BAVARIAN NORDIC ANNOUNCES COLLABORATION TO EVALUATE CV301 AND TECENTRIQ IN BLADDER CANCER

On March 10, 2017 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported an agreement with F. Hoffmann-La Roche Ltd (Roche) whereby Roche has agreed to supply their PD-L1 blocking antibody Tecentriq (atezolizumab) for a clinical study combining Bavarian Nordic’s cancer vaccine, CV301, and Tecentriq in patients with urothelial carcinoma, or bladder cancer (Press release, Bavarian Nordic, MAR 10, 2017, View Source [SID1234518061]).

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Bavarian Nordic plans to conduct a phase 2 study in patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, a patient population where Tecentriq has accelerated approval in the U.S. CV301 is designed to generate a T cell response to both CEA and MUC1, two tumor antigens that are highly over expressed in bladder cancers. This study will evaluate the hypothesis that combining a checkpoint inhibitor with a cancer vaccine such as CV301 could be synergistic by enhancing the immune response seen in this patient population to date. The study is anticipated to initiate around the end of 2017.

"In keeping with our strategy to expand the potential of CV301, we are extremely pleased to enter into this collaboration with Roche. This represents our second collaboration in the advancement of CV301 as combination therapy in multiple cancers. We look forward to the initiation of this study and to explore the potential synergy of our programs for the benefit of patients with bladder cancer," said Paul Chaplin, President and CEO of Bavarian Nordic.

Under the terms of the agreement, Roche has committed to supplying Tecentriq to Bavarian Nordic during the phase 2 trial. Bavarian Nordic will be responsible for conducting the clinical trial, and both companies will share data from the trial. Bavarian Nordic continues to retain all commercial rights to CV301.

About CV301
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 and colorectal cancer. Similar to PROSTVAC, CV301 uses a prime/boost dosing schedule. CV301 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. In December 2016, the MAGNI-lung-01 study was initiated. This Phase 1b/2 study evaluates the combination of CV301 and OPDIVO (nivolumab) from Bristol-Myers Squibb in patients with non-small cell lung cancer.