Bavarian Nordic Announces First Patient Treated in a Phase 1 Study of MVA-BN(r) Brachyury in Advanced Cancer
July 24 2014 - 12:56AM
Bavarian Nordic A/S (OMX:BAVA) (OTC:BVNRY) announced today that the
first patient has been treated in an NCI-sponsored Phase 1 study of
MVA-BN Brachyury in patients with advanced cancer.
MVA-BN Brachyury is a novel, active immunotherapy developed
using Bavarian Nordic's proprietary validated MVA platform. This
immunotherapy is designed to induce a robust immune response
against Brachyury, a tumor-associated antigen which is
overexpressed in every major solid tumor setting. Brachyury is
believed to play a key role in both the metastasis and progression
of tumors. Tumors which overexpress Brachyury are believed to be
highly resistant to current therapies and are associated with
decreased survival rates.
Paul Chaplin, President and CEO of Bavarian Nordic said:
"Brachyury is an exciting and novel target which in recent years
has come to be associated with highly difficult to treat,
aggressive tumors, and we are pleased to introduce our newest
pipeline candidate into the clinic. These tumors either fail to
respond to current cancer treatments, or have metastasized beyond
localized therapies. Using our proprietary and specialized
immunotherapy platform, we created a drug candidate which can
harness the immune system to target Brachyury and may offer a
treatment option to those patients with aggressive or late stage
disease. We are proud to be working with the NCI to become one of
the leaders in this exciting space as Brachyury continues to gain
interest with both investigators and drug developers."
The study is an open label, Phase 1 trial that will enroll
patients with advanced cancer into three cohorts (6 patients per
dose cohort) with dose escalation of MVA-BN Brachyury. Additional
patients may be enrolled at the maximum tolerated dose. The
objective of the study is to determine the safety and tolerability
of escalating doses of MVA-BN Brachyury and to evaluate immunologic
responses as measured by an increase in Brachyury-specific T cells.
Principal Investigator is Christopher R. Heery, M.D., NCI. Full
details for the study can be found here:
http://clinicaltrials.gov/ct2/show/NCT02179515.
About MVA-BN Brachyury
Brachyury is a transcription factor that is involved in
mesodermal development in the embryo, and involved in
epithelial-mesenchymal transition (EMT) in tumor cells, a key step
in tumor invasion and metastasis. MVA-BN Brachyury is based on
MVA-BN (Modified vaccinia Ankara Bavarian Nordic), which has been
clinically tested in more than 7,300 subjects, including cancer
patients, and has shown to be well-tolerated and to induce a strong
immune response. The product candidate also employs the TRICOM
technology (human T cell costimulatory molecules; B7.1, ICAM-1 and
LFA-3), which has been extensively studied in both preclinical and
clinical studies and have demonstrated their ability to induce
robust T-cell activation and provide evidence of clinical benefit.
TRICOM is employed in the Company's other active immunotherapy
candidates, PROSTVAC and CV-301.
MVA-BN Brachyury has been shown to be a good target for active T
cell immunotherapy in preclinical models.
About Bavarian Nordic
Bavarian Nordic is an international biotechnology company
developing and manufacturing novel cancer immunotherapies and
vaccines for infectious diseases. Lead product candidates are
PROSTVAC(r), an immunotherapy product candidate for advanced
prostate cancer that is the subject of an ongoing pivotal Phase 3
clinical trial, and IMVAMUNE(r), a non-replicating smallpox vaccine
candidate in Phase 3 development, which is being developed and
supplied for emergency use to the U.S. Strategic National Stockpile
under a contract with the U.S. Government. The vaccine is approved
in Canada under the trade name IMVAMUNE and in the European Union
under the trade name IMVANEX(r).
Bavarian Nordic's shares are listed on NASDAQ OMX Copenhagen
under the symbol BAVA (Reuters: BAVA.CO, Bloomberg: BAVA.DC). The
company has a sponsored Level 1 ADR program listed in the US (OTC)
under the symbol BVNRY.
For more information, visit www.bavarian-nordic.com.
Forward-looking statements
This announcement includes forward-looking statements that
involve risks, uncertainties and other factors, many of which are
outside of our control that could cause actual results to differ
materially from the results discussed in the forward-looking
statements. Forward-looking statements include statements
concerning our plans, objectives, goals, future events, performance
and/or other information that is not historical information. We
undertake no obligation to publicly update or revise
forward-looking statements to reflect subsequent events or
circumstances after the date made, except as required by law.
Contacts
Seth Lewis, Vice President Investor Relations (US). Phone +1 978
298 5654
Bavarian Nordic AS (PK) (USOTC:BVNRY)
Historical Stock Chart
From Nov 2024 to Dec 2024
Bavarian Nordic AS (PK) (USOTC:BVNRY)
Historical Stock Chart
From Dec 2023 to Dec 2024