Radiopharm Theranostics Advances RAD 402 for Prostate Cancer Treatment
RADIOPHARM THERANOSTICS LIMITED (RAD) Share Update December 2024 Monday 9th
Radiopharm Theranostics Completes Preclinical Package for Prostate Cancer Treatment
Radiopharm Theranostics Limited (ASX:RAD) has successfully completed the preclinical data package for its KLK3-targeting radiotherapeutic, RAD 402, marking a significant step towards First-In-Human trials.
Instant Summary:
- Completion of preclinical studies for RAD 402 with positive safety data.
- RAD 402 shows promising biodistribution and tumor targeting.
- First-In-Human trials expected to begin in H2 2025.
Preclinical Success for RAD 402
Radiopharm Theranostics has announced the successful completion of its preclinical studies for RAD 402, a KLK3-targeting radiotherapeutic. The studies demonstrated that the 161 Tb-labelled RAD 402 is safe and shows a promising biodistribution profile. This comprehensive dataset validates the potential of RAD 402 for advancing into First-In-Human therapeutic studies.
The preclinical toxicology reported positive data, with no observed adverse effects. Biodistribution studies in mouse xenografts showed high tumor targeting, limited kidney and bone marrow uptake, and a hepatic excretion profile, aligning with expectations for a monoclonal antibody. These findings support the rationale for First-In-Human clinical studies.
Next Steps in Development
Radiopharm is currently advancing its clinical development plans for RAD 402, with GMP manufacturing of the drug and its conjugate expected to be completed in Q1 2025. The company is on track to commence Phase I First-In-Human studies in the second half of 2025.
RAD 402 targets KLK3, a protein expressed in prostate tissue and most prostate adenocarcinomas. The drug is an anti-KLK3 monoclonal antibody labeled with Terbium-161, which emits additional Auger and conversion electrons alongside its β-radiation, potentially improving therapeutic efficacy compared to existing treatments.
The successful preclinical results for RAD 402 are a positive development for Radiopharm Theranostics, potentially enhancing its position in the oncology radiopharmaceutical market. The advancement towards human trials could attract investor interest, given the ongoing unmet need for advanced prostate cancer treatments. This progress might positively influence the company's stock as it moves closer to offering a first-in-class treatment option.
Investor Reaction:
Analysts are likely to view the completion of the preclinical package as a significant milestone, highlighting Radiopharm's potential to innovate in cancer treatment. The commencement of human trials will be closely watched, as successful outcomes could lead to increased investor confidence and potential stock appreciation.
Conclusion:
Radiopharm Theranostics' progress with RAD 402 marks an exciting development in the fight against advanced prostate cancer. Investors should keep an eye on upcoming clinical trials and the potential market impact of this innovative treatment. The company's strategic advancements could offer significant opportunities for growth and investment.