The company focuses on developing precision, cell-targeting investigational therapies on its Illuminox™ technology platform. Illuminox is based on a cancer therapy called photoimmunotherapy, which was developed by Dr. Hisataka Kobayashi and the team from the National Cancer Institute in the United States. This technology platform is just an antibody, a small molecule that represents a new form of therapy with the potential to selectively target cancer cells while sparing surrounding normal tissues through light-activatable antibody-dye conjugates.
Illuminox entails drug and laser device components. While the former consists of a targeting moiety conjugated with one or more dyes leading to selective cell surface binding, the latter consists of a light source that locally illuminates the targeted cells with non-thermal light to transiently activate the drug. Used as an alternative method to fight cancer, this combination of technology identifies an antibody that binds directly to an antigen coupled with a dye. The patient initially gets treated with the drug and, the next day is treated with the device where the light is used and dosed at a particular wavelength to the tumor.
Rakuten Medical: Pioneering a Novel Approach in Treating Cancer
We at Rakuten Medical are focused on bringing an investigational treatment approach for our patients to provide them with one if the best options to fight cancer
One of the first drugs developed on Illuminox is ASP-1929, an antibody-drug conjugate comprised of the antibody cetuximab and a light activatable dye. ASP-1929 binds to epidermal growth factor receptors (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck cancer, esophageal cancer, lung cancer, colon cancer, and pancreatic cancer. ASP-1929 has achieved Fast Track designation from the FDA and approval from the Ministry of Health, PMDA Japan, which is considered one of the most conservative regulatory bodies globally. Currently, the drug is under investigation in a global phase 3 clinical trial for recurrent head and neck cancer.
Although Illuminox therapies are under the radar of various regulatory authorities, the company is developing a viable commercial process to work with its vendors, commercial manufacturing organizations, and collaborators. The delay in regulatory approval mainly stems from the time-consuming nature of drug evaluation and regulatory approval. As an assertion to this, Garcia adds, “When you are trying to develop a novel, innovative program, which is first in class, it is challenging. And, fortunately, we have got approval in Japan with our lead program.” In addition to this, Rakuten Medical is also moving forward with product development by conducting clinical trials of monotherapy and combination therapy with other drugs.
Garcia credits the Illuminox platform’s value proposition to the team of Rakuten Medical, led by Mikitani. Having its subject matter expertise, the company plans its expansion to other countries such as China, India, and the other Asia Pacific regions. With such technology offering in place, Rakuten Medical has gained major traction in the US. Soon, the company will enter phase three trial in the US. Moving forward, the company will build its strategy for identifying and expanding new Illuminox programs. “We are committed to developing a treatment for as many patients as possible, as soon as safely possible, with an ultimate goal of conquering cancer one day,” concludes Garcia.