Rakuten Medical to start a Global Phase 3 Trial of Alluminox Treatment using ASP-1929 for Recurrent Head and Neck Cancer in India

Mumbai (Maharashtra) [India], May 23 (ANI/BusinessWire India): Rakuten Medical, Inc. (Rakuten Medical), a global biotechnology company developing and commercializing precision, cell-targeting therapies based on its proprietary Alluminox™ platform, today announced that the Company has been granted permission from the Indian Central Drugs Standard Control Organization (CDSCO) to conduct its global, pivotal Phase 3 clinical trial (ASP-1929-301/ClinicalTrials.gov Identifier:

NCT03769506

) evaluating Alluminox treatment (photoimmunotherapy) using ASP-1929 in patients with locoregional, recurrent head and neck squamous cell carcinomas (HNSCC) in India, and the registration of clinical trial information with the Clinical Trial Registry of India (CTRI) has been completed (CTRI Identifier:

CTRI/2023/05/052728

). The study sites will include several leading medical institutions in India such as the Tata Memorial Centre and Narayana Health, and the treatment will be administered to enrolled patients once ready.

This ASP-1929-301 study is currently underway in several countries such as the U.S. and Taiwan, and will enroll 275 patients globally including Indian patients.

In India, more than 200,000 new cases of head and neck cancer are diagnosed each year, which accounts for approximately 25% of all new head and neck cancer cases worldwide1. One of the reasons for this is the widespread use of chewing tobacco.

More than 28% of all adults (15 years and above) in India are users of tobacco, and approx. 75% of them use smokeless tobacco, including chewing tobacco2. It has been reported that more than half of oral cancer (a type of head and neck cancer) in India is attributable to smokeless tobacco, including chewing tobacco3. In addition to the high occurrence of head and neck cancer, it is known that the majority of these patients present with advanced disease, which also corresponds with poorer outcomes4.

Such high volumes of advanced stage patients can present many challenges for the surgeons and medical oncologists who treat head and neck cancer. Time and treatment options are limited. Surgery, radiation, and chemotherapy are all commonly used to manage this patient population – but more options are needed.

The multi-center, randomized, open-label, global Phase 3 study of Alluminox treatment using ASP-1929 will evaluate the efficacy and safety of ASP-1929 in patients with locoregional, recurrent HNSCC who have previously failed or progressed on or after at least two lines of therapy, of which at least one line must be systemic therapy, and are not eligible for surgery or radiation. Participants will be randomized to receive experimental therapy or investigator’s choice of systemic therapy (2:1).

The dual-primary endpoints of the study are progression-free survival and overall survival, and a key secondary endpoint includes objective response rate.

“We are very pleased to be conducting the pivotal Phase 3 study of Alluminox treatment using ASP-1929 in India, where there is a high unmet need for head and neck cancer treatment,” said Mickey Mikitani, Co-CEO of Rakuten Medical.

“The addition of India to this important study will help to accelerate the development of this drug. We will continue to do our utmost to bring a new treatment option to patients with head and neck cancer around the world as soon as possible, working closely with medical institutions and regulatory authorities in each country.”

ASP-1929 is a conjugation of an antibody cetuximab and IRDye® 700DX, a light activatable dye, and is Rakuten Medical’s first pipeline drug developed on its Alluminox™ platform. It binds to epidermal growth factor receptor (EGFR), which is highly expressed in head and neck cancers. After binding to cancer cells, ASP-1929 is locally activated by non-thermal red light (690 nm) illumination, which leads to selective cell killing in pre-clinical observations.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the drug in January 2018. In Japan, in September 2020, ASP-1929 received marketing approval from the Ministry of Health, Labour and Welfare for unresectable locally advanced or recurrent head and neck cancer as brand name Akalux®, together with BioBlade® Laser System, the medical device used in combination with the drug under the Conditional Early Approval System. Outside of Japan, ASP-1929 and the laser device system have not yet been approved by any regulatory authority.

1. Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Pineros M, Znaor A, Soerjomataram I, Bray F (2020). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.fr/today , accessed May 3, 2023
2. Global Adult Tobacco Survey (GATS) India Fact Sheet 2016-17. Centers for Disease Control and Prevention (CDC). https://www.tobaccofreekids.org/assets/global/pdfs/en/GATS_India_2016-17_FactSheet.pdf
3. Gupta PC, Arora M, Sinha DN, Asma S, Parascandola M (eds.); Smokeless Tobacco and Public Health in India. Ministry of Health & Family Welfare, Government of India; New Delhi; 2016. https://nhm.gov.in/NTCP/Surveys-Reports-Publications/Smokeless_Tobacco_and_Public_Health_in_India.pdf
4. Kulkarni MR. Head and Neck Cancer Burden in India. Int J Head and Neck Surg 2013;4(1):29-35 https://www.ijhns.com/doi/pdf/10.5005/jp-journals-10001-1132

• Rakuten Medical’s therapies based on Alluminox™ platform are investigational outside of Japan, and not approved in India for commercial use. This story is provided by BusinessWire India. ANI will not be responsible in any way for the content of this article.