Galena Biopharma Research Pioneer Presented With 2014 Award for Excellence in Technology Transfer
April 24 2014 - 7:05AM
Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company
developing and commercializing innovative, targeted oncology
treatments that address major unmet medical needs to advance cancer
care, today announced that the 2014 Award for Excellence in
Technology Transfer was granted to The Henry M. Jackson Foundation
for the Advancement of Military Medicine, Inc. (HJF) and the
Uniformed Services University of the Health Sciences (USU). The
award was presented by the Federal Laboratory Consortium for
Technology Transfer for work by George Peoples, M.D., chief of
surgical oncology at the San Antonio Military Medical Center, and
his colleagues, for the licensing of NeuVax™ (nelipepimut-S), a
breast cancer vaccine to reduce breast cancer recurrence.
Dr. Peoples and other researchers at the University of Texas
M.D. Anderson Cancer Center in Houston discovered the E75 peptide,
now known as NeuVax. Galena owns the worldwide license for
NeuVax for all uses and is currently developing the drug in
multiple clinical trials including its pivotal, Phase 3 PRESENT
(Prevention of Recurrence in Early-Stage, Node-Positive Breast
Cancer with Low to Intermediate HER2 Expression with NeuVax
Treatment) study. The official announcement can be found
here: USU-HJF Effort to License Promising Breast
Cancer Vaccine Wins Award.
"The pioneering scientific and clinical work done by Dr. Peoples
and his team has brought NeuVax from discovery to a pivotal Phase 3
trial with the aim of preventing breast cancer recurrence for women
with no current treatment options," said Mark J. Ahn, Ph.D.,
President and Chief Executive Officer of Galena Biopharma. "We
offer our heartfelt congratulations to the teams at the HJF and
USU, and are grateful for our ongoing affiliations with these
esteemed organizations."
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).
According to the National Cancer Institute, over 230,000 women
in the U.S. are diagnosed with breast cancer annually. Of these
women, only about 25% are HER2 positive (IHC 3+). NeuVax targets
the approximately 50%-60% of these women who are HER2 low to
intermediate (IHC 1+/2+ or FISH < 2.0) and achieve remission
with current standard of care, but have no available HER2-targeted
adjuvant treatment options to maintain their disease-free
status.
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 our 2014 target revenue from the sale of Abstral®
and the progress of Galena's clinical trials, 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 filed with the SEC. Actual
results may differ materially from those contemplated by these
forward-looking statements. Galena does not undertake to update any
of these forward-looking statements to reflect a change in its
views or events or circumstances that occur after the date of this
press release.
CONTACT: Remy Bernarda
VP, Marketing & Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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