Quarterly update
2022-07-12
NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a clinical-stage T cell-focused biopharmaceutical company, today released its first Quarterly Update that aims to summarize and put into perspective the most recent progress of the broad NT-I7 development program.
Key Highlights – April to End of June
- NIT has amplified its development effort with the FDA clearance of a new clinical trial (NIT‑120) and the decision to expand recruitment in 2 arms of study NIT-110.
- NIT presented converging and promising early clinical results at two medical congresses and two public-speaking business platforms.
- Most recently, it earned an important publication in Nature Communications.
NIT has amplified its development effort with the FDA clearance of a new clinical trial (NIT-120) and the decision to expand recruitment in 2 arms of study NIT-110
● On May 11, NIT received clearance from the US Food and Drug Administration (FDA) for a phase 2 study (NIT-120) investigating the combination of NT-I7 and pembrolizumab for the treatment of recurrent glioblastoma (GBM).
● On June 6, during the ASCO 2022 congress, NIT announced the expansion of patient recruitment in the microsatellite stable-colorectal cancers (MSS-CRC) and pancreatic ductal adenocarcinoma cancers (PDAC) cohorts of study NIT-110. It plans to recruit a total of 50 additional patients (25 in the MSS-CRC cohort and 25 in the PDAC cohort) to obtain additional safety and efficacy data.
NIT presented converging and promising early clinical results at two medical congresses and two public-speaking business platforms.
● On April 8-13, at the American Association for Cancer Research (AACR) Annual Meeting, the company presented the results of a pre-clinical study where NT-I7 was evaluated in combination with IL-2 (hIL-2/TCB2c), and in combination with anti-TIGIT or anti-VEGF therapies. NT-I7 has demonstrated in previous studies that it can increase the number of central memory T cells, whereas IL-2 activates the effector/effector memory T cell. The combination of their different mechanisms of action created a heightened anti-tumor response. Especially, the number of Tpex (Precursor exhausted T cell) and Ttrans (Transitory exhausted T cell) mainly increased by NT-I7, whereas the number of Ttranse and Tex (exhausted T cell) mainly increased by IL-2.
Data from a second pre-clinical study showed that NT-I7 in combination with anti-TIGIT or anti-VEGF, enhanced anti-tumor responses, and this effect was further increased when NT‑I7 was combined with anti-TIGIT and anti-PD-1 in triple combination.
The pre-clinical results presented at AACR 2022 showed the potential of NT-I7 as part of a double or triple-regimen, paving the way to advance these combinations in clinical trials, further enhancing NT-I7 clinical value.
● On 3-7 June, at the American Society of Clinical Oncology (ASCO) Annual Meeting, the preliminary results of the phase 2a study NIT-110 were presented in a poster discussion. NT-I7 combined with pembrolizumab showed anti-tumor activity and a manageable toxicity profile in heavily pretreated patients for whom checkpoint inhibitors (CPI) are usually ineffective. In another poster presentation dedicated to the phase 1b/2a study NIT-106, the combination of NT-I7 with atezolizumab showed preliminary favorable safety and anticancer activity in CPI-relapsed/refractory high-risk skin cancer patients. The recommended phase 2 dose (RP2D) was determined to enable the phase 2a dose expansion. Finally, a Trial-in-Progress poster reported the ongoing progress of NT-I7 plus CAR-T development, in the phase 1b study NIT-112.
● On May 24, at the Immuno-Oncology Summit Europe 2022, NIT presented the “promising early clinical efficacy of NT-I7 in combination with pembrolizumab in immune-cold tumors”.
● On June 14, another presentation was made at the BIO International Convention on “Expanding the Frontier of Immuno-Oncology with NT-I7, a long-acting IL-7, in combination of checkpoint inhibitors and CAR-Ts”.
NIT earned an important publication in Nature Communications
● On June 13, the results of an in vivo study combining NT-I7 with chimeric antigen receptor (CAR) T cells directed against CD19+ B cell lymphoma and acute myeloid leukemia were reported in Nature Communications. NT-I7 can dramatically enhance CAR T cell expansion, persistence, and anti-tumor activity in vivo, resulting in significant improvement in survival in mice.
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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.
Forward-looking Statements
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