Radiopharm signs supply agreement with Cyclotek for prostate cancer drug

SYDNEY/BUNDOORA - Radiopharm Theranostics (ASX:RAD, NASDAQ:RADX) has signed a supply agreement with Cyclotek to radiolabel its prostate cancer drug candidate RAD 402 with Terbium-161 in Australia, the company announced Tuesday. According to InvestingPro data, the clinical-stage company, currently valued at $35.3 million, maintains a strong liquidity position with a current ratio of 3.37x, indicating robust short-term financial stability.

The agreement marks the final step needed before submitting for ethics approval and initiates a Phase 1 clinical trial for RAD 402, which is expected to begin in the second half of 2025.

RAD 402 is an anti-Kallikrein Related Peptidase 3 (KLK3) monoclonal antibody radiotherapeutic designed to target KLK3, a protein highly expressed in the prostate with limited expression in other tissues. The drug uses Terbium-161, which emits additional Auger and conversion electrons alongside its β-radiation compared to Lutetium-177, potentially improving therapeutic efficacy.

Under the agreement, Cyclotek will produce and provide doses of Terbium-161-labeled RAD 402 to support Radiopharm’s upcoming clinical trial in Australia.

The development comes as Radiopharm’s stock has experienced a challenging period, with InvestingPro data showing a 32% decline over the past year and an 8% drop in the last week. "This agreement is an important milestone for the development of RAD 402 and is the last step needed to submit for ethics approval and begin our Phase 1 clinical trial in prostate cancer," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics.

Greg Santamaria, CEO of Cyclotek, stated that the company is "pleased to partner with Radiopharm to facilitate the development of their innovative radiotherapeutic."

The trial will be the first company-sponsored Phase 1 trial in prostate cancer using Terbium-161, according to the press release statement.

Radiopharm Theranostics is a clinical-stage biopharmaceutical company developing radiopharmaceuticals for diagnostic and therapeutic applications in oncology. While the company currently operates at a loss with negative EBITDA of $20.4 million, InvestingPro analysis reveals 8 additional key insights about the company’s financial health and growth prospects, available to subscribers.

In other recent news, Radiopharm Theranostics Ltd has achieved several significant milestones. The U.S. Food and Drug Administration granted Fast Track designation to Radiopharm’s novel imaging agent, RAD101, which aims to expedite the development of treatments for metastatic cancers. This designation could potentially speed up the approval process for RAD101, allowing it to reach patients sooner if clinical trials are successful. Additionally, Radiopharm has commenced patient dosing in a therapeutic trial for its investigational drug, 177Lu-RAD202, marking a new phase in its research efforts.

The company also shared preclinical data on its Lu177-B7H3-mAb therapy, showcasing its ongoing commitment to developing targeted cancer treatments. Furthermore, Radiopharm secured a supply agreement with ITM for Lutetium-177, a critical component in targeted cancer therapies, ensuring a steady supply for its product pipeline. In another development, Radiopharm announced the acceleration of its RAD204 Phase 1 dose escalation trial, which could influence the timeline for the drug’s development. These updates reflect the company’s continued progress in advancing its radiopharmaceutical pipeline.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.