AstraZeneca (AZ) has invested up to $6bn in a new partnership with Japanese pharma company Daiichi Sankyo (Daiichi) for the development of a novel antibody drug conjugate (ADC).
The focus of the deal is an experimental ADC – DS-1062 – which is currently in development for the treatment of a number of multiple tumours which express the cell-surface glycoprotein TROP2.
According to AZ, TROP2 is over-expressed in the majority of non-small cell lung cancers (NSCLC) and breast cancers. Both cancer types are of particular interest for AZ as it plans to extend its oncology franchise beyond its approved therapies, which include PD-1 inhibitor Imfinzi (durvalumab), lymphoma treatment Calquence (acalabrutinib) and its recently approved, Daiichi-partnered HER2-targeting ADC, Enhertu (trastuzumab deruxtecan).
Enhertu was the focus of a previous collaboration between AZ and Daiichi – in March 2019, AZ agreed a $6.9bn deal for access to the drug. Last December, the therapy was approved by the US Food and Drug Administration (FDA) for the treatment of metastatic HER2-positive breast cancer in patients who have been previously treated with two or more HER-2-based regimens.
The new deal for DS-1062 signals AZ’s continued interest in Daiichi’s ADC candidates. DS-1062 could also cover more ground for AZ and open up a significant patient population for both companies – TROP2 is expressed in up to 80% of triple-negative breast cancer patients, and has also been identified in a majority of NSCLC patients.
The NSCLC market is particularly lucrative, and is currently dominated by Merck & Co’s Keytruda (pembrolizumab), a PD-1 inhibitor which has become a standard treatment for newly-diagnosed NSCLC patients since its initial approval in 2015.
Under the terms of the deal, AZ will pay Daiichi $1bn upfront in staged payments, with additional conditional amounts of up to $1bn when the drug achieves regulatory approval and up to $4bn for sales-related milestones. Both companies will jointly develop and commercialise DS-1062 worldwide, apart from in Japan where Daiichi will retain exclusive rights.
“We see significant potential in this antibody drug conjugate in lung as well as in breast and other cancers that commonly express TROP2. We are delighted to enter this new collaboration with Daiichi Sankyo and to build on the successful launch of Enhertu to further expand our pipeline and leadership in oncology,” said Pascal Soriot, chief executive officer of AZ.
Sunao Manabe, representative director, president and CEO of Daiichi Sankyo, said: “This new strategic collaboration with AstraZeneca, a company with extensive experience and significant expertise in the global oncology business, will enable us to deliver DS-1062 to more patients around the world as quickly as possible. As we have done with Enhertu, we will jointly design and implement strategies to maximise the value of DS-1062.”