Daiichi partners with Alteogen in $300M Enhertu subcutaneous deal

Daiichi Sankyo has entered into a significant partnership with Alteogen to leverage its hyaluronidase technology for developing a subcutaneous (SC) version of Daiichi's prominent antibody-drug conjugate (ADC). This collaboration, valued at up to $300 million, aims to formulate a SC variant of Enhertu, scientifically known as fam-trastuzumab deruxtecan-nxki, which is co-marketed with AstraZeneca. Enhertu, a treatment for various cancers including breast, lung, and gastric, recently received accelerated approval from the FDA for HER2-positive solid tumors.

As part of the agreement, Daiichi Sankyo will make an initial payment of $20 million to obtain an exclusive license to Alteogen's ALT-B4 hyaluronidase, which is essential for the development of the SC version of Enhertu. Additionally, Alteogen stands to gain up to $280 million in milestone payments along with royalties if the project reaches its goals. This advancement is poised to make Enhertu the first SC ADC, marking a significant innovation in oncology treatment options.

The use of hyaluronidase technology for SC formulations is not entirely new; it has been increasingly adopted for transforming infusible biologics into injectable forms. However, its application to ADCs is unprecedented. A recent example of hyaluronidase technology in action is Roche's Tecentriq Hybreza, the first injectable PD-L1 inhibitor available in the US. This SC version, administered in just seven minutes, utilizes a proprietary recombinant human hyaluronidase licensed from Halozyme.

Alteogen’s Hybrozyme platform plays a crucial role in enhancing the absorption of biologics by integrating an enzyme that significantly improves enzymatic activity and thermal stability. This platform's effectiveness has already been recognized through three other agreements with various biopharmaceutical companies for its hyaluronidase technology.

The collaboration between Daiichi Sankyo and Alteogen highlights the growing trend and potential of SC formulations in the biopharmaceutical industry. The move towards SC versions of traditionally infused drugs offers numerous benefits, including greater convenience for patients, reduced administration times, and potentially improved drug absorption rates.

This partnership not only underscores Daiichi Sankyo's commitment to innovation in cancer treatment but also positions Alteogen's hyaluronidase technology as a valuable asset in the biopharma sector. If successful, the development of SC Enhertu could set a new standard for ADC administration, offering a more efficient and patient-friendly alternative to intravenous infusions. As the project progresses, the biopharma community will be watching closely to see if this pioneering approach can achieve its milestones and ultimately transform cancer care practices.