Biotechnology

Six radiopharmaceutical companies make a difference

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Radiopharmaceuticals are a type of pharmaceutical drug that contains radioisotopes that bind with biological molecules to target specific cells and tissues. A pioneer in the field of precision medicine, a growing body of research shows that this medical class can provide radiotherapy with enhanced specificity for cancer cells.

With a market value of $5.2 billion by 2022, it is projected to nearly double that in ten years. As more companies seek to develop new therapies to address the unmet needs of people with cancer, here are six radiopharmaceutical companies that have secured funding over the last year, to further advance their networks.

Alpha9 Theranostics

Theranostics is a new field in medicine that combines therapy with diagnostics. Alpha9 Theranostics is developing radiopharmaceuticals to advance this research area.

This radiopharmaceutical consists of binders, linkers, chelators, and radioisotopes. Binders target proteins on the surface of cancer cells, while chelator retain radioisotopes – which usually consist of lutetium or actinium for killing cancer cells and gallium or fluorine tumor imaging and diagnosis. The linker links the binder and chelator together.

The company aims to target different sites in different cancers. It is currently developing a therapy that can target the prostate-specific membrane antigen (PSMA) expressed in prostate cancer. It is also undergoing advances in treatment research for melanoma and solid tumors, where certain G protein-coupled receptors (GPCRs) are overexpressed, making these sites feasible targets.

Founded in 2019, Alpha9 Theranostics has headquarters in Vancouver in Canada as well as in the biotechnology center Boston in the US. Recently, the company announced that it has received $75 million in a Series B financing round led by Nextech Invest, to strengthen its radiopharmaceutical portfolio. It has secured a total of $84 million.

Bivisi

With around 1.4 million diagnoses globally in 2020, prostate cancer is one of the most common cancers worldwide. Headquartered in Shanghai, Bivision biotech China has designed JH02, for the diagnosis and treatment of prostate cancer.

The candidate, which is currently in its preclinical stage, like other radiopharmaceutical drugs, consists of a radionuclide – a positron emitter for imaging and an alpha emitter for therapy – attached to a complex containing a chelator, linker, and target-binding ligand. , thereby acting as a theranostics agent for prostate cancer. Likewise, the young biotech is advancing in preclinical testing for other pipeline products – JH04, JH06, JH08 – that target solid tumors.

After raising CN¥100 million ($14 million) in two funding rounds last year involving participation from investors such as Gaorong Capital, Kaitai Capital and VI Ventures, the company is looking to resume clinical trials this year.

Fusion Pharmacy

Specializing in precision medicine, Fusion Pharmaceuticals is a radiopharmaceutical company based in Ontario in Canada. The company’s main program FPI-2265 is based on its proprietary Fast-Clear technology, which was created to increase the safety of radiopharma drug delivery.

Biotech has developed a linker that brings together target binding molecules and alpha-emitting medical isotopes. FPI-2265 was designed to target prostate-specific membrane antigen (PSMA) for the treatment of metastatic castration-resistant prostate cancer, and is currently in phase 2 clinical trials. In addition to FPI-2265, the company also has FPI-2059 which is an actinium alpha combination therapy. -225 which targets neurotensin receptor 1 (NTSR1). It is currently being evaluated in a phase 2 trial for metastatic castration-resistant prostate cancer. It also developed FPI-2059 for the treatment of NTSR1-expressing solid tumors.

Earlier this year, Fusion Pharmaceuticals raised $60 million in post-IPO equity rounds, and has received a total investment of $230.9 million over the years.

Prime Biotechnology

With a market size of $11 billion in the Asia Pacific region, according to statistics 2020, precision medicine is gaining popularity in Taiwan after the country launched the Taiwan Precision Medicine Initiative recently. Radiopharmaceutical company Primo Biotechnology is making headway in this area in the country.

The company is focused on developing non-invasive radiopharmaceutical imaging technology to diagnose various types of cancer. The company exploits the diagnostic potential of the fludeoxyglucose 18F (F-18 FDG) radiotracer to detect early-stage cancer, especially colorectal cancer, esophageal cancer, and lung adenocarcinoma. Biotech aims to personalize and accelerate cancer treatment through radioligand theranostics (RLT), which aims to target receptors and proteins in the tumor microenvironment.

In a series A round, Primo Biotechnology raised $2.5 million, funded by startup angel investor AVA Angels, in January this year.

RadioMedix

Based in Texas in the US, RadioMedix is ​​a clinical stage biotech founded in 2006. The company focuses on targeted radionuclide therapy with a theranostic approach. With the aim of increasing sensitivity, efficacy and specificity, the company offers drug discovery and radiopharmaceutical manufacturing services.

RadioMedix develops small molecule, peptide, radioactively labeled monoclonal antibodies, such as gallium 68, lutetium 177, and copper 64. RadioMedix is ​​also conducting research on the potential of alpha emitters such as actinium 225 and lead 212 in cancer therapy. The drug DetectNET is a 64 copper-based diagnostic agent for neuroendocrine cancer. After obtaining positive phase 3 trial results, the company received an orphan drug designation from the US Food and Drug Administration (FDA). It is currently under review for its new drug application with the FDA.

Along with DetectNET, biotech also specializes in developing treatments for breast, ovarian, lung and prostate cancers as well as glioblastoma multiforme – a type of fast-growing brain tumor.

After holding its first round of funding last year, the company received $40 million in a series A round led by the Portland Investment Counsel.

RayzeBio

Founded five years ago in California in the US, the radiopharmaceutical company RayzeBio is focused on developing cancer therapies from radioisotopes.

This is done through a process that starts with solid tumor target selection, after which appropriate target binders are identified and optimized. This includes peptides and small molecules. Then performed in vitro screening followed by X-ray crystallography, which is a powerful technique in drug delivery. After this, radiolabeling was carried out. This is a type of isotope labeling used in drug development where researchers can track how the drug under study is metabolized by the body. After that, in vivo screening was completed, a preclinical screening method for anticancer drugs.

The most advanced in its line is the RYZ101, which is currently in clinical trials. RYZ101 is a radiopharmaceutical drug designed to deliver actinium-225 – a synthetic radioisotope considered a breakthrough in cancer treatment – ​​to tumors. It is being studied in patients with neuroendocrine tumors and small cell lung cancer. Recently, a phase 3 trial for the treatment of SSTR + gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in patients previously on lutetium-177-labeled somatostatin analogue therapy began, with the first patient receiving RYZ101 in May.

RayzeBio has raised a total of $418 million over four funding rounds, having raised $160 million in a Series D round led by Viking Global Investors, Wellington Management and Sofinnova Investments in 2022.

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