Therapy Areas: Infectious Diseases
Bavarian Nordic announces first patent dosed and initiation of clinical trial evaluating the combination therapy of CV301 and Durvalumab in metastatic colorectal and pancreatic cancers
5 November 2018 -

Bavarian Nordic A/S (CPH:BAVA) (OTC: BVNRY), a fully integrated biotechnology company, announced on Friday the dosing of the first patient in a clinical study evaluating CV301, the company's targeted immunotherapy candidate, and durvalumab, AstraZeneca's PD-L1 inhibitor, in combination with maintenance chemotherapy, for patients with metastatic colorectal or pancreatic cancers.

The company said its CV301 targets tumour-associated antigens, CEA and MUC1, which are overexpressed on multiple solid tumours, including colorectal and pancreatic cancers.

Preclinical data has shown that vaccination resulted in the induction of tumour specific T-cells that infiltrated the tumour resulting in the upregulation of PD-L1 on tumour cells. The upregulation of PD-L1 is a marker indicating the tumour is under attack from T-cells, presenting an opportunity for a greater response in patients who might otherwise not benefit from treatment with a checkpoint inhibitor alone.

According to the company, CV301 is administered in an innovative manner designed to generate a potent and durable T-cell response. Patients receive an enhanced priming regimen of the highly attenuated, non-replicating vaccinia virus MVA-BN-CV301 in four different injection sites on days one and 29, followed by boosters of the recombinant fowlpox virus FPV-CV301 at tapering intervals during the course of the treatment with durvalumab and maintenance chemotherapy.

This investigator-sponsored trial is being led by Dr Michael Pishvaian, associate professor in the department of Haematology/Oncology at the Lombardi Comprehensive Cancer Centre at Georgetown University Medical Centre in Washington, DC, with material support from Bavarian Nordic and AstraZeneca.

Also, the clinical trial is being conducted at several other top cancer centres including the Mayo Clinic, Indiana University and Emory University.

This trial will begin with a small 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 maintenance chemotherapy.

The phase 2 portion of the study will consist of two parallel trials, enrolling up to 26 patients with metastatic disease for each disease setting. The primary endpoint for both arms of the study will be progression-free survival (PFS) with multiple secondary endpoints, including objective response rate (ORR), overall survival (OS), and disease control rate (DCR).

Bavarian Nordic is focused on the development of innovative and safe therapies against cancer and infectious diseases.

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