Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 134 |
| INN | Cetuximab saratolacan |
| Status | Approved |
| Drug code(s) | RM-1929, ASP-1929, Cetuximab-IRDye® 700DX |
| Brand name | Akalux® IV Infusion |
| mAb sequence source | mAb chimeric |
| General Molecular Category | Immunoconjugate, Photoimmunotherapy |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | IRDye® 700DX |
| Discovery method/technology | None |
| Target(s) | EGFR |
| Indications of clinical studies | Head and neck squamous cell carcinomas |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved Japan |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | April 15, 2015 |
| Start of Phase 2 | |
| Start of Phase 3 | December 01, 2018 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2020 |
| Date of first US approval | |
| INN, US product name | Cetuximab saratolacan |
| US or EU approved indications | None |
| Company | Rakuten Medical Inc. |
| Licensee/Partner | None |
| Comments about company or candidate | Sep 2020: Approved in Japan NCT03769506 Phase 3 study started in May 2019. May 2019: Efficacy and safety data from a phase I/IIa trial in Head and neck cancer (Recurrent, Second-line therapy or greater, Late-stage disease) presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO-2019) Dec. 17, 2018: Rakuten Aspyrian, a biotechnology company developing precision-targeted cancer therapies based on its proprietary Photoimmunotherapy platform, today announced that enrollment is underway in its global, pivotal Phase 3 clinical trial evaluating lead product candidate ASP-1929 in patients with recurrent local regional head and neck squamous cell carcinomas (HNSCC). Rakuten Aspyrian expects to enroll 275 patients at 75 sites in the U.S., Europe and Asia. Company anticipates starting a Phase 3 study (A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus Physician’s Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed on or After Two Lines of Therapy) in Q3 or Q4 2018. Fast track designation for head & neck squamous call carcinoma. IND filed in April 2015; NCT02422979 Phase 1 study started in June 2015 changed to a Phase 1/2 study in June 2017; active not recruiting as of Sep 2018 |
| Full address of company | 11080 Roselle Street, San Diego, CA 92121 North America United States of America https://rakuten-med.com/us/ |
Aspyrian is developing a new class of precision-targeted oncologic drugs for the treatment of solid tumors based on the Photoimmunotherapy platform licensed exclusively from the National Cancer Institute (USA). Photoimmunotherapy utilizes cancer-selective antibodies conjugated to the molecule IRDye® 700DX that is activated with a laser at the tumor site to induce rapid cancer cell destruction. RM-1929 is cetuximab conjugated to IRDye700DX.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |