# Improved Treatment of Colorectal Cancer with CF10

> **NIH NIH R42** · DEEP CREEK PHARMA, LLC · 2024 · $1,018,545

## Abstract

PROJECT SUMMARY
Decades of modulating the anti-cancer activity of fluoropyrimidine drugs (FPs) thru schedule optimization,
biochemical modulation, and drug combinations have provided a significant, but limited, survival advantage for
treating colorectal cancer (CRC) patients with locally advanced or metastatic disease (mCRC). However,
outcomes remain poor for patients with mCRC and since targeted therapies and immunotherapies provide only
a limited benefit to a sub-set of CRC patients, new approaches are urgently needed. Deep Creek Pharma
together academic partner Wake Forest School of Medicine (WFSM) is developing CF10, the first DNA-based
FP polymer, as an improved treatment for CRC. In pre-clinical studies through Phase 1 STTR support, we have
demonstrated that CF10 is much more potent than 5-FU to CRC cells and demonstrated improved survival
relative to 5-FU in multiple colon tumor models in rodents. Further, CF10 displayed reduced systemic toxicities
relative to 5-FU making it a strong candidate for clinical development. We have also established CF10 displays
distinct pharmacological and mechanistic properties relative to conventional FP drugs. Based on these findings,
DeepCreek Pharma and WFSM/Gmeiner Lab propose to jointly investigate CF10 as a candidate for clinical
development.
A major unmet need is treatment of mCRC that is refractory to FOLFOX (5-FU, Leucovorin (LV), oxaliplatin), and
other front-line therapies for mCRC. The proposed research in phase II will therefore focus on (Aim 1) Developing
CF10 lipid nanoparticles (LNPs) and testing for improved activity, including in a therapy-resistant CRC liver
metastasis model. LNP formulation has proven to be a robust delivery strategy for multiple nucleic acid drugs,
and identifying a preferred LNP formulation will promote CF10 clinical development. In Aim 2 of the Phase II
studies we will perform safety pharmacology studies of CF10 and CF10:LNPs in rodents while in Aim 3 we will
evaluate pharmacokinetics (PK) and biodistribution in non-human primates (NHPs). Studies in NHPs accurately
reflect human physiology and metabolism and are particularly important for regulatory apprval. Collectively, our
Phase II STTR studies will provide critical data for to advance CF10 into clinical trials and ultimately its
commercialization.

## Key facts

- **NIH application ID:** 10835053
- **Project number:** 5R42CA254834-03
- **Recipient organization:** DEEP CREEK PHARMA, LLC
- **Principal Investigator:** William H. Gmeiner
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,018,545
- **Award type:** 5
- **Project period:** 2023-05-01 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10835053

## Citation

> US National Institutes of Health, RePORTER application 10835053, Improved Treatment of Colorectal Cancer with CF10 (5R42CA254834-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10835053. Licensed CC0.

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