Vaccinex to present update on PDAC/Pepinemab study, new ActivMAb application

Vaccinex announced that it will present data on a new ActivMAb application on September 28th and an update on the Phase 1b/2 pepinemab study in patients with PDAC on September 29th. Vaccinex will provide an overview of the design and enrollment for the pancreatic ductal adenocarcinoma study. Currently, seven patients are enrolled. Treatment has been well-tolerated by these patients to date and a mixed response with some lesions showing radiologic partial and even complete response has been observed in one patient. The trial, which employs a Bayesian Optimal Interval Design in the Phase 1b segment and a Simon two stage assessment in the Phase 2 segment, is expected to enroll up to 40 patients. The study rationale builds on safety and efficacy data from the CLASSICAL-Lung study of pepinemab and avelumab and the observation that pepinemab appears to modulate the tumor microenvironment by increasing effector cell infiltration and reducing immune suppression, rendering “cold” tumors such as PDAC to become “hot”. The study is being conducted with grant support from the Gateway Discovery Award.