NSS-01 is a preclinical topoisomerase I inhibitor with pancreatic and colorectal cancer as co-equal priorities. Development goals span a standalone drug candidate, investigation as a potential replacement for irinotecan or topotecan in selected combinations, and exploration as an alternative topoisomerase I ADC payload.
NSS-01 retained strong anticancer activity in the presence of human serum albumin. In company-reported cell assays, it showed greater antiproliferative potency than irinotecan, topotecan and SN-38 across bladder, breast and ovarian cancer models.
Preclinical candidate. Not approved for human use.
Natural State Science has spent more than five years developing NSS-01. Pancreatic and colorectal cancer are co-equal priorities, with in vivo studies evaluating antitumor activity, including in the presence of human serum albumin (HSA). Five matched colorectal in vivo comparisons examine activity against comparator drugs across different testing conditions. Cell-based research extends to additional solid tumors, including ovarian, bladder and breast cancer, also in the presence of HSA.
In the reported colorectal in vivo studies, NSS-01 showed lower mean tumor growth than the comparator drugs tested, including irinotecan, SN-38 and topotecan, under study-specific doses and administration regimens. The company reports no observed toxicity that limited dosing in the evaluated regimens.
We welcome licensing, acquisition of the NSS-01 program, or co-development with a partner equipped to advance the program. The opportunity includes proprietary synthesis and formulation work.
Both pancreatic treatment groups showed median tumor regression. In separate preclinical studies, four of six primary tumors regressed at day 28 and three of five at day 21.
The company reports no metastatic lesions detected in either NSS-01-treated group during the pancreatic study periods, while untreated controls showed metastatic findings. Assessments included luminescent imaging and necropsy.
Study contextNSS-01 produced lower mean tumor growth than SN-38 or irinotecan in all five matched comparisons. Reported relative reductions ranged from 42% to 65%, across different preclinical models and administration regimens.
Comparative findingsCompany-reported findings. Colorectal comparisons were analyzed separately; percentages describe lower mean growth from baseline, distinct from pancreatic tumor regression.
Human serum albumin is a major protein in human blood. It can influence camptothecin activity through drug binding and the balance between lactone and carboxylate forms. The effects differ among derivatives, and albumin interactions vary across experimental models.
NSS-01 research directly evaluates activity in HSA-containing cell assays and human-albumin-expressing in vivo models. In the company’s 24-hour bladder, breast and ovarian assays with 20 mg/mL HSA, NSS-01 had the lowest mean IC₅₀ among NSS-01, SN-38, topotecan and irinotecan.
Together with the pancreatic and colorectal in vivo findings, this provides a rationale for standalone development and for investigating combination and ADC payload opportunities.
Scientific background: albumin interactions and drug stability; experimental model differences. Comparative assay findings are company-reported; methods and values are available on the Evidence page.
See how NSS-01 was evaluatedPancreatic and colorectal studies, HSA-containing assays, laboratory synthesis, analytical characterization and formulation testing.
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.
Build on existing work to define clinical-supply, drug-exposure, safety and regulatory requirements for the proposed clinical program.
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.
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