To support its growing antibody-drug conjugate portfolio, AstraZeneca on Monday said it is investing $1.5 billion in a Singapore production site that will include all steps of the ADC manufacturing process.
AstraZeneca on Monday revealed plans to construct an end-to-end production facility in Singapore, designed to span the entire manufacturing process for its growing portfolio of antibody-drug conjugates.
The U.K.-Swedish pharma has earmarked $1.5 billion for the plant with plans to start design and construction by the end of 2024 and be operationally ready by 2029. The Singapore facility, supported by the country’s Economic Development Board, will allow the company to manufacture antibody-drug conjugates (ADCs) at a commercial scale, according to the announcement.
The new facility will be AstraZeneca’s first end-to-end production site for ADCs capable of producing the antibody molecule, the chemotherapy drug and the linker. The plant will also be able to combine these three main elements of the ADCs as well as fill vials with the completed substances.
In line with the pharma’s sustainability drive, AstraZeneca will partner with the Singapore government to employ green solutions for its facility, which will emit zero carbon from its first day of operations, according to the announcement.
CEO Pascal Soriot in a statement said that the company is “excited” about the facility, which will allow the pharma to boost its global supply for its “industry-leading portfolio of cancer medicines” including clinical and preclinical ADCs.
AstraZeneca has six clinical-stage ADCs including datopotamab deruxtecan, an anti-TROP2 ADC being developed under a partnership with Daiichi Sankyo. In February 2024, the FDA accepted the partners’ Biologics License Application for the candidate, proposing datopotamab deruxtecan as a treatment of advanced or metastatic non-small cell lung cancer (NSCLC) in patients who had been exposed to prior systemic therapy.
In this indication, datopotamab deruxtecan is backed by the Phase III TROPION-Lung01 study. The trial found that the ADC met its dual primary endpoints, significantly improving progression-free survival and overall survival versus docetaxel, which is the current standard of care.
The FDA’s verdict is due in the fourth quarter of this year. If approved, datopotamab deruxtecan would become the first TROP2-targeting ADC in lung cancer.
AstraZeneca also owns the blockbuster ADC Enhertu (fam-trastuzumab deruxtecan-nxki), also under a partnership with Daiichi Sankyo. Enhertu was first approved in December 2019 for the treatment of unresectable or metastatic HER2-positive breast cancer in patients who had undergone at least two previous lines of treatment.
Enhertu has since picked up other indications including HER2-low metastatic breast cancer and previously treated HER2-positive NSCLC. In April 2024, the ADC won a tumor-agnostic approval allowing its use in patients with HER2-positive solid tumors that had been exposed to prior systemic treatment and who have no other viable treatment options.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
