Radiopharmaceuticals are a kind of pharmaceutical drug that contain radioisotopes that bind to biological molecules in order to target specific cells and tissues. A pioneer in the field of precision medicine, a growing body of research suggests that this class of medicine could deliver radiotherapy with enhanced specificity to cancer cells.
With a market value of $5.2 billion in 2022, it is projected to nearly double in ten years. As more and more companies seek to develop novel therapies to address the unmet needs of people with cancer, here are six radiopharmaceutical companies that have acquired funding over the past year, to further advance their pipelines.
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Theranostics is an emerging field in medicine that combines therapeutics with diagnostics. Alpha9 Theranostics is developing radiopharmaceuticals to advance in this line of research.
These radiopharmaceuticals consist of a binder, a linker, a chelator, and a radioisotope. The binder targets the proteins on the surface of cancer cells, while the chelator holds the radioisotope – which is usually made up of lutetium or actinium to kill cancer cells and gallium or fluorine tumor imaging and diagnosis. The linker connects the binder and the chelator together.
The company aims to target various sites in different cancers. It is developing a therapy that can target the prostate specific membrane antigen (PSMA) which is expressed in prostate cancer. It is also progressing in treatment research for melanomas and solid tumors, where certain G protein coupled receptors (GPCR) are overexpressed, making these sites target-worthy.
Founded in 2019, Alpha9 Theranostics has headquarters in Vancouver in Canada as well as in the biotech hub of Boston in the U.S.. Recently, the company announced that it had received $75 million in a series B financing round led by Nextech Invest, to strengthen its radiopharmaceuticals portfolio. It has secured a total of $84 million.
With around 1.4 million diagnoses globally in 2020, prostate cancer is one of the most common cancers in the world. Headquartered in Shanghai, Chinese biotech Bivision has designed JH02, for both the diagnosis and treatment of prostate cancer.
The candidate, which is currently in its preclinical stage, like other radiopharmaceutical drugs, is comprised of a radionuclide – a positron emitter for imaging and an alpha emitter for therapeutics – which is attached to a complex that contains a chelator, linker and target binding ligand, thereby acting as a theranostics agent for prostate cancer. Similarly, the young biotech is advancing in preclinical testing for its other pipeline products – JH04, JH06, JH08 – that target solid tumors.
After having raised CN¥100 million ($14 million) in two funding rounds last year that saw participation from investors such as Gaorong Capital, Kaitai Capital and VI Ventures, the company is looking to move forward with clinical trials this year.
Specializing in precision medicine, Fusion Pharmaceuticals is a radiopharmaceutical company that is based in Ontario in Canada. The company’s lead program FPI-2265 is based on its proprietary Fast-Clear technology, which was created to improve the safety of the delivery of radiopharma drugs.
The biotech has developed a linker that adjoins the target-binding molecule and the alpha-emitting medical isotopes. FPI-2265 is 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. Apart from FPI-2265, the company also has FPI-2059, which is an alpha therapy combining actinium-225 that targets neurotensin receptor 1 (NTSR1). It is currently being evaluated in phase 2 trials for metastatic castration resistant prostate cancer. It is also developing FPI-2059 for the treatment of solid tumors expressing NTSR1.
Earlier this year, Fusion Pharmaceuticals secured $60 million in a post IPO equity round, and has received a total of $230.9 million in investments over the years.
With a market size of $11 billion in the Asia Pacific region, according to 2020 statistics, precision medicine is gaining ground in Taiwan after the country launched its Taiwan Precision Medicine Initiative recently. Radiopharmaceutical company Primo Biotechnology is making strides in this field in the country.
The company is focused on developing its non-invasive radiopharmaceutical imaging technology to diagnose various cancers. The company leverages the diagnostic potential of the radiotracer fludeoxyglucose 18F (F-18 FDG) to detect early-stage cancers, particularly colorectal cancer, esophageal cancer and lung adenocarcinoma. The biotech aims to personalize and expedite cancer care 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, which was financed by startup angel investor AVA Angels, in January, this year.
Based in Texas in the U.S., RadioMedix is a clinical-stage biotech that was established in 2006. The company is focused on targeted radionuclide therapies with a theranostic approach. With a goal to improve sensitivity, efficacy and specificity, the company offers services in drug discovery and the manufacture of radiopharmaceuticals.
RadioMedix develops small molecules, peptides, radiolabeled monoclonal antibodies, like gallium 68, lutetium 177 and copper 64. It is also doing research in the potential of alpha emitters such as actinium 225 and lead 212 in cancer therapy. Its drug DetectNET is a copper 64 based diagnostic agent for neuroendocrine cancers. Having obtained positive phase 3 trial results, the company received orphan drug designation from the U.S. Food and Drug Administration (FDA). It is presently being reviewed for its new drug application with the FDA.
Along with DetectNET, the biotech is also specializing in developing treatments for breast, ovarian, lung and prostate cancer as well as glioblastoma multiforme – a type of fast-growing brain tumor.
Having held its first funding round last year, the company received $40 million in the series A round that was led by Portland Investment Counsel.
Set up five years ago in California in the U.S., radiopharmaceutical company RayzeBio is focused on developing cancer therapies from radioisotopes.
This is done through a process that begins with selecting the solid tumor target, after which an appropriate target binder is identified and optimized. These include peptides and small molecules. Then, in vitro screening is done followed by X ray crystallography, which is a powerful technique in drug delivery. After this, radiolabeling is conducted. This is a type of isotope labeling that is used in drug development where researchers are able to track how an investigational drug is metabolized by the body. Following this, in vivo screening is completed, a preclinical screening method for anticancer medicines.
Most advanced in its pipeline is RYZ101, which is currently in clinical trials. RYZ101 is a radiopharmaceutical drug that is designed to deliver actinium-225 – a synthetic radioisotope that has been regarded as 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 who had previously undergone lutetium-177 labeled somatostatin analogue therapy began, with the first patient being administered RYZ101 in May.
RayzeBio has amassed a total of $418 million over four funding rounds, after it raised $160 million in a series D round that was led by Viking Global Investors, Wellington Management and Sofinnova Investments in 2022.