PD-32766 / PeptiDream - LARVOL DELTA

First-in-human phase 0 safety, imaging, pharmacokinetics, and dosimetry study of 64Cu-PD-32766, a carbonic anhydrase IX (CAIX)-targeting peptide, in patients with clear cell renal cell carcinoma (ccRCC). (ASCO-GU 2025) - "64Cu-PD-32766 demonstrated an excellent positivity rate in ccRCC patients with no significant adverse events and tolerated radiation dose to normal organs, proving high diagnostic capability and suggesting future therapeutic uses by labeling with therapeutic radionuclides."

Clinical • P1 data • PK/PD data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • CA9

Carbonic anhydrase IX-targeted small molecule radiopharmaceuticals: A review of their role in clear cell renal cell carcinoma theranostics. (PubMed, Nucl Med Biol) - "[68Ga]Ga-NY104, [99mTc]Tc-PHC-102, [68Ga]Ga-DPI-4452, [18F]F-VM4-037 and [18F]F-U-104 exhibit promising CAIX targeting. Structural optimization of these compounds holds promise for developing CAIX inhibitors with enhanced selectivity and lower toxicity for ccRCC therapy. At the clinical translation level, a series of novel probes represented by [68Ga]Ga-NY104 and [64Cu]Cu-PD-32766 have entered clinical investigation, enabling high-sensitivity and high-specificity detection of both primary and metastatic ccRCC lesions via PET/CT imaging. Moreover, theranostic platforms based on identical molecular scaffolds (e.g., US2 platform, DPI-4452) have laid the foundation for a "see-and-treat" precision medicine paradigm."

Journal • Review • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CA9

A novel carbonic anhydrase IX targeting radiopeptide, 64Cu-PD-32766 and 177Lu-PD-32766, exhibit promising theranostic potential in ccRCC tumors (AACR 2024) - "PD-32766 has preferable properties for imaging and therapy with radionuclides and a great potential for theranostic use in ccRCC."

Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • CA9

Identification and characterization of 64 Cu- and 225 Ac-PD-32766, a Carbonic Anhydrase IX targeting macrocyclic peptide radiotheranostic pair for clear cell renal cell carcinoma (ccRCC) (EANM 2025) - No abstract available

Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • CA9

225Ac-PD-32766, a Carbonic Anhydrase IX-targeted therapeutic radiopeptide, shows robust antitumor effect in colorectal cancer model. (SNMMI 2025) - "225Ac is an excellent therapeutic nuclide for PD-32766, and 225Ac-PD-32766 is a promising therapeutic agent for CRC."

Preclinical • Colorectal Cancer • Oncology • Solid Tumor • CA9 • HIF1A

NorthStar Medical Radioisotopes and PDRadiopharma Announce Research and Development Agreement, Master Isotope Supply Agreement for Ac-225 and Contract Manufacturing and Master Services Agreement (Businesswire) - "NorthStar Medical Radioisotopes, LLC, and PeptiDream Inc...today announced that PeptiDream’s wholly owned subsidiary PDRadiopharma Inc...has entered into a strategic collaboration with NorthStar...Under the terms of the collaboration, NorthStar will: Provide PDRadiopharma with an initial statement of work for R&D services for their lead therapeutic asset 225Ac-CA9 (225Ac-PD-32766); Utilize its new, state-of-the art contract development and manufacturing facility to provide Ac-225 and manufacture patient doses of novel diagnostics and therapies to serve patients in PDRadiopharma clinical trials, and; Perform research and development activities to support continued development of PDRadiopharma portfolio assets."

Licensing / partnership • Oncology