Sydney-headquartered radiopharmaceutical product developer Radiopharm Theranostics (ASX: RAD) has received a critical US Food and Drug Administration (US FDA) amendment for the production and distribution of its unique pancreatic cancer marker identifier RAD 301 in New York City, USA.
The New York State Board of Pharmacy has also approved the distribution of Radiopharm’s 68Ga-Trivehexin (RAD 301) treatment across the State.
These approvals will allow Radiopharm to proceed with a phase I study of 68Ga-Trivehexin’s potential to detect lesions in patients with pancreatic ductal adenocarcinoma (PDAC).
Cancer marker targeted
The company has developed Trivehexin as a peptide-based molecule that targets αvβ6-integrin, a cellular marker for tumour invasion and metastatic growth, the appearance of which correlates with decreased survival in several carcinomas.
Radiopharm chief executive officer, Riccardo Canevari, said the αvβ6-integrin receptor is found in high density on most pancreatic carcinoma cells, making it an attractive diagnostic and therapeutic target.
Mr Canevari has confirmed the study will be conducted at the Montefiore Medical Centre, Albert Einstein College of Medicine in New York, with patient screening expected to start next week.
“We are very pleased that we now have the green light to start our Phase 1 imaging trial of RAD 301 in patients with pancreatic cancer, one of the highest areas of unmet medical need,” Mr Canevari said.
“The team at the Montefiore Medical Centre in NYC is excited and fully committed to conducting this very important clinical trial. Radiopharm Theranostics’s team is equally motivated for a successful and fast execution of this phase I study.”
A deadly cancer
Recent data from the Australian Institute of Health and Welfare (AIHW) estimates that more Australians than ever before will be claimed by pancreatic cancer, which for the first time is being acknowledged as a common cancer.
According to the Australian Pancreatic Cancer Society, pancreatic cancer has a devastatingly low five-year survival rate of only 12.5%.
The disease is predicted to claim more lives than breast cancer this year (an estimated 3,669 people) and has the lowest survival rate of all common cancers.
Over 4500 people will be diagnosed with pancreatic cancer this year, and 80% of patients will die within 12 months.
In the 2022-23 budget, the federal government set-aside $20 million to improve outcomes and survival for people with pancreatic cancer.
Approval for lung cancer study
Earlier this month Radiopharm received Human Research Ethics Committee (HREC) approval to commence its first-in-human phase I study in Australia for the company’s therapy for patients with PDL1-positive non-small cell lung cancer (NSCLC).
The key technology in that trial is Radiopharm’s proprietary nanobody from its NanoMab platform, which targets the PDL1 expression in NSCLC, the most common type of lung cancer.
Within Australia, approximately 12,200 patients are diagnosed with lung cancer per year, making it the fifth most common in the country.
Worldwide it was estimated that there are more than 2.2 million cases of lung cancer in 20202, with NSCLC accounting for approximately 85% of all lung cancer cases.