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RESEARCH TRIANGLE PARK – ProKidney LLC, a Winston-Salem-based clinical-stage biotechnology company founded in 2015 and targeting chronic kidney disease (CKD) with a proprietary cell therapy, plans to create up to 330 jobs and establish a new manufacturing facility in Greensboro by 2027.
On Tuesday, the NC Department of Commerce and Gov. Roy Cooper announced that ProKidney will invest up to $485 million into the project, of which $25.5 million will be invested to establish a 210,000-square-foot facility on about 22 acres in Greensboro. The facility will support the future commercial manufacturing of REACT (REnal Autologous Cell Therapy), the company’s lead product candidate targeting CKD.
“Innovative life science companies like ProKidney understand that North Carolina offers the key ingredients for business success,” said Cooper, in a news release. “Our leadership in this important industry sector is recognized around the world, thanks to the specialized workforce training and education systems that support North Carolina’s biotech companies.”
Regional strength in cell and gene therapy
Nancy Johnston, executive director for North Carolina Biotechnology Center’s Piedmont Triad Office, said, “The Piedmont Triad region’s strengths align with North Carolina’s leadership in biomanufacturing, including cell and gene therapies contributing to the state’s competitiveness in this sector.
“This notable investment in a homegrown company demonstrates the interconnectivity of our regional life sciences community and our skilled workforce infrastructure to support long-term company growth and high-paying jobs.”
The region’s strength in cell and gene therapy was on display only two weeks ago in downtown Winston-Salem during the World Stem Cell Summit and Regenerative Medicine Essentials Course combined meeting at Wake Forest Biotech Place, home of the Wake Forest Institute for Regenerative Medicine (WFIRM).
The state’s announcement comes on the heels of incentive packages approved earlier this month by Guilford County and Greensboro. On June 1, the Guilford County Board of Commissioners unanimously approved giving ProKidney, currently located in Winston-Salem, more than $15 million in incentives to be paid out over 10 years. On June 6, the Greensboro City Council also unanimously approved giving ProKidney more than $13 million in incentives. These incentives are based on ProKidney hitting certain milestones, including the creation of at least 330 new jobs on or before Dec. 31, 2028.
“We considered many factors in determining where best to build future commercial manufacturing capacity for REACT,” said Tim Bertram, PhD, chief executive officer of ProKidney, in the state’s news release. “Because of North Carolina’s depth and breadth of biotechnology talent, the advantage of locating the plant near our headquarters and pilot manufacturing plant in Winston-Salem, NC, and the state’s interest in continuing to grow its biotechnology industry, we determined that adding manufacturing capacity here in Greensboro would be in the best interest of ProKidney, its shareholders and its local stakeholders. We look forward to continue growing our business along with the state that we have called home since our founding.”
Although wages will vary depending on the position, the average salary for the new positions at the facility is estimated to be $74,636. The current average wage in Guilford County is $57,190.
State Support for Life Sciences Jobs
ProKidney’s project in North Carolina will be facilitated, in part, by a Job Development Investment Grant (JDIG) approved by the state’s Economic Investment Committee earlier today, according to the state’s announcement.
Over the grant’s 12-year term, the project is estimated to grow the state’s economy by $1.7 billion. Using a formula that considers tax revenues generated by the 330 new jobs, along with a company investment of $485 million, the JDIG agreement authorizes the potential reimbursement to the company of up to $5,132,700, spread over 12 years.
Chronic Kidney Disease Impact
Worldwide, CKD affects about 700 million individuals, or 10% of the world’s population. In the US, approximately 37 million adults are estimated to have Chronic Kidney Disease (CKD), and most are undiagnosed. 40% of people with severely reduced kidney function (not on dialysis) are not aware of having CKD. In the United States, diabetes and high blood pressure are the leading causes of kidney failure, accounting for three out of four new cases, according to the National Institute of Diabetes and Digestive and Kidney Diseases.
Importantly, there are not currently any existing treatments to restore kidney function once it has been lost.
ProKidney’s cell therapy platform has the potential to be transformative. REACT is designed to stabilize or improve kidney function in a CKD patient’s diseased kidneys. REACT is an investigational cell therapy product that includes selected renal cells (SRCs) prepared from the patient’s renal biopsy tissue.
“SRCs are formulated into a product for reinjection into the patient’s kidney using a minimally invasive outpatient procedure. Because REACT is a personalized treatment composed of cells prepared from a patient’s own kidney, there is no need for treatment with immunosuppressive therapies, which are required during a patient’s lifetime when a patient receives a kidney transplant from another, allogeneic donor,” per the company.
REACT has received Regenerative Medicine Advanced Therapy designation from the FDA for slowing the progression of CKD and improving kidney function. ProKidney is conducting a Phase 3 development program and multiple Phase 2 clinical trials for REACT in subjects with moderate to severe diabetic kidney disease. The company is also conducting a Phase 1 clinical trial for REACT in subjects with congenital anomalies of the kidney and urinary tract.
ProKidney says that REACT has been well tolerated by subjects with moderate to severe diabetic kidney disease in Phase 1 and 2 clinical testing to date. Early studies indicate a potential for REACT to stabilize, or even improve, renal function, according to the company.
The company went public in 2022 through a reverse merger with a special purpose acquisition company. In 2019, ProKidney acquired inRegen and its affiliate Twin City Bio, establishing the foundation for advancement of REACT. Media reports put the number of full-time employees at ProKidney at about 80 across offices in Winston-Salem and Raleigh.