Bionovo was an Americanbiotechnology company focused on the discovery and development of botanically derived treatments for women's health and cancer based in Emeryville, California. The company had two drug candidates in U.S. Food and Drug Administration clinical trials- Menerba a selective estrogen receptor beta agonist for hot flashes associated with menopause and Bezielle for advanced breast cancer. The company has ceased activity and its stock, although still listed, not moved from 0,00 USD since the end of 2012. No statement has been made by the management, nor any indication has been given that the company is still active. The last press statement was about the sell of all the technical equipment and lay off of 90% of the staff. In short words, the company is as good as bankrupted and shut down, although the management never officially admitted it.
Discovery and development platform
Bionovo used traditional Chinese medicine 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. 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.
Bezielle is an oral drug designed for the treatment of advanced breast cancer. 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. 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 and very little on glycolysis for energy production. In contrast, cancer cells depend largely on glycolysis 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.
Early stage drug candidates
Seala for vaginal atrophy was approved by the FDA to begin a Phase I/II clinical trial 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 clinical trial for the treatment of pancreatic cancer upon funding.
