Radiopharm to begin US trials of cancer drug after FDA tick

Radiopharm Theranostics has been given the keys to the United States outpatient clinics to begin imaging trials of patients with pancreatic cancer after receiving the tick of approval from the US Food and Drug Administration for its cancer-seeking peptide.

The USFDA has granted Radiopharm investigational new drug approval which will allow the company to test its patented RAD301 integrin technology in the real world.

Radiopharm has wasted no time following approval in preparing a test site at New York’s Montefiore Einstein Cancer Centre and expects its first patient by March 2023.

US trials are penciled in to continue until September 2023 for Radiopharm’s product which has already returned data from 88 patients elsewhere around the world.

The company’s drug is designed to bind to the specific protein commonly found in cancer which could help with early detection.

Trial principal investigator Dr Lionel Zuckier said "patients with pancreatic cancer have limited therapeutic options, and on top of that face challenges in their initial diagnosis and follow up.”

“The medical community needs improved imaging agents to facilitate optimised patient diagnosis and management.”

Dr Zuckier works at the Montefiore Einstein Cancer Centre in New York where clinical trials will take place and which has been on the cutting edge of drug discovery and development for five decades through early-phase testing such as this.

According to the American Cancer Society some 62,000 people in the US alone will be diagnosed with pancreatic cancer every year, two-thirds of whom will die.

Radiopharm Theranostics Chief Executive Officer Riccardo Canevari said "we’re looking forward to working further with this peptide to prove its ability to deliver high quality imaging results in diagnosing pancreatic cancer.”

RAD301 is among a swag of cancer diagnostic and therapeutic developments in Radiopharm’s arsenal which could prove game-changers in treating many forms of the disease.

In mid-December its breast cancer-diagnosing product RAD201 scored well on test results when no adverse effects were recorded among six patients taking part in the imaging trial.

In June Radiopharm penned a deal with a US biotech firm for an agent which could detect and treat aggressive brain tumours.

The company also launched Australian trials of its potentially lung cancer-busting nanobodies with oncology provider GenesisCare.

A tumour-killing antibody for bone cancer treatment also passed an early approval stage in the US.

Human benefit aside, Radiopharm’s products are seeking to latch on to the US$284bn global oncology market which is expected to grow to US$581bn by 2030 according to Precedence Research.

It is estimated about 10 million people die every year from cancer, the most common of which are lung, breast, bowel and prostate.

With so many irons in the fire and the world hungry for effective cancer diagnosis and treatment products. 2023 is shaping up to be a big year for the Australian biotech firm.

Is your ASX-listed company doing something interesting? Contact: matt.birney@businessnews.com.au