Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company
developing hematology and oncology therapeutics that address unmet
medical needs, today announced that two clinical trials evaluating
NeuVax™ (nelipepimut-S) in combination with trastuzumab
(Herceptin®; Genentech/Roche) for the prevention of recurrence in
breast cancer patients have enrolled the protocol-defined number of
patients to complete enrollment. The milestones were reported by
the clinical research organization conducting both trials – a Phase
2b clinical trial in HER2 1+/2+ patients and a Phase 2 clinical
trial in HER2 3+ patients.
“Completing enrollment in both of these trials represents a
major milestone for NeuVax development,” said Bijan Nejadnik, M.D.,
Executive Vice President and Chief Medical Officer of Galena. “The
combination of trastuzumab and NeuVax has been shown to be
synergistic in preclinical investigation, and we believe could be
an effective treatment to prevent breast cancer recurrence in
patients with no other treatment options. We would like to
thank our investigators and patients who are participating in these
trials as we look forward to the interim results next year for the
Phase 2b trial and the primary endpoints for both trials in
2019.”
Phase 2b Clinical Trial in HER2 1+/2+
Patients
The Phase 2b clinical trial has enrolled the necessary 300
patients to complete enrollment. The clinical trial is a
randomized, multicenter, investigator-sponsored, study enrolling
HER2 1+ and 2+, HLA A2+, A3+, A24 and/or A26, node positive, and
high-risk node negative breast cancer patients. Eligible patients
are randomized to receive NeuVax + GM-CSF + trastuzumab or
trastuzumab + GM-CSF alone. Once enrolled, all patients receive the
standard trastuzumab dosing for 12 months. One cohort also receives
six doses of NeuVax given as a primary vaccine series starting with
the third dose of trastuzumab and then goes on to receive a NeuVax
booster inoculation once every six months for up to 36 months. The
next milestone for the trial will be the interim efficacy analysis
that is scheduled to be performed by the Data Safety Monitoring
Board (DSMB) in the first quarter of 2018. The primary endpoint of
the study is disease-free survival after 24 months, with results
expected from that milestone in the fourth quarter of 2019.
Genentech/Roche is providing the trastuzumab and partial funding
for this trial.
Data presented in October 2016 demonstrated that this novel
combination of trastuzumab and NeuVax with HER2 low-expressing
patients is well tolerated and the cardiac effects of trastuzumab
are not impacted by the addition of NeuVax. In February 2017, the
DSMB reported that there were no safety concerns with the trial and
the trial is not futile. The recommendation from the DSMB was 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. Therefore, the DSMB expects to perform the interim
efficacy analysis in the first quarter of 2018.
Phase 2 Clinical Trial in HER2 3+ Patients
The Phase 2 clinical trial has enrolled the necessary 100
patients to complete enrollment. This multi-center, prospective,
randomized, single-blinded trial enrolled patients with a diagnosis
of HER2 3+ breast cancer who are HLA A2+ or HLA A3+ and are
determined to be at high-risk for recurrence. High-risk is defined
as having received neoadjuvant therapy with an approved regimen
that includes trastuzumab but not obtaining a pathological complete
response at surgery, or underwent surgery as a first intervention
and was found to be pathologically node-positive (≥ 4 positive
lymph nodes, or having 1-3 positive lymph nodes (pN1) if hormone
receptor negative). These high-risk patients are known to have
higher recurrence rates than other HER2 3+ breast cancer patients.
Eligible patients are randomized to receive NeuVax + GM-CSF +
trastuzumab or trastuzumab + GM-CSF alone. Once enrolled, all
patients receive the standard trastuzumab dosing for 12 months. One
cohort also receives six doses of NeuVax given as a primary vaccine
series starting with the third dose of trastuzumab and then goes on
to receive a NeuVax booster inoculation once every six months for
up to 36 months. The primary endpoint of the study is
disease-free survival after 24 months, with results expected from
that milestone in the fourth quarter of 2019. Partial funding for
this trial was awarded through the Congressionally Directed Medical
Research Program funded through the Department of Defense, via a
Breast Cancer Research Program Breakthrough Award.
In February 2017, the DSMB reported that there were no safety
concerns with the trial and the trial is not futile. The
pre-specified interim safety analysis was 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. The recommendation from the DSMB was
to continue the HER2 3+ trial unmodified.
