Radiopharm receives positive early cancer treatment feedback from FDA

Radiopharmaceutical products developer Radiopharm Theranostics (ASX: RAD) is celebrating a positive initial meeting with the US Food and Drug Administration (FDA) for its proposed development of radiopharmaceutical products for diagnostic and therapeutic applications.

In what the company is describing as a significant milestone, Radiopharm has successfully undertaken a pre-Investigational New Drug (IND) meeting with the FDA with regards to its for F18-pivalate (RAD 101) application.

RAD 101 is a unique imaging agent made up of F18 radioisotope and pivalate, a small molecule that targets fatty acid synthetase.

Tests undertaken by the Imperial College of London obtained positive data from a Phase IIa imaging trial of RAD 101.

Those trials found that patients with brain metastases showed significant tumour uptake that was consistent with and independent from the tumour of origin, highlighting the potential for the use of pivalate to monitor cerebral metastasis.

Riccardo Canevari, chief executive officer and managing director of Radiopharm Theranostics, said the initial DFA meeting is a significant milestone towards the further development of the company’s IND application for late-stage clinical trials.

The company will now file an IND application to initiate a multi-centre imaging brain metastasis trial during the third quarter of 2023 with the aim of dosing the first patient by year end.

“Pivalate represents a new class of targeted radiopharmaceuticals with RAD 101 data demonstrating very positive performance in brain metastasis,” Mr Canevari said.

“We are engaging with the FDA to expedite clinical development of RAD 101, considering the high unmet medical need in around 300,000 patients that are diagnosed with brain mets in the US every year.”

Australian treatment plans

In late 2022, Radiopham announced a strategic research collaboration with global cancer care provider GenesisCare, to develop novel radiopharmaceuticals for Australians living with complex, hard- to-treat cancers.

Under the partnership the two companies will conduct several world-first Phase 1 clinical trials in Australia, focusing on areas of high-unmet need in oncology.

As part of the collaboration, GenesisCare’s Contract Research Organisation (CRO) and Imaging Research Organisation (IRO), has already been awarded contracts to implement three clinical trials in Australia, involving Radiopharm’s portfolio of radiopharmaceutical nanobodies.

How Radiopharmaceuticals work

The process involves attaching a radioisotope to a targeting agent such as a small molecule or antibody.

Patients are given a very small amount of safe radioactive medication injected into the blood stream.

The agent specifically binds to and delivers a radioactive payload to tumour cells.

The payload can serve either diagnostically (through imaging) or therapeutically or both.

In the case of therapeutic applications it allows the mechanism to be extremely selective to precisely deliver a radioactive payload to the tumour.