# Clinical Translation of Interstitial Chemophototherapy with Light-Activated Nanoparticulate Doxorubicin

> **NIH NIH SB1** · POP BIOTECHNOLOGIES, INC · 2024 · $249,873

## Abstract

Summary
POP BIO’s goal is to commercialize interstitial chemo-phototherapy (I-CPT) as a new therapeutic option for
locally advanced liver cancers. Doxorubicin (Dox) can be actively loaded into long circulating, serum-stable,
porphyrin- phospholipid (PoP) liposomes and be released with 665-nm laser light (PhotoDox). This approach
leads to vastly enhanced drug accumulation in irradiated tissues, resulting in ultrapotent tumor ablation. In the
phase I STTR, we employed this dosimetry-treatment planning platform to guide light administration of I-CPT
with PhotoDox. We demonstrated that this treatment planning with light dosimetry is effective in ablating large
orthotopic hepatocellular carcinoma tumors in rats. The phase II STTR focuses on optimizing treatment planning
with light dosimetry using larger (~50cm3) tumors in woodchucks as well as developing a GLP toxicology package
as part of an FDA IND submission based on our pre-IND meeting. POP BIO has previously generated non-GLP
toxicity data of PhotoDox in rats including cursory establishment of the maximum tolerated dose. In 2019, POP
BIO held a pre-IND meeting with the FDA, who confirmed the suitability of the 505(b)(2) route for components of
PhotoDox and provided guidance about the required toxicological studies required prior to first-in-human studies.
The toxicology program will also generate sera samples in two animal models that need to be analyzed by LC/MS
(the request of this application). In this Commercial Readiness Program application we propose to further
advance I-CPT with PhotoDox towards an IND for enabling future clinical studies by assessing the
pharmacokinetics of Dox, doxorubicinol (Dox-ol), the major metabolite of Dox, and PPa-lipid, the photoactive
excipient of PhotoDox, as well as the stability of PhotoDox under accelerated storage conditions. These tasks
are required by the FDA as part of our IND package. The sera samples to assess pharmacokinetics have been
generated as part of the parent Phase II STTR award’s GLP toxicology program. Under GLP conditions using
LC/MS, the sera concentration of free Dox, liposome entrapped Dox, Dox-ol, and PPa-lipid will be measured.
Subsequent pharmacokinetic analysis, as part of this application, will be performed by Roswell Park’s
Bioanalytics, Metabolomics & Pharmacokinetics (BMPK) Shared Resource. The result of this application will be
the generation of data directly used in POP BIO’s IND package generation. If successful, I-CPT with PhotoDox
stands to benefit the majority of new liver cancer patients, who have inoperable and problematic primary tumors.

## Key facts

- **NIH application ID:** 10830696
- **Project number:** 1SB1CA288098-01
- **Recipient organization:** POP BIOTECHNOLOGIES, INC
- **Principal Investigator:** Hilliard Kutscher
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $249,873
- **Award type:** 1
- **Project period:** 2024-04-01 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10830696

## Citation

> US National Institutes of Health, RePORTER application 10830696, Clinical Translation of Interstitial Chemophototherapy with Light-Activated Nanoparticulate Doxorubicin (1SB1CA288098-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10830696. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*