News Update
2024-05-13
May 12, 2024 — ROCKVILLE, MD: NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, announced today that Duke University (North Carolina) has been awarded up to $6 million from NIAID to study NT-I7 (efineptakin alfa) for the treatment of Hematopoietic Acute Radiation Syndrome (H-ARS) in animal models.
According to Duke University, the contract will support research led by Dr. Benny Chen at the Duke University School of Medicine. His team will focus on studying the benefits of rapid T cell recovery following NT-I7 administration after radiation exposure. Their research aims to demonstrate how this potential treatment improves survival and decreases the incidence of major morbidities.
Following a recent consultation with the US Food and Drug Administration (FDA), NeoImmuneTech has developed a detailed experimental strategy for exploratory animal studies which would be supportive for the FDA approval of NT-I7 in H-ARS. The research conducted by Dr. Benny Chen's team, funded by the NIAID contract, will demonstrate how NT-I7 may benefit in H-ARS and further contribute to the broader understanding of NT-I7’s efficacy in H-ARS.
Dr. Luke Oh, President and CEO of NeoImmuneTech, said, "We are implementing multiple strategies in parallel to ensure that NT-I7 is approved for H-ARS as soon as possible, with the potential to be the first treatment for lymphocyte recovery in H-ARS. We are directly communicating with the FDA to ensure comprehensive data from our animal studies is consistent with the administration’s Biologics License Application (BLA) criteria. We are on track to have all the key data needed for BLA submission by 2025."
Dr. Benny Chen, Professor of Medicine, Division of Hematologic Malignancies and Cellular Therapy at the Duke University School of Medicine, is a member of NeoImmuneTech's Scientific Advisory Board. His team has been conducting research on the efficacy of NT-I7 in T cell amplification and recovery following radiation exposure since 2019. Their non-clinical findings were presented at the Radiation Injury Treatment Network (RITN) and the Radiation Research Society (RRS) in 2022.
The content of this announcement is solely the responsibility of NeoImmuneTech and does not necessarily represent the official views of the National Institutes of Health.
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About NT-I7 (efineptakin alfa) (rhIL-7-hyFc)
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7 and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors, hematologic malignancies, and as a vaccine adjuvant. Studies are being planned for testing in additional solid tumors and other immunology-focused indications.
About NeoImmuneTech, Inc.
NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company, dedicated to expanding the horizon of immuno-oncology and enhancing immunity. NIT is led by a strong executive team and talented members with rich industry experience. NIT is expanding rapidly in its operations, as well as partnering with industry and academic leaders to investigate NT-I7 as monotherapy and in combination with various immunotherapeutics. For more information, please visit www.neoimmunetech.com.
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