STA and WuXi Biologics – the respective small and large molecule contract development and manufacturing organisation (CDMO) divisions of WuXi AppTec – are seeing increased demand for their ADC services, buoyed by recent regulatory approvals.
“In the last few years, the ADC therapeutic class has become one of the hottest areas of research thanks to its unique characteristics,” Youchu Wang, VP of Process R&D at STA told Biopharma-Reporter.
“It’s especially true now that there are four approved drugs on the market and many discovery companies both biotech and pharma are exploring targets.”
Roche’s Kadcyla (ado-trastuzumab emtansine) and Takeda/Seattle Genetic’s Adcetris (brentuximab vedotin) have been available in a number of markets for several years. But in August, the US Food and Drug Administration (FDA) approved Pfizer’s Besponsa (inotuzumab ozogamicin), and the following month the reapproval of Pfizer’s Mylotarg (gemtuzumab ozogamicin) put the number of ADCs in the US at four.
And according to Wang, there are now more than eight ADCs in Phase III trials and more than 60 in Phases I and II, and this is driving demand for STA and WuXi’s services.
“We are seeing demand increasingly coming from companies focusing on this area, but significantly from locations all the world including the US, Europe, China – rather than just the USA as we might have seen five years ago.”
To support this, WuXi Biologics is investing in a new ADC-conjugation and fill and finish facility in Wuxi city, China, he told us, set to be available by the end of 2018. And as demand continues to grow, “STA may invest in additional larger scale high potency facilities” over the next few years.
CDMO market
WuXi/STA is one of a number of CDMOs offering ADC-specific services. Piramal, ADC Bio and Althea are among some of the others which have recently invested in the space.
“For the CDMO market, integrated companies are especially important, as biotechs are unlikely to have much in-house manufacturing to take the product through development,” Wang said. “So the ability to work with global partners that can handle it is a huge advantage, and by this I mean from pre-clinical through to commercial.”
He argued the combined services offered between STA and WuXi Biologics brings integrated capabilities for developing the process and manufacture the cytotoxic payload, the linker and the antibody in-house, as well as running the conjugation to support all stages of the product’s development cycle
“As we see a growing market of the ADC therapeutics, it’s undoubtable that companies will prefer to work with integrated, global partners to speed up their development and commercialisation.”