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Quarterly update

QUARTERLY UPDATE (Q4 2022)

2023-01-06

Key Highlights – October to End of December

- In an oral session at the Society of Immunotherapy of Cancer (SITC) congress, NIT presented new evidence of NT-I7 clinical efficacy in combination with pembrolizumab in relapsed/refractory (r/r) gastrointestinal tumors.

- NeoImmuneTech presented its first data on NT-I7 (efineptakin alfa) in combination with CAR-T tisagenlecleucel at American Society of Hematology (ASH) annual congress.

- NIT became a member of the United Nations (UN) Global Compact.

 

Strong presence at ASH and SITC annual meetings where NIT presented new evidence on NT-I7

◎ On November 8-12, at SITC annual meeting, Dr. A. Naing (University of Texas, MD Anderson Cancer Center) discussed preliminary results of the phase 2a clinical trial NIT-110 focused on the follow-up of two cohorts of patients with relapsed/refractory (r/r) gastrointestinal indications. Results showed an ORR of 30.8% and a DCR of 69.2% per iRECIST across the groups in patients without liver metastasis (n=13/50). Among the patients without liver metastasis, the probability of survival rate through 60 weeks was 100%, which is significantly higher than in those with liver metastasis. It was also confirmed that the combination of NT-I7 plus pembrolizumab boosts CD8+ T cell infiltration in patients regardless of liver metastasis. Data also suggested that increased CD8+ T cell infiltration correlates with higher OS and favors a tumor microenvironment that contributes to the overall high DCR observed in these hard-to-treat CPI-resistant indications.

◎ On December 10-13, NIT presented poster data on NIT-112 phase 1b trial, the first and only clinical trial that aims to evaluate the safety, tolerability, and preliminary anti-tumor activity of NT-I7, after treatment with tisagenlecleucel (Kymriah®) in patients with relapsed/refractory large B-cell Lymphoma (r/r LBCL) at ASH congress. A single dose of NT-I7 at the CAR-T contraction phase (day 21) was able to increase both the absolute lymphocyte count (ALC) and the CAR-T absolute numbers. No serious adverse events like CRS and ICAN were observed.

 

 

NIT has continued its on-going effort to present the clinical achievement of NT-I7

◎ On October 3-4, at the Biomarker and Immuno Congress in San Diego, California, USA, Byung Ha Lee, PhD, SVP & Chief Scientific Officer of NIT gave an oral presentation on “Developing A Translational Strategy For A T Cell Pipeline”.

◎ On October 12, at the Immuno-Oncology Summit in Boston, Massachusetts, USA, Byung Ha Lee, PhD, SVP & Chief Scientific Officer of NIT gave a presentation on the “Promising Early Clinical Efficacy in Immune Cold Tumors with NT-I7 in Combination with Pembrolizumab”.

◎ On August 4-5 and October 16-19, respectively at the Radiation Injury Treatment Network (RITN) 2022 Workshop and the Radiation Research Society (RRS) 68th Annual International Meeting, NIT presented the first preclinical results from a study conducted by Duke University with the support of NIT on the effect of NT-I7 on T cell reconstitution following total body irradiation (TBI).

 

Building and strengthening NIT’s deeply rooted commitment for Environmental, Social and Governance (ESG) activities.

◎ On October 11, NIT announced that it became a member of the UN Global Compact. This global, strategic initiative illustrates NIT’s commitment to responsible business practices in the areas of human rights, labor, environment, and corruption.

 

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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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