Radiopharm Theranostics Increases Stake in Joint Venture as B7H3-Targeting Radiopharmaceutical Betabart Advances to Phase I Trial
Key Insights
Radiopharm Theranostics has increased its ownership in Radiopharm Ventures (search) from 75% to 87.5%, reflecting confidence in the joint venture's cancer therapeutic pipeline progress.
The lead candidate Betabart (search), a monoclonal antibody targeting B7H3 (search) radiolabeled with 177Lu, received FDA IND clearance and represents the first clinical trial globally targeting B7H3 with a systemic radiopharmaceutical.
The Phase I therapeutic trial for multiple solid tumors is expected to dose its first patient in Q1 2026, with multiple centers already activated.
Radiopharm Theranostics has increased its ownership stake in Radiopharm Ventures (search), LLC from 75% to 87.5%, signaling growing confidence in the joint venture's cancer therapeutic pipeline as its lead B7H3 (search)-targeting radiopharmaceutical prepares to enter human testing. The clinical-stage biopharmaceutical company announced the ownership increase as Betabart (search), the venture's leading monoclonal antibody candidate, advances toward its first-in-human Phase I trial expected to begin dosing patients in Q1 2026.
First-in-Class B7H3 Radiopharmaceutical Approaches Clinical Testing
Betabart (search) represents a significant milestone in radiopharmaceutical development as the first clinical trial globally targeting B7H3 (search) with a systemic radiopharmaceutical. The monoclonal antibody radiolabeled with 177Lu successfully received Investigational New Drug clearance from the U.S. Food and Drug Administration in July 2025. The upcoming Phase I therapeutic trial will evaluate the candidate in multiple solid tumors, with several centers already activated for patient enrollment.
B7H3 (search) serves as a compelling therapeutic target due to its unique expression profile. The immune checkpoint protein is very infrequently seen in healthy cells but is consistently overexpressed in the majority of cancer tissues. High expression of B7H3 in cancer is associated with greater tumor size and lymphatic invasion, making it an attractive target for radiopharmaceutical therapy.
"We are very encouraged by the progress to date within Radiopharm Ventures (search)," said Riccardo Canevari, CEO & Managing Director of Radiopharm. "Now is an exciting time to increase our ownership in the joint venture, as we will soon have first-in-human results of Betabart (search) (RV01) from our dose escalating therapeutic Phase I study. We remain confident in the potential value of this program and its potential to benefit patients battling a multitude of solid tumor cancers."
Expanding Pipeline Shows Promise
Beyond Betabart (search), Radiopharm Ventures (search) has demonstrated progress across its broader pipeline. Two additional preclinical candidates have shown early positive results and have progressed toward final candidate selection, with potential applications across multiple solid tumor types. These candidates are expected to reach final selection in 2026, further expanding the joint venture's therapeutic portfolio.
Strategic Partnership Leverages Complementary Expertise
Radiopharm and The University of Texas MD Anderson Cancer Center launched Radiopharm Ventures (search), LLC in September 2022 to develop novel radiopharmaceutical products for cancer treatment. The joint venture strategically combines MD Anderson's expertise in antigen discovery and molecular imaging with Radiopharm's capabilities in developing targeted radiopharmaceutical therapies.
Radiopharm Theranostics operates as a clinical-stage radiotherapeutics company developing innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. The company maintains a diverse pipeline of platform technologies spanning peptides, small molecules, and monoclonal antibodies for cancer applications. Its current clinical program includes one Phase 2 and four Phase 1 trials across various solid tumor cancers, including lung, breast, and brain metastases.