About Bavarian Nordic A/S

Bavarian Nordic A/S develops, manufactures and commercializes a portfolio of novel vaccines for the prevention and/or treatment of life-threatening infectious diseases and cancer. Product Pipeline The company’s pipeline comprises multiple product candidates, which are subject to approximately 20 ongoing clinical studies in infectious diseases and cancer. IMVAMUNE IMVAMUNE is a non-replicating smallpox vaccine approved in Europe for use in the general adult population (marketed under the trade name IMVANEX). It is approved in Canada for use in a public health emergency for adults who are contraindicated to replicating smallpox vaccines. As part of the partnership with the U.S. Government, the company is working towards the approval of IMVAMUNE in the U.S. The second and final Phase 3 study to support FDA approval of IMVAMUNE was completed in February 2018. The company intends to file a Biological License Application in 2018. MVA-BN RSV MVA-BN RSV is the company’s product candidate in clinical Phase 2 development for the prevention of respiratory syncytial virus vaccine (RSV). The vaccine is designed to target 5 different proteins to ensure an immune response against both RSV subtypes (A & B). In 2017, the company reported results from a randomized, placebo-controlled Phase 2 dose finding study of the vaccine. Cancer Immunotherapy CV301 (Immunotherapy for Multiple Cancers) The company’s clinical strategy for CV301 is realized with four clinical studies, spanning multiple disease settings, in combination with four different checkpoint inhibitors. Lung Cancer The first study to explore the combination of CV301 with checkpoint inhibitors is targeting patients with non-small cell lung cancer (NSCLC). The study focuses on establishing the safety of the combination of CV301 and KEYTRUDA (pembrolizumab) and would progress into a Phase 2 proof of concept study during 2018. Bladder Cancer During 2018, the company intends to initiate a Phase 2 study of the combination of CV301 and TECENTRIQ (atezolizumab), Roche’s FDA- and EMA approved PD-L1 inhibitor, in patients with locally advanced or metastatic urothelial carcinoma (bladder cancer) who have disease progression during or following platinum-containing chemotherapy or are ineligible for platinum-containing chemotherapy. The two-stage designed study would start with enrolment of patients in each arm, establish if a minimum signal of efficacy could be determined, and if so, expand enrolment. Colorectal Cancer In 2018, two new additional studies have been introduced into the pipeline, both focused on colorectal and associated cancers, exploring two different indications and two different checkpoint inhibitors. The first study is a dual arm, open label Phase 1/2 study to evaluate the safety and clinical activity of the combination of AstraZeneca’s anti-PD-L1 durvalumab with CV301 in combination with maintenance chemotherapy for patients with metastatic colorectal (mCRC) or pancreatic cancer whose disease is stable on, or responding to first-line therapy for metastatic disease. The second study is a Phase 2 trial that would enroll patients with oligometastatic micro-satellite stable mCRC eligible for complete resection. Prior to surgical resection of their tumors, patients would be randomized to receive four cycles of either chemotherapy, as well as nivolumab or a combination of chemotherapy, nivolumab, and CV301. PROSTVAC (Prostate Cancer Immunotherapy) PROSTVAC is a prostate specific antigen-targeted immunotherapy candidate, which is investigated in multiple clinical trials across various stages of prostate cancer. Initial results from an ongoing Phase 2 combination trial of PROSTVAC and nivolumab as neoadjuvant therapy in patients with localized prostate cancer are anticipated during 2018, which could provide evidence of a clinical benefit of the combination of PROSTVAC and checkpoint inhibitors. BN-Brachyury (Immunotherapy Targeting the Metastatic Process) BN-Brachyury is a novel cancer immunotherapy candidate with potential to treat chordoma (a rare tumor of the spine), as well as other metastatic cancers, including triple negative breast cancer and NSCLC, which are known to have high expression levels of brachyury. The product candidate consists of a primer (MVA-BN) and a booster dose (fowlpox), which have been modified to express brachyury and to encode three costimulatory molecules, known as TRICOM. In early 2018, the company initiated an open-label Phase 1 trial to evaluate the safety and tolerability of the MVA BN Brachyury vaccine, followed by a brachyury encoded fowlpox (FPV) booster in patients. Later in 2018, the company intends to initiate a Phase 2 study that combines the vaccine with radiation in patients with advanced chordoma. Under this program, the vaccine candidate might obtain orphan status with the FDA and also be eligible for the FDA’s Orphan Products Clinical Trials Grants Program, which supports the clinical development of products for use in rare diseases or conditions where no current therapy exists. The company would also apply for a Breakthrough Therapy Designation with the FDA. Additional Phase 2 plans include a combination study with a PD-1 or PD-L1 checkpoint inhibitor in an undisclosed indication. Partnered Projects The company’s partnered programs include product candidates licensed to Janssen Pharmaceuticals, Inc. (Janssen) as part of its collaboration to explore the potential of prime-boost vaccination strategies combining Janssen’s AdVac technology with its MVA-BN platform. MVA-BN Filo: MVA-BN Filo is a filovirus vaccine candidate that contains the gene of the glycoproteins of Ebola Zaire, Ebola Sudan and Marburg virus, and is designed to provide protection against the three major common causes of viral hemorrhagic fever. Preclinical studies conducted at the National Institutes of Health showed that combining the company’s adenovirus– based vaccine candidate, Ad26. ZEBOV with the company’s MVA-BN Filo vaccine in a prime-boost vaccine regimen offered protection against Ebola. Together with an array of consortium partners, Janssen is conducting multiple clinical Phase 1, 2 and 3 trials in healthy adults, children, elderly and immunocompromised populations across Europe, U.S. and Africa with the intention of registering the vaccine. MVA-BN HPV: MVA-BN HPV is being developed for use in a prime-boost vaccine regimen with Janssen’s AdVac technology. The prime-boost vaccine represents an approach for treating chronic HPV infections, as well as preventing precancerous stages of HPV-induced cancer. A Phase 1 clinical study of the vaccine candidate is planned for initiation in 2018. MVA-BN HIV: MVA-BN HIV is being developed for use in a prime-boost vaccine regimen with Janssen’s AdVac technology MVA-BN HBV: MVA-BN HBV is being developed for use in a prime-boost vaccine regimen with Janssen’s AdVac technology. Preclinical activities are ongoing. Strategy The company’s strategy intends to secure and maintain a sustainable foundation and includes both various significant near-term triggers, as well as long-term prospects within various focus areas, such as maintaining the global leadership of its smallpox vaccine franchise; rapidly advancing its pipeline of infectious disease programs; and establishing a broad and deep cancer immunotherapy franchise. Research and Development For the year ended, December 31, 2017, the company’s research and development expenses were DKK 519 million. History Bavarian Nordic A/S was founded in 1994.