Daiichi Sankyo Invests Roughly $1.08 Billion to Expand German Production and Development Site for ADCs

Daiichi Sankyo announced on Feb. 16, 2024 that it will invest approximately €1 billion (US$1.08 billion) into its Pfaffenhofen an der Ilm, Germany, site to expand production and development and transform the site into an international innovation center. Among other therapies, the site will serve the development and production of antibody drug conjugates (ADCs). The expansion is expected to be completed by 2030, with at least 350 new jobs to be created by completion.

In addition to the establishment of additional production capacity in the cardiovascular disease area, new laboratories will be created, particularly for ADC technology. Looking to the future, novel cancer therapies against breast, lung, and stomach cancer, among others, will be developed and manufactured in the Pfaffenhofen site.

“The fact that we will focus more on oncological therapies in Pfaffenhofen in the future is positive in two respects, especially for patients. … On the one hand, we can make a significant contribution to the increased global demand for ADC cancer therapies. On the other hand, we are demonstrating our future viability and the top quality that we provide here,” said Matthias Kühn, site manager at Daiichi Sankyo Europe in Pfaffenhofen, in a company press release.

Among the elements of expansion will be the construction of a new building for Daiichi Sankyo's technology for ADCs. This building is scheduled to be completed by the end of 2026. FDA recently accepted the biologics license application (BLA) for Daiichi Sankyo’s ADC product, datopotamab deruxtecan, the company announced on Feb. 19, 2024. The BLA is seeking approval for treating adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer who have received prior systemic therapy.

The BLA is based on results from a pivotal Phase III trial (TROPION-Lung01), in which datopotamab deruxtecan demonstrated a statistically significant improvement for the dual primary endpoint of progression-free survival compared to docetaxel (current standard of care) in patients with locally advanced or metastatic NSCLC treated with at least one prior line of therapy. The trial is ongoing, and overall survival will be assessed at final analysis.

Datopotamab deruxtecan is an investigational trophoblast cell-surface antigen 2 (TROP2)-directed ADC that was designed with Daiichi Sankyo’s proprietary DXd ADC technology. It comprises a humanized anti-TROP2 immunoglobulin G1 monoclonal antibody (developed in collaboration with Sapporo Medical University) attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) using tetrapeptide-based cleavable linkers, according to a company press release.

Daiichi Sankyo has a global collaboration with AstraZeneca to jointly develop and commercialize datopotamab deruxtecan, which the companies entered into in July 2020 (1), except in Japan where Daiichi Sankyo maintains exclusive rights.

“We are encouraged by [FDA's] acceptance of the BLA as we endeavor to make datopotamab deruxtecan the first TROP2-directed antibody drug conjugate approved to treat patients with nonsquamous non-small cell lung cancer after disease progression on prior systemic therapy. We look forward to working closely with [FDA] to bring datopotamab deruxtecan to patients,” said Ken Takeshita, global head, R&D, Daiichi Sankyo, in another company press release.

“Datopotamab deruxtecan has the potential to offer patients with previously treated advanced nonsquamous non-small cell lung cancer an effective and tolerable alternative to conventional chemotherapy,” said Susan Galbraith, executive vice-president, Oncology R&D, AstraZeneca, in the release. “With regulatory discussions ongoing around the world and a parallel submission underway in the [United States] in breast cancer, this is only the beginning of our efforts to make this novel treatment available to patients as quickly as possible.”

A parallel BLA for datopotamab deruxtecan, based on results from the Phase III trial, is pending acceptance in the US for treating adult patients with metastatic hormone receptor-positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer. Additional regulatory submissions in lung and breast cancer are also underway globally.

Source: Daiichi Sankyo for site expansion and regulatory update