Colorectal and Pancreatic Cancer Vaccine Candidate Launches Clinical Study

Immunotherapy candidate CV301 and durvalumab, IMFINZI, which is a PD-L1 inhibitor combination for patients with metastatic colorectal or pancreatic cancers

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A new collaboration was announced today that will investigate CV301, an immunotherapy candidate, and durvalumab, IMFINZI, which is a PD-L1 inhibitor, in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancers.

This clinical study, which is sponsored by Georgetown University, will be led by Dr. Michael Pishvaian, Assistant Professor in the Department of Hematology/Oncology at the Lombardi Comprehensive Cancer Center at Georgetown University Medical Center.

Under this collaboration with Georgetown University, both Bavarian Nordic and AstraZeneca will contribute clinical trial material and provide financial support for a planned Phase 1/2 clinical study.

This is a dual arm, open-label phase I/II study to evaluate the safety and clinical activity of the combination of durvalumab with CV301 in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancer whose disease is stable on, or responding to 1st line therapy for metastatic disease.

Patients with metastatic colorectal or pancreatic adenocarcinoma who still have an adequate performance status and normal hepatic and renal function will be eligible.

The Phase 1/2 trial will begin with a lead-in study to determine the safety and tolerability of the combination, as well as the recommended Phase 2 dose of durvalumab in combination with CV301 and chemotherapy.

The Phase 2 portion of the study’s primary endpoint for both arms of the study will be progression-free survival with multiple secondary endpoints, including objective response rate, overall survival, and disease control rate.

"While therapeutic options for these patients remain limited, combining a targeted cancer vaccine with a checkpoint inhibitor could result in a novel approach to fighting these diseases, as well as improved patient outcomes," said Dr. Michael Pishvaian, Georgetown University.

CV301 is an immunotherapy candidate which is being developed under a CRADA with the National Cancer Institute (NCI). CV301 targets two tumor-associated antigens, CEA and MUC1, which are over-expressed in multiple solid tumors, including lung, bladder, colorectal and pancreatic cancers.

CV301 is a poxvirus-based prime/boost vaccine that incorporates a modified version of vaccinia (MVA-BN, a proprietary technology of Bavarian Nordic) as a priming dose, followed by multiple fowlpox boosts, and encodes the TRICOM costimulatory molecules.

Preclinical data shows the ability of CV301 to upregulate PD-L1 by mounting an immune response against a tumor target.

In addition to durvalumab, CV301 is being investigated in combination with other immune checkpoint inhibitors such as:

  • KEYTRUDA®(pembrolizumab) from Merck in non-small cell lung cancer and,
  • TECENTRIQ® (atezolizumab) from Roche in bladder cancer.

Bavarian Nordic is a fully integrated biotechnology company focused on the development of innovative and safe therapies against cancer and infectious diseases. For more information visit