CEO of Radiopharm Theranostics (RAD: $0.185), Riccardo Canevari, believes that the next big platform in oncology, following immunotherapy and cell therapies, will be radiopharmaceuticals.
Canevari highlighted the said the approval of Lutathera (in 2018) from Novartis (where Canevari was working at the time), for the treatment of neuroendocrine tumours and the more recent approval this year of Pluvicto (also from Novartis) as key events for the sector. Lutathera achieved a stunning efficacy result in its pivotal trial achieving a hazard ratio of 0.21, meaning a 79% risk reductio of disease progression or death. For Pluvicto, reaching primary and secondary endpoints in prostate cancer was a game changer.
The interest is supported by the acquisitions of Advanced Accelerator Applications (AAA) in 2017 and Endocyte by Novartis in 2018 for US$3.9 billion and US$2.1 billion respectively. AstraZeneca also entered the space in 2020 in a collaboration with Fusion Pharmaceuticals in Canada and in 2021 Bayer acquired Noria Therapeutics and PSMA Therapeutics.
Whilst radiopharmaceuticals are only approved for the treatment of two solid tumour types, Canevari argued that there is no reason why the approach should not be successful against other solid tumours as well. He believes that it is only a matter of time when the other major pharmaceutical companies will enter the space.
Radiopharm is a new company in this field, having been formed in February last year, raising $20 million in a private raise in July, followed by an IPO on the ASX in November, raising $50 million (at $0.60 per share).
Canevari previously led the team at AAA when it was acquired by Novartis. He worked on both Lutathera and Pluvicto.
Radiopharm has five discrete assets it is commercialising, exploring monoclonal antibodies, a peptide, a single chain antibody and a small molecule as targeting agents using a range of commercially available imaging and therapeutic isotopes. The targeting agent is the most important asset Canevari argues in radiotheranostics. Radiopharm is seeking to hit several targets with its molecules. These include HER2, PDL1 and PSA.
The five Radiopharma programs are all in oncology with patients treated in three of those programs (167 patients so far). Of interest is that three of those programs are with alpha therapeutics (Ac225) although Canevari said the company is isotope agnostic using both alpha and beta emitters. He does not believe one is better than the other but depends on the type of disease (tissue) being treated.
The company will use the imaging products mainly for patient selection with the emphasis being on the therapies.
Radiopharm has four Phase IIa imaging trials underway with the lead asset, with one of those studies, imaging brain metastases, due to read out around mid year. Canevari believes this may show significant results over the standard-of-care.
In the second half of this year three Phase I therapeutic studies with two different assets are due to start – in breast cancer (targeting HER2), in NSCLC (targeting PDL1) and prostate cancer (targeting PSA with Ac225 as the isotope) – together with an imaging study with its fourth asset. Results from all four of those studies are expected next year. Two of the therapeutic studies will be conducted in Australia with the second two studies to be run in the US. The aim is to also commence an additional six therapeutic studies next year.
One of the challenges with using the alpha-emitter Ac225 is that it needs to be internalised into the cell very quickly as it releases daughter nuclides. This occurs with the recent targeting agent licensed, the humanised monoclonal antibody DUNP19, which binds to LRRC15. LRRC15 has very limited expression on healthy cells. Canevari believes this is an even better target than FAPi (fibroblast activation protein inhibitor), which has become a popular target in oncology. With radiopharmaceuticals safety is key, with the dose always being able to be increased to improve efficacy.
Radiopharmaceuticals this week appointed a COO, Vittorio Puppa, who will be based in New York City.
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