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. 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 Cancer
New cases of breast cancer occur at an annual rate of 125 per
100,000 women in the U.S., with over 250,000 new cases and 40,000
deaths expected in 2017. 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). The
prevalence data from 2013 showed an estimated 3,053,450 women
living with breast cancer in the United States.
According to the National Cancer Institute (NCI), only about 25%
of breast cancers diagnosed are HER2 positive (IHC 3+). NeuVax
targets 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.
Sources: National Cancer Institute and NCI Surveillance,
Epidemiology, and End Results Program
About Galena Biopharma
Galena Biopharma, Inc. is a biopharmaceutical company developing
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 statements that include the words
“expect,” “intend,” “plan,” “believe,” “project,” “estimate,”
“may,” “should,” “anticipate,” “will” and similar statements of a
future or forward looking nature identify forward-looking
statements for purposes of the federal securities laws and
otherwise. Forward-looking statements are neither historical facts
nor assurances of future performance. All statements, other than
statements of historical facts, included in this press release
regarding strategy, future operations, future financial position,
prospects, plans and objectives of management are forward-looking
statements. Examples of such statements include, but are not
limited to, statements relating to the efficacy of the combination
of trastuzumab and NeuVax in the treatment of breast cancer, the
timing of the interim efficacy analysis for the Phase 2b clinical
trial, the timing of the primary endpoints for both the Phase 2b
and the Phase 2 trial, and the planned Phase 2 trial in patients
with gastric cancer. Actual results and performance could
differ materially from those projected in the forward-looking
statements as a result of many factors, including, without
limitation, risks and uncertainties associated the conduct of
clinical trials and the risks and uncertainties relating to Galena
and its business that can be found under the caption “Risk Factors”
and elsewhere in the Company’s SEC filings and reports, including
in Galena’s Annual Report on Form 10-K, filed with the SEC on March
15, 2017 and Galena’s Quarterly Report on Form 10-Q, filed with the
SEC on August 14, 2017 and in subsequently filed Form 10-Qs. Galena
disclaims any intent or obligation to update these forward-looking
statements to reflect events or circumstances that exist after the
date on which they were made.
Additional Information about the Proposed Merger
involving Galena Biopharma, Inc. and SELLAS Life Sciences Group
Ltd. and Where to Find It
In connection with the previously disclosed proposed merger
involving Galena and SELLAS Life Sciences Group Ltd., SELLAS,
Galena and SELLAS intend to file relevant materials with the
Securities and Exchange Commission, or the SEC. On September 22,
2017,Galena filed a registration statement on Form S-4 with the SEC
that contains a preliminary proxy statement/prospectus/consent
solicitation statement. Galena and SELLAS will mail the
final proxy statement/prospectus/consent solicitation statement to
their respective stockholders when it becomes available. Investors
and stockholders of Galena and SELLAS are urged to read the
materials Galena and SELLAS file with the SEC, including the final
proxy statement/prospectus/consent solicitation statement, when
they become available because they will contain important
information about Galena, SELLAS and the proposed merger.
The proxy statement/prospectus/consent solicitation statement and
other relevant materials (when they become available), and any
other documents filed by Galena with the SEC, may be obtained free
of charge at the SEC web site at www.sec.gov. In addition, copies
of the documents filed with the SEC by Galena will be available
free of charge on the Company’s website at www.galenabiopharma.com
(under “Investors” – “Financials” – “SEC Filings”) or by directing
a written request to: Galena Biopharma, Inc., 2000 Crow Canyon
Place, Suite 380, San Ramon, CA 94583, Attention: Investor
Relations or by email to: ir@galenabiopharma.com.
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offering of securities
in connection with the proposed merger shall be made except by
means of a prospectus meeting the requirements of Section 10 of the
Securities Act of 1933, as amended.
Participants in the Solicitation
Galena and its directors and executive officers and SELLAS and
its directors and executive officers may be deemed to be
participants in the solicitation of proxies from the stockholders
of Galena in connection with the proposed merger. Information
regarding the special interests of these directors and executive
officers in the proposed merger are included in the proxy
statement/prospectus/consent solicitation statement referred to
above.
NeuVax is a trademark of Galena Biopharma, Inc.
Contact:
Remy Bernarda SVP, Investor Relations & Corporate
Communications(925) 498-7709ir@galenabiopharma.com
Source: Galena Biopharma, Inc.
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