Neovia Oncology, (Beijing, Taiwan, & Seattle), has begun its first Phase 1 clinical trial for its lead cancer drug NEV-801, a novel, multi-inhibitor drug able to enhance immunotherapy response in patients with advanced drug-resistant cancers.
During its pre-clinical proof-of-concept studies, conducted in China and America, NEV-801 showed exciting potential, including curative effects, to treat Chronic Myeloid Leukemia that had become resistant to the gold-standard therapy (imatinib), as well as advanced colon cancer that had become resistant to multiple therapies.
No bone-marrow toxicity or gastro-intestinal side effects were observed at the highest administered doses in pre-clinical studies.
The initial clinical trial will be run by principal investigators in America at Dana Farber Cancer Institute, Boston; and Sarah Cannon Research Institute, Nashville. Neovia also plans studies in China in the near future.
Immunotherapy rarely controls clinically significant tumors that fail to express target antigens, and thereby fail to elicit an effective immune response. However, there is mounting evidence that tumor antigen production can be precisely stimulated to promote immune recognition and response.
NEV-801 is a conjugated compound made from an alkaloid isolated from the Chinese tree Camptotheca acuminate and podophyllotoxin derived from the roots of the may apple plant that grows in the wild in North America. Combined, it becomes a simultaneous multi-inhibitor of Topoisomerase I and Topoisomerase II activity, HIF-1 transcriptional activation, and hypoxic induction of VEGF mRNA and protein expression, targeting Werner syndrome protein (WRN) (a RecQ helicase), thereby overcoming MDR gene 1-mediated resistance. The simultaneous inhibition of multiple cancer pathways forces distressed tumors to express target antigens, thereby potentially enhancing the efficacy of immunotherapy.
“Patient enrollment marks the formal beginning of a clinical trial and so we are excited to get underway after much preparation and hard work by our team,” said Gerald Su, COO, “This is the first program to have advanced through Neovia’s innovative development pipeline that includes more than 60 potential drugs. It represents a milestone in the transition of Neovia to clinical-stage and validates us to potential investors and partners who can now help us grow and provide more potential therapies to cancer patients.”
Neovia Oncology is developing safe, multi-inhibitor cancer drugs that enhance immune response to overcome drug resistance and seeks partners and investors for growth.