NeoImmuneTech Announces First Patient Dosed in Phase 1b Study of NT-I7 (efineptakin alfa) and Kymriah® (tisagenlecleucel) in Relapsed/Refractory Large B-Cell Lymphoma
ROCKVILLE, Md.–(BUSINESS WIRE)–NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, today announced that the first patient has been dosed in a Phase 1b study of its lead drug candidate, NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), following CAR-T cell therapy tisagenlecleucel (Kymriah®) in patients with relapsed/refractory (r/r) Large B-Cell Lymphoma (LBCL).
Diffuse Large B-Cell Lymphoma (DLBCL) is the most commonly occurring subtype of Non-Hodgkin Lymphoma (NHL), accounting for 25% to 30% of all NHL and >20,000 cases in the U.S. annually1. Despite improvement in therapeutic options, treatment is often not curative with as many as 50% of patients developing relapsed or refractory disease2.
“We have shown in multiple animal models that the addition of NT-I7 to CAR-T cells substantially increased CAR-T cell proliferation, persistence, and target-specific tumor killing, resulting in significantly prolonged survival of the treated animals,” said NgocDiep Le, M.D., Ph.D., Executive VP and Chief Medical Officer of NeoImmuneTech (NIT). “Now that we have begun dosing in this study, we look forward to evaluating the potential of NT-I7 therapy to prolong clinical response and survival for patients with r/r LBCL.”
Se Hwan Yang, Ph.D., President and Chief Executive Officer of NIT added, “While CAR-T cell therapies have revolutionized the way we treat multiple hematologic malignancies, relapsed or refractory illness still impacts many patients with LBCL who are in need of additional treatment options. By advancing this Phase 1b study, we hope to pave the way for a new therapeutic solution that could enhance the clinical impact of Kymriah® alone and ultimately improve patient outcomes.”
This multicenter Phase 1b study will evaluate the safety, tolerability, and preliminary anti-tumor activity of NT-I7 administration following standard-of-care tisagenlecleucel CAR-T cell therapy, and determine the recommended Phase 2 dose of the combination for further future clinical development.
More information on this trial can be found at www.clinicaltrials.gov, identifier: 05075603.
Kymriah® is a registered trademark of Novartis AG.
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.
NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company, dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases. NIT is led by the scientific founder and inventor of NT-I7 (efineptakin alfa) and complemented by a strong executive team with rich industry experience at companies such as Novartis, BMS, GSK, Pfizer, Amgen, Eli Lilly, MedImmune/AstraZeneca and PwC. NIT is expanding rapidly in personnel and 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.
The statements contained herein may contain certain forward-looking statements relating to NeoImmuneTech, Inc. (the “Company”) that are based on its beliefs and expectations about the future. These forward-looking statements are based on a number of assumptions about the future, some of which are beyond the Company’s control and are not a guarantee of future performance or developments. Such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. The Company does not undertake any obligation to update any forward-looking statements to reflect events that occur or circumstances that arise after the date of these documents. Accordingly, you should not place reliance on any forward-looking information or statements contained herein.
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1 Vrabac, D., Smit, A., Rojansky, R. et al. DLBCL-Morph: Morphological features computed using deep learning for an annotated digital DLBCL image set. Sci Data 8, 135 (2021). https://doi.org/10.1038/s41597-021-00915-w
2 Crump M., Neelapu, S., Farooq, U. et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 130:1800–1808 (2017). doi: 10.1182/blood-2017-03-769620
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