Galena Biopharma Appoints Bijan Nejadnik, M.D., as Executive Vice President and Chief Medical Officer
October 30 2015 - 7:05AM
Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company
developing and commercializing innovative, targeted oncology
therapeutics that address major medical needs across the full
spectrum of cancer care, today announced that Bijan Nejadnik, M.D.,
has been hired as the Company's Executive Vice President and Chief
Medical Officer, effective today.
Dr. Nejadnik will be responsible for managing all of Galena's
clinical development programs, which consist of multiple mid- to
late-stage clinical assets, including immunotherapy programs led by
NeuVax™ (nelipepimut-S) and GALE-301 (Folate Binding Protein).
NeuVax is currently in a pivotal, Phase 3 clinical trial with
several concurrent Phase 2 trials both as a single agent and in
combination with other therapies. GALE-301 recently completed a
Phase 2a clinical trial in ovarian and endometrial cancer.
"The appointment of Dr. Bijan Nejadnik as our new Chief Medical
Officer comes at an important juncture for Galena as the company
anticipates reaching several key milestones across our clinical
development pipeline," said Mark W. Schwartz, Ph.D., President and
CEO. "Bijan's knowledge in oncology and immunotherapy, as well as
his experience leading the design, planning and execution of early
and late-stage clinical programs, will be instrumental to Galena as
we continue to advance and expand our product portfolio, including
our immunotherapy franchise, led by NeuVax. We are thrilled to have
Bijan join the Galena team and look forward to his
contributions."
Dr. Bijan Nejadnik has more than 22 years of academic and
industry experience, including twelve years with pharmaceutical and
biotech companies including Jazz Pharmaceuticals, Johnson &
Johnson, and Purdue Pharma. During his career, he has managed
numerous clinical development teams and programs with a therapeutic
focus in hematology-oncology, immunology and central nervous system
diseases. In this capacity, Dr. Nejadnik has successfully developed
numerous biologics and small molecules, advancing these agents
towards Biologics License Application (BLA) and New Drug
Application (NDA) submissions.
Dr. Nejadnik joins Galena from Jazz Pharmaceuticals where he was
the Executive Director, Hematology-Oncology and led the clinical
team towards a recently filed NDA. Prior to Jazz, he spent seven
years at Johnson & Johnson working on numerous compounds in
early and late stage registrational trials in immunology and
oncology. Dr. Nejadnik spent more than 13 years in teaching,
research and caring for patients at world-renowned academic
institutions including Stanford University School of Medicine,
Johns Hopkins University School of Medicine, University of
California, Davis, and State University of New York, Syracuse. Dr.
Nejadnik graduated from the University of Louvain in Belgium for
both his undergraduate degree in premedical studies, graduating
Summa Cum Laude, and his medical degree, graduating Magna Cum
Laude. He completed his internship and residency programs
specializing in internal medicine focused on hematology-oncology at
the University of Louvain and Oregon Health Sciences University. He
completed his fellowships at Cornell University's Weill Medical
College and Johns Hopkins University School of Medicine. Dr.
Nejadnik has led or participated in more than 20 peer-reviewed
publications.
About NeuVax™ (nelipepimut-S)
NeuVax™ (nelipepimut-S) is a first-in-class, HER2-directed
cancer immunotherapy under evaluation to prevent breast cancer
recurrence after standard of care treatment in the adjuvant
setting. It is the immunodominant peptide 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 specific HLA 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-S immune response can also generate CTLs to other
immunogenic peptides through inter- and intra-antigenic epitope
spreading.
NeuVax is currently in an international, Phase 3 PRESENT
(Prevention of Recurrence in
Early-Stage, Node-Positive Breast
Cancer with Low to Intermediate HER2 Expression
with NeuVax Treatment) study
under a Special Protocol Assessment (SPA) granted by the U.S. Food
and Drug Administration (FDA). PRESENT is targeting node positive
HER2 IHC 1+/2+ patients (clinicaltrials.gov identifier:
NCT01479244). Galena has two additional breast cancer studies
ongoing with NeuVax in combination with trastuzumab (Herceptin®;
Genentech/Roche): a Phase 2b trial in node positive and triple
negative HER2 IHC 1+/2+ (clinicaltrials.gov identifier:
NCT01570036); and, a Phase 2 trial in high risk, node positive or
negative HER2 IHC 3+ patients (clinicaltrials.gov identifier:
NCT02297698). Phase 2 clinical trials with NeuVax are also
planned in patients with ductal carcinoma in situ (DCIS), and in
patients with gastric cancer.
About GALE-301
GALE-301 is a cancer immunotherapy that consists of a peptide
derived from Folate Binding Protein (FBP) combined with the immune
adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF)
for the prevention of cancer recurrence in the adjuvant
setting. FBP is a well-validated therapeutic target that is
highly over-expressed in ovarian, endometrial and breast cancers.
FBP is the source of immunogenic peptides that can stimulate
cytotoxic T lymphocytes (CTLs) to recognize and destroy
FBP-expressing cancer cells. Enrollment has been completed in the
GALE-301 Phase 2a portion of the Phase 1/2a clinical trial in two
gynecological cancers: ovarian and endometrial adenocarcinomas
(ClinicalTrials.gov Identifier: NCT01580696).
About Galena Biopharma
Galena Biopharma, Inc. (NASDAQ:GALE) is a biopharmaceutical
company developing and commercializing innovative, targeted
oncology therapeutics that address major medical needs across the
full spectrum of cancer care. Galena's development
portfolio ranges from mid- to late-stage clinical assets, including
a robust immunotherapy program led by NeuVax™ (nelipepimut-S)
currently in an international, Phase 3 clinical trial. The
Company's commercial drugs include Abstral® (fentanyl) Sublingual
Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Collectively,
Galena's clinical and commercial strategy focuses on identifying
and advancing therapeutic opportunities to improve cancer
care, from direct treatment of the disease to the reduction of
its debilitating side-effects. 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 commercialization of our
commercial products and development of Galena's product candidates,
including NeuVax, patient enrollment in our clinical trials, as
well as other statements related to the progress and timing of our
development activities, present or future licensing, collaborative
or financing arrangements or that otherwise relate to future
periods. 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, 2014 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. 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.
Abstral and NeuVax are trademarks of Galena Biopharma,
Inc. All other trademarks are the property of their respective
owners.
CONTACT: Remy Bernarda
SVP, Investor Relations & Corporate Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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