Neovia Oncology Announces Completion of Phase I(a) Study of NEV-801, a Novel Dual Topoisomerase Drug-Drug Conjugate

Delaware,  June 6, 2026 — Neovia Oncology today announced the successful completion of the Phase I(a) clinical study of NEV-801, the company's lead investigational oncology candidate and a proprietary Drug-Drug Conjugate (DDC) engineered to target Topoisomerase I and Topoisomerase II pathways with a unique mechanism of action.

The Phase I(a) dose-escalation study enrolled 33 patients with advanced solid tumors and evaluated escalating doses of NEV-801 from 20 mg/m² to 600 mg/m². The primary objectives of the study were safety, tolerability, and pharmacokinetic assessment.

Across all dose levels evaluated, NEV-801 demonstrated a favorable safety profile, with no treatment-related Serious Adverse Events (SAEs), no Grade 3 or Grade 4 treatment-related adverse events, and no observed neutropenia, ocular toxicity or interstitial lung disease (ILD). Stable disease and objective tumor responses were observed in multiple patients, including heavily pretreated individuals with advanced malignancies. With 62% stable disease, 56% tumor inhibition and 22% Partial response (>30% tumor size reduction) in higher dose cohorts NEV-801 demonstrated a dose related effect.

"One of the central challenges in oncology is that tumors often adapt to single-mechanism therapies," said Trevor G. Blake, Founder and Chief Executive Officer of Neovia Oncology. "NEV-801 was specifically designed to address that challenge through targeting of two critical topoisomerase pathways involved in tumor cell replication, survival and resistance development. The completion of Phase I(a) provides encouraging evidence that this approach can be delivered with a favorable tolerability profile based on its unique mechanism of action."

Addressing a Long-Standing Challenge in Oncology

Topoisomerase inhibitors remain among the most widely used classes of anti-cancer agents. However, resistance frequently emerges through adaptive biological mechanisms that limit long-term treatment benefit.

NEV-801 was designed to combine proprietary Topoisomerase I and Topoisomerase II inhibitory components within a single molecular construct. Preclinical studies suggest that this dual-targeting approach may influence multiple cellular pathways associated with tumor proliferation, DNA repair, hypoxia signaling, and treatment resistance.

In addition to direct anti-tumor activity, laboratory studies have demonstrated potential synergy with immune checkpoint inhibitors and monoclonal antibody therapies, supporting future exploration of combination treatment strategies.

"Historically, topoisomerase-targeting therapies have relied on single-enzyme inhibition," said Li-Xi Yang, M.D., Ph.D., Chief Scientific Officer and inventor of NEV-801. "NEV-801 was developed around a different hypothesis—that coordinated modulation of both Topoisomerase I and II pathways may provide a more comprehensive approach to disrupting tumor survival mechanisms while maintaining an acceptable safety profile."

Potential Platform Applications

Beyond its development as a stand-alone therapeutic, Neovia believes NEV-801 may have broader applications across the evolving oncology landscape.

Preclinical research has demonstrated activity in multiple tumor models and suggests compatibility with antibody-based treatment strategies. The company is actively evaluating opportunities to leverage the unique properties of NEV-801 in combination regimens and next-generation targeted oncology platforms.

Advancing Toward the Next Stage of Development

The favorable safety and tolerability findings from Phase I(a) support continued clinical advancement of NEV-801 in patients with advanced and treatment-resistant solid tumors.

Neovia Oncology is currently evaluating development pathways and strategic collaborations to accelerate the next phase of clinical investigation.

About NEV-801

NEV-801 is a patented Drug-Drug Conjugate (DDC) that combines proprietary analogs of Topoisomerase I and Topoisomerase II inhibitors within a single molecular entity. The investigational therapy is designed to provide coordinated multi-target engagement through a plasma-stable linker system intended to optimize delivery within the tumor microenvironment.

NEV-801 has completed Phase I(a) clinical evaluation and remains an investigational product. Its safety and efficacy have not been established by the U.S. Food and Drug Administration or any other regulatory authority.