Bionovo (NASDAQ: BNVI.OB) was an American

biotechnology Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used ...

company focused on the discovery and development of botanically derived treatments for women's health and cancer based in Emeryville,

California California is a state in the Western United States, located along the Pacific Coast. With nearly 39.2million residents across a total area of approximately , it is the most populous U.S. state and the 3rd largest by area. It is also the m ...

. The company had multiple drug candidates in U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA) clinical trials-

Menerba Menerba, also known as Menopause Formula 101 (MF-101), is a botanical drug candidate that acts as a selective estrogen receptor modulator (SERM) which is being studied for its potential to relieve hot flashes associated with menopause. Menerba, an ...

(formerly known as MF101) a selective

estrogen receptor beta Estrogen receptor beta (ERβ) also known as NR3A2 (nuclear receptor subfamily 3, group A, member 2) is one of two main types of estrogen receptor—a nuclear receptor which is activated by the sex hormone estrogen. In humans ERβ is encoded by ...

agonist for

hot flashes Hot flashes (also known as hot flushes) are a form of flushing, often caused by the changing hormone levels that are characteristic of menopause. They are typically experienced as a feeling of intense heat with sweating and rapid heartbeat, and ...

associated with

menopause Menopause, also known as the climacteric, is the time in women's lives when menstrual periods stop permanently, and they are no longer able to bear children. Menopause usually occurs between the age of 47 and 54. Medical professionals often ...

Seala (formerly VG101) a selective estrogen receptor beta agonist for menopausal vaginal dryness and Bezielle (formerly BZL101) for advanced

breast cancer Breast cancer is cancer that develops from breast tissue. Signs of breast cancer may include a lump in the breast, a change in breast shape, dimpling of the skin, milk rejection, fluid coming from the nipple, a newly inverted nipple, or a r ...

. The company has ceased activity after filing for Chapter 7 bankruptcy protection in California. Bionovo's stock is no longer listed.

Discovery and development platform

Bionovo used

traditional Chinese medicine Traditional Chinese medicine (TCM) is an alternative medical practice drawn from traditional medicine in China. It has been described as "fraught with pseudoscience", with the majority of its treatments having no logical mechanism of acti ...

(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 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 Production methods fall into three main categories: job (one-off production), batch (multiple items, one step at a time for all items), and flow Job production Job production is used when a product is produced with the labor of one or few work ...

. They are developing their drugs in accordance with the U.S. FDA's botanical drug guidelines.

Drug pipeline

Bionovo's drug pipeline had 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

(ERβ) agonist designed to treat vasomotor symptoms (

) associated with

. Although Menerba is a selective estrogen receptor modulator (SERM), it is distinct from the other FDA-approved SERMs, such as

tamoxifen Tamoxifen, sold under the brand name Nolvadex among others, is a selective estrogen receptor modulator used to prevent breast cancer in women and treat breast cancer in women and men. It is also being studied for other types of cancer. It has b ...

and

raloxifene Raloxifene, sold under the brand name Evista among others, is a medication used to prevent and treat osteoporosis in postmenopausal women and those on glucocorticoids. For osteoporosis it is less preferred than bisphosphonates. It is also used to ...

, since these drugs have mixed agonist/antagonist activity and are not selective in transcriptional regulation to one of the two known

estrogen receptor Estrogen receptors (ERs) are a group of proteins found inside cells. They are receptors that are activated by the hormone estrogen (17β-estradiol). Two classes of ER exist: nuclear estrogen receptors ( ERα and ERβ), which are members of the ...

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

. The drug is derived from the herb, Scutellaria Barbata, which is used in

to treat

cancer Cancer is a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body. These contrast with benign tumors, which do not spread. Possible signs and symptoms include a lump, abnormal b ...

. 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. Bezielle’s

mechanism of action In pharmacology, the term mechanism of action (MOA) refers to the specific biochemical interaction through which a drug substance produces its pharmacological effect. A mechanism of action usually includes mention of the specific molecular targ ...

targets diseased cells while leaving normal cells healthy and intact by inhibiting glycolysis production. Normal cells depend primarily on the

citric acid cycle The citric acid cycle (CAC)—also known as the Krebs cycle or the TCA cycle (tricarboxylic acid cycle)—is a series of chemical reactions to release stored energy through the oxidation of acetyl-CoA derived from carbohydrates, fats, and protein ...

(>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 Oxidative stress reflects an imbalance between the systemic manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage. Disturbances in the normal ...

in cancer cells leading to severe

DNA damage DNA repair is a collection of processes by which a cell identifies and corrects damage to the DNA molecules that encode its genome. In human cells, both normal metabolic activities and environmental factors such as radiation can cause DNA d ...

, 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 was approved by the FDA to begin a Phase I/II

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, diet ...

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 was scheduled to begin a Phase I/II

for the treatment of pancreatic cancer upon funding.

References

External links

* {{official, http://www.bionovo.com Menopause Cancer organizations based in the United States Companies based in Emeryville, California