About ABV-1501 for Breast Cancer (TNBC)
Product Overview
Breast cancer is the most frequent cancer among women (23% of all new cancer cases) and the second-leading cause of deaths in women worldwide. About 20% of diagnosed breast cancers have the phenotype of triple negative breast cancer (TNBC),
ABV-1501 is a polysaccharide extract from Grifola frondosa Maitake mushroom and exhibits immune-modulation effects in peripheral blood in its Phase I/II clinical trial conducted at Memorial Sloan Kettering Cancer Center (MSKCC) in breast cancer patients. ABV-1501 Phase II IND for combination therapy targeted at Triple Negative Breast Cancer (“TNBC”) was approved by UD FDA in 2016. We are currently working for filing the clinical trial application to the Taiwan FDA (“TFDA”) for conducting this Phase II trial in Taiwan.
INDICATED USE
- Triple Negative Breast Cancer (TNBC)
DEVELOPMENT PARTNERS
- TBD
DEVELOPMENT STATUS
- Filing the clinical trial application to the Taiwan FDA (“TFDA”) for conducting this Phase II trial is in progress.
- 2016 US FDA IND Approval
PATENT STATUS
- Patent Granted in the United States, Great Britain, Japan, Germany, France, Italy, China, and Taiwan
TOXICOLOGY
- No dose-limiting toxicity encountered
CLINICAL TRIAL
- Phase II study to be initiated in Q1 2021
SAFETY
- ABV-1501 has been used for more than 10 years as functional food
MOUSE STUDIES
- Cancer-cell implanted mice treated with chemotherapy demonstrated enhancement of anti-tumor activity and reduction of chemotherapy-induced side effects
HUMAN STUDIES
- Non-randomized human studies demonstrated amelioration of chemotherapeutic side effects
TNBC ABV-1501 Development Timeline
DISCLAIMER: Clinical trials may be in early stages. There is no guarantee that any specific outcome will be achieved. Investments may be speculative, illiquid and there is a risk of loss. Past performance is not indicative of future results.