Phase 2a trial of the drug by the company to begin in the United States in the second half of the 2021 in non-small cell lung cancer
NeoTX Therapeutics, an Israel-based clinical-stage immune-oncology firm, has recently announced receiving FDA clearance for its Investigational New Drug (IND) application for Naptumomab estafenatox (NAP).
Speculations have it that NeoTX is currently developing targeted anticancer immunotherapies via its patented Tumor Targeted Superantigen (TSS) platform.
Speaking of the proprietary drug, NAP, which is the firm’s lead TSS molecule, binds well a genetically engineered bacterial element to the tumor wall, while simultaneously expanding and activating the tumor specific immune cells.
It would be important to state that NAP has already demonstrated preliminary safety and anti-tumor activity in early-stage clinical trials in solid tumors.
According to credible reports, the Phase 2a open trial is expected to evaluate NAP, merged with docetaxel in about 35 patients with checkpoint inhibitor pretreated, metastatic or advanced non-small lung cancer.
Moreover, the trial is also likely to study and analyze the safety, progression free survival, overall survival, pharmacodynamics, duration of response, and pharmacokinetics of the drug on the subjects.
Commenting on the latest accomplishment, CEO of NeoTX, Asher Nathan, Ph.D, cited that the FDA clearance stands to be an exciting breakthrough for the company in the times when it has been looking forward to the development of robust treatment for non-small cell lung cancer.
Asher added that the preclinical and preliminary clinical studies have put forth results that depict NAP’s potential in combination with other treatment modalities to treat the chronic disorder.
He further mentioned that non-small cell lung cancer is deemed to be one the fatal cancers, which has urged the company to seek the assessment of NAP in clinic paired with chemotherapy as a potential new treatment option following the failure of current standards of care.
Source Credit: https://www.globenewswire.com/news-release/2021/04/19/2212035/0/en/NeoTX-Announces-FDA-Clearance-of-IND-for-Phase-2-Clinical-Trial-of-Naptumomab-Estafenatox-NAP-its-lead-Tumor-Targeted-Superantigen-Candidate.html