NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, today presented new data from two clinical trials evaluating the company’s lead asset NT-I7 (efineptakin alfa), a novel T cell amplifier, in three posters at the Society for Immunotherapy of Cancer (SITC) annual meeting. The data come from two cohorts of the Phase 2a portion of a Phase 1b/2a clinical trial evaluating NT-I7 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of patients with relapsed/refractory advanced solid tumors, as well as a Phase 1 investigator-initiated trial evaluating NT-I7 following adjuvant chemotherapy (temozolomide [TMZ]) and radiation in patients with high-grade gliomas (HGG).
The combination data of NT-I7 and pembrolizumab were presented in two posters, titled “Initial Biomarker and Clinical Data of a Phase 2a Study of NT-I7, a Long-Acting Interleukin-7, plus Pembrolizumab: Cohort of Subjects with Checkpoint Inhibitor-naïve Advanced MSS-Colorectal Cancer” and “Preliminary Biomarker and Clinical Data of a Phase 2a Study of NT-I7, a Long-Acting Interleukin-7, plus Pembrolizumab: Cohort of Subjects with Checkpoint Inhibitor-naïve Advanced Pancreatic Cancer,” by lead authors Richard D. Kim, M.D., Moffitt Cancer Center, and Aung Naing, M.D., The University of Texas MD Anderson Cancer Center, respectively.
The data show that the combination of NT-I7 and pembrolizumab was well tolerated and showed early anti-tumor activity in patients with checkpoint inhibitor (CPI)-naive relapsed/refractory (r/r) pancreatic and microsatellite-stable colorectal cancers (MSS-CRC), two immune-cold tumor types. The interim analysis of the phase 2 met the primary endpoint of overall response rate (ORR) in these cohorts. The median follow-up of the efficacy data was ~5.8 months in the MSS-CRC Cohort and ~4.6 months in the Pancreatic Cancer Cohort. Three immune partial responses (iPR) by iRECIST were observed, including one partial response (PR) by RECIST 1.1 in 17 evaluable MSS-CRC patients, as well as one iPR/PR observed in 17 evaluable pancreatic cancer patients. The pancreatic cancer responder was confirmed to have a microsatellite-stable tumor. Responses were first observed at weeks 12, 18, and 24 post-first dose. Increase of T cell infiltration in the tumor microenvironment were observed in the responders, a key indicator that the tumor microenvironment is shifting from immune-cold to immune-hot. Importantly, an even greater magnitude of increase in stem-cell memory CD8+ T cells (Tscm) was observed in the blood.
The data for NT-I7 following chemoradiation were presented in a poster titled “NT-I7, a long-acting interleukin-7, promotes expansion of CD8 T cells and NK cells and immune activation in patients with newly diagnosed high-grade gliomas after chemoradiation,” by lead author Jian Campian, M.D., Ph.D., Mayo Clinic.
The data show that NT-I7 is well tolerated following chemoradiation therapy in HGG patients. Notable ALC increases were observed, with more prominent increases in patients dosed at the 540µg/kg or higher levels of NT-I7. Marked increase of Tscm was also observed, in this case in absence of a checkpoint inhibitor. Durable progression-free survival (PFS) was noted in MGMTp unmethylated HGG patients, a sub-group who often have a poorer prognosis. Six out of eight patients treated at the therapeutic dose of 720µg/kg or higher are continuing on in the study.
“We are excited to share that the combination of NT-I7 and pembrolizumab was found to be well tolerated and showed early signs of clinical activity in patients with difficult-to-treat cancers, like relapsed/refractory pancreatic and microsatellite-stable colorectal cancer,” said Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech. “Immune-cold tumors such as MSS-CRC and pancreatic cancer have shown very limited clinical activity with current standard of care therapies. We are also encouraged by the preliminary clinical efficacy results in NT-I7 following chemoradiation. These clinical data support our continued efforts in these and other tumor types, and we look forward to future analyses of the data as we move forward.”
The links to the posters are as follows:
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.
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.
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 complemented by a strong executive team with rich industry experience at companies such as Novartis, BMS, GSK, Pfizer, Amgen, Eli Lilly, MedImmune/AstraZeneca and PwC. 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.
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.
- Initial Biomarker and Clinical Data of a Phase 2a Study of NT-I7, a Long-Acting Interleukin-7, plus Pembrolizumab: Cohort of Subjects with Checkpoint Inhibitor-naïve Advanced MSS-Colorectal Cancer: https://qr1.be/TLS3
- Preliminary Biomarker and Clinical Data of a Phase 2a Study of NT-I7, a Long-Acting Interleukin-7, plus Pembrolizumab: Cohort of Subjects with Checkpoint Inhibitor-naïve Advanced Pancreatic Cancer: https://qr1.be/K8VH
- NT-I7, a long-acting interleukin-7, promotes expansion of CD8 T cells and NK cells and immune activation in patients with newly diagnosed high-grade gliomas after chemoradiation: https://qr1.be/M4KV