Vaccinex, Inc. 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 (PDAC) study (NCT05102721). 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 (BOIN) 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 (Conquer Cancer Foundation /ASCO). Vaccinex will describe use of the new ?Antigen Virus?

application, a potential tool to improve antibody development for high complexity, hard-to-drug targets, such as G-protein coupled receptors (GPCRs) and ion channels. This technology, a powerful complement to the existing ActivMAb platform, allows the direct incorporation of properly folded, complex multi-pass membrane proteins into specially designed poxviruses. They believe based on rigorous evaluation that the ActivMab® system can readily generate functional and properly folded complex proteins that can be used for selection of novel, high value, antibody therapeutics.