Galena Biopharma Provides 2016 Outlook
January 13 2016 - 7:05AM
Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company
committed to the development and commercialization of targeted
oncology therapeutics that address major unmet medical needs, today
provided the Company’s outlook for 2016.
Mark W. Schwartz, Ph.D., President and Chief Executive Officer,
commented, “Galena’s strategy to advance our high value cancer
immunotherapy clinical development pipeline has resulted in a
progression to eight clinical trials ongoing or planned that are
supportive of our core focus. Importantly, we expect to reach
two key milestones in 2016 with the readout of our NeuVax™
(nelipepimut-S) Phase 3 PRESENT interim safety and futility
analysis in the second quarter and the launch of a randomized,
Phase 2b trial for GALE-301/302 in the second half of the
year.”
Dr. Schwartz continued, “The advances in the immunotherapy field
reinforce the importance of our approach, and we are pleased with
our position as the leader in developing therapies to prevent
cancer recurrence. Our programs are first-in-class in their
respective indications and we believe are in very strong
competitive positions. Most prominently, we are treating
women in areas where there are no approved targeted therapies and
where there is a very high unmet medical need to prevent their
cancer from returning. Our immunotherapy assets have a proven
mechanism of action and we believe we have selected the right
patient populations to achieve success. And, as we have done
successfully thus far, we will continue to seek collaborations to
leverage our financial resources and further advance our assets
into other indications.”
Dr. Schwartz added, “Consistent with our strategic focus, we are
bolstering our leadership team to provide critical expertise as we
begin to prepare for the potential submission of a Biologics
License Agreement (BLA) for NeuVax. Last quarter, Dr. Bijan
Nejadnik joined us as our Chief Medical Officer having previously
worked at Jazz Pharmaceuticals and Johnson & Johnson. We have
also enlisted a national executive recruiting firm to lead the
search for two new members for our Board of Directors and an
experienced Chief Financial Officer. We expect to make
significant clinical progress over the course of the year and look
forward to having additional experience and perspective at the
highest levels of the company.”
Dr. Schwartz concluded, “I would also like to address our recent
financial offering that allowed us to secure our cash balance for
the year. While our ongoing, anticipated cash burn including
current and planned clinical trials is expected to be between $11
to 13 million per quarter, we will also have non-recurring expenses
as a result of the previously announced commercial divesture and
settlement of the outstanding litigation. As such, it was
important for us to enhance our balance sheet ahead of our expected
milestones to ensure the company remains financially strong over
the course of 2016.”
2016 Outlook:
Galena expects to achieve a number of key milestones this year
across its novel cancer immunotherapy programs. Effective
immunotherapy treatment is associated with high numbers of
cytotoxic T-Cells (CTLs), and it has been shown that increasing
tumor specific CTLs is critical for overcoming many of the
challenges associated with some of the current immunotherapy
treatments. Galena’s peptide based vaccines, NeuVax and
GALE-301/302, have demonstrated, in multiple trials, they can
effectively induce, activate and expand CTLs.
Galena’s vaccines harness the power of the patient’s immune
system to seek out and destroy any residual, or occult, cancer
cells via their proven mechanism of action stimulating T-Cell
proliferation and expansion. The Company’s current programs
are designed to prevent recurrence in breast, gastric, and ovarian
cancers in the adjuvant setting where patients have relatively
healthy immune systems. As the number of cancer survivors
continues to grow, preventing recurrence of the disease becomes
more important as metastatic tumors are most often fatal.
Employing this approach, the company is currently engaged in
multiple clinical trials with NeuVax and GALE-301/302 combined with
the immune adjuvant, granulocyte macrophage-colony stimulating
factor (GM-CSF).
Galena’s lead development asset, NeuVax, has several milestones
upcoming for 2016:
- The pivotal, Phase 3 PRESENT (Prevention of
Recurrence in
Early-Stage, Node-Positive Breast
Cancer with Low to Intermediate HER2 Expression
with NeuVax Treatment) study is
fully enrolled and is expected to reach two key milestones in the
first half of the year. In the first quarter, the trial
should see the 70th patient event, which is defined as a recurrence
or death from any cause. Once this occurs, the Independent
Data Safety and Monitoring committee will evaluate the data and
provide the company with the safety and futility interim
analysis. This analysis is expected in the second
quarter.
- The company expects to initiate a Phase 2 trial in patients
with Ductal Carcinoma in Situ (DCIS) in the first quarter.
This trial is being run in partnership with the National Cancer
Institute.
- For the Phase 2b randomized, combination trial with NeuVax and
trastuzumab, Galena expects to present interim safety data as well
as patient immunology data on the A24 and A25 Human Leukocyte
Antigen (HLA) status in the fourth quarter.
Galena’s second immuno-oncology program consists of two assets,
GALE-301 and GALE-302, targeting folate binding protein
receptor-alpha, a well-validated therapeutic target in ovarian
cancer. Based on positive data from the clinical programs,
Galena plans the following:
- Initiate a randomized, Phase 2b trial in ovarian cancer in the
second half of this year based upon promising data from two ongoing
trials: the GALE-301 Phase 2a clinical trial and the
GALE-301/GALE-302 Phase 1b trial.
- Present GALE-301/302 booster data in the second quarter.
- Present GALE-301 Phase 2a, two-year data in the fourth
quarter.
Galena’s final clinical program is a hematology compound known
as GALE-401, or Anagrelide Controlled Release. GALE-401 has
completed its Phase 2 proof-of-concept clinical trial for the
reduction of elevated platelet counts in patients with
thrombocythemia, secondary to myeloproliferative neoplasms (MPNs).
The Company plans to publish the final Phase 2 report and
confirm the 505(b)2 pathway with the U.S. Food and Drug
Administration in the second half of the year.
About Galena Biopharma
Galena Biopharma, Inc. is a biopharmaceutical company committed
to the development and commercialization of targeted oncology
therapeutics that address major unmet medical needs. Galena’s
development portfolio is focused primarily on addressing the
rapidly growing patient populations of cancer survivors by
harnessing the power of the immune system to prevent cancer
recurrence. The Company’s pipeline consists of multiple mid- to
late-stage clinical assets, including novel cancer immunotherapy
programs led by NeuVax™ (nelipepimut-S) and GALE-301. NeuVax
is currently in a pivotal, Phase 3 clinical trial with several
concurrent Phase 2 trials ongoing both as a single agent and in
combination with other therapies. GALE-301 is in a Phase 2a
clinical trial in ovarian and endometrial cancers and in a Phase 1b
given sequentially with GALE-302. 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
product candidates, 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, expected outcomes with regulatory
agencies, and projected market opportunities for product candidates
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.
NeuVax is a trademark of Galena Biopharma, Inc.
Contact:
Remy Bernarda SVP, Investor Relations & Corporate
Communications(925) 498-7709ir@galenabiopharma.com
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