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NEV-801 is a clinical stage combination drug for conquering advanced cancers. It is a novel, multi-target inhibitor with low toxicity and high efficacy for effectively overcoming the problem of multi-drug resistant solid cancers and potentiating targeted therapy and immunotherapy.  The results of Phase I clinical trials have proved its superior anticancer activity against a variety of late-staged resistant multi-drug tumor types.  Its wide spectrum of molecular targets and pathways would include topoisomerase I & II, HIF-1alpha, the PI3K/AKT signaling pathway, and NF-kB/AMPK/mTOR/ULK1 axis, apoptotic pathway and autophagy.  Its highly synergistic effects when combined with immunotherapy would be related to its antigen up-regulation and immunogenic cell death.

 

In pre-clinical studies, NEV-801 demonstrated very strong monotherapy activity, inducing 37.5% complete regressions in imatinib-resistant tumor model CML562 xenograft bearing mice, and 98% tumor growth inhibition in human colon cancer xenograft bearing mice as well as 100% complete response in ovarian TC1 mice model when used in combination with PD-1 and CTLA-4.  NEV-801 was well-tolerated in non-human primate (NHP) toxicology studies and maximum tolerated dose (MTD) was not able to be obtained at very high doses, indicating that its MTD is many times higher than that of irinotecan, topotecan, etoposide, paclitaxel, docetaxel or imatinib or others.

 

In a phase I(a) study of 33 patients with late-stage drug-resistant cancers, NEV-801 demonstrated 62% stable disease across all doses and 20%partial response (>30% tumor reduction) with a long duration at doses above 320mg/m2. NEV 801 is proving markedly effective against drug-resistant adenocarcinomas heavily pre-treated with paclitaxel, cisplatin/carboplatin, irinotecan/topotecan, etoposide, camecitabine, regorafenib, fluorouracil, trifluridine-Tiparicil, Bevacizumab, Panitumumab, as well as other target drugs.  Compared to the Phase I efficacy results of many known clinically used standard drugs, NEV-801 efficacy is greater.  Furthermore, the dose of NEV-801 was escalated from 20mg/m2 to 600mg/m2 with zero serious adverse events associated with drug and an absence of toxicities associated with standard chemotherapy, targeted therapy and immunotherapy.

The distinct mechanism of drug action and non-overlapping toxicity profile offers the potential to combine NEV-801 with other therapies for enhanced benefit/risk. The antigen up-regulation created by delivering such large payloads to the tumor could enhance immunotherapy and targeted treatments.