Rakuten Medical's ASP-1929 Phase III Trial with Keytruda Set for Second Half of 2024
Rakuten Medical is gearing up to launch a Phase III trial in the latter part of this year to assess the efficacy of its photoimmunotherapy, ASP-1929, in combination with Merck & Co's Keytruda as a first-line treatment for recurrent head and neck squamous cell carcinoma (HNSCC). This initiative stems from encouraging interim results observed in a Phase Ib/II trial, prompting optimism about the therapeutic potential of the combination. Notably, ASP-1929 is a distinctive antibody-dye conjugate integrating cetuximab, an EGFR antagonist, and a light-activated dye, IRDue 700DX, which responds to red light through a photochemical reaction.
Key Takeaways
- Rakuten's Phase III trial entails assessing the photoimmunotherapy with Keytruda for recurrent HNSCC in the latter part of 2024.
- ASP-1929, an antibody-dye conjugate, demonstrated favorable interim results in the Phase Ib/II trial.
- The combined therapy aims to enhance first-line treatment for recurrent HNSCC, focusing on overall survival.
- ASP-1929 earned FDA fast track designation in 2018 and garnered approval in Japan for specific head and neck cancers.
- The Phase III trial, financed by the recent $119 million Series E round, is set to enroll 275 participants with recurrent HNSCC.
Analysis
The upcoming Phase III trial involving Rakuten Medical's ASP-1929 in conjunction with Merck's Keytruda for recurrent HNSCC holds the promise of reshaping first-line treatments, leveraging ASP-1929's unique modality incorporating a light-activated dye. Encouraging interim data indicates the potential for improved survival rates, while concerns persist regarding severe adverse reactions. This development significantly impacts oncology stakeholders, including patients, healthcare providers, and investors, with potential implications for long-term survival rates and market expansion. The trial's success could validate innovative drug combinations, secure additional funding, and influence future research and development strategies in targeted cancer therapies.
Did You Know?
- Photoimmunotherapy: This treatment method fuses the specificity of monoclonal antibodies with the cell-killing capacity of photodynamic therapy. ASP-1929, in this context, represents a photoimmunotherapy agent employing a light-activated dye (IRDye 700DX) conjugated to cetuximab, which targets EGFR. Upon exposure to red light, the dye activates, triggering a photochemical reaction that selectively induces cell death in cancer cells expressing EGFR.
- EGFR Antagonist (Cetuximab): Cetuximab, a monoclonal antibody, specifically targets the Epidermal Growth Factor Receptor (EGFR), a protein commonly overexpressed in various cancers. By binding to EGFR, cetuximab thwarts the receptor's activation by growth factors, thereby impeding the proliferation and survival of cancer cells. In ASP-1929, cetuximab facilitates the targeted delivery of the light-activated dye to EGFR-expressing cancer cells.
- Series E Financing: This denotes the fifth financing round for a company, usually preceding an IPO or when substantial capital is needed to scale operations or develop new products. In Rakuten Medical's case, the $119 million secured in Series E supports the advancement of its Alluminox drug discovery platform and the ongoing Phase III trial of ASP-1929.