68Ga-RAD 301 (68Ga-Trivehexin) Demonstrates Strong Potential for Imaging of αvβ6-Integrin Expression in Pancreatic Cancer Patients

Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce that a clinical study featuring 68Ga-Trivehexin (68Ga-RAD 301), conducted by Dr. Rehm and colleagues from the Technische Universität Dresden, has now been published in Frontiers in Nuclear Medicine.

• Clinical study of 44 patients published in ‘Frontiers in Nuclear Medicine’ by Dr Jana Rehm and colleagues demonstrated that Ga68-labelled RAD 301 is a safe and suitable agent for imaging in pancreatic cancer.
  
• Results indicate that the primary tumor and metastases were well-visualized with a high tumor-to-background ratio.
• A Phase I imaging trial (NCT05799274) with 68Ga-RAD 301 in pancreatic cancer patients to assess the safety and imaging characteristics of RAD 301 is currently ongoing.

The paper, entitled “αvβ6-integrin targeted PET/CT imaging in pancreatic cancer patients using 68Ga-Trivehexin”¹, describes the clinical results of a retrospective study of the biokinetics of 68Ga- RAD 301 in pancreatic cancer patients. This 44-patient study is reported as the largest cohort of individuals imaged with RAD 301 with any tracer.

The primary tumor, as well as metastases in the liver, lymph nodes, peritoneum, lung, bone, spleen, pleural cavity, and soft tissues, were visualized with a high tumor-to-background ratio. With no adverse events recorded, the findings indicate that RAD 301 is a suitable and safe diagnostic agent for imaging αvβ6-integrin expression in pancreatic cancer.

RAD 301 is a peptide that targets αvβ6-integrin, a cellular marker for tumor invasion and metastatic growth, the expression of which correlates with decreased survival in several carcinomas, particularly pancreatic. The αvβ6-integrin receptor is found in high density on most pancreatic carcinoma and head and neck squamous carcinoma cells, making it an attractive potential diagnostic and therapeutic target in Pancreatic Ductal Adenocarcinoma (PDAC) and Head-and-Neck Squamous Cell Carcinoma².

A Phase I imaging trial (NCT05799274) with 68Ga-RAD 301 in PDAC patients is currently being conducted at the Montefiore Medical Center, Albert Eistein College of Medicine, NY, USA. The study will assess the safety, radiation dosimetry and imaging characteristics of RAD 301 in patients with advanced PDAC³. In May 2023, the FDA granted Radiopharm with an Orphan Drug Designation (ODD) for RAD 301 in pancreatic cancer.

“Current imaging standards of care for the detection of PDAC have significant limitations, making this one of the highest areas of unmet medical need and posing a major challenge for healthcare providers in imaging PDAC patients,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “These findings reinforce the clinical potential of RAD 301 as an imaging agent for the more sensitive and selective detection of pancreatic cancer and its metastases, ultimately advancing PDAC patient management.”

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