Daiichi Sankyo has entered into an exclusive licence agreement worth up to $300m with Alteogen to develop a subcutaneous version of its AstraZeneca-partnered antibody-drug conjugate (ADC) Enhertu (fam-trastuzumab deruxtecan-nxki).
The deal gives Daiichi Sankyo the worldwide rights to use Alteogen’s hyaluronidase-utilising hybrozyme technology, ALT-B4, to develop and commercialise the new formulation.
Under the terms of the agreement, Alteogen will receive an upfront payment of $20m and will be eligible for up to $280m based on Daiichi Sankyo’s achievement of specified development, regulatory and sales milestones, plus tiered royalties.
ADCs are a new class of cancer therapies designed to precisely target and kill tumour cells while sparing healthy ones.
Enhertu, administered as an intravenous (IV) infusion, is specifically directed at HER2, a tyrosine kinase receptor growth-promoting protein expressed on the surface of various tissue cells throughout the body. In some cancers, HER2 expression is amplified or the cells have activating mutations, and HER2 protein overexpression is often associated with aggressive disease and poor prognosis.
The therapy already holds approvals for a range of indications, including certain cases of breast cancer, non-small cell lung cancer and gastric cancer.
It was also recently granted accelerated approval by the US Food and Drug Administration to treat a subset of patients with advanced solid tumours.
Alteogen’s ALT-B4 can enable the large volume subcutaneous administration of drugs that are typically administered as an IV infusion by temporarily hydrolysing hyaluronan in the extracellular matrix, according to the South Korea-based biopharma.
Soon Jae Park, Alteogen’s chief executive officer, 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.”
The announcement comes less than two months after Daiichi Sankyo and Merck & Co – known as MSD outside the US and Canada – shared positive results from a late-stage trial of their HER3-directed ADC patritumab deruxtecan in patients with locally advanced or metastatic EGFR-mutated NSCLC who have previously received EGFR tyrosine kinase inhibitor treatment.