After developing an innovative CAR-T cell therapy candidate that showed promising clinical data, Legend Biotech entered into an exclusive, worldwide license and collaboration agreement with Janssen Biotech Inc. in December 2017. The goal: to develop and commercialize this investigational product known as ciltacabtagene autoleucel (cilta-cel).
In Europe, Legend Biotech Belgium B.V. and Janssen Pharmaceutica N.V. are constructing a cell therapy manufacturing hub in Flanders’ Ghent biotech valley. The facility, which is still under construction, is scheduled to be operational by 2023 and will serve as the EMEA production hub initially operated by Legend and Janssen. Once the facility has been approved by the Federal Agency for Medicines and Health Products (FAMHP), it will be operated by Legend Biotech to manufacture cilta-cel.
Founded in 2014, Legend Biotech focuses on the discovery and development of novel cell therapies for the treatment of diseases that are intractable or incurable today, including cancer. Its lead product, ciltacabtagene autoleucel or cilta-cel, is an investigational B-cell maturation antigen-targeted chimeric antigen receptor T-cell (CAR-T) therapy. CAR-T cell therapy is a complex and highly personalized technology where a person’s own T-cells are extracted from the blood and reprogrammed to target and kill cancer cells.
Cilta-cel aims to treat relapsed or refractory multiple myeloma and is currently being reviewed by the European Medicines Agency (EMA). Once marketing authorization is obtained, cilta-cel will be marketed by Janssen in this region
In 2021, Legend Biotech and Janssen started construction of a European manufacturing and logistics hub for CAR-T at Tech Lane Ghent Science Park, a vibrant ecosystem of international corporate R&D centers, public research institutes and high-tech growth enterprises in Flanders. It’s Legend Biotech’s first presence in continental Europe. “With this 26,000-square-meter hub, we are bringing a significant manufacturing capacity into Flanders’ ecosystem. This is quite a unique scale within cell therapy,” says Birk Vanderweeën, General Manager Europe at Legend Biotech. “Jansen has been an indispensable partner in laying the groundwork for the facility.”
Once it has been approved by the Belgian regulatory authority Federal Agency for Medicines and Health Products (FAMHP), Legend Biotech will operate the Ghent facility and oversee clinical and commercial production of cilta-cel at this manufacturing hub. “Through this partnership with Janssen, we have not only gained access to Flanders’ incredible talent pool, but we have also become part of a strong biopharma ecosystem. We couldn’t be more thrilled. We believe that our company fits perfectly within Flanders’ prominent life sciences community,” Birk Vanderweeën adds.
Legend Biotech currently employs over 1,000 people in the US, China, Belgium and Ireland, where its European HQ is based. Through the investment in Flanders, the fast-growing company expects to hire a significant number of employees over the next few years.
“The Ghent biotech cluster not only gives us access to strong local talent. It also offers the ability to invest in our workforce thanks to the solid training support we’ve received from the government of Flanders,” says Liz Gosen, Senior Vice President of Technical Operations at Legend Biotech. “The new hub in Ghent will focus on the production of cell therapies, which are tailored to each individual patient. CAR-T is an exciting and sophisticated technology that requires highly skilled and trained people to develop and manufacture.”
“When we were deciding where to invest, quite a few locations in different countries were in the running,” Liz Gosen adds. “Belgium’s northern region, Flanders, is known to be a center of excellence in life sciences. Add to that its ideal geographical location in the heart of Europe, its proximity to Brussels Airport and strong governmental support, and it’s clear that Flanders ticks all the right boxes.”
Nonetheless, setting up a business in a new market can still be quite an effort. Lis Gosen: “On that note, we are extremely grateful for the help and advice we received from Flanders Investment & Trade, which guided us toward the right people and partnerships.”
The investment marks only the beginning of Legend Biotech’s European ambitions. “Our new site in Flanders is our first manufacturing facility in continental Europe, and it will play a critical role in our mission to develop and deliver innovative cell therapies to patients globally,” Liz Gosen asserts. “Legend Biotech has more than ten programs in the pipeline. The work we do today, if successful, will lay the foundation for us to provide different options across Europe in the years to come.”
In February 2020, the European Commission granted orphan designation to cilta-cel, which intends to support the development of innovative medicines addressing a significant unmet need for patients with life-threatening or chronically debilitating rare diseases with a prevalence of less than 5 in 10,000 in the EU. Liz Gosen: “We are eagerly anticipating the approval of cilta-cel by EMA and the European Commission, and it is our ambition to continue growing our manufacturing presence in Europe, with Flanders as our home base.”
“CAR-T cell therapy will play a part in the future of healthcare, with the potential to give hope to cancer patients currently in need of new options,” Birk Vanderweeën concludes. “Legend and Janssen are not just constructing the right infrastructure for this product; we are focused on building our cell therapy capability for many years to come. It’s wonderful to be recognized for our ambitions by the government of Flanders.”