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Neovia develops oncology drugs that may enhance immunotherapy response to overcome drug resistance and has begun a Phase 1 clinical trial designed to evaluate our lead multi-inhibitor, (NEV-801), that has the potential to treat patients with advanced drug-resistant cancers as monotherapy, or in combination with immunotherapy.

Shocking as it seems, overall cancer survival has barely changed over the past decade. Despite the advancement of target and other therapies, the 70 cancer drugs approved in that time gave patients only an average 2.1 more months of life than older drugs, according to a study in J.A.M.A.

And those are the successes. Two-thirds of cancer drugs approved in the past two years have no evidence showing that they extend survival at all. Add to that gloomy picture the debilitating side effects of most current therapies and an average annual cost of $170,000, and it is no surprise the scientific and investor communities have turned attention sharply to immune therapies.

Immune therapies work by stimulating a patient’s natural immune system to combat cancer cells. There are dozens of approaches to immuno-oncology, designed to attack various cancer-related targets and work in concert with existing drugs. Combination therapy is heralded as the best approach, but the problems with current therapies remain the same… limited survival and side effects.

Also problematic is that immune recognition rarely controls advanced tumors. Even the most effective immune response will fail if tumors fail to express target antigens. Antigens are proteins found on the surface of tumor cells. They serve as a signal that the cell has to be destroyed before it proliferates While there are still many obstacles to immune destruction of tumors, tumor antigen recognition is well documented to occur, and this has prompted a search for agents with improved antigen-enhancing properties.

NEV-801 could be able to up-regulate antigen expression in a variety of blood and solid cancers in response to its multi-inhibitor characteristics. Pre-clinical results indicate enhanced antigen expression by tumor cells due to NEV-801 simultaneous multi-inhibition of Topoisomerase I and Topoisomerase II activity and HIF-1 transcriptional activation. Hypoxic induction of VEGF mRNA and protein expression, targeting Werner syndrome protein (WRN) (a RecQ helicase), overcoming multi-drug-resistant gene 1-mediated resistance.

Topoisomerase 1, known for its role in unwinding DNA during transcription, has also recently been demonstrated to play a role in coordinating the innate immune response in diseases characterized by excessive inflammation. (April 29, 2016, issue of Science.)

Additionally in pre-clinical studies NEV-801 had zero myelosuppression or GI side effects at all administered doses and demonstrated a 37.5% cure rate and a tumor growth inhibition of 98% versus current marketed therapies.

NEV-801 began phase I clinical trials in February 2017.