NexImmune, Inc. has received IND clearance for the Company's first cellular therapy product candidate addressing solid tumors. NEXI-003, an autologous antigen-specific T cell product (CD3+/CD4-), is being developed for patients with relapsed or refractory human papillomavirus (HPV)-related cancers. The Phase 1 trial will enroll patients at multiple clinical sites across the United States.

The proposed study is a two-part, multicenter, open-label, dose-finding, first-in-human (FIH) study to characterize the safety and clinical activity of NexImmune's HPV tumor-relevant antigen-specific CD8+ T cell product candidate (NEXI-003) in patients with relapsed or refractory locally advanced or metastatic HPV-related oropharyngeal cancers (with confirmed histopathology detection of HPV-16 and/or HPV-18 expression), who have received at least 1 prior regimen of standard therapy according to local standard of care guidance(s). 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. All patients will be followed for at least one year.

Following initial data and after the recommended Phase 2 dose has been confirmed, NexImmune plans to expand the NEXI-003 development program to include other HPV related malignancies and evaluate potential SOC combination options across the patient populations.