To Conquer Cancer with Light: Rakuten Medical Accelerates Global Trials on First-in-Class Next-Gen Treatment

For patients with head and neck cancer, surviving the disease often comes at a devastating cost—losing the ability to speak, eat, or even recognize one’s own face. Across the Asia-Pacific, these cancers are both more prevalent and frequently diagnosed at later stages, leaving patients with limited and invasive treatment options.

Rakuten Medical, a U.S.-based biotech company with deep roots in Asia, believes it doesn’t have to be this way. Its photoimmunotherapy platform, Alluminox™, delivers a first-in-class, drug-device treatment that combines antibody targeting with light activation to selectively destroy cancer cells while sparing healthy tissue. Already approved and in use in Japan, the therapy offers a minimally-invasive alternative for patients where traditional surgery or chemotherapy may be life-altering.

Now in a global Phase 3 trial, Rakuten Medical is eyeing Taiwan not just as a trial site—but as a launchpad for a more humane future of cancer care—one that treats aggressively, but preserves voice, identity, and the ability to live.

From Health Ministry to Biotech Boardroom

Leading this global push is Minami Maeda, President of Rakuten Medical, whose background spans Japan’s Ministry of Health, the Prime Minister’s Office, McKinsey & Company, and now, biotech. Despite shifting sectors, Maeda’s goal has remained the same: drive transformative change.

“I’ve always wanted to make society better—whether through government, consulting, or now biotech,” he shared. “At the Ministry, cancer treatment costs were rising 10 to 15 percent each year, but outcomes weren’t improving. We were prolonging life, not curing. That’s not sustainable.”

Maeda’s path shifted when he met Rakuten Group CEO Hiroshi “Mickey” Mikitani, who introduced him to a novel light-based therapy combining a drug with a targeted illumination device. Intrigued by its potential, Maeda joined Rakuten Medical as its 30th global employee. Since then, he has helped transform the company into a global clinical-stage innovator—overseeing initiatives like the Phase 3 ECLIPSE trial and a regional commercialization partnership with Orient EuroPharma (OEP) spanning Taiwan, Singapore, Malaysia, and the Philippines.

The Challenge: Surviving Cancer Without Losing Everything

In head and neck cancers, treatment often comes at a steep cost: disfigurement, speech loss, swallowing difficulty, or lifelong feeding tubes. Even successful treatment can lead to emotional devastation and social isolation.

“Not many people realize this, but head and neck cancers have one of the highest suicide rates,” Maeda noted. “When you lose the ability to eat, speak, or even recognize your own face in the mirror—those are things tied to human dignity.”

These impacts are especially acute in Asia, where oral cancer strikes younger, working-age individuals. Patients are often forced to choose between life and quality of life—between surviving and maintaining identity.

Rakuten Medical aims to eliminate that trade-off. Its lead candidate, ASP‑1929, targets tumors with precision using a combination of antibody-dye conjugates and localized red-light activation, potentially avoiding long-term physical and psychological damage.

Minami Maeda, President of Rakuten Medical, shares how Taiwan’s strong clinical infrastructure and high medical need make it a strategic launchpad for this next-generation therapy. Image: GeneOnline.

ASP‑1929: First-in-Class Photoimmunotherapy

ASP‑1929 is the world’s first approved photoimmunotherapy, currently used in Japan for patients with locally advanced or recurrent head and neck cancer. The treatment combines a drug-device system: a light-activatable dye (IR700) is bound to an antibody that targets tumor cells. When exposed to 690nm red light, the dye triggers rapid cell membrane disruption—killing the cancer cells and releasing tumor antigens to activate the immune system.

In real-world clinical use, ASP‑1929 photoimmunotherapy has demonstrated promising outcomes. A single-site observational study in Japan (n=26) reported a 77% response rate, including complete responses in up to 19%, with median overall survival extending to 28.2 months—a threefold improvement over prior Phase 1/2a trial data. These findings are further supported by post-marketing surveillance involving 136 patients, in which ASP-1929 photoimmunotherapy demonstrated a 68% response rate, including 32% complete responses.

