Alteogen 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).
This 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, which is a South Korea-based biopharmaceutical company. The former 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 Korean firm 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.
Alteogen CEO Soon Jae Park said: “Our collaboration with Daiichi Sankyo is groundbreaking in the ADC field, being the first to use hyaluronidase for a subcutaneous ADC marks a significant milestone in the oncology field, and we look forward to our collaboration with Daiichi Sankyo in bringing this product to the market.”
Earlier this year, Alteogen reported that the South Korean Ministry of Food and Drug Safety (MFDS) approved its new drug application (NDA) for Tergase, a recombinant hyaluronidase developed using the Hybrozyme technology.
Tergase, a human recombinant hyaluronidase, is primarily intended for use in dermal filler removal but has additional applications, including as a local anaesthetic solution in eye surgeries and for pain management in orthopaedics.
