January 29, 2024 — ROCKVILLE, MD: NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a clinical-stage T cell-focused biopharmaceutical company, today announced the approval of additional cohorts in the Phase 2 study in head and neck cancer by the Korean Ministry of Food and Drug Safety (MFDS) The study led by Professor Hye-Ryun Kim at Severance Hospital has also received approval by the institution review board.
The Phase 2 neoadjuvant study examines the vaccine GX-188E (tirvalimogene teraplasmid) in combination with GX-I7/NT-I7 (efineptakin alfa) and Keytruda® (pembrolizumab). It targets patients with HPV 16/18 positive, resectable, locally advanced head and neck squamous cell carcinoma (LA HNSCC). Initiated in 2022, it originally comprised a total of 11 patients with HPV-positive head and neck cancer.
With support from the Biotech companies Genexin and NeoImmuneTech, Dr. Kim's team will expand the study to add three additional cohorts each comprising of 15 patients. This expansion raises the total to four cohorts of 56 patients. The study protocol allows changes in the doses of Keytruda® and GX-I7/NT-I7 across cohorts, while maintaining a consistent dose and regimen of GX-188E (2 mg intramuscular). This approach aims to further explore each investigational drug's role in the triple combination, assess combined effects, and evaluate overall safety and major pathologic responses.
At the 2023 American Society of Clinical Oncology (ASCO) Professor Hye-Ryeon Kim and colleagues in the Department of Medical Oncology at Yonsei University Severance Hospital, presented results from the initial cohort. These findings showed that none of the original 11 patients in the trial experienced any surgical delays or increased complications. Additionally, 63.6% (seven patients) achieved a major pathologic response (MPR) and 36.3% (four patients reached pathologic complete response (pCR), confirming the primary efficacy and safety of the triple combination.
The proposed mechanism of action suggests that GX-188E induces cancer cell-specific T-cell responses in HPV-16/18-induced head and neck cancer. GX-I7/NT-I7 amplifies T-cells numbers and Keytruda® blocks the immunosuppressive function of cancer cells against T-cells.
Dr. Se Hwan Yang, Ph.D., Chief Executive Officer of NeoImmuneTech, Inc. said: “Head and neck squamous cell carcinoma (HNSCC) is a cancer with poor prognosis originating from squamous cells in the head and neck region, including the oral cavity, pharynx, and larynx. It is often linked to high mortality. Currently no immuno-oncology drugs are available for patients with HPV-positive head and neck cancer scheduled for surgery. We are optimistic that this new protocol will show that the effectiveness of the triple combination GX-188E - GX-I7/NT-I7 - pembrolizumab as a preoperative adjuvant therapy.”
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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 benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and 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 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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