“What we’re doing is preserving what matters,” said Maeda. “We’re treating the cancer, yes—but we’re also helping patients keep their voice, their ability to eat, to live.”

ECLIPSE Trial: Global Rigor, Local Urgency

Rakuten Medical’s global Phase 3 trial, known as ECLIPSE, is currently enrolling patients in the United States, Japan, and Taiwan, with plans to open additional sites in Ukraine and Poland. In Taiwan alone, nearly 10 clinical centers are actively recruiting patients—a sign of both local engagement and strong institutional support.

The trial is evaluating ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line treatment for locoregional recurrent head and neck squamous cell carcinoma (HNSCC). The study builds on previous clinical data from the United States, and is designed to demonstrate the treatment’s safety, efficacy, and global scalability.

At ASCO 2025, Rakuten Medical presented their Trial-in-Progress poster detailing the study’s methodology, therapeutic mechanism, and international rollout—an important milestone that signals growing recognition within the oncology research community.

“Enrollment in Taiwan has been very strong,” Maeda said. “We’re seeing great collaboration across surgical and oncology teams, which really highlights both the medical need here and the interest in better, less invasive treatment options for head and neck cancer.”

Rakuten Medical aims to complete trial enrollment by 2027, with a target to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) by the end of 2028. A successful BLA submission would mark a critical step toward securing commercial approval in the U.S.—the world’s largest pharmaceutical market—and would serve as a regulatory benchmark for other countries, including those in Asia-Pacific.

Why Taiwan? Scalability for High Need, High Readiness

Taiwan’s high oral cancer burden makes it a compelling candidate for early market introduction. The disease, often linked to betel nut chewing and tobacco use, affects a younger demographic and presents a persistent public health challenge. Against this backdrop, Rakuten Medical sees an opportunity not just to treat—but to transform outcomes.

According to Maeda, ASP‑1929 photoimmunotherapy’s design makes it particularly well-suited to healthcare environments that demand both accessibility and efficiency. The therapy requires no extensive infrastructure overhaul: it’s portable, cost-effective, and non-disruptive to hospital workflows, with minimal downtime for patients.

“We’re not just targeting major academic centers,” Maeda noted. “Our technology is scalable. It fits both top-tier hospitals and more community-based settings.”

This scalability is central to Rakuten Medical’s broader platform strategy. While the ECLIPSE trial paves the way for commercial entry in recurrent head and neck cancer, the ASP-1929 photoimmunotherapy is already being explored for additional tumor types—including vulvar, vaginal, cervical, and esophageal cancers—through investigator-initiated trials.

Beyond ASP‑1929, the pipeline includes:

• RM‑1995: Targets CD25+ regulatory T cells in liver metastases
• RM‑0256: A PD-L1-directed therapy for solid tumors including skin and breast cancers
• Preclinical assets: Targeting HER2, PSMA, and MUC1—relevant to breast, prostate, and bladder cancers, among others

“We want to make sure we have therapies lined up for all types of solid tumors,” said Maeda. “The goal is to cover every major indication where immune targeting plus local precision therapy can make a difference.”

On the device side, Rakuten Medical has bolstered its in-house capabilities by acquiring Medlight SA specializing in illumination systems—ensuring vertical integration across the drug-device combination platform. This strategic move gives the company full control over its technology stack, from antibody conjugates to hardware manufacturing, positioning it for efficient scaling and quality assurance.

A Mission Grounded in Humanity

While the science and systems are key, Rakuten Medical’s mission is ultimately patient-driven. The company’s origin story is deeply personal—born from CEO Mickey Mikitani’s search for better treatment after his father’s cancer diagnosis. That sense of urgency still shapes the company’s ethos today.

“We’re one of the few companies with a late-stage asset that’s already approved in Japan and supported by real-world data,” Maeda said. “That puts us in a unique position—not just to innovate, but to deliver.”

With the ECLIPSE trial underway, real-world results from Japan, and an expanding clinical and commercial footprint, Rakuten Medical is not just pursuing a new drug approval—it’s shaping a new category of care. One that treats aggressively, but heals gently. One that aims not just for survival—but for dignity, mobility, and the chance to keep living life.

Author

Bernice Lottering