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NexImmune, Inc. NEXI has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for its first cellular therapy product candidate NEXI-003 addressing solid tumors. 

NEXI-003 is being developed for patients with relapsed or refractory human papillomavirus (HPV)-related cancers.

The Phase 1 study is a two-part, dose-finding, first-in-human (FIH) study to characterize the safety and clinical activity of NEXI-003 in patients with relapsed or refractory locally advanced or metastatic HPV-related oropharyngeal cancers.

The dose escalation phase will consist of multiple safety cohorts investigating increasing doses of NEXI-003 followed by an expansion phase that will enroll 24 to 36 patients overall, depending on the number of dose escalations.

The Phase 1 trial will enroll patients at multiple clinical sites across the United States.

Kristi Jones, CEO, stated, “The FDA clearance of our third IND marks another significant milestone for NexImmune and demonstrates our team’s continued focus and commitment to bringing novel therapies to patients with significant unmet need.  NEXI-003 is our third T cell therapy and first candidate to address solid tumors. NEXI-003 consists of T cell populations simultaneously directed against multiple HPV tumor-relevant antigen targets.  The T cells in our product candidate will consist of T cell subtypes critical to both potential anti-tumor activity and a phenotype intended to produce long-term immunologic memory required for durable responses.”

Price Action : NexImmune shares are trading around 27 percent higher at $1.86 on Thursday during after hour session.

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