Galena Biopharma Receives Notice of Allowance of Broad U.S. Patent for NeuVax(TM) (nelipepimut-S)
July 01 2014 - 7:05AM
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company
developing and commercializing innovative, targeted oncology
treatments that address major unmet medical needs to advance cancer
care, today announced the notice of allowance of a U.S. Patent for
NeuVax™ (nelipepimut-S) covering the use of NeuVax alone or in
combination to prevent recurrence of any HER2/neu expressing tumor
having a fluorescence in situ hybridization (FISH) rating of less
than about 2.0. NeuVax is a peptide immunotherapy for the
prevention of cancer recurrence and is Galena's lead development
agent in multiple ongoing and planned clinical trials. Once
issued, the patent will expire in 2028, not including any patent
term extensions.
FISH is a diagnostic test used to identify patients with high
levels of HER2 gene expression, or FISH greater than 2.0. These
patients are eligible for existing approved HER2-directed
treatments. Currently there are no approved HER2-directed
therapies for patients who express lower levels of HER2, or less
than 2.0 by the FISH testing scale.
The patent will cover the use of NeuVax in patients with a FISH
of less then about 2.0, as a stand-alone therapy or in combination
with an adjuvant and/or other agents (e.g. other drugs such as
Herceptin® (trastuzumab; Genentech/Roche)). Importantly, this
NeuVax patent provides Galena with coverage for any tumor
expressing low-to-intermediate levels of HER2.
"This allowance further strengthens our broad patent estate for
NeuVax, covering all tumor types expressing low-to-intermediate
levels of HER2 both as a monotherapy and in combination with other
agents," said Mark J. Ahn, Ph.D., President and Chief Executive
Officer. "Our clinical development program with NeuVax
continues to grow with ongoing and planned clinical trials in
breast and gastric cancers. We look forward to completing
enrollment in our Phase 3 PRESENT trial this year and advancing
NeuVax in other programs to prevent cancer recurrence for
patients."
About NeuVax™ (nelipepimut-S)
NeuVax™ (nelipepimut-S) is the immunodominant nonapeptide
derived from the extracellular domain of the HER2 protein, a
well-established target for therapeutic intervention in breast
carcinoma. The nelipepimut-S sequence stimulates specific CD8+
cytotoxic T lymphocytes (CTLs) following binding to HLA-A2/A3
molecules on antigen presenting cells (APC). These activated
specific CTLs recognize, neutralize and destroy, through cell
lysis, HER2 expressing cancer cells, including occult cancer cells
and micrometastatic foci. The nelipepimut immune response can also
generate CTLs to other immunogenic peptides through inter- and
intra-antigenic epitope spreading. Based on a successful Phase 2
trial, which achieved its primary endpoint of disease-free survival
(DFS), the U.S. Food and Drug Administration (FDA) granted NeuVax a
Special Protocol Assessment (SPA) for its Phase 3 PRESENT
(Prevention of Recurrence in Early-Stage, Node-Positive Breast
Cancer with Low to Intermediate HER2 Expression with NeuVax
Treatment) study. The PRESENT trial is ongoing and additional
information on the study can be found at www.neuvax.com. A
randomized, multicenter investigator sponsored, 300 patient Phase
2b clinical trial is also enrolling patients to study NeuVax in
combination with Herceptin® (trastuzumab; Genentech/Roche).
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based
biopharmaceutical company developing and commercializing
innovative, targeted oncology treatments that address major unmet
medical needs to advance cancer care. For more information
visit www.galenabiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Such statements include, but are not limited to,
statements about the progress of the development of Galena's NeuVax
product candidate, as well as statements about our
expectations, plans and prospects. These forward-looking statements
are subject to a number of risks, uncertainties and assumptions,
including those identified under "Risk Factors" in Galena's Annual
Report on Form 10-K for the year ended December 31, 2013 and most
recent Quarterly Reports on Form 10-Q filed with the SEC. Actual
results may differ materially from those contemplated by these
forward-looking statements.
CONTACT: Remy Bernarda
VP, Marketing & Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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