On June 14, 2021 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported new data presentations from two clinical studies at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (Press release, NeoImmuneTech, JUN 14, 2021, View Source [SID1234583670]). The company presented data from clinical studies evaluating NT-I7, a novel long-acting human IL-7, 1. in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) as a treatment for advanced solid tumors, and 2. given concurrently with adjuvant chemotherapy in patients with high-grade gliomas.
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Data from a Phase 1b/2a study evaluating NT-I7 in combination with KEYTRUDA in patients with solid tumors were presented by Aung Naing, M.D., FACP, Professor of the Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center. These data showed that this combination was well tolerated and support continued evaluation in the phase 2a portion of the study. Encouraging efficacy signals were also noted with this therapeutic regimen, including significant increase in T cell counts in both the tumor microenvironment and peripheral blood, indicating strong pharmacodynamic effects. Additionally, one patient with metastatic mucosal melanoma who had not responded to prior combination therapy of 2 checkpoint inhibitors, nivolumab (a PD-1 inhibitor) and ipilimumab (a CTLA-4 inhibitor), had a rapid, confirmed partial response with the combination of NT-I7 + KEYTRUDA.
Data from a Phase 1/2 study evaluating NT-I7 with standard-of-care adjuvant chemotherapy in patients with newly diagnosed high-grade gliomas, after concurrent chemoradiotherapy, were presented by neuro-oncologist Jian Campian, M.D., Ph.D., Associate Professor of Medicine at Washington University School of Medicine in St. Louis, who is leading the trial. These data also showed that NT-I7 was well tolerated and supports continued evaluation in the phase 2 portion of the study. Notably, ALC increased in a dose-dependent manner with a range of 1.3 – 4.1 fold at week 4 after NT-I7 injection and lasted up to 12 weeks. Immune profiling and cytokine analysis are ongoing and will be updated.
"We are pleased to have shared the latest data from two of NIT’s ongoing studies evaluating the therapeutic potential of our lead asset, NT-I7," said NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech. "These data, together with the previously presented data for NT-I7 + KEYTRUDA in triple-negative breast cancer, demonstrate that combining NT-I7 with other anti-cancer agents thus far is safe and tolerable in the clinic, and shows encouraging early efficacy signals. We look forward to continuing clinical evaluation and advancing these trials further."
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.
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 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.