|Headquarters||Emeryville, CA, USA|
|Key people||Isaac Cohen, Founder and CEO, Mary Tagliaferri, Founder, President and CMO|
Bionovo (NASDAQ: BNVI) 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) a selective estrogen receptor beta agonist for hot flashes associated with menopause and Bezielle (formerly BZL101) for advanced breast cancer.
Discovery and development platform
Bionovo uses traditional Chinese medicine (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.
Bionovo's drug pipeline currently has two drug candidates in clinical trials and several additional candidates positioned to enter clinical trials upon the receipt of funding or partnership.
Bionovo’s lead drug candidate, Menerba (formerly known as MF101), is a novel selective estrogen receptor beta (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.
Bezielle (also called BZL101) 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 (>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.
Early stage drug candidates
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- Cvoro, A.; Paruthiyil, S.; Jones, J. O.; Tzagarakis-Foster, C.; Clegg, N. J.; Tatomer, D.; Medina, R. T.; Tagliaferri, M. et al. (2006). "Selective Activation of Estrogen Receptor- Transcriptional Pathways by an Herbal Extract". Endocrinology 148 (2): 538–547. doi:10.1210/en.2006-0803. PMID 17095596.
- Fong S, Shoemaker M, Cadaoas J, et al. (April 2008). "Molecular mechanisms underlying selective cytotoxic activity of BZL101, an extract of Scutellaria barbata, towards breast cancer cells". Cancer Biology & Therapy 7 (4): 577–86. doi:10.4161/cbt.7.4.5535. PMID 18305410.
- Coombs, Amy (May 30, 2008). "FDA lets botanicals grow into a new sector". San Francisco Business Times.
- Grady D, Sawaya GF, Johnson KC, et al. (2009). "MF101, a selective estrogen receptor beta modulator for the treatment of menopausal hot flushes: a phase II clinical trial". Menopause 16 (3): 458–65. doi:10.1097/gme.0b013e31818e64dd. PMID 19182698.
- "Bionovo's MF101 Shows Positive Safety, Tolerability and Efficacy in Phase II Trial". RxTrials Institute Drug Pipeline Alert 5 (110). June 5, 2007.
- "Bionovo Announces Development Plans For Menopausal Hot Flash Drug Candidate, Menerba (MF101), Following FDA Meetings" (Press release). Bionovo. December 4, 2008. Retrieved July 27, 2010.
- Can Ancient Herbs Treat Cancer? Time, 15 October 2007.
- Herba Scutellaria Barbata (Code C2661) National Cancer Institute Thesaurus.
- Rugo H, Shtivelman E, Perez A, et al. (September 2007). "Phase I trial and antitumor effects of BZL101 for patients with advanced breast cancer". Breast Cancer Research and Treatment 105 (1): 17–28. doi:10.1007/s10549-006-9430-6. PMID 17111207.
- Perez, Alejandra T.; Arun, Banu; Tripathy, Debu; Tagliaferri, Mary A.; Shaw, Heather S.; Kimmick, Gretchen G.; Cohen, Isaac; Shtivelman, Emma et al. (2010). "A phase 1B dose escalation trial of Scutellaria barbata (BZL101) for patients with metastatic breast cancer". Breast Cancer Research and Treatment 120 (1): 111. doi:10.1007/s10549-009-0678-5. PMID 20054647.
- Press Release: Bionovo Announces Publication of Positive Results From the Phase 1B Clinical Trial of Bezielle (BZL101) for Metastatic Breast Cancer 24 January 2010.
- VG101 Phase I/II to Treat Vulvar and Vaginal Atrophy in Post-Menopausal Women
- Press Release: "Bionovo to Present Recent Findings of BN107, its Anticancer Agent, at the 31st Annual San Antonio Breast Cancer Symposium" 12 December 2008.
- Press Release: Bionovo Announces 2008 Highlights and Year-End Financial Results 12 March 2009.
- Bionovo's Promising Pipeline Targets Large Potential Markets Seeking Alpha, 18 June 2007.
- Official Bionovo Website