Radiopharm Theranostics has moved closer to securing investigational new drug (IND) approval for a cancer-fighting radio-antibody after manufacturing the first batch of its “BetaBart” radiotherapeutic agent.
The company says BetaBart, which targets the B7-H3 protein that is commonly over-expressed in human tumours, has shown positive pre-clinical results in trials with animals by shrinking tumours and improving survival rates.
BetaBart has been developed alongside its Texas-based joint venture (JV) partner MD Anderson Cancer Centre (MDACC) and it has now submitted a pre-IND meeting with the powerful United States Food and Drug Administration (FDA) in a bid to secure the approval.
The FDA green light will trigger phase one and two human therapeutic trials for BetaBart in the US to test the antibody on multiple tumour types. Management is eyeing a start to the trials mid-next year.
Radiopharm’s key intellectual property stems from the use of introduced antibodies to transport tiny radioactive doses to individual tumour cells and seek out cancer-attracting proteins – a science known as radiopharmaceutical therapy – thereby delivering a finely targeted response to cancer growth.
In being able to zero in on the 4Ig protein subtype, B7-H3 – the most commonly found on human tumours – BetaBart is a first-of-its-kind radiopharmaceutical in development.
Radiopharm Theranostics managing director and chief executive officer Riccardo Canevari said: "We are extremely pleased with the strong collaboration with MD Anderson and the early results we saw with BetaBart (RV-01) are impressive, so we’re looking forward to developing this further."
BetaBart is the first product jointly-developed by Radiopharm Ventures, a subsidiary of Radiopharm and the MDACC. The JV – in which Radiopharm recently boosted its share to 75 per cent with a $4 million cash injection – was created in 2022 in a bid to develop novel radiopharmaceutical products for cancer treatment by tapping into MDACC’s expertise in antigen discovery and molecular imaging alongside Radiopharm’s capabilities in developing radiopharmaceutical therapies.
Following the successful animal trials, BetaBart has been specifically engineered by the JV to best suit human use by using the commonly-available 177 Lutetium radioactive isotope that emits the less ionising beta radiation, thereby reducing the likelihood of toxicity issues.
As Radiopharm marches forward with the development of several new radiopharmaceutical agents – combating a variety of cancer types including prostrate, brain and lung – the company coffers have also been bolstered by a significant injection of some $70 million in capital from fund managers and up to an additional $15 million from American medical giant, Lantheus.
Management has spent much of its time in the past few years refining and perfecting its intellectual property. Now, it seems, it is close to putting its best foot forward to grab the vital FDA approval for BetaBart.
In such a new area of science, Radiopharm is starting to make some serious waves.
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By James Pearson
