Clinical-stage and privately funded biotechnology company Rakuten Medical, previously known as Aspyrian Pharmaceuticals, developing precision-targeted cancer therapies based on the company’s proprietary Photoimmunotherapy or PIT platform, has raised approximately US $100 million on July 31, 2019, in a Series C-1 Preferred Stock financing from Rakuten, a global leader in internet services headquartered in Japan.

This new investment is increasing Rakuten’s equity share of Rakuten Medical to 22.6 percent.

The capital will be used to expand the development of the company’s oncology-focused PIT platform, strengthen its business and commercial functions, and provide resources to further identify and evaluate new investigational compounds and indications for the potential treatment of other types of cancers using Photoimmunotherapy.

Photoimmunotherapy is an investigational, anti-cancer treatment platform that includes a drug and device combination that utilizes monoclonal antibodies conjugated to a dye (IRDye® 700DX).

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One of the unique characteristics of this antibody-700DX conjugate is that it only gains anticancer activity as a therapeutic agent when it is bound to the target cell membrane and is activated with a laser emitting 690 nm near infrared light (NIR) at the tumor site. When this occurs, the antibody-IR700 conjugate causes a rapid disruption of membrane integrity leading to rapid cell death that appears to follow necrotic processes rather than mechanisms of apoptosis. However, if the agent is not bound to the target cell, even upon NIR illumination, there are no discernible effects. As a result, this novel approach has minimal side effects on surrounding normal tissue. [1]

Photoimmunotherapy may also lead to the systemic induction of innate and adaptive immunity.

Figure 1.0 Effects on Photoimmunotherapy on cancer cell membrane integrity. The left panel shows the phase contrast image of cancer cells prior to treatment. The middle panel shows the fluorescence detection of the antibody conjugate with IRDye 700DX bound to the cell membrane, and the right panel shows the phase contrast image of the cells after light illumination. Note that the cell integrity has been severely damaged after treatment (adapted from Mitsunaga M et al., BMC Cancer. 2012 Aug 8;12:345).

ASP-1929, Rakuten Medical’s lead product based on the , , has achieved Fast Track designation from both the U.S. Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour, and Welfare. and is conducting a global Phase 3 clinical trial for recurrent head and neck squamous cell carcinoma. Additional Phase 2 studies for ASP-1929 PIT are also underway to evaluate the safety in patients with other cancer types.

Accelerating development
“The additional investment from Rakuten solidifies our commitment to accelerating Rakuten Medical’s business and commercial development,” said Mickey Mikitani, chairman and CEO of Rakuten Medical.

“I believe we can cultivate a sustainable health care ecosystem to provide patients with safe and easy access to, and better care in, the treatment of cancer, regardless of their nationality or income. Culturally, the technology industry has revolutionized society by being bold, action-driven and innovative. We hope to do the same at Rakuten Medical by exploring opportunities that will combine Rakuten’s technology expertise with Rakuten Medical’s first-in-class Photoimmunotherapy platform,” Mikitani said.

[1] Portillo S. Aspyrian’s Photoimmunotherapy based on the IRDye® 700 DX Platform Shows Efficacy in a Number of Studies. ADC Review | J. Antibody-drug Conjugates. October 1, 2015. Online. Last accessed August 1, 2019.

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