Radiopharm Theranostics Receives Approval to Initiate Phase 1 Therapeutic Trial of RAD 402 (KLK3-mAb with Tb161) in Advanced Prostate Cancer
MWN-AI** Summary
Radiopharm Theranostics, a clinical-stage biopharmaceutical company focused on oncology radiopharmaceuticals, has received approval from the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate a Phase 1 First-In-Human clinical trial for its novel therapeutic, RAD 402. This innovative treatment is designed for patients with metastatic or locally advanced prostate cancer and targets the Kallikrein Related Peptidase 3 (KLK3), a biomarker frequently associated with prostate cancer.
RAD 402 is a humanized IgG1 monoclonal antibody that binds to KLK3 with high affinity, radiolabelled with the radionuclide terbium-161 (Tb-161). The antitumor efficacy of RAD 402 is attributed to the dual emission of beta particles and Auger electrons from Tb-161, which enhances its therapeutic potential. Preclinical studies have demonstrated promising biodistribution characteristics, indicating strong tumor targeting while minimizing uptake in bone and marrow, aligning with the efficacy profile expected of monoclonal antibodies.
CEO Riccardo Canevari emphasized that obtaining HREC approval is a pivotal milestone, not only for the company but also for patients seeking innovative treatments for prostate cancer. This Phase 1 trial marks an important step forward, as it is believed to be the first company-sponsored therapeutic trial utilizing Tb-161.
Radiopharm has previously established a supply agreement with Terthera for the Tb-161 production and has partnered with Cyclotek for the radiolabeling process. The company, listed on ASX and NASDAQ, is committed to developing a diverse pipeline of radiopharmaceutical products, addressing high unmet medical needs in cancer treatment, including ongoing trials across a variety of solid tumors.
MWN-AI** Analysis
Radiopharm Theranostics (ASX: RAD) has reached a significant milestone with the approval to initiate a Phase 1 clinical trial of RAD 402, a novel treatment targeting advanced prostate cancer. This trial could serve as a pivotal moment for the company, reflecting both scientific promise and potential for investor interest.
RAD 402 employs a humanized IgG1 monoclonal antibody that selectively targets KLK3, a biomarker commonly associated with prostate cancer. The involvement of Tb-161, with its dual emission mechanism, offers a unique therapeutic angle that could enhance treatment efficacy while minimizing damage to surrounding healthy tissues.
Given the rising incidence of prostate cancer globally and the increasing demand for effective treatments, Radiopharm is positioning itself strategically within a market characterized by high unmet needs. The approval from the Bellberry Human Research Ethics Committee underscores the scientific credibility of the company's innovation and builds confidence in the upcoming clinical trial.
From an investment perspective, this news could catalyze a positive sentiment in the market. Institutional and retail investors often seek opportunities in biopharmaceutical firms that demonstrate promising preclinical data and regulatory endorsements. This approval places Radiopharm in a competitive spotlight, particularly as the first company to sponsor a therapeutic trial using Tb-161, thus enhancing its visibility among potential partners and stakeholders.
Investors should closely monitor the trial’s progress and the company's ability to execute its development plans, including successful recruitment and trial outcomes. Positive results from the Phase 1 trial could provide further impetus for the share price. In conclusion, Radiopharm Theranostics presents an intriguing opportunity for investors as it navigates this critical phase in its development trajectory, especially in light of its innovative approaches and the pressing need for advanced treatments in oncology.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
RAD 402 is a humanized IgG1 internalized by prostate cells, binding KLK3 with high affinity
Tb-161 antitumor activity driven by the dual emission of beta particles and Auger electrons
SYDNEY, Nov. 18, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that it has been granted Bellberry Human Research Ethics Committee (HREC) approval in Australia to initiate its First-In-Human (FIH) Phase 1 clinical trial of its Kallikrein Related Peptidase 3 (KLK3)-targeting radiotherapeutic, RAD 402, for the treatment of metastatic or locally advanced prostate cancer.
RAD 402 is an anti-KLK3 monoclonal antibody radiolabelled with the radionuclide 161Tb for the treatment of prostate cancer. Prostate Specific Antigen (PSA) is a widely used biomarker to detect prostate cancer and is encoded by the KLK3 gene. KLK3 is expressed in the prostate along with most adenocarcinomas of the prostate including their metastases.
Previous comprehensive preclinical proof-of-concept Biodistribution studies of RAD 402 in mouse xenografts showed strong tumour targeting, limited bone and marrow uptake, and a hepatic excretion profile consistent with expectations for a monoclonal antibody. Radiopharm has signed in 2022 a supply agreement with Terthera for the production of Tb161 and in 2025 with Cyclotek for radiolabeling RAD402 with 161Tb, supporting the initiation of the Phase 1 FiH trial of RAD 402.
“Receiving HREC approval marks a key milestone for Radiopharm and for patients in need of safer, more effective new treatments for prostate cancer,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “This clearance enables us to advance RAD 402 into our first-in-human Phase 1 clinical trial, which, to my knowledge, is the first company-sponsored therapeutic trial using 161Tb. We are highly encouraged by RAD 402’s potential antitumor activity, driven by the dual emission of beta particles and Auger electrons from Tb-161. Targeting KLK3 in advanced prostate cancer represents a novel and promising mechanism of action. The strength of our preclinical data, combined with regulatory endorsement, underscores RAD 402’s first-in-class potential.”
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and four Phase 1 trials in a variety of solid tumor cancers, including lung, breast, and brain metastases. Learn more at radiopharmtheranostics.com .
Authorised on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper.
For more information:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Anne Marie Fields
Precision AQ (Formerly Stern IR)
E: annemarie.fields@precisionaq.com
Paul Hopper
Executive Chairman
P: +61 406 671 515
E: paulhopper@lifescienceportfolio.com
Media
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
FAQ**
How does the unique beta particle and Auger electron emission from Tb-161 enhance the antitumor activity of RAD 402 as compared to existing prostate cancer therapies from Radiopharm Theranostics Limited RADX?
What specific patient demographics are targeted for the Phase 1 clinical trial of RAD 402 conducted by Radiopharm Theranostics Limited RADX, and what key endpoints will be used to measure its effectiveness?
Can you elaborate on the significance of KLK3 as a target for RAD 402 and how it differentiates Radiopharm Theranostics Limited RADX from other prostate cancer treatments currently in development?
What are the next steps for Radiopharm Theranostics Limited RADX following the successful initiation of the Phase 1 trial of RAD 402, and how will the results influence future clinical development?
**MWN-AI FAQ is based on asking OpenAI questions about Radiopharm Theranostics Limited (NASDAQ: RADX).
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