Jay T. Ripton is a freelance healthcare, technology, and business writer out of Scottsdale. He loves to write to inform, educate, and provoke minds. Follow him on twitter @JTRipton.
Recent major investments signal growth in an emerging therapeutic sector.
Over the last 20 years there has been a tidal wave of innovation when it comes to the treatment of cancer. Traditional “pillars” of treatment—surgery, chemotherapy, and radiation therapy—have been joined by targeted therapies and immunotherapy. Targeted therapies help shut down specific proteins in cancer cells that help them grow, divide, and spread, while immunotherapies stimulate or suppress the body’s immune system to help fight cancer.
Both targeted therapies and immunotherapies are proving to be effective approaches to cancer treatment. However, there is another new approach that is attracting investment and creating excitement. Researchers are developing a new class of drugs called radiopharmaceuticals, which deliver radiation therapy directly and specifically to cancer cells. Radiopharmaceuticals, also referred to as medicinal radio compounds, are a group of drugs containing radioactive isotopes, and can be used as both diagnostic and therapeutic agents.
Although radiation has been used for more than a century to treat cancer, radiopharmaceuticals are relatively new. The last few years have brought an explosion of research and clinical trials for new radiopharmaceuticals. The early consensus is that targeting radiation therapy at the cellular level has the potential to reduce the risk of both short-term and long-term side effects of treatment, while proving effective at killing even the smallest deposits of cancer cells throughout the body.
Limited side effects and precision delivery are 2 big reasons pharmaceutical organizations like Y-mAbs, AstraZeneca, Merck, Bristol Myers Squibb and others are betting on radiopharmaceuticals. These were just a few of the big names present at the recent Targeted Radiopharmaceuticals (TRP) Summit.
“Many of us that now specialize in radiopharmaceuticals have been in the field of radiation therapy for decades,” said John Zehner, nuclear pharmacist and CEO of SpectronRx. “Although radiocompounds are a fairly new innovation, there is literally a century of research and practice that has brought us to where we are today. This is an exciting time for our field, cancer research and the treatment of complex cancers.”
SpectronRx is a leading Contract Radiopharma Development and Manufacturing Organization (cRDMO), specializing in early stage development, clinical trial supply, commercial supply and specialty services for radiopharmaceuticals. Their client roster includes Y-mAbs, NuView, Telix Pharmaceuticals, and some very large, yet to be announced, pharmaceutical powerhouses. And demand is growing.
“In response to increased demand for early phase radiopharma therapeutic and diagnostic development services, we have experienced significant growth as a partner for global and domestic life sciences companies,” added SpectronRx President Anwer Rizvi. “Our partners trust in us because of our expertise, which ranges from phase zero through to commercialization, our staff and our facilities. Pharmaceutical companies, large and small, can scale quickly and safely when they leverage our offerings.”
Traditional pharmaceutical organizations may choose to partner with companies like SpectronRx for the development of radio compounds based on experience, infrastructure, cost management and time to market. To build a radiopharmaceutical development and manufacturing organization from the ground up would take several years; this would require expertise in radioactive isotopes and radio compounds, special licensing, a significant amount of working capital, specialized equipment and facilities, and much more.
For cRDMOs like SpectronRx, betting big on the growing demand for its specialty services is worth it, especially given the potential for radio compounds to treat complex cancer cases. It’s another reason venture capital firms and investment bankers have become active in the space. RayzeBio recently made headlines with a $150 million raise. As the emerging leader in radiopharmaceuticals, RayzeBio is developing a pipeline against validated oncology drug targets to deliver radioisotopes that emit alpha particles such as Actinium-225.
RayzeBio’s developments include mid-stage peptide binders for a host of solid tumor targets, which are radiolabeled with Actinium-225. The company is also working to develop seven other programs, some of which will be first-in-class radiopharmaceutical products if they are granted authorization. RayzeBio plans to use its funds to expand its San Diego headquarters, develop its pipeline, and solidify manufacturing options for its radioisotope-drug conjugates.
Y-mAbs Therapeutics is another pharmaceutical company investing in the space. The company recently partnered with SpectronRx to secure access to clinical and commercial-scale radiolabeling capacity for its monoclonal antibody, omburtamab. Y-mAbs Therapeutics is a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer.
SpectronRx is producing both the clinical and commercial supplies of radiolabeled omburtamab for Y-mAbs. The agreement between Y-mAbs and SpectronRx is designed to secure clinical and commercial scale radiolabeling capacity for omburtamab, and allows for supply to the US market upon potential FDA approval of radiolabeled omburtamab. The FDA recently cleared an investigational new drug (IND) application for YmAb’s lutetium-177 that is labeled omburtamab for the treatment of B7-H3 positive Central Nervous System (CNS) and Leptomeningeal metastases (LM) from tumors in adult patients.
These are just a few of the recent developments that highlight the progress being made within the field of radiopharmaceuticals. With the global market for radiopharmaceuticals valued at $6.1 billion in 2019, and is estimated to reach $12.6 billion by 2027, developments will continue to grow at a significant pace.
JT Ripton is a business consultant and freelance writer.