“We have a lot on our plate,” said Ole Larsen, the Executive VP and Chief Financial Officer for Bavarian Nordic in Denmark.
Over 20 years, Bavarian Nordic has grown to become a two-technology platform company for vaccines with a multipurpose production facility. In 2013 its lead product, the smallpox vaccine IMVANEX/ IMVAMUNE, won market approval for Europe and Canada.
More than 28 million doses of this vaccine have been produced and delivered, primarily to the United States Strategic National Stockpile under an emergency use authorization. Since 2003 Bavarian Nordic has contracted over USD 1 billion with US Government agencies for vaccines coming off its platform for use in bio-defense.
In October, 2014, the company announced it had licensed its vaccine targeting the Ebola virus to one of the Janssen Pharmaceutical Companies of Johnson & Johnson in a deal valued at USD 187 million. As part of the deal, Johnson & Johnson Development Corporation invested USD 43 million to take a nearly 5% equity stake in the company. J&J also has an exclusive collaboration option to evaluate MVA-BN for another three undisclosed infectious disease targets.
Ole Larsen, Bavarian-Nordic
CFO Larsen said that Bavarian Nordic has guided a second consecutive year of break-even performance with the 2014 results and expected net free liquidity of USD 200 million.
With a pipeline of nine candidates in clinical development and three candidates in preclinical testing, Larsen said the business development team at BIO-Europe Spring® in Paris is updating potential commercial partners on its mid-stage programs and is looking for oncology collaborations for combination trials. “We will share our scientific rationale for our early stage developments in oncology and infectious disease with potential partners.”
The lead product coming out of the pipeline is PROSTVAC, a monotherapy for late-stage prostate cancer. In December 2014, Bavarian Nordic completed enrollment of 1,200 patients for the PROSPECT Phase III clinical trial. Results are expected in late 2016/early 2017 with three interim analysis points.
“The Phase II study showed the best results in this class with an eight-and-a-half -month increase in median survival in the terminal stage of the disease over the placebos arm. The safety profile is also quite unique for a cancer treatment with flu-like symptoms and soreness where the needle was injected, compared to the adverse side effects of standards of therapy,” said Larsen.
PROSTVAC has also shown promising therapeutic potential in clinical trials in earlier disease stages and combining it with other modalities.
“While Bavarian Nordic is very well-known in Denmark, it is less known in Europe, and hardly known in the US,” he said.
“Most big pharma companies know about us and BIO-Europe Spring in Paris will be a moment when we can update companies on our progress. Yet there are many smaller and medium-sized companies that could be interested in platform or clinical collaborations, and we need to get on their radar.
“Some people only know us for our bio-defense business with the US government, and some people only know about our cancer business. We want to be sure they hear the entire story because we believe it is compelling.
“We are a European biotech and we have been limited over the last couple years with resources only to move forward our smallpox vaccine and our prostate cancer vaccine. Now we can move ahead other candidates into late stage clinical phases, and we would like to grow our pipeline with new clinical trials in both cancer and infectious disease.
“What will be relevant for partners at BIO-Europe Spring is that our MVA (modified vaccinia Ankara) platform enables the insertion of disease specific antigens into our smallpox vaccine vectors, so we will be looking for co-operations combining this vaccine vector with other companies’ antigens. This is not only a smallpox vaccine, it is a vessel. You could look at it as a truck on which can be loaded other antigens to get a recombinant vaccine that targets other diseases.
“Similarly, we will be looking in oncology for clinical co-operations exploring the therapeutic potential of CV-301 in combination with checkpoint inhibitors. There are a lot of checkpoint inhibitors and we have identified those that may be the most interesting in combination with our vaccine and give a priority to discussing these.
“We are in partnership with the US National Cancer Institute (NCI), which we started to work with back in 2008 through a Cooperative Research and Development Agreement (CRADA) where we are providing new constructs and clinical trial materials to the Institute so they can conduct clinical studies. As we have the right to all the data coming out of NCI trials with our constructs, it holds a tremendous value for the company. And through our collaboration with NCI we have a lot of studies showing synergistic effects of PROSTVAC with other cancer treatments. Everyone in the cancer field is talking about combination therapies with checkpoint inhibitors. Here we actually are very well positioned as we have encouraging clinical data.
“Another program we are advancing is MVA-BN brachyury, a novel immunotherapy candidate with broad potential. This is NCI-funded as the Institute has seen brachyury is over-expressed in the spread of tumors and they are now doing on our behalf a Phase I trial. I believe we are completely alone in this field, and we have high hopes here.
“We have stated that we will move forward CV-301, which is a cousin to our prostate cancer vaccine. PROSTVAC contains one prostate-specific antigen, PSA, while CV-301 contains two, MUC-1 and CEA antigens, which are over-expressed in big cancers like lung, colon, ovarian, bladder. We will announce in a couple months which indications we are going to prioritize for further development, and whether it will be as a monotherapy or in combination. With what we have seen over the past 18 months, we believe it is very likely that the treatment of the future is combination treatment. To move in combinations, we need to take the right decisions, as these studies are not cheap to realize.
“For our platform in infectious disease we effectively won a blue stamp from the US government for this vaccine back in 2003 and we have partnered with various departments like the National Institutes of Health, Biomedical Advanced Research and Development Authority, the Department of Defense, and Homeland Security.
“Over time these US contracts have built up the company’s infrastructure. This means we have a large-scale manufacturing facility, and we are the only one who can produce MVA at these quantities.
“Now we not only have a blue stamp from the US government for our platform, but an endorsement from a large pharmaceutical as well. Early data has shown both J&J and GlaxoSmithKline’s Ebola vaccines only offer full protection for a limited period of two or three months. To ensure long-term protection they need a boost. Our vaccine boosts the immune system and secures a long-term protection by educating the immune system so that it remembers what the virus looks like.
“Another good thing about our vaccine is that it is attenuated. If you think of the old smallpox vaccine that leaves a small scar on your shoulder, this vaccine replicates, and it has side effects as it grows in your body. By attenuating the vaccine on our technology platform, it does not replicate in the body making it a much safer vaccine. We are currently developing a freeze dry formulation of this smallpox vaccine that could lead to more orders.
“A high priority target for us is respiratory syncytial virus (RSV), where there is a high unmet medical need as it is a major cause of respiratory illness in young children as well as among elderly populations. We have developed a construct that targets both major antigenic groups of RSV, A and B. With this unmet medical need, the market potential in RSV is huge. Our preclinical data is very encouraging and this construct is based on a proven platform. We will move into Phase I this year, and we could be in a position where we can accelerate the program if our resources allow.
Asked if Bavarian Nordic would look at potential in-licensing to expand its technology, Larsen said, “Right now, being a smaller company, we have our hands full. An important lesson we have learned from other companies is to stay focused doing what we are good at doing. We will not be distracted.”
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