NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a clinical-stage T cell-focused biopharmaceutical company, today released the Quarterly Update that aims to summarize and put into perspective the most recent progress of the broad NT-I7 development program, from July to September 2022.
Key Highlights – July to End of September
- Continued progress of NT-I7’s development program with an important new milestone from the US FDA
- NIT has renewed its Scientific Advisory Board (SAB) to benefit from appropriate guidance on emerging needs that come with accelerating the later phases of NT-I7 development.
1. Continued progress of NT-I7’s development program with an important new milestone from the US FDA
◎ On June 6-July 4, NIT echoed the two posters displayed at the ESMO GI congress, which presented new subset data from the immunologically cold microsatellite stable colorectal cancers (MSS-CRC) cohort, and from the pancreatic ductal adenocarcinoma cancers (PDAC) cohort from the ongoing clinical study NIT-110. In both cohorts, the clinical efficacy of combining NT-I7 with pembrolizumab appeared encouraging in these immunologically cold indications, which are normally associated with complete lack of efficacy to checkpoint inhibitor (CPI) monotherapy.
◎ On July 12, the US FDA granted Orphan Drug Designation (ODD) to NT-I7 for the treatment of glioblastoma multiforme. Current studies in GBM include study NIT-107 in newly diagnosed GBM patients and study NIT-120 in recurrent GBM patients. Preliminary data from study NIT-107 presented at the Society for Immunotherapy of Cancer Annual Meeting (SITC), in November 2021, showed favorable trends of progression free survival (PFS) and overall survival (OS) in NT-I7 treated high-grade glioma (HGG) patients after chemoradiotherapy.
◎ On September 9- 11, NIT disclosed new data at the European Society for Medical Oncology (ESMO) Congress, that suggests that NT-I7 plus pembrolizumab combination treatment enhances infiltration of PD-1+ T cells in cold tumors. In the phase 2a study NIT-110, the combination induced infiltration of CD8 T cells into the tumor microenvironment in more than 80% of analyzed samples. The infiltration of CD8 T cells showed an increase of over 5-fold in over 50% of on-treatment samples after only one dose of NT-I7.
◎ NIT’s scientific team also participated in a series of events to continue to showcase the scientific and clinical interest of NT-I7:
- On July 26-28, at the Cytokine-Based Drug Development Summit, Byung Ha Lee, Ph.D.(SVP and Chief Scientific Officer of NIT) presented “IL-7 therapy: Oncology & Beyond”. Sara Ferrando-Martinez, Ph.D.(Principal Scientist & Head of Clinical Sciences at NIT) presented “IL-7, The Great Forgotten”.
- On August 4, Dr. Yujing Zou, Ph.D. presented a poster at the Radiation Injury Treatment Network (RITN) 2022 Workshop (Alexandria, VA): “NT-I7, a long-acting recombinant human interleukin-7, enhances T cell reconstitution following total body irradiation”.
2. NIT renews its Scientific Advisory Board to get appropriate guidance on the emerging needs of preparing for later phases of clinical trials
◎ On August 8, NIT announced the addition of new members to its Scientific Advisory Board (SAB). Dr. Keith Watson (Owner & Managing Director, KRW BioReg Solutions, UK), Prof. Richard Kim (University of South Florida College of Medicine, US), Associate Prof. Hyunseok Kang (University of California, San Francisco, US), and Associate Prof. Young Kwang Chae (Northwestern University Feinberg School of Medicine, US) are joining Prof. Ahmed Rafi (Emory University School of Medicine, US) on NeoImmuneTech’s SAB.
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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 benefits. 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, Inc.
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 has a strong executive team with rich industry experience. 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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