Daiichi Sankyo inks $300m Enhertu licensing deal with Alteogen

Daiichi Sankyo has forged an exclusive licensing partnership with Alteogen, valued at up to $300 million, to create a subcutaneous form of the antibody-drug conjugate (ADC) Enhertu (fam-trastuzumab deruxtecan-nxki), which is co-developed with AstraZeneca. This agreement grants Daiichi Sankyo global rights to leverage Alteogen's hyaluronidase-utilizing hybrozyme technology, ALT-B4, for the development and marketing of the new formulation.

The terms of the deal include an upfront payment of $20 million to Alteogen. Additionally, Alteogen stands to gain up to $280 million contingent on Daiichi Sankyo achieving certain development, regulatory, and sales milestones, along with tiered royalties. ADCs represent a novel class of cancer treatments designed to selectively target and eliminate tumor cells while minimizing damage to healthy cells.

Enhertu is administered intravenously and specifically targets HER2, a receptor protein that promotes cell growth and is found on the surface of various tissue cells. Overexpression of HER2, often seen in certain cancers, is linked to aggressive disease and poor outcomes. Enhertu is already approved for multiple uses, including particular types of breast cancer, non-small cell lung cancer, and gastric cancer. Recently, it received accelerated approval from the US Food and Drug Administration for treating a subset of patients with advanced solid tumors.

Alteogen's ALT-B4 technology allows large-volume drugs, typically given intravenously, to be administered subcutaneously by temporarily breaking down hyaluronan in the extracellular matrix. This approach could significantly improve the convenience and accessibility of such treatments.

Soon Jae Park, CEO of Alteogen, expressed enthusiasm about the collaboration, highlighting its groundbreaking nature in the ADC field. He emphasized that this partnership marks a significant milestone in oncology, being the first to utilize hyaluronidase for a subcutaneous ADC. Park also expressed optimism about the joint efforts with Daiichi Sankyo to bring this innovative product to market.

This announcement follows closely on the heels of positive results from a late-stage trial by Daiichi Sankyo and Merck & Co, known as MSD outside the US and Canada. The trial focused on their HER3-directed ADC, patritumab deruxtecan, in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who had previously undergone EGFR tyrosine kinase inhibitor treatment.