NCC and PeptiDream Begin First Dose of 64Cu-PD-32766 in Clear Cell Renal Carcinoma Patient

KAWASAKI, Japan—The National Cancer Center Hospital East and biopharmaceutical company PeptiDream Inc. have commenced the administration of 64Cu-PD-32766, a radiopharmaceutical developed for clear cell renal cell carcinoma (ccRCC). This marks the first human imaging study involving the 64Cu-labeled compound, aimed at evaluating its safety, pharmacokinetics, and tumor accumulation in patients with ccRCC.

Clinical Study Overview

The clinical research was green-lit by the National Cancer Center Japan’s review board in April 2024. The study investigates the diagnostic and potential therapeutic benefits of 64Cu-PD-32766, particularly for patients newly diagnosed, relapsed, or suspected of relapsing in cases of ccRCC. The principal investigator for this early-phase clinical trial is Dr. Anri Inaki from the National Cancer Center Hospital East. The trial includes six subjects and primarily measures per-patient PET sensitivity, with secondary outcomes assessing per-lesion PET sensitivity, safety, pharmacokinetics, and estimated irradiation dose.

Significance of CAIX Targeting

64Cu-PD-32766 targets Carbonic Anhydrase IX (CAIX), a cell surface antigen abundantly expressed in ccRCC but minimally present in normal tissues. This makes CAIX an optimal target for both diagnosis and therapy. The diagnostic efficacy and radiotherapeutic potential of 64Cu-PD-32766 are being explored to accelerate the development of radiopharmaceuticals. The investigational agent has been developed using PeptiDream's Peptide Discovery Platform System (PDPS) technology, with in vivo imaging and efficacy studies conducted by PDRadiopharma Inc., a subsidiary of PeptiDream.

Potential Impact

The key advantage of this study is the ability to generate early human imaging data, providing an initial assessment of the diagnostic utility of 64Cu-PD-32766 and its potential therapeutic benefits when labeled with a therapeutic isotope. This early-phase data is critical for designing subsequent clinical trials, thus speeding up the clinical development process.

Comments from Key Figure

Dr. Toshihiko Doi, Director of National Cancer Center Hospital East, expressed enthusiasm about the study's initiation, emphasizing its potential to improve healthcare by merging PeptiDream's peptide technology with radionuclide imaging and therapeutic capabilities. Dr. Patrick C. Reid, President and CEO of PeptiDream, echoed this sentiment, highlighting the collaborative effort and the groundbreaking nature of this study. He praised the entire team for their dedication and looked forward to sharing future results.

About Renal Cell Carcinoma

Renal Cell Carcinoma (RCC) is the ninth most common cancer in the United States, representing 2% of global cancer diagnoses and deaths. Clear cell RCC (ccRCC) accounts for approximately 70% of RCC cases. The five-year survival rate for RCC is around 12%, with an estimated 400,000 new cases diagnosed worldwide in 2020.

Conclusion

The initiation of the human imaging study of 64Cu-PD-32766 represents a significant step in the quest to improve diagnostic and therapeutic options for ccRCC. By targeting the CAIX antigen, the study aims to provide valuable insights that could lead to more effective treatments for patients with this challenging condition. The collaboration between the National Cancer Center Hospital East and PeptiDream Inc. showcases a promising approach to advancing cancer care through innovative radiopharmaceuticals.

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