Pioneering a Novel Class of Investigational Cancer Theraputics
A differentiated investigational DDC platform.
NEV-801 is a Novel Investigational drug-drug conjugate with a newly clarified mechanism of action that may distinguish it from conventional topoisomerase poisons.
The Problem
Many cancer therapies attack aggressively. Fewer change the rules.
For decades, topoisomerase-directed therapies have played an important role in oncology and today are a popular payload of choice for Antibody Drug Conjugates.
But toxicity, resistance, and limited flexibility in combination have constrained what these agents can become.
The next advance is not simply more force.
It’s better design.
The Neovia Approach
Engineered to work differently from the start.
NEV-801 was designed as a novel dual-mechanism conjugate that combines novel analogs related to irinotecan and etoposide in a plasma-stable architecture engineered for controlled release in tumor microenvironments. That design supports extended exposure, tumor delivery, and broader anti-tumor activity.
Additionally, NEV-801 has a Novel mechanism of action to Topo I and Topo II poisons currently in development or used in treatment.
Clinical Reality
In Phase-I dose escalation trial (20-600 mg/SqM) in heavily pretreated and refractory patients (chemo, immuno & radiation therapies) with difficult-to-treat late-stage solid tumors, NEV-801 demonstrated a favorable safety profile with anti-tumor activity in previously drug-resistant cancers. and efficacy
https://www.clinicaltrials.gov/study/NCT02797795
These results are pending publication.
The Breakthrough - Now We Understand Why.
This may be the distinction that changes the entire narrative for Topoisomerase inhibition and ADC structure.
New mechanism insight suggests NEV-801 behaves as a non-poisonous compound rather than a conventional interfacial poisoning agent. That difference matters.
It may position the program not as a refinement of a known cytotoxic class, but as a more differentiated therapeutic approach with broader scientific and strategic relevance for the field.
To learn more about the mechanism of action a non-disclosure agreement is required.
Early human data show the profile every oncology company hopes to see at this stage.
• Across 33 patients in Phase I(a) dose escalation, NEV-801 demonstrated a notably clean tolerability profile, with no serious adverse events, no Grade 3/4 adverse events, no neutropenia, no GI disturbance associated with the parent compounds, and no ocular toxicity reported.
• Early efficacy signals included stable disease across cohorts of 62% tumor inhibition at higher doses of 56% and 22% partial responses.
• Additionally, NEV-801 showed efficacy in patients who previously failed on the parent compound and mAbs.
This opportunity extends beyond a single development path.
NEV-801 has shown potential as a biomarker-agnostic solid tumor therapy, a combination-enabled program, and a possible foundation for future ADC payload development.
This creates multiple strategic paths from a single core innovation.
A different mechanism deserves different attention.
Neovia Oncology is advancing NEV-801 toward the next phase of development and strategic partnership. Neovia is ready for further studies with aligned companion diagnostics, manufacturing, and ADC developments.
Detailed preclinical and clinical data are also available under confidentiality.
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*This website contains forward-looking statements regarding investigational product candidates, clinical development plans, regulatory pathways, and potential therapeutic applications. Actual results may differ materially due to risks and uncertainties inherent in drug development.