Radiopharm Theranostics expands pioneering lung cancer treatment study to Perth

Radiopharm Theranostics (ASX: RAD) has expanded its phase 1 study into a novel radiotherapeutic treatment for non-small-cell lung cancer (NSCLC).

A new location in Perth, Western Australia has been added for a first‐in‐human phase I study focusing on a treatment for programmed death ligand 1 (PD‐L1)‐positive NSCLC.

Radiopharm was granted approval in October 2023 to commence the RAD204 treatment trial and it officially opened at Princess Alexandra hospital in Brisbane on 4 January with the support of leading oncology care provider GenesisCare.

Involving 21 patients with metastatic NSCLC, the trial is a dose-escalation study designed to evaluate the safety and efficacy of an antibody targeting PD-L1.

Radiopharm’s proprietary nanobody from its NanoMabs platform, which targets PD‐L1‐positive expression in NSCLC, is underpinning the trial.

The addition of Hollywood Private hospital to the multi-centre trial is expected to accelerate patient recruitment.

Results from the trial are anticipated in early 2025.

Pancreatic cancer trial

Radiopharm recently received approval from the US Food and Drug Administration for an amended investigational new drug application to allow for a phase 1 clinical trial of 68Ga‐Trivehexin (RAD301) in New York City.

This study has been designed to evaluate the efficacy of 68Ga‐Trivehexin in detecting lesions in patients with pancreatic ductal adenocarcinoma.

Trivehexin, a peptide‐based molecule, targets αvβ6‐integrin, a cellular marker associated with tumor invasion and metastatic growth and its expression correlates with decreased survival in several carcinomas.

Radiopharm has identified the αvβ6‐integrin receptor as being largely present in most pancreatic carcinoma cells, making it a promising diagnostic and therapeutic target.

The company says this trial represents a significant step forward in addressing the high unmet medical need in pancreatic cancer treatment.

Prior to this trial, 99 patients had already received Trivehexin under compassionate use or investigator‐initiated trials, laying the groundwork for this phase 1 study.

Healthy cash position

Radiopharm is well-funded to continue its trial work and its bank balance was boosted in the December quarter when it received a total of $4,851,839 under the Australian Government’s research and development (R&D) tax incentive program.

The refund acknowledged the company’s R&D activities conducted during FY2023 and will contribute essential funding for the ongoing development of its portfolio of radiopharmaceutical products.

The company also added a further approximately $2.1 million during the quarter via a non‐renounceable entitlement offer.

Subsequent to the reporting period, the company received approximately $1.7m from the shortfall of this offer.