Radiopharm Theranostics Receives FDA Investigational New Drug Clearance for RV-01 Cancer Therapy

Radiopharm Theranostics (ASX: RAD) has received investigational new drug clearance from the US Food and Drug Administration (FDA) for therapeutic candidate Betabart (RV-01).

RV-01 targets the B7H3 immune checkpoint molecule that plays a role in cancer development and progression.

The FDA clearance will now allow the company to initiate a first-in-human Phase 1 clinical trial of RV-01, which it has developed in conjunction with the prestigious MD Anderson Cancer Centre at the University of Texas.

Promising Agent

Radiopharm managing director Riccardo Canevari said RV-01 was a promising radiotherapeutic that had shown tumour shrinkage and prolonged survival in animal studies.

“RV-01 is the first monoclonal antibody developed through our collaboration with MD Cancer Centre and we believe it has the potential to become a highly-differentiated radiopharmaceutical for patients with aggressive solid tumours,” he said.

“Monoclonal antibodies are primarily cleared by the liver which is known for its radio-resistance and this characteristic — when combined with the shortened half-life of RV-01 and a strong affinity for BH73 — may offer a significant advantage over other targeted radiotherapeutics with a renal excretion pathway.”

Compelling Target

B7H3 is highly-expressed in tumours and has emerged as a compelling target for antibody-based cancer immunotherapies.

Deregulated B7H3 expression is consistently correlated with enhanced tumour aggressiveness and poor clinical outcomes.

Mr Canevari said targeting the 4Ig isoform of B7H3 with a selective radioligand therapy such as RV-01 may also offer a novel strategy for treating refractory or high-risk tumours.

Supply Agreement

Earlier this year, Radiopharm signed an agreement with German biotech ITM Isotope Technologies Munich for the supply of non-carrier-added 177Lutetium for use in the development of RV-01 and other programs in its clinical pipeline.

“Ensuring the supply of key isotopes continues to be a priority for our team, allowing us to accelerate our clinical programs,” Mr Canevari said.

“177Lutetium is required for three of our more advanced assets and this supply agreement is an important step to ensure quality, reliability and redundancy in our clinical development plans.”

Board Appointment

Radiopharm has appointed internationally-recognised medical oncologist Dr Oliver Sartor to its scientific advisory board.

Dr Sartor specialises in prostate cancer and radiopharmaceutical therapies and currently serves as chair of the genitourinary cancer disease group at US-based Mayo Clinic.

Since 1990, Dr Sartor has focused on prostate cancer clinical research, authoring more than 500 peer‑reviewed publications and leading multiple pivotal Phase 3 trials leading to FDA approvals.

“Dr Sartor brings an unparalleled depth of expertise in clinical translation and radiopharmaceutical therapies—his insight and leadership on our scientific advisory board will be valuable as we advance our therapeutic pipeline,” Mr Canevari said.

R&D Tax Incentive

Radiopharm has received a research and development (R&D) tax refund for the 2024 financial year of $4.48 million including $94,559 interest.

It is part of a federal government incentive that provides eligible companies with a refundable tax offset of up to 43.5%.

Radiopharm will use the refund for continued development of its radiopharmaceutical portfolio for diagnostic and therapeutic applications.