Barcelona, February 24, 2021.- VCN Biosciences, a clinical-stage immuno-oncology company focused on the development of the next generation of oncolytic adenoviruses, today announced that VCN-01 at a dose of 3.3x1012 vp/patient can be safely administered in combination with Durbalumab when administered 15 days apart. Accordingly, in an Investigator Meeting, it was decided that VCN-01 will be further investigated at a higher dose of 1x1013 vp/patient in combination with Durvalumab.
ClinicalTrials.gov Identifier: NCT03799744. Phase I Clinical Study aimed to Evaluate the Safety, Tolerability, and Efficacy of VCN-01 in Combination With Durvalumab (MEDI4736) in Subjects With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck.ClinicalTrials.gov Identifier: NCT03799744. Phase I Clinical Study aimed to Evaluate the Safety, Tolerability, and Efficacy of VCN-01 in Combination With Durvalumab (MEDI4736) in Subjects With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck.
VCN-01 is a genetically modified oncolytic adenovirus characterized by the presence of four independent genetic modifications on the backbone of the wild-type HAd5 adenovirus genome, encoding human PH20, that confer tumor selectivity and anti-tumor activity.
Durvalumab is a human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that inhibits binding of PD-L1. The proposed mechanism of action (MOA) for durvalumab is interference in the interaction of PD-L1 with PD-1 and CD80 (B7.1). Blockade of PD-L1/PD-1 and PD-L1/CD80 interactions releases the inhibition of immune responses, including those that may result in tumor elimination.
Research Hypothesis: The presence of VCN-01 into the tumor after systemic administration will help to overcome the observed resistance to durvalumab and other PD-1/PD-L1 checkpoint inhibitors.
Primary objectives: To evaluate the safety and tolerability of a single intravenous injection of VCN-01 combined with durvalumab in two administration regimens (concomitant or durvalumab starting two weeks later "sequential schedule"), and to determine the recommended phase II dose (RP2D) of the combination.
For more information regarding this clinical trial, please visit: https://clinicaltrials.gov/ct2/show/NCT03799744?term=VCN-01&draw=2&rank=2
About VCN Biosciences
VCN Biosciences is a clinical-stage immuno-oncology company focused on the development of the next generation of oncolytic adenoviruses. VCN candidates are designed to obtain clinical activity after systemic administration and are able to remodel the complex matrix in the tumor to allow enhanced spreading of therapeutic molecules and the immune system. VCN Biosciences lead product, VCN-01, is a oncolytic adenovirus with unique characteristics being studied in clinical trials for cancers for which there is no cure, including pancreatic carcinoma and retinoblastoma. For more information, please visit www.vcnbiosciences.com.