Radiopharm Therapeutics (ASX: RAD, NASDAQ: RADX) has received approval from the Data Safety and Monitoring Committee (DSMC) to accelerate the Phase 1 HEAT trial for RAD-202. This step essentially means skipping the 40mCi dose level in favour of directly escalating doses from 30mCi to 75mCi.
This represents a significant clinical achievement for Radiopharm, demonstrating confidence in the drug’s safety and potential for treating HER2-positive advanced solid tumors.
RAD received approval to fast track trial for RAD-202
What Prompted The Acceleration?
The DSMC reviewed the initial results of the first patient cohort, who were administered 30mCi of Lu177-RAD202. The data showed positive safety, pharmacokinetic, and biodistribution profiles. There were no adverse safety events that warranted changes to the protocol.
The DSMC, therefore, recommended skipping the 40mCi dose level and going directly to a dose of 75mCi in the next cohort. This speeds up the dose-escalation pathway and decreases trial duration. It also helps bring Radiopharm closer to identifying its Phase 2 recommended dose.
Why Is This Decision Important?
The DSMC constitutes an independent body monitoring trial safety and data integrity, and the approval of this United States body would put the minds of the regulators, researchers, and investors at rest.
The CEO of Radiopharm Riccardo Canevari was pleased about the approval, noting strong early signals from the trial. Acceleration means “encouraging safety” and shows the need for new therapies for HER2-positive metastatic cancers.
The company remains on track for the presentation of data from the first two patient cohorts by year-end 2025.
Radiopharm CEO hails trial acceleration as key step for HER2 cancer therapy
How Does RAD-202 Work Against Cancer?
RAD-202 is a single-domain monoclonal antibody (sdAb) being developed to target the HER2 receptor. HER2 overexpression is observed commonly in breast cancer and several other solid tumours, hence it is a well-validated oncology target.
By coupling HER2-specific antibodies with Lutetium-177, RAD-202 gives precision radiation to cancer cells directly. In this manner, healthy tissue is protected from harm while there is maximum response from the tumour.
In an earlier diagnostic study involving ten HER2-positive breast cancer patients, RAD-202 proved the concept with positive safety and biodistribution for the therapeutic program to go forward.
Radiopharm’s Broader Pipeline
Radiopharm Theranostics is advancing an international portfolio of radiopharmaceutical products. According to the website, the company’s pipeline includes one Phase 2 and three Phase 1 trials in diverse indications, including lung, brain, and breast cancers.
The therapeutic programs under development are employing a broad range of peptides, small molecules, and antibodies that find greater use lately in novel therapies based on the HEAT study being run at multiple centres across Australia, thereby granting prominence of Australia to oncology research.
Together with RAD-202, Radiopharm is extending its research collaborations, which include the recent collaboration with Starpharma. These types of developments further secure its position in a competitive field of precision oncology.
Can Radiopharm Maintain Trial Momentum?
Progressing swiftly through dose-escalation phases offers opportunity and risk. If higher dosing remains safe, Rapidpharm will proceed at a fast pace toward identifying a Phase 2 pathway, which would then, I believe, Most likely bolster investor interest and pull in new partners.
Unfortunately, at higher dosages, new side effects might show up. Any concerns in the safety profile would pose a hindrance to trial progression and negatively impact market sentiment. A balance between rapidity and caution is the precondition for Radiopharm’s success.
Global Oncology Drug Market Forecast
Radiopharm Strengthens Its Oncology Position
The global oncology drugs market is projected to surpass USD 564.50 billion by 2033, expanding at a CAGR of 11.50% between 2023 and 2033.
With an accelerated approval, Radiopharm signalled that radiopharmaceutical therapies in oncology are increasingly considered crucial. In view of their faster pace through clinical phases, the company wishes to avail new treatments to patients with few alternatives.
The DSMC’s confidence adds strength to Radiopharm’s name as it continues to compete in what is increasingly a global oncology market.
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Frequently Asked Questions
Q1: What is the HEAT trial?
Phase 1 dose-escalation trial of Lu177-RAD202 in HER2-positive advanced solid tumours.
Q2: How does RAD-202 differ from existing HER2 treatments?
RAD-202 differs from currently approved HER2 drugs because the HER2 target is combined with radiation delivery using Lutetium-177.
Q3: Where is the trial being conducted?
The study is ongoing in multiple clinical centres around Australia.
Q4: When will the 75mCi cohort begin enrolment?
The second cohort of 75mCi is expected to begin enrolling patients in Q4 2025.
