The first-in-human Neovia Oncology Phase 1 trial (NCT02797795) assessing the safety and effectiveness of the investigational drug NEV-801 in advanced cancers has enrolled its first patient. NEV-801 is a new multi-inhibitor drug meant to enhance response to immunotherapy by stimulating the expression of target antigens.
“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,” Trevor Blake, co-founder and CEO of Neovia Oncology, said in a news release.
“This is the first program to have advanced through Neovia’s innovative development pipeline that includes more than 60 potential drugs,” he said. “It represents a milestone in the transition of the company from pre-clinical 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.”
Immunotherapy drugs often rely on the expression of target antigens at the surface of cancer cells. If cancer cells don’t present these antigens, immune cells cannot recognize them as foreign and fail to launch an effective immune response against the tumor.
NEV-801 is meant to stimulate the production of antigens that promote immune recognition and response. It is a multi-inhibitor drug that simultaneously inhibits the activity of topoisomerase I and topoisomerase II (enzymes required for DNA replication and gene expression), the expression of HIF-1, and the hypoxic induction of VEGF (involved in blood vessel formation and cancer cell proliferation).
The simultaneous inhibition of several cancer pathways forces distressed tumors to express target antigens that can be effectively recognized by immune cells, suggesting that this drug could potentially enhance the effectiveness of a wide range of immunotherapies.
In preclinical proof-of-concept studies, NEV-801 showed promise in chronic myeloid leukemia mouse models that were resistant to the standard therapy, Glivec (imatinib), and in advanced colon cancer models resistant to multiple therapies, without significant side effects.
The Phase 1 trial, which will enroll up to 78 participants, is an open-label, dose-escalation study designed to assess the safety and efficacy of NEV801 in patients with advanced cancers.
The trial will be conducted in two parts. In part A, patients will be treated with an intravenous infusion of NEV-801 on days 1, 8, 15, and 22 of continuous 28-day cycles until disease progression or unacceptable toxicity. This dose-escalating part will include three patients in each dose cohort.
In part B, the effectiveness of the maximum tolerated dose, determined in part A, will be assessed in patients with selected tumor types.
The study will be conducted by researchers at the Dana Farber Cancer Institute in Boston and at the Sarah Cannon Research Institute in Nashville.
