Rakuten Medical Pipeline
Rakuten Medical’s first investigational drug based on the Illuminox™ platform is ASP-1929. ASP-1929 is an antibody-dye conjugate comprised of the antibody, cetuximab and IRDye® 700DX, a light activatable dye. ASP-1929 specifically targets the epidermal growth factor receptor (EGFR). EGFR is broadly expressed in tumors such as head and neck squamous cell carcinoma, cutaneous squamous cell carcinoma, esophageal, gastric, prostate, lung and pancreatic cancers as well as glioblastoma multiforme.
ASP-1929 is administered and binds to EGFRs on tumor cells. The drug is then locally activated with non-thermal red light using an investigational device laser system and fiber optics. Pre-clinical data indicate that upon illumination, ASP-1929 induces rapid cell membrane disruption of targeted cells, leading to cell necrosis, and immunogenic cell death. Pre-clinical data has also shown that applying the ASP-1929 to target cancer cells within tumors implanted in immunocompetent mouse models can induce innate and adaptive anti-cancer immune responses. ASP-1929 has not yet been approved by any regulatory authority.
Rakuten Medical is currently conducting a global Phase 3 multi-center clinical trial with ASP-1929 to evaluate the its efficacy and safety in patients with recurrent head and neck squamous cell carcinoma. In addition, a Phase 1b/2 trial investigating ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy in EGFR expressing advanced solid tumors including recurrent or metastatic head and neck squamous cell carcinoma or advanced cutaneous squamous cell carcinoma will be initiated later this year.
The graph below displays the ongoing and planned trials.
CURRENT AND COMPLETED CLINICAL TRIALS
- A phase 3 randomized, double-arm, open-label, controlled trial of ASP-1929 photoimmunotherapy versus standard of care for locoregional recurrent head and neck squamous cell carcinoma in patients who have failed after at least two lines of therapy
- A phase 1b/2 open-label study of ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy in EGFR expressing advanced solid tumors
- A phase 1/2a multicenter, open-label, dose-escalation, combination study of RM-1929* and photoimmunotherapy in patients with recurrent head and neck cancer, who in the opinion of their physician, cannot be satisfactorily treated with surgery, radiation or platinum chemotherapy
- A phase 1 single-center, open-label, combination study of RM-1929 and photoimmunotherapy in patients with recurrent squamous cell head and neck cancer (Japan).
*RM-1929 and ASP-1929 are analogous. Extensive physiochemical studies showed that they have comparable physical and chemical properties
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