Dear valued stakeholders,
Regarding the suspension of three clinical trials, NIT-104, NIT-106, and NIT-109, we provide the following information:
NIT-104 is a clinical trial conducted on glioblastoma patients, aiming to determine the maximum tolerated dose (MTD) and optimal biological dose (OBD) of NT-I7. Safety and tolerability were confirmed in the 60ug/kg and 360ug/kg dose groups among glioblastoma patients with lymphopenia, demonstrating the proof of concept of T cell and immune activation.
NIT-107, the follow-up clinical trial to NIT-104, has already determined the MTD of 720ug/kg and observed the T cell amplification effect after NT-I7 administration. The purpose of this clinical trial has been achieved, leading to the decision to discontinue it. We will now focus on the progress of NIT-107 for newly diagnosed glioblastoma.
NIT-106 is a clinical trial involving patients with high-risk skin cancers, such as melanoma, Merkel cell carcinoma, and squamous cell carcinoma. It aimed to evaluate the antitumor efficacy and safety of NT-I7 in combination with Atezolizumab (Tecentriq). The trial confirmed safety and tolerability in skin cancer patients up to the recommended dose of 1200ug/kg for phase 2 clinical trials. Notably, positive results were presented at the American Society of Clinical Oncology (ASCO) in 2022, leading to the recruitment of an expansion cohort in 4Q of 2022 (Phase 2a).
However, due to the approval of immune checkpoint inhibitors as first-line, second-line, and third-line treatments for this indication, the recruitment of subjects who had not received previously planned immune checkpoint inhibitors became challenging. Consequently, we have decided to suspend the trial to focus on developing other indications where immune checkpoint inhibitors have not proven effective.
Meanwhile, we will continue our collaboration with Roche for NIT-119, a clinical trial of the first-line non-small cell lung cancer treatment is in progress.
NIT-109, a clinical trial for gastric cancer patients, aims to confirm the improved efficacy of the NT-I7 and nivolumab combination group compared to nivolumab alone. The trial confirmed the safety and tolerability of NT-I7 in combination with nivolumab, with the optimal dose for the expansion group test determined as 1200ug/kg. It successfully demonstrated the Proof of Concept of T cell and immune activation in solid cancer patients through NT-I7 administration.
However, the rapidly changing gastric cancer treatment market, following nivolumab's approval as a first-line treatment by the FDA and EMA, posed challenges in patient recruitment. Only patients eligible for the nivolumab combination administration group could be recruited, and difficulties arose with the control group treatment being approved as the first-line option.
Consequently, similar to other clinical trials, we have decided to suspend NIT-109 to concentrate on developing other indications that are currently progressing rapidly. Additionally, we plan to continue follow-up discussions with BMS, agreeing to discontinue this trial, and explore collaboration opportunities for other indications. The established European clinical network will be fully utilized when clinical trials resume in Europe in the future.
Furthermore, we are diligently conducting planned clinical trials within our scheduled budget. As of the end of June 2023, the company holds approximately US$ 70 million in cash, making a capital increase unnecessary at this time. Our focus remains on developing ARS treatments, as well as advancing ongoing clinical trials for pancreatic cancer, glioblastoma, and colorectal cancer, which are actively underway. Our determination to develop NT-I7 as a new drug remains unwavering, and we are committed to achieving our development goals.
Thank you for your continued support and understanding.