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news.Alteogen has entered into an exclusive license agreement with Daiichi Sankyo for the development and commercialisation of a subcutaneous version of ENHERTU (fam-trastuzumab deruxtecan-nxki), an antibody drug conjugate (ADC).
ALT-B4 will be used for developing the subcutaneous formulation ENHERTU. Credit: National Cancer Institute on Unsplash.
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ALT-B4 will be used for developing the subcutaneous formulation ENHERTU.
As per the agreement, Daiichi Sankyo will gain global rights to utilise Alteogen’s ALT-B4, a human recombinant hyaluronidase enzyme.
Furthermore, Alteogen is entitled to receive an upfront payment and milestone payments upon the achievement of certain development, regulatory, and sales-based goals from Daiichi Sankyo.
Alteogen is also eligible for tiered royalty payments on product sales upon commercialisation and will supply ALT-B4 for both clinical and commercial use to Daiichi Sankyo.
Developed using Alteogen’s Hybrozyme technology, ALT-B4 facilitates the subcutaneous administration of large-volume drugs usually delivered via intravenous (IV) infusion. The enzyme works by temporarily hydrolysing hyaluronan in the extracellular matrix.
Alteogen CEO Dr 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.”
Founded in 2008, Alteogen specialises in developing biologics, including ADCs, biobetters, and biosimilars.
The company’s portfolio comprises clinical-stage long-acting therapeutic proteins and next-generation ADCs developed through its platform technologies, NexP-fusion and NexMab.
ENHERTU is a human epidermal growth factor receptor 2 (HER2) directed antibody drug conjugate (ADC).
Daiichi Sankyo has been co-developing and co-commercialising ENHERTU along with AstraZeneca.
The asset received conditional approval in China for treating patients with non-small cell lung cancer with HER2 mutations in October this year.
This approval from China’s National Medical Products Administration (NMPA) is based on the data from the Phase II studies, DESTINY-Lung02 and DESTINY-Lung05.
