In this episode of The Onco’Zine Brief Peter Hofland talks with Peggy Berry, Vice president of Global Regulatory Affairs at Rakuten Medical.*
Rakuten Medical is developing a technology platform called Illuminox™ which is based on a cancer therapy called Near Infrared Photoimmunotherapy. This technology was originally developed by Hisataka Kobayashi, M.D., Ph.D. and his team at the National Cancer Institute (NCI) in the United States. 
Rakuten Medical’s first investigational drug, based on its Illuminox™ platform technology, is called cetuximab saratolacan (previously known as ASP-1929 and RM-1929).
Cetuximab saratolacan is an antibody-dye conjugate which includes the antibody, cetuximab (Erbitux®; Eli Lilly and Merck Serono) and a near-infrared, water-soluble, silicon-phthalocyanine derivative, photosensitizer or light activatable dye called IRdye700DX (IR700).
The antibody-dye conjugate specifically targets the epidermal growth factor receptor or EGFR, which is broadly expressed in tumors such as head and neck cancer, gastric cancer, prostate cancer, lung and pancreatic cancers as well as glioblastoma.
The investigational agent has a unique mechanism of action. After cetuximab saratolacan is administered and binds to EGFRs on tumor cells, the drug is locally activated with non-thermal red light using a device laser system (called BioBlade® Laser System), which is the medical device used in the combination with cetuximab saratolacan.
Pre-clinical data shows that following activation, cetuximab saratolacan induces rapid cell membrane disruption of the targeted cancer cells, leading to cell necrosis, and immune-o-genic cell death. Pre-clinical data also shows that cetuximab saratolacan can also induce innate and adaptive anti-cancer immune responses.
Rakuten Medical is currently conducting a global Phase III multi-center clinical trial with cetuximab saratolacan to evaluate the efficacy and safety in patients with recurrent head and neck squamous cell carcinoma.
In this program, we talk about the platform technology and the regulatory aspects of developing this novel approach. We also talk about clinical trials, trial recruitment and real-world data.
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* Previously know as Aspyrian Therapeutics
 Kobayashi H, Choyke PL. Near-Infrared Photoimmunotherapy of Cancer. Acc Chem Res. 2019 Aug 20;52(8):2332-2339. doi: 10.1021/acs.accounts.9b00273. Epub 2019 Jul 23. PMID: 31335117; PMCID: PMC6704485.
 Baselga J. Why the epidermal growth factor receptor? The rationale for cancer therapy. Oncologist. 2002;7 Suppl 4:2-8. doi: 10.1634/theoncologist.7-suppl_4-2. PMID: 12202782.