On September 27, 2023 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease (NDD) through the inhibition of SEMA4D, reported 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 (Press release, Vaccinex, SEP 27, 2023, View Source [SID1234635460]).
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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 (Free ASCO Whitepaper)).
Update on Phase 1b/2 Pepinemab/PDAC Study (NCT05102721)
Meeting AACR SPECIAL CONFERENCE IN CANCER RESEARCH: PANCREATIC CANCER
Date:
September 29, 2023
Poster Time: 4:40 p.m. to 6:40 p.m.
Session Title: A Phase 1b/2 trial of pepinemab and avelumab as second line immunotherapy for patients with chemotherapy refractory metastatic pancreatic adenocarcinoma
Presenter Luis Ruffolo, MD, University of Rochester Cancer Center & Wilmot Cancer Institute, Rochester, NY, USA
Presentation will be available here
New ActivMAb "Antigen Virus" Application
Meeting CHI’s 20th Annual DOT Conf: Antibodies Against Membrane Proteins
Date:
September 28, 2023
Time: 8:35 a.m. ET: GPCR Sessio
Session Title: Discovery of High-Affinity Functional Antibodies Specific for CXCR5 and Other Multi-Pass Membrane Proteins
Presenter Ernest Smith, Ph.D., Senior Vice President, Research
Presentation will be available here
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. We believe based on our 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. A new manuscript describing this technology was recently published in mAbs, a leading biotech journal.
About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can trigger collapse of the actin cytoskeleton and loss of homeostatic functions of astrocytes and glial cells in the brain and dendritic cells in immune tissue. Pepinemab has been administered to more than 400 patients and appears to be well-tolerated and to have a favorable safety profile.
Vaccinex has global commercial and development rights to pepinemab and is the sponsor of the NCT05102721 PDAC trial. BAVENCIO/avelumab is provided by Merck KGaA, Darmstadt, Germany, previously as part of an alliance between the healthcare business of Merck KGaA, Darmstadt, Germany and Pfizer.
About ActivMAb
ActivMAb is a proprietary mammalian cell-based antibody discovery platform developed by Vaccinex with unique capabilities for multi-pass membrane targets such as G-protein-coupled receptors (GPCRs). The ActivMAb technology has multiple applications including: complex membrane antigen presentation and expression, antibody and antigen discovery, directed evolution and protein optimization.
The first clinical candidate selected through use of this technology (SRF114, a fully human monoclonal antibody targeting CCR8 for the potential treatment of solid tumors), entered development in a Phase 1/2 study sponsored by our licensee, Surface Oncology, recently acquired by Coherus Biosciences, Inc. The technology and its potential applications for drug discovery against complex membrane protein targets have been described in several publications and is the focus of collaborations with leading biopharmaceutical companies.