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NeoImmuneTech Receives U.S. FDA IND Clearance for Phase 1b Study of NT-I7 (efineptakin alfa) and Kymriah® (tisagenlecleucel) in Relapsed/Refractory Large B-Cell Lymphoma

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NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for the combination of its lead drug candidate, NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), and Kymriah® (tisagenlecleucel), a CD19 CAR T-cell therapy, for the treatment of patients with relapsed/refractory large B cell lymphoma (r/r LBCL). This IND clearance allows NeoImmuneTech (NIT) to initiate a multicenter Phase 1b study evaluating the safety, tolerability, and preliminary anti-tumor activity of NT-I7 administration following standard-of-care Kymriah CAR T-cell therapy.

Diffuse large B-cell lymphoma 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. annually. Despite improvement in therapeutic options, treatment is often not curative with as many as 50% of patients with adverse risk factors developing relapsed or refractory disease.

"CAR T-cell therapy has undoubtedly changed the treatment paradigm of LBCL; however there is still a large patient population who will relapse or develop refractory disease," commented John DiPersio, M.D., Ph.D., Chief, Division of Oncology; Director, Center for Gene and Cellular Immunotherapy; and Deputy Director, Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital. "In multiple animal models, 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. In the clinic, treatment with NT-I7 has shown to increase T cell counts in the blood and is well tolerated. Administration of NT-I7 following Kymriah may increase the expansion and persistence of Kymriah and facilitate the reconstitution of patients' own immune system to fight cancer."

In addition to establishing the safety, tolerability, and assessing the preliminary anti-tumor activity of NT-I7 following Kymriah, this Phase 1b study will determine the recommended Phase 2 dose to be used for further clinical development of the combination.

"This latest IND clearance marks another achievement for our robust clinical development program of NT-I7, which has multiple ongoing trials in both cancer and infectious diseases," said NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech. "As CAR T cell expansion is a strong predictor of response to CAR T-cell therapy, we believe that treatment with NT-I7 following Kymriah could potentially enhance the response rate and duration of response to Kymriah, and ultimately improve the clinical outcome for patients with r/r LBCL. We eagerly look forward to executing this important clinical trial as soon as possible to hopefully deliver another breakthrough treatment for these patients."

Kymriah® is a registered trademark of Novartis AG.

About NT-I7

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 increased 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). 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 and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

About NeoImmuneTech

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.

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