Tumor regression
evaluated in vivo.
Both treated groups showed median tumor-volume regression in the company’s pancreatic research.
Review pancreatic findingsTwo cancer priorities.
One NSS-01 program.
NSS-01 is a preclinical small-molecule topoisomerase I inhibitor with pancreatic and colorectal cancer as co-equal development priorities. We seek to advance the unconjugated candidate as a standalone drug and evaluate its potential to replace irinotecan or topotecan in selected combination regimens and serve as an ADC payload.
PROGRAM AT A GLANCEOne lead candidate.
One lead candidate.
Two cancer priorities.
Pancreatic tumor-regression studies and comparative colorectal research form the program’s two core areas of in vivo evidence. Research in additional tumor types supports decisions about future development.
- Candidate
- Unconjugated NSS-01
- Mechanism
- Topoisomerase I inhibition
- Development stage
- Preclinical
- Primary development priorities
- Pancreatic and colorectal cancer
- In vivo research
- Pancreatic and colorectal models
- Additional in vitro research
- Ovarian, bladder, breast and glioblastoma
Tumor regression
Comparative activity
across five comparisons.
NSS-01 showed 42–65% lower mean tumor growth than SN-38 or irinotecan across five matched colorectal comparisons.
Review colorectal findingsDEVELOPMENT OPPORTUNITIESOne molecule.
One molecule.
Three development paths.
Pancreatic and colorectal cancer are co-equal priorities for NSS-01. Research in the presence of human serum albumin (HSA) is central to the program’s scientific rationale. The opportunity spans development of the drug itself, its potential role within combination regimens and its evaluation as a topoisomerase I ADC payload.
Standalone drug candidate
Advance unconjugated NSS-01 as a single-agent oncology candidate and evaluate its potential as an alternative to irinotecan or topotecan. Pancreatic and colorectal preclinical findings provide the research foundation.
Potential combination replacement
Evaluate whether NSS-01 could replace the camptothecin-derived component of selected combination regimens, including approaches that use irinotecan or topotecan.
Alternative ADC payload
Evaluate NSS-01 as an alternative topoisomerase I payload for ADC programs that use this drug class, with suitability assessed for each antibody–linker–payload design.
The efficacy findings presented here concern unconjugated NSS-01.
SYNTHESIS & FORMULATIONThe program extends
The program extends
beyond the efficacy studies.
Proprietary synthesis
The company has developed NSS-01 synthesis with analytical controls for product composition. The synthesis process forms part of the proposed transaction.
Formulation development
The company reports nanocrystal formulation work and a colloidal nanoparticle delivery system.
Exploratory conjugated forms
Targeted-delivery research remains exploratory. The efficacy evidence presented on this site concerns unconjugated NSS-01.
DEVELOPMENT PROGRESSEstablished work.
01 02 03 04
Established work.
A clear next stage.
NSS-01 has an existing foundation in preclinical efficacy, laboratory synthesis, analytical characterization, formulation and dosing evaluation. The next stage builds on this work toward clinical development.
WORK ALREADY PERFORMED
Synthesis & analytical development
Laboratory synthesis, purification and analytical characterization have been performed, including HPLC monitoring, microwave process optimization and preparative scale-up.
Formulation & delivery research
Company-reported work includes physicochemical and solubility studies, nanocrystal formulation, colloidal delivery and liposomal formulation testing.
Preclinical dosing strategies evaluated
NSS-01 has demonstrated antitumor activity across several preclinical dosing regimens, including divided-dose schedules and exploratory oral administration. The company reports no observed toxicity that limited dosing in the evaluated regimens.
This work provides a foundation for further dose selection and development planning.
NEXT-STAGE PRIORITIES
Clinical supply & CMC advancement
Build on existing synthesis and analytical work to define process transfer, clinical supply and quality controls for the proposed clinical program.
Drug exposure & PK/PD
Assess the exposure-response package needed to connect existing activity and tolerability findings to dose selection.
Regulatory safety package
Assess the existing safety package and address the requirements of the proposed clinical route, schedule and patient population.
Regulatory & clinical strategy
Align indication-specific clinical plans for pancreatic and colorectal cancer with phase-appropriate regulatory requirements.
Next-stage scope will be defined with a development partner against the requirements of the proposed clinical program.
INTELLECTUAL PROPERTYA published
A published
PCT application.
The published application addresses therapeutic use, synthesis and formulation.
- Application
- PCT/US2025/042138
- Publication
- WO2026039718A1
- Published
- February 19, 2026
The company overview describes the application as pending.
View the published applicationTHE NEXT CHAPTERAdvance the program.
Advance the program.
Start the conversation.
We welcome licensing, acquisition of the NSS-01 program, or co-development with a pharmaceutical or biotechnology partner to advance NSS-01 toward clinical development.
Explore transaction options