- Agreement provides exclusive access to state-of-the-art GMP manufacturing suites to support Phase 2 clinical studies
- Potential to expand the agreement to support commercial-scale manufacturing
NEW YORK and LOUISVILLE, Ky, Sept. 15, 2022 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company discovering and developing innovative gamma-delta T cell therapies that utilize its DeltEx platform, today announced it has selected the UofL Health - Brown Cancer Center GMP Manufacturing Facility at the University of Louisville, 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 (UofL), 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 facilities with the experience and capacity required to support multicenter clinical trials and commercial manufacturing,” said Kate Rochlin, Ph.D., Chief Operating Officer 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 (IND) 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 immunotherapies for patients throughout the United States,” said James Cripps, Ph.D., manager of the Brown Cancer Center 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 Louisville 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.
Facility team in the of the UofL Health - Brown Cancer Center GMP Manufacturing Facility at the University of Louisville.
INB-400 is IN8bio’s DeltEx Allogeneic DRI. INB-400 expands the application of DRI gamma-delta T cells into other solid tumor types through the development of allogeneic or “off-the-shelf” DeltEx DRI therapies. INB-400 will be a genetically modified DeltEx allogeneic candidate in both newly diagnosed and relapsed refractory glioblastoma.
IN8bio is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing gamma-delta T cell product candidates for solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. IN8bio’s DeltEx platform employs allogeneic, autologous, iPSC, and genetically modified approaches to develop cell therapies that synergize with chemotherapy to effectively identify and eradicate tumor cells.
IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types. For more information about IN8bio and its programs, please visit www.IN8bio.com.
Forward Looking Statements
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the success of IN8bio’s partnership with UofL Health - Brown Cancer Center GMP Manufacturing Facility at the University of Louisville; the timing of initiation, progress and scope of clinical trials for IN8bio’s product candidates; the potential of IN8bio’s DeltEx platform to discover and develop innovative product candidates, including iPSC-derived cell therapies; and IN8bio’s ability to achieve planned milestones, including data readouts from its trials and plans to file an IND application. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones, presented by the ongoing COVID-19 pandemic; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates; the risk that IN8bio may not realize the intended benefits of its DeltEx platform; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio’s product candidates; expectations for regulatory approvals to conduct trials or to market products; IN8bio’s reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 12, 2022, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
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