2 , is a nuclear receptor which is activated by the sex hormone estrogen. In humans, ER-β is encoded by the ESR2 gene.- Function :...
agonist for hot flashes associated with menopause
Menopause
Menopause is a term used to describe the permanent cessation of the primary functions of the human ovaries: the ripening and release of ova and the release of hormones that cause both the creation of the uterine lining and the subsequent shedding of the uterine lining...
and Bezielle (formerly BZL101) for advanced breast cancer
Breast cancer
Breast cancer is cancer originating from breast tissue, most commonly from the inner lining of milk ducts or the lobules that supply the ducts with milk. Cancers originating from ducts are known as ductal carcinomas; those originating from lobules are known as lobular carcinomas...
.
Discovery and development platform
Bionovo uses traditional Chinese medicineTraditional Chinese medicine
Traditional Chinese Medicine refers to a broad range of medicine practices sharing common theoretical concepts which have been developed in China and are based on a tradition of more than 2,000 years, including various forms of herbal medicine, acupuncture, massage , exercise , and dietary therapy...
(TCM) as its discovery engine, isolating, purifying and testing potent active ingredients from herbs and other botanicals, then formulating them into products which can be packaged as powders or pills for easy use by patients.
The company has identified the active chemical components underpinning the mechanism of action for all of their lead drug candidates, and in some cases, has developed synthetic methods of production
Methods of Production
Production methods fall into three main categories; however, all production methods can be assisted with CAM and CAD equipment .-Job Production and Prototype Production:...
. They are developing their drugs in accordance with the U.S. FDA's botanical drug guidelines.
Drug pipeline
Bionovo's drug pipelineDrug pipeline
A drug pipeline is the set of compounds that a pharmaceutical company has under development at any given point in time....
currently has two drug candidates in clinical trials and several additional candidates positioned to enter clinical trials upon the receipt of funding or partnership.
Menerba
Bionovo’s lead drug candidate, Menerba (formerly known as MF101), is a novel selective estrogen receptor betaEstrogen receptor beta
Estrogen receptor beta , also known as NR3A2 , is a nuclear receptor which is activated by the sex hormone estrogen. In humans, ER-β is encoded by the ESR2 gene.- Function :...
(ERβ) agonist designed to treat vasomotor symptoms (hot flashes) associated with menopause
Menopause
Menopause is a term used to describe the permanent cessation of the primary functions of the human ovaries: the ripening and release of ova and the release of hormones that cause both the creation of the uterine lining and the subsequent shedding of the uterine lining...
.
Although Menerba is a selective estrogen receptor modulator
Selective estrogen receptor modulator
Selective Estrogen Receptor Modulators are a class of compounds that act on the estrogen receptor. A characteristic that distinguishes these substances from pure receptor agonists and antagonists is that their action is different in various tissues, thereby granting the possibility to selectively...
(SERM), it is distinct from the other FDA-approved SERMs, such as tamoxifen
Tamoxifen
Tamoxifen is an antagonist of the estrogen receptor in breast tissue via its active metabolite, hydroxytamoxifen. In other tissues such as the endometrium, it behaves as an agonist, hence tamoxifen may be characterized as a mixed agonist/antagonist...
and raloxifene
Raloxifene
Raloxifene is an oral selective estrogen receptor modulator that has estrogenic actions on bone and anti-estrogenic actions on the uterus and breast...
, since these drugs have mixed agonist/antagonist activity and are not selective in transcriptional regulation to one of the two known estrogen receptor
Estrogen receptor
Estrogen receptor refers to a group of receptors that are activated by the hormone 17β-estradiol . Two types of estrogen receptor exist: ER, which is a member of the nuclear hormone family of intracellular receptors, and the estrogen G protein-coupled receptor GPR30 , which is a G protein-coupled...
subtypes.
Menerba completed its Phase II clinical trial, showing the drug to be safe, clinically efficacious and well tolerated. The drug will begin its Phase III clinical trial pending FDA approval.
Bezielle
Bezielle (also called BZL101) is an oral drug designed for the treatment of advanced breast cancerBreast cancer
Breast cancer is cancer originating from breast tissue, most commonly from the inner lining of milk ducts or the lobules that supply the ducts with milk. Cancers originating from ducts are known as ductal carcinomas; those originating from lobules are known as lobular carcinomas...
. The drug is derived from the herb, Scutellaria Barbata, which is used in traditional Chinese medicine
Traditional Chinese medicine
Traditional Chinese Medicine refers to a broad range of medicine practices sharing common theoretical concepts which have been developed in China and are based on a tradition of more than 2,000 years, including various forms of herbal medicine, acupuncture, massage , exercise , and dietary therapy...
to treat cancer
Cancer
Cancer , known medically as a malignant neoplasm, is a large group of different diseases, all involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. The cancer may also spread to more distant parts of the...
. Bezielle is selectively cytotoxic to most of twelve breast cancer cell lines examined as well as to a number of cancer cell lines of different tissue origins such as prostate, lung, colon, ovarian and pancreatic cancers. At the same dose, Bezielle does not induce appreciable cell death in normal cells such as fibroblasts and normal mammary epithelial cells and lines.
Bezielle’s 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...
targets diseased cells while leaving normal cells healthy and intact by inhibiting glycolysis
Glycolysis
Glycolysis is the metabolic pathway that converts glucose C6H12O6, into pyruvate, CH3COCOO− + H+...
production. Normal cells depend primarily on the citric acid cycle
Citric acid cycle
The citric acid cycle — also known as the tricarboxylic acid cycle , the Krebs cycle, or the Szent-Györgyi-Krebs cycle — is a series of chemical reactions which is used by all aerobic living organisms to generate energy through the oxidization of acetate derived from carbohydrates, fats and...
(>85%) and very little on glycolysis
Glycolysis
Glycolysis is the metabolic pathway that converts glucose C6H12O6, into pyruvate, CH3COCOO− + H+...
(<7%) for energy production. In contrast, cancer cells depend largely on glycolysis
Glycolysis
Glycolysis is the metabolic pathway that converts glucose C6H12O6, into pyruvate, CH3COCOO− + H+...
(>85%) for energy production. Bezielle induces strong oxidative stress
Oxidative stress
Oxidative stress represents an imbalance between the production and manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage...
in cancer cells leading to severe DNA damage, but in normal cells the effect is blunted due to their different metabolic profile. Cancer cells attempt but ultimately fail to repair DNA damage that results in the inhibition of glycolysis and cancer cell death while normal cells remain unharmed. Bezielle has completed Phase 1A and 1B clinical trials for advanced metastatic breast cancer.
Early stage drug candidates
Seala (also known as VG101) for vaginal atrophy has been approved by the FDA to begin a Phase I/II clinical trialClinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
upon receipt of funding.
BN107 and BN108, both designed to treat advanced breast cancer, are slated to begin Phase I/II clinical trials upon funding.
Bezielle is scheduled to begin a Phase I/II clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
for the treatment of pancreatic cancer
Pancreatic cancer
Pancreatic cancer refers to a malignant neoplasm of the pancreas. The most common type of pancreatic cancer, accounting for 95% of these tumors is adenocarcinoma, which arises within the exocrine component of the pancreas. A minority arises from the islet cells and is classified as a...
upon funding.