JAPAN —Astellas Pharma, a Tokyo-based biopharmaceutical company, has entered into a research collaboration with tech giant Sony Corporation to develop a groundbreaking platform for oncology therapeutics called antibody-drug conjugates (ADCs).
This partnership will utilize Sony’s biotech R&D arm, which will contribute its unique polymeric material known as Kiravia Backbone to serve as a linker for the novel ADC.
The linker molecule is a crucial component of ADCs as it determines both the effectiveness and potential adverse effects of the therapy.
An ideal linker should release the cytotoxic drug selectively within cancer cells, striking a balance between stability and instability.
If the linker is too stable, it may fail to release the drug, while an unstable linker can prematurely release the payload, causing harm to healthy cells.
The significance of choosing an appropriate linker was highlighted by the case of Pfizer’s Mylotarg, the first ADC approved in 2000.
It was later withdrawn from the market in 2010 due to severe liver toxicity caused by an unstable linker. In 2017, the drug was reintroduced at a lower dose following a redesign, but with a black-box warning from the FDA.
Astellas believes that Sony’s polymer design will effectively deliver the anti-cancer payload of the ADC to the targeted malignant cells, thereby enhancing efficacy while minimizing off-target side effects.
The collaboration between Astellas and Sony began with feasibility studies in human cancer cells in July 2022.
As part of the agreement, the companies will now focus on developing a novel ADC platform, with Astellas responsible for conducting non-clinical studies of the candidates.
Notably, Astellas already has a successful ADC on the market called Padcev, developed in partnership with Seagen for the treatment of urothelial cancer. Padcev generated impressive sales of US$451 million in 2022.
Astellas’ strategic expansion extends beyond oncology. Earlier this month, the company announced its acquisition of Iveric Bio for nearly US$6 billion, aiming to strengthen its focus on blindness and regeneration.
Iveric Bio’s C5 inhibitor is currently under priority review with the FDA, with a PDUFA goal date set for August 2023.
While Astellas’ annual revenue experienced a 5% decline last year, dropping to just under US$11 billion, the company remains committed to diversifying its portfolio and driving innovation in the pharmaceutical industry.
The ADC space has been witnessing a surge in activity. In March, Pfizer acquired Seagen for US$43 billion, with their ADC Adcetris approved for lymphoma and generating US$839 million in sales in 2022.
AstraZeneca also made significant ADC-related deals this year, investing up to US$600 million in LaNova Medicines for an ADC targeting GPRC5D in multiple myeloma.
Additionally, AstraZeneca paid US$63 million upfront to KYM Biosciences for its Claudin 18.2 ADC, with potential milestone payments of up to US$1.1 billion.
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