Alteogen, a South Korea-based biopharmaceutical company, has entered into an exclusive licensing agreement with Daiichi Sankyo to develop and commercialise a subcutaneous version of Enhertu (fam-trastuzumab deruxtecan-nxki), a HER2-targeted antibody-drug conjugate (ADC).

The agreement grants Daiichi Sankyo the global rights to apply Alteogen’s ALT-B4, a human recombinant hyaluronidase enabled by Hybrozyme technology, for the subcutaneous delivery of Enhertu. The cancer drug has been co-developed and marketed by Daiichi Sankyo in partnership with AstraZeneca.

Under the terms of the agreement, Daiichi Sankyo will make an initial payment to Alteogen, and may also provide additional milestone payments based on specified achievements in the drug’s development, regulatory approval, and commercial sales. Moreover, Alteogen will receive tiered royalties from sales of the final subcutaneous Enhertu product. As per the terms, the Altogen will be responsible for supplying ALT-B4 to Daiichi Sankyo for both clinical trials and eventual commercial distribution.

ALT-B4 is a recombinant hyaluronidase enzyme developed using Hybrozyme technology, designed to facilitate large-volume subcutaneous administration of drugs that are typically delivered by intravenous infusion. It achieves this by temporarily hydrolysing hyaluronan in the extracellular matrix, which allows for greater volume in subcutaneous administration.