- Both combination trials are deemed not futile and Data Safety Monitoring Board recommends that both trials continue
- Interim efficacy analysis for the low-to-intermediate (HER2 1+/2+) trial now expected by the end of 2017
SAN RAMON, Calif., Feb. 06, 2017 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed
to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, today announced
the results from a meeting of the Data Safety Monitoring Board (DSMB) for the two investigator-sponsored (IST) combination clinical
trials with NeuVax™ (nelipepimut-S) plus trastuzumab. The trials are being run in breast cancer patients to assess the
ability of the combination of trastuzumab and the HER2 vaccine nelipepimut-S (administered with the immunoadjuvant granulocyte
macrophage-colony stimulating factor) to prevent recurrence in the adjuvant setting.
In light of the early termination of the NeuVax Phase 3 PRESENT (Prevention of Recurrence in
Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2
Expression with NeuVax Treatment) trial last year, the independent DSMB
performed separate futility assessments on each of the NeuVax plus trastuzumab combination trials. The DSMB reported that
there are no safety concerns with either trial and neither was found to be futile.
For the Phase 2b trial in patients with low-to-intermediate HER2 expression (HER2 1+/2+), n=242 patients were evaluated, and the
recommendation from the DSMB is to continue the trial with one revision to the statistical analysis plan regarding the timing of
the pre-specified interim analysis. Given the lengthy duration of enrollment for the trial, the DSMB determined that the
pre-specified interim efficacy analysis be moved up from 12 months to 6 months after the last patient is enrolled. Completion of
enrollment is expected in the second quarter of 2017; therefore, the DSMB expects to perform the interim efficacy analysis near the
end of 2017.
For the Phase 2 trial in high-risk, HER2 3+ patients, and per the trial protocol, the pre-specified interim safety analysis was
also completed on n=50 patients and demonstrated that the agent is well tolerated with no increased cardiotoxicity associated
with giving NeuVax in combination with trastuzumab. These findings were similar to the findings presented in October 2016
from the HER2 1+/2+ trial. The recommendation from the DSMB is to continue the HER2 3+ trial unmodified.
“The recommendations from the DSMB are very positive for NeuVax in combination with trastuzumab as there were no safety concerns
and the studies were not deemed futile. Given these findings, the trials can continue per the DSMB recommendation,” said
Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. “We are also pleased that we will be able to reach
the interim efficacy analysis in our Phase 2b HER2 1+/2+ trial earlier than expected with that readout now planned by the end of
this year. It is important to note that these IST trials are designed with a different methodology to identify recurrences
clinically and not via proactive imaging as was done in the PRESENT trial. We are grateful to our investigators running these
trials and their continued dedication to breast cancer patients as they study potential new therapeutic options to prevent
recurrence.”
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. NeuVax contains 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. In clinical studies,
NeuVax is combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF).
NeuVax is currently in two breast cancer studies 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). A Phase 2 clinical trial
is also ongoing with NeuVax in patients with ductal carcinoma in situ (DCIS) (clinicaltrials.gov identifier: NCT02636582), and a
Phase 2 trial is planned in patients with gastric cancer.
About Breast Cancer1
New cases of breast cancer occur at an annual rate of 125 per 100,000 women in the U.S., with an estimated 246,660 new cases and
40,450 deaths in 2016. Approximately 89.7% of breast cancer patients are expected to survive five years after diagnosis.
Approximately 12.4% of women will be diagnosed with breast cancer at some point during their lifetime (2011 – 2013 data). Of
the women diagnosed with breast cancer annually, about 25% are HER2 positive (IHC 3+) and approximately 50%-60% of these women
express HER2 at a low to intermediate range (IHC 1+/2+ or FISH < 2.0). The prevalence data from 2013 showed an estimated
3,053,450 women living with breast cancer in the United States.
1National Cancer Institute Surveillance, Epidemiology, and End Results Program
About Galena Biopharma
Galena Biopharma, Inc. is a biopharmaceutical company committed to the development and commercialization of hematology and
oncology therapeutics that address unmet medical needs. Galena’s pipeline consists of multiple mid-to-late-stage clinical assets
led by its hematology asset, GALE-401, and its novel cancer immunotherapy programs including NeuVax™ (nelipepimut-S) and
GALE-301/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, Galena’s current and prospective financial condition, liquidity and access to capital, 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, 2015 and most recent Quarterly Reports on Form 10-Q and current reports on Form 8-K 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.
Source: Galena Biopharma, Inc.
Contact: Remy Bernarda SVP, Investor Relations & Corporate Communications (925) 498-7709 ir@galenabiopharma.com
