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Rakuten Medical Taiwan Announces Commencing a Phase 2 Clinical Trial for Head and Neck Squamous Cell Carcinoma Photoimmunotherapy based on the Alluminox™ platform at 5 Leading Medical Centers

Source: Rakuten Medical

Rakuten Medical Taiwan, Inc. today announced that their ASP-1929 Photoimmunotherapy Phase 2 clinical trial ( Identifier: NCT05265013) has enrolled and treated its first patient. This trial is using ASP-1929 photoimmunotherapy based on the Alluminox™ platform in combination with anti-PD1 therapy in head and neck squamous cell carcinoma to measure patient’s Objective Response Rate (ORR). The trial will be conducted in 3 medical centers in North Taiwan and 2 medical centers in Central Taiwan.

According to official cancer registration report, head and neck cancer ranks third in male cancer incidence and fourth in male cancer mortality in Taiwan, with an annual incremental of about 10,000 patients. Majority1 of the patients are males between the ages of 40 and 60. Local recurrence or metastasis is one of the leading causes of death in head and neck cancer patients2, and nearly one-half of recurrent or metastatic patients survive for less than one year3. After receiving treatment, about 40% of patients will still face in situ or local recurrence4.

Dr. Chun Wei Huang from Department of Otorhinolaryngology, Head and Neck Surgery of China Medical University Hospital, who participated in the trial, explained: “Currently patients have limited treatment options after recurrence. When surgery, chemotherapy combined with targeted therapy, radiotherapy, etc. fail to show obvious efficacy in treating head and neck cancer, not only the patients but the medical teams are disappointed. Patients are also prone to losing confidence for further treatment. In addition to this phase II clinical trial, Taiwan is also expected to join more clinical trials. The introduction of more clinical trials presents not only new chances for patients, but also new possibilities for head and neck cancer treatment.”

“ASP-1929 has been conditionally approved by the MHLW in Japan and we are establishing more clinical evidence to help cancer patients around the world. The investment of this Phase 2 trial reiterates our long-term commitment in developing Taiwan as the foothold to Asia expansion. The enrollment of first patient also demonstrates the robust momentum and tight-knit collaboration of Rakuten Medical around the globe. We look forward to providing patients with impactful new treatment options as soon as possible.” said Mickey Mikitani, Co-CEO of Rakuten Medical, Inc.

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[1] Health Promotion Administration, Ministry of Health and Welfare, 2019 Cancer Registration Report

[2] A Novel CXCR4-Targeted Diphtheria Toxin Nanoparticle Inhibits Invasion and Metastatic Dissemination in a Head and Neck Squamous Cell Carcinoma Mouse Model. Pharmaceutics. 2022 Apr 18;14(4):887. doi:10.3390/pharmaceutics14040887

[3] Argiris A, Harrington KJ, Tahara M, Schulten J, Chomette P, Ferreira Castro A, Licitra L. Evidence-Based Treatment Options in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck. Front Oncol. 2017 May 9;7:72. doi: 10.3389/fonc.2017.00072.

[4] Daniela Alterio, Giulia Marvaso, Annamaria Ferrari, Stefania Volpe, Roberto Orecchia, Barbara Alicja Jereczek-Fossa (2019.) Modern radiotherapy for head and neck cancer

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