Bavarian Nordic Announces First Patient Treated in a Phase II Study Evaluating its Immunotherapy Candidate in Bladder Cancer

Bavarian Nordic A/S has announced the first patient has now been treated in a randomized, prospective Phase II study of its active immunotherapy candidate CV-301 in bladder cancer.

In the study, sponsored by the National Cancer Institute, 54 patients with high grade non-muscle invasive bladder cancer whose cancer has progressed after initial BCG (Bacillus Calmette-Guerin) treatment will be treated with BCG alone or in combination with CV-301. BCG has been approved in many countries to prevent the recurrence of superficial bladder tumours.

The study's primary endpoint is to determine if there is an improvement in disease-free survival for patients receiving BCG treatment and CV-301 immunotherapy compared to those receiving BCG treatment alone. It is the hypothesis that the combined administration of BCG and CV-301 may augment the BCG-induced cytotoxic T lymphocyte response against bladder cancer cells expressing MUC-1 and/or CEA and potentially reverse BCG failure in patients that progressed following a prior induction course of the therapy. Lead investigator for the study is Piyush K. Agarwal, MD, Head, Bladder Cancer Section, National Cancer Institute, NIH.

An abstract on this study, entitled "A Randomized, Prospective, Phase II Study to Determine the Efficacy of Bacillus Calmette-Guerin (BCG) given in combination with PANVAC versus BCG given alone in Adults with High Grade Non-Muscle Invasive Bladder Cancer (NMIBC) who failed at least 1 Induction Course of BCG," has been accepted for presentation in the Trials in Progress section at the 2014 ASCO Annual Meeting in Chicago, IL from 30 May to 3 June 3. Abstract #TPS4590. Poster Board: #157B. Presenter: Sam Joseph Brancato, MD.

James B. Breitmeyer, President of Bavarian Nordic's Cancer Immunotherapy Division said: "We are very pleased that development of our cancer immunotherapy candidates is expanding further into new indications and new combination approaches. We are hopeful that combination therapy with CV-301 will yield positive results for bladder cancer patients who currently face limited treatment options."