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Quarterly update

QUARTERLY UPDATE (2Q 2022)

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

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.

 

Some of the data contained in these documents were obtained from various external sources, and the Company has not independently verified such data. Accordingly, the Company makes no representations as to the accuracy or completeness of the data, and such data involves risks and uncertainties, and is subject to change based on various factors.

 

Media inquiries : press@neoimmunetech.com

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