IN8bio Inc., a clinical-stage bio-pharmaceutical company discovering and developing innovative gamma-delta T-cell therapies that utilize its DeltEx platform, has selected the BCC GMP Manufacturing Facility at the UofL, home of the Dunbar CAR T-Cell Program, as its manufacturing partner for INB-400.

The collaboration provides IN8bio exclusive access to a state-of-the-art GMP manufacturing facility and is structured to support the company’s anticipated INB-400 Phase 2 clinical program in glioblastoma.

“We are proud to be partnering with the University of Louisville, the UofL Health–Brown Cancer Center and the Dunbar CAR T-Cell Program who have been at the forefront of clinical development and patient access to novel cellular immunotherapies. One of the biggest challenges facing cell therapy companies is efficient access to high-quality manufacturing facili-ties with the experience and capacity required to support multicenter clinical trials and commercial manu-facturing,” said Kate Rochlin, COO of IN8bio. “The Dunbar CAR T-Cell Program has a superb facility designed specifically to advance the development of promising T-cell therapies. We are excited to progress our INB-400 program towards a company-sponsored investigational new drug application that will advance this program into Phase 2.”

“Since their inception, the UofL Health–Brown Cancer Center GMP Manufacturing Facility and the Dunbar CAR T-Cell Program at the University of Louisville have been committed to bringing these lifesaving immunotherapies to adult and pediatric cancer patients throughout Kentucky and the region. This manufacturing agreement with IN8bio will allow our facility to provide these groundbreaking immuno-therapies for patients throughout the United States,” said James Cripps, manager of the BCC GMP Manufacturing Facility.

“It is with the greatest excitement for the Evan Dunbar Foundation CAR T-cell program that we announce that IN8bio has joined us in this world-changing research,” said Thomas E. Dunbar. “Along with the amazing work at the University of Louisville, I believe that IN8bio can join with us in achieving the goals of the Evan Dunbar Foundation CAR T-cell program. These three organizations working together will create trials that will impact hundreds, if not thousands of patients.

“I am so honored and pleased to see our vision of cancer research come closer to trial and real-time treatment of patients. This has been my lifelong dream and is the most fulfilling way to honor my son, Evan Dunbar, my wife, Dr. Stephanie Altobellis, my father, Wallace and the rest of my family.”

The Dunbar CAR T-Cell Program was created in 2019 thanks to a $1-million pledge from Dunbar, a Louis-ville resident. It is a state-of-the-art manufacturing facility custom built to collaborate with the biotech industry to advance cutting-edge cell and gene therapies. T-cell therapies utilize immune cells that are genetically modified to fight cancer. The modified cells are infused into the patient with the goal of fighting the cancer and creating long-term immunity to delay or prevent recurrence. The facility is led by and staffed with experts in cell therapy manufacturing who will work closely with the IN8bio team to produce the DeltEx DRI cells for INB-400.

Excerpted from UofLToday by Betty Coffman