Alteogen Signs USD 280 Million Licensing Agreement with Daiichi Sankyo
echnology to Develop Subcutaneous Injection for ADC Cancer Drug 'Enhertu'
Alteogen is advancing in the development of the world’s first subcutaneous (SC) injection for antibody-drug conjugates (ADCs).
On the 8th, Alteogen announced it signed an exclusive licensing agreement with Japanese pharmaceutical company Daiichi Sankyo for its human hyaluronidase, ALT-B4. The two companies will use ALT-B4 to develop a subcutaneous version of the ADC cancer treatment Enhertu.
Under the terms of the deal, Alteogen will receive an upfront payment of USD 20 million, with additional potential milestone payments of up to USD 280 million based on development, regulatory approvals, and sales across various countries.
Injecting drugs into subcutaneous tissue has advantages over oral administration, including faster absorption, reduced impact from digestive fluids, and shorter administration times. However, since the subcutaneous layer is protected by hyaluronic acid, drug delivery can be challenging. Hyaluronidase overcomes this by breaking down hyaluronic acid, facilitating drug absorption into subcutaneous tissue.
ALT-B4, the hyaluronidase technology licensed by Alteogen, is derived from human cells and increases subcutaneous permeability, enabling better drug absorption. In February, Alteogen also signed an exclusive license agreement with MSD for the development of a subcutaneous formulation of Keytruda, a blockbuster immuno-oncology drug, using ALT-B4.
The potential of subcutaneous formulation development is particularly promising for Enhertu, Daiichi Sankyo’s ADC treatment. ADCs combine an antibody, which targets cancer cells, with a drug that kills them, enabling targeted cancer cell elimination while sparing healthy cells. This precision makes ADCs one of the next-generation cancer treatments.
Enhertu, specifically designed for HER2-positive breast cancer, combines trastuzumab (an antibody targeting the HER2 protein) with deruxtecan, a cancer-killing agent. In April of this year, the U.S. FDA approved Enhertu as a treatment for all solid tumors with HER2 expression, and it achieved blockbuster status with USD 2.78 billion in sales last year.
If Daiichi Sankyo successfully develops an SC version of Enhertu with Alteogen’s hyaluronidase technology, it would become the world’s first SC formulation of an ADC cancer treatment. For Alteogen, this collaboration is expected to catalyze further partnerships with other global pharmaceutical companies.
An Alteogen spokesperson noted, “Given that most ADC treatment patients are advanced-stage cancer patients, developing an SC formulation could provide substantial advantages.”
Alteogen’s CEO, Park Soon-jae, added, “Through our partnership with Daiichi Sankyo, we aim to develop an SC formulation for Enhertu that provides patients and healthcare providers with an alternative administration route. We look forward to incorporating ALT-B4 into more treatments to expand therapeutic options for patients.”