FDA Clears PharmaResearch IND for Nano-Based Cancer Drug PRD-101

FDA’s clearance of South Korea-based PharmaResearch’s investigational new drug (IND) application for its anticancer drug candidate, PRD-101, allows the company to initiate a Phase I clinical trial to conduct a first-in-human evaluation of the nano-formulated candidate. PRD-101 was developed using the company’s proprietary DNA optimizing technology (DOT). The Phase I study will evaluate the therapy in patients with advanced solid tumors, the company announced on Feb. 6, 2026 (1).

“The FDA clearance of our IND application marks an important milestone for PRD-101. Through this Phase I trial, we aim to further characterize PRD-101 and continue advancing our oncology pipeline,” the company stated in a press release (1).

What Is PRD-101 and how does the DOT platform differentiate it?

The company formulated PRD-101 using nucleotide fragments generated through DOT, which is designed to optimize DNA-derived components for therapeutic use. The candidate uses the company’s advanced DOT nanoparticle delivery system, which is intended to improve drug loading efficiency and pharmacokinetic behavior compared with conventional anticancer formulations. The platform approach reflects broader industry efforts to address toxicity and delivery limitations that have constrained the clinical utility of many oncology drugs.

How will the Phase 1 trial evaluate this candidate in advanced solid tumors?

The Phase I study will be conducted at up to seven clinical sites in the United States and is expected to enroll approximately 90 patients with locally advanced or metastatic solid tumors. The trial is designed to assess safety, tolerability, and pharmacokinetics, consistent with early-stage evaluation of novel nanoparticle-based oncology agents. Data from the study are expected to inform dose selection and future clinical development, according to the company (1).

Nano-enabled drug delivery has emerged as a strategic focus in oncology, with the goal of improving therapeutic index by enhancing tumor exposure while reducing systemic toxicity. Traditional anticancer agents often require dose limitations due to adverse effects, restricting eligibility and long-term use (2).

Why could nano-based drug delivery address limitations of conventional cancer therapies?

PharmaResearch anticipates that PRD-101 may help address these challenges by modifying how therapeutic payloads are delivered and distributed in the body. Development of PRD-101 has been supported by collaborative research with investigators at the University of California, Irvine, alongside contributions from organizations such as US National Cancer Institute–affiliated programs like the Nanotechnology Characterization Laboratory.

PharmaResearch holds patents and exclusive licenses related to PRD-101, positioning the candidate as a proprietary asset within its oncology pipeline. According to the company, the IND clearance represents a key step toward validating its DOT platform in a regulated clinical setting (1). While the current study focuses on safety and pharmacokinetics, the broader objective is to establish a foundation for nucleotide-based nanoparticle therapeutics in oncology, an area where delivery innovation remains a critical unmet need (3).

The company aims to pursue PRD-101 as part of a broader strategy to expand its biopharmaceutical portfolio beyond its established regenerative medicine and biomaterial platforms. The company has built core technologies around DOT-derived components, including polydeoxyribonucleotide and polynucleotide formulations.

As the PRD-101 Phase I trial progresses, results are expected to contribute to the growing body of evidence around nano-enabled drug delivery in cancer, informing whether nucleotide-based nanoparticles can meaningfully improve tolerability and expand treatment options for patients with advanced disease (4).

References

1. PharmaResearch. PharmaResearch Receives U.S. FDA Clearance to Initiate Phase 1 Clinical Trial of Nano Anticancer Drug, PRD-101. Press Release. Feb. 6, 2026.
2. Yao, Y.; Zhou, Y.; Liu, L.; et al. Nanoparticle-Based Drug Delivery in Cancer Therapy and Its Role in Overcoming Drug Resistance. Front. Mol. Biosci. 2020, 7, 193. DOI: 10.3389/fmolb.2020.00193
3. Gonzalez, J. C.; Park, K. W.; Evans, D. B.; et al. Nano Approaches to Nucleic Acid Delivery: Barriers, Solutions, and Current Landscape. Wiley Interdiscip. Rev.:Nanomed. Nanobiotechnol. 2025, 17 (2), e70010. DOI: 10.1002/wnan.70010
4. Vaughan, H. J.; Green, J. J.; Tzeng, S. Y. Cancer-Targeting Nanoparticles for Combinatorial Nucleic Acid Delivery. Adv. Mater. 2020, 32 (13), e1901081. DOI: 10.1002/adma.201901081