Can RV01’s Shortened Half-Life Reduce Toxicity Risks in Cancer Therapy?
Radiopharm Theranostics has unveiled encouraging preclinical results for its Lu177-B7H3 monoclonal antibody, RV01, paving the way for a mid-2025 Investigational New Drug submission and a Phase 1 trial later that year.
- Lu177-B7H3-mAb RV01 shows high tumour uptake and favourable biodistribution
- Fc region modifications shorten antibody half-life, potentially reducing toxicity
- Preclinical package completion supports mid-2025 IND submission
- Phase 1 therapeutic basket study expected to start in late 2025
- Partnership with MD Anderson Cancer Center targets solid tumours expressing B7-H3
Preclinical Breakthrough for RV01
Radiopharm Theranostics, a clinical-stage biopharmaceutical company listed on the ASX and Nasdaq, has reported promising preclinical data for its novel radiopharmaceutical therapy, RV01. This therapy employs a Lu177-labelled monoclonal antibody targeting the B7-H3 protein, which is highly expressed in various solid tumours but not in healthy tissues. The recent studies demonstrated that RV01 maintains high tumour uptake while exhibiting a favourable biodistribution profile, a critical factor for effective and safe cancer treatment.
Innovative Antibody Design Reduces Toxicity Risks
One of the standout features of RV01 is its engineered Fc region, which shortens the antibody’s half-life compared to traditional monoclonal antibodies. While typical antibodies circulate for over a week, RV01 peaks within one to two days. This modification is designed to limit off-target exposure to the radioactive isotope, potentially mitigating the toxicities commonly associated with monoclonal antibody therapies. Additionally, the antibody’s faster liver excretion leverages the liver’s radio-resistant nature, offering an advantage over kidney excretion pathways that can lead to significant toxicity.
Pathway to Clinical Trials
These preclinical results complete the necessary package for Radiopharm Theranostics to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration by mid-2025. The company plans to initiate a first-in-human Phase 1 basket study targeting multiple solid tumour cancers by the end of 2025. This study will evaluate RV01’s safety and efficacy across tumour types expressing the B7-H3 protein, a target associated with poor prognosis in many cancers.
Collaboration and Future Prospects
The development of RV01 is in partnership with the MD Anderson Cancer Center, a leading institution in oncology research. Previous mouse studies have shown that the antibody not only induces complete regression of established tumours but also stimulates the immune system and may confer immune memory, suggesting a potential for durable responses. Radiopharm Theranostics’ broader pipeline includes multiple radiopharmaceutical candidates in various stages of clinical development, underscoring its commitment to innovative cancer therapies.
Implications for Oncology Treatment
If these promising preclinical findings translate successfully into clinical outcomes, RV01 could represent a significant advancement in targeted radiopharmaceutical therapy for solid tumours. The combination of high tumour specificity, reduced systemic exposure, and potential immune activation positions RV01 as a compelling candidate in the evolving landscape of cancer treatment.
Bottom Line?
Radiopharm’s next steps toward clinical trials will be closely watched as RV01 aims to redefine targeted cancer therapy.
Questions in the middle?
- Will the shortened half-life of RV01 translate into a better safety profile in humans?
- How broadly applicable will RV01 be across different solid tumour types expressing B7-H3?
- What regulatory feedback will Radiopharm receive following the IND submission?
