AtomVie Global Radiopharma Announces First Patient Dosage in Innovative Clinical Trial
In a groundbreaking moment in cancer treatment, AtomVie Global Radiopharma has successfully delivered the first patient dose in the Phase 1/2a clinical trial for Radiopharm Theranostics’ innovative radiopharmaceutical, 177Lu-BetaBart (RV-01). This milestone was achieved as the company provided GMP (Good Manufacturing Practice) manufacturing and distribution services for the drug, following the successful development and qualification of radiolabeling processes and analytical methods with a phased approach, which expedited the IND (Investigational New Drug) application.
The Phase 1/2a study is designed to examine the safety, biological distribution, dosimetry, and preliminary anti-tumor activity of 177Lu-BetaBart, while also determining the recommended dose for future studies. This innovative therapeutic agent is a monoclonal antibody conjugated with Lutetium-177, which selectively targets B7-H3, an immune checkpoint molecule that is overexpressed in numerous solid tumor types.
Bruno Paquin, CEO of AtomVie, highlighted that the successful administration of the first patient dose aligns with their commitment to ensuring that high-quality radiopharmaceuticals are produced, released, and delivered promptly so that patients can access groundbreaking therapies without delay. He emphasized that their team's dedication to operational excellence and reliability supports partners from early clinical development through to global supply.
Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics, expressed that administering the first patient dose in their clinical study represents a significant milestone for the company. He acknowledged AtomVie’s expertise in manufacturing and commitment to quality as vital in advancing BetaBart for patients with aggressive and hard-to-treat solid tumors.
BetaBart (RV-01) represents the first radiopharmaceutical developed by Radiopharm Ventures, a joint venture between Radiopharm Theranostics and the MD Anderson Cancer Center at the University of Texas. Preclinical studies have shown that treatment with this radiopharmaceutical can shrink tumors and extend survival in treated animal models.
The Phase 1/2a clinical study (NCT07189871) aims to establish the safety profile, biodistribution, pharmacokinetics, and dosimetry of 177Lu-BetaBart. The trial is targeting to enroll 61 participants with documented histories of histologically confirmed castration-resistant prostate cancer, colorectal cancer, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, ovarian cancer, cervical cancer, endometrial cancer, triple-negative breast cancer, or esophageal squamous cell carcinoma.
Radiopharm Theranostics is a clinical-stage radiotherapeutics company developing a platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in high unmet medical needs. It is listed on the ASX (RAD) and NASDAQ (RADX) and boasts a pipeline of diverse and highly differentiated platform technologies employing peptides, small molecules, and monoclonal antibodies for cancer treatment. Their clinical program includes a Phase 2 and three Phase 1 trials targeting various solid tumor types, including lung, breast, and brain metastases.
For further information, please contact:
Riccardo Canevari, CEO and Managing Director
Phone: +1 862 309 0293
Email: [email protected]
About AtomVie
AtomVie is a leading CDMO for GMP manufacturing and worldwide distribution of clinical and commercial radiopharmaceuticals. They offer a comprehensive range of scientific, technical, regulatory, quality, and logistical services combined with specialized infrastructure for the development of radiopharmaceuticals from early phase clinical studies to commercialization. AtomVie currently supports international clients conducting clinical studies in over 28 countries globally, and is in the process of constructing a new state-of-the-art, purpose-built facility of 72,300 square feet, expected to be operational in the second half of 2026. For more information, visit atomvie.com.
The Phase 1/2a study is designed to examine the safety, biological distribution, dosimetry, and preliminary anti-tumor activity of 177Lu-BetaBart, while also determining the recommended dose for future studies. This innovative therapeutic agent is a monoclonal antibody conjugated with Lutetium-177, which selectively targets B7-H3, an immune checkpoint molecule that is overexpressed in numerous solid tumor types.
Bruno Paquin, CEO of AtomVie, highlighted that the successful administration of the first patient dose aligns with their commitment to ensuring that high-quality radiopharmaceuticals are produced, released, and delivered promptly so that patients can access groundbreaking therapies without delay. He emphasized that their team's dedication to operational excellence and reliability supports partners from early clinical development through to global supply.
Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics, expressed that administering the first patient dose in their clinical study represents a significant milestone for the company. He acknowledged AtomVie’s expertise in manufacturing and commitment to quality as vital in advancing BetaBart for patients with aggressive and hard-to-treat solid tumors.
BetaBart (RV-01) represents the first radiopharmaceutical developed by Radiopharm Ventures, a joint venture between Radiopharm Theranostics and the MD Anderson Cancer Center at the University of Texas. Preclinical studies have shown that treatment with this radiopharmaceutical can shrink tumors and extend survival in treated animal models.
The Phase 1/2a clinical study (NCT07189871) aims to establish the safety profile, biodistribution, pharmacokinetics, and dosimetry of 177Lu-BetaBart. The trial is targeting to enroll 61 participants with documented histories of histologically confirmed castration-resistant prostate cancer, colorectal cancer, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, ovarian cancer, cervical cancer, endometrial cancer, triple-negative breast cancer, or esophageal squamous cell carcinoma.
Radiopharm Theranostics is a clinical-stage radiotherapeutics company developing a platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in high unmet medical needs. It is listed on the ASX (RAD) and NASDAQ (RADX) and boasts a pipeline of diverse and highly differentiated platform technologies employing peptides, small molecules, and monoclonal antibodies for cancer treatment. Their clinical program includes a Phase 2 and three Phase 1 trials targeting various solid tumor types, including lung, breast, and brain metastases.
For further information, please contact:
Riccardo Canevari, CEO and Managing Director
Phone: +1 862 309 0293
Email: [email protected]
About AtomVie
AtomVie is a leading CDMO for GMP manufacturing and worldwide distribution of clinical and commercial radiopharmaceuticals. They offer a comprehensive range of scientific, technical, regulatory, quality, and logistical services combined with specialized infrastructure for the development of radiopharmaceuticals from early phase clinical studies to commercialization. AtomVie currently supports international clients conducting clinical studies in over 28 countries globally, and is in the process of constructing a new state-of-the-art, purpose-built facility of 72,300 square feet, expected to be operational in the second half of 2026. For more information, visit atomvie.com.
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