CARsgen Therapeutics Plans $157M, 200 Job Cell Therapy Facility in Durham County

Published May 21, 2021

Shanghai-based cancer immunotherapy innovator CARsgen joined the surge of gene- and cell-based therapy companies setting up shop in North Carolina today when it announced plans to invest $157 million to establish a Durham site that will employ 200 people by the end of 2026.

CARsgen Therapeutics Corporation, the U.S. entity of CARsgen, said it’s establishing the new Triangle facility to expand its capacity for manufacturing chimeric antigen receptor T cell (CAR-T) therapies, which are potentially game-changing weapons in the battle against cancer.

The two-phase plan calls for establishing a 35,000-square-foot research and development lab, followed by a 100,000-square-foot commercial manufacturing facility. The jobs at the site are to pay an average of $76,061 a year — slightly more than the Durham average of $75,892.

“Global companies know that North Carolina is a world class leader in biotechnology,” said Governor Roy Cooper in a statement about the announcement. “Our state’s skilled workers, educational institutions and business environment provide life science companies with the tools they need to succeed.”

CAR-T is an approach to fighting cancer using T cells – a type of immune system white blood cell that recognizes invading germs and cancer cells. Scientists are developing ways to engineer T cells to carry this “cancer bullet” called a tumor-targeting chimeric antigen receptor. These engineered cells have the potential to save the lives of many patients unresponsive to traditional chemotherapy and radiation regimens.

Uses patients’ own cells as cancer bullets

CARsgen is one of numerous companies developing autologous CAR-T therapies, which use patient-derived T cells that are extracted and individually “re-manufactured” in a lab for each patient, using that patient’s own cells to produce a cancer-fighting immune reaction when re-infused back into that patient’s body. 

The company was founded in 2014 by Zonghai Li, Ph.D., who leads as president, CEO, and chief scientific officer. It has established a broad pipeline of CAR-T product candidates covering several solid and blood tumors in areas of significant unmet medical need, including liver, lung, stomach, and brain cancers. The company has relationships with Shanghai Cancer Institute and Shanghai Renji Hospital.

The company has launched several “first-in-class” CAR-T clinical trials to treat relapsed/refractory tumors, including CAR-Claudin18.2-T for gastric and pancreatic cancer, CAR-GPC3-T for hepatocellular carcinoma and squamous lung cancer and CAR-EGFR/EGFRvIII-T for the deadly brain cancer glioblastoma. 

CARsgen also has ongoing clinical programs with product candidates to treat multiple myeloma and leukemia. The company maintains clinical research offices in Houston. It considered locating this new facility in Maryland, which offered a $35 million incentive package, but chose North Carolina, even though state and local incentives totaled only about $2.2 million.

“We are very excited to receive the JDIG grant approval from the State of North Carolina,” said Li. “CARsgen will continuously develop and embed innovations to advance the revolutionary CAR-T cell therapy for unmet clinical needs. The company has launched clinical studies of our leading CT053 and CT041 CAR-T cell therapies in the United States. The new facilities will expand our global cGMP manufacturing capacity to produce the innovative CAR-T cell products for the U.S. patients.”

Mike Walden, economist at North Carolina State University, said the CARsgen investment is ultimately expected to increase the state’s gross domestic product by $1 billion.

“We are thrilled that CARsgen has decided to join Durham’s life sciences community,” said Katie Stember, Ph.D., associate director of life science economic development for the North Carolina Biotechnology Center, who provided technical support in the CARsgen recruitment.  “CARsgen’s CAR-T development and manufacturing expertise will enhance North Carolina’s growing cluster of cell- and gene-based therapy companies working toward cures for cancer — including local leaders in CAR-T immuno-oncology Precision Biosciences and Cellectis.”

CARsgen’s development of genetically engineered immunotherapies for treating cancer aligns closely with North Carolina’s expertise in, and commitments to, gene editing, oncology, and precision health. 

NC attractive to cell- and gene-based therapeutics companies

The ecosystem attracting companies like CARsgen includes North Carolina’s three comprehensive cancer centers — UNC Lineberger, Duke Cancer Institute, and Wake Forest Baptist Health. And it includes the NC Rare Disease Network and the North Carolina Precision Health Collaborative, which serve to enhance the collaborative efforts of stakeholders including payers, health systems, state government, and academic and industry researchers. 

Also, CARsgen’s technology platform and plans for cell therapy manufacturing align well with the growing cluster of gene- and cell-based therapy companies in North Carolina, plus recent expansion of peer companies in the cell- and gene-based therapy space including Biogen, Adverum Biotechnologies, Taysha Gene Therapies, Beam Therapeutics, and bluebird bio.

Partnering with NCBiotech on the CARsgen recruitment were the North Carolina Department of Commerce and the Economic Development Partnership of N.C., the North Carolina General Assembly, the North Carolina Community College System, Duke Energy, the City of Durham, Durham County and the Greater Durham Chamber of Commerce.

“It’s exciting to see a company at the cutting edge of science join our growing biotech industry cluster,” said North Carolina Commerce Secretary Machelle Baker Sanders. “From companies exploring gene therapies to the innovative work CARsgen is conducting with immune-oncology, there’s no question that North Carolina will continue to play an important role in the future of this industry and the many lives of those impacted by the life sciences sector.” 

Autologous CAR-T therapies under development by CARsgen and others currently on the market from other companies rely on patient-derived T cells, which are extracted and individually “re-manufactured” in a lab, then re-infused to each patient.

Another approach by companies such as Precision Biosciences use allogeneic CAR-T cells derived from qualified donors. Those T cells are manufactured in large batches and are cryopreserved (safely preserved, intact, at extremely low temperatures) for shipment, storage, and off-the-shelf use. 

Besides Precision Biosciences, companies pursuing allogeneic “cancer-bullet” products include startups such as Acepodia, Appia Bio, Caribou Biosciences, Celularity Century, and Immunity Bio. 

Originally published by the NC Biotech Center —