NeoTX Announces FDA Clearance of IND for Phase 2 Clinical Trial of Naptumomab Estafenatox (NAP), its lead Tumor Targeted Superantigen Candidate

On April 19, 2021 NeoTX Therapeutics (NeoTX), a clinical-stage immuno-oncology company, reported that it received clearance from the U.S. Food and Drug Administration (FDA) for the Company’s Investigational New Drug (IND) application for naptumomab estafenatox (NAP) (Press release, NeoTX, APR 19, 2021, View Source [SID1234640358]). NeoTX is developing targeted anticancer immunotherapies utilizing its proprietary Tumor Targeted Superantigen (TTS) platform. NAP, the company’s lead TTS molecule, binds a genetically engineered bacterial determinant to the tumor surface while simultaneously activating and expanding tumor specific immune cells. NAP has demonstrated preliminary safety and anti-tumor activity in early-stage clinical trials in solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This FDA clearance is an exciting milestone for NeoTX," said Asher Nathan, Ph.D., chief executive officer of NeoTX. "Preclinical and preliminary clinical studies have demonstrated that NAP has potential in combination with other treatment modalities. Non-small cell lung cancer is one of the deadliest cancers, and we are looking forward to assessing NAP in the clinic in combination with chemotherapy as a potential new treatment option after failure of current standards of care."

The Phase 2a open label trial will evaluate NAP in combination with docetaxel in 35 patients with checkpoint inhibitor pretreated, advanced or metastatic non-small cell lung cancer. The primary endpoint is objective response rate as measured by RECIST 1.1 criteria. The trial will also evaluate safety, duration of response, progression free survival, overall survival, pharmacokinetics and pharmacodynamics.