Construction Completion is One of the Pre-requisites to Beginning the Deltacel™ Clinical Trial Activation Later This Year and Addresses a Key Clinical Hold Citation
Kiromic BioPharma, Inc. (NASDAQ:KRBP) (“Kiromic” or the “Company”),a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence and data mining platform to develop cell and gene therapies with a focus on immuno-oncology, announces the timely completion of construction on its expanded current good manufacturing practice (cGMP) manufacturing facility in Houston. This significant milestone was accomplished within the timeline established by the Company, specifically June 30, 2022.
The expanded facility located at Kiromic’s headquarters is one of the conditions required for the Company to begin the activation of its cell therapy clinical trial for the Deltacel™ product candidate by the end of this year. The completion also addresses a key component in the clinical hold communication the Company received from the U.S. Food and Drug Administration (FDA) in June 2021.
“The on-time completion of our cGMP manufacturing facility is one of the conditions necessary to begin the activation of the Deltacel™ clinical trial by the end of this year,” stated Pietro Bersani, Kiromic BioPharma’s Chief Executive Officer. “The facility supports an expanding product pipeline of cell therapies designed to target solid tumors, furthering our commitment to delivering lifesaving treatments to patients with cancer who have limited therapeutic options. We believe our allogeneic, off-the-shelf manufacturing process will result in shorter lead times and lower costs, thereby increasing the availability of these promising cellular therapies for oncology patients.”
The expanded 34,000-square-foot facility includes flexible cellular therapy and viral vector suites, a dedicated cGMP microbiology lab, a dedicated cGMP quality control (QC) lab, a research and development laboratory, and an FDA Code of Federal Regulations (CFR-9) compliant vivarium.
