Initiation of a Phase 1/2 Combination Clinical Trial with
Galinpepimut-S and KEYTRUDA® (pembrolizumab) Across
Various Indications Expected in 1H, 2018
HAMILTON, Bermuda and
NEW YORK, Oct. 2, 2017 /PRNewswire/ -- SELLAS Life
Sciences Group, Ltd. (SELLAS), a development-stage
biopharmaceutical company focused on novel cancer immunotherapies
for a broad range of cancer indications, today announced entry into
a Clinical Trial Collaboration and Supply Agreement for the conduct
of a combination clinical trial targeting multiple cancer types
with Merck & Co., Inc., Kenilworth,
N.J., USA (known as MSD outside the United States and Canada). SELLAS' Wilms tumor-1
(WT1)-targeting peptide immunotherapeutic agent, galinpepimut-S,
will be administered in combination with MSD's anti-PD-1 therapy
KEYTRUDA® (pembrolizumab) in a Phase 1/2 trial enrolling
patients in five cancer indications, including both hematologic
malignancies and solid tumors.
The purpose of the trials is to determine if the administration
of galinpepimut-S in combination with KEYTRUDA has the potential to
demonstrate clinical activity in the presence of macroscopic
disease, where monotherapy with either agent would have a more
limited effect. The rationale for the study is based upon the
presumed immunobiologic and pharmacodynamic synergy between the two
agents, whereby the negative influence of tumor microenvironment
factors on the immune response is mitigated by PD-1 inhibition (by
KEYTRUDA) thus allowing the patients' own immune cells to invade
and destroy cancerous growth deposits specifically sensitized
against WT1 (by galinpepimut-S).
Angelos Stergiou, MD, ScD h.c.,
Vice Chairman and Chief Executive Officer of SELLAS, stated,
"SELLAS is enthused to embark upon this trial with MSD as we look
to expand the utility of galinpepimut-S in combination with other
agents. The KEYTRUDA/galinpepimut-S active immunotherapy
combination is positioned to exploit the unique features of each of
these two agents through potential synergistic immune-based
mechanisms of antitumor action. If positive, this clinical effort
will allow us to evaluate indications whereby galinpepimut-S and
KEYTRUDA could be further studied in combination, providing the
basis for a potentially promising cancer immunotherapy approach in
the future."
The Phase 1/2 trial will utilize a combination of galinpepimut-S
plus KEYTRUDA in patients with WT1-positive relapsed or refractory
tumors. Specifically, the study is expected to explore the
following cancer indications: colorectal (arm enriched in but not
exclusive to patients with microsatellite instability-low [MSI-L]),
ovarian, small cell lung, triple-negative breast, and AML. This
study will assess the efficacy and safety of the combination,
comparing overall response rates (ORRs) and immune response markers
achieved with the combination versus prespecified rates based on
those seen with KEYTRUDA alone in comparable patient populations.
The trial is anticipated to begin in the first half of 2018.
Galinpepimut-S is currently expected to enter a pivotal, Phase 3
clinical trial in patients with acute myeloid leukemia (AML) and is
also in various development phases in multiple myeloma (MM) and
ovarian cancer, while additional indications are expected as a
monotherapy or in combination with other immuno-oncology agents.
Galinpepimut-S demonstrated positive Phase 2 clinical results as
well as induction of strong and sustained immune responses (both
CD4+ and CD8+) against the WT1 antigen in AML and malignant pleural
mesothelioma in 2016 and MM in 2017, while being able to access a
broad range of human leukocyte antigen (HLA) types; tolerability
has been good across indications to date.
The Clinical Trial and Collaboration Supply Agreement is between
Sellas Life Sciences Group Ltd. and MSD through a subsidiary.
Additional details of the collaboration were not disclosed.
About SELLAS Life Sciences Group
SELLAS Life Sciences Group Ltd. is a development-stage
biopharmaceutical company focused on novel cancer immunoherapeutics
for a broad range of cancer indications. SELLAS' product candidate,
galinpepimut-S, is a cancer immunotherapeutic agent licensed from
Memorial Sloan Kettering Cancer Center that targets the WT1
protein, which is present in a large number of different tumor
types. . Galinpepimut-S has potential as a monotherapy or in
combination to address a broad spectrum of hematologic, or blood,
cancers and solid tumor indications. Galinpepimut-S is Phase
3-ready for two indications, AML and malignant pleural
mesotheliomia (MPM), and is also in development as a potential
treatment for multiple myeloma and ovarian cancer. SELLAS
plans to study galinpepimut-S in up to four additional
indications. SELLAS recently received Orphan Drug
designations from the U.S. Food & Drug Administration (FDA), as
well as the European Medicines Agency, for galinpepimut-S in AML
and MPM; as well as Fast Track designation for AML and MPM from the
FDA. SELLAS was founded in 2012 and is currently
headquartered in Hamilton,
Bermuda, with additional offices in New York City, NY. For more information on
SELLAS, please visit www.sellaslifesciences.com.
Forward-Looking Statement of SELLAS
This press release contains forward-looking statements,
including, but not limited to, statements related to the potential
of galinpepimut-S as a treatment for multiple myeloma, acute
myeloid leukemia, mesothelioma and other cancers, as well as
statements regarding SELLAS' planned Phase 1/2 trial studying
galinpepimut-S in combination with KEYTRUDA. These
forward-looking statements are based on SELLAS' current plans,
objectives, estimates, expectations and intentions, and inherently
involve significant risks and uncertainties. Actual results
and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, without limitation, risks
and uncertainties associated with immune-oncology product
development and clinical success thereof, the uncertainty of
regulatory approval, and other risks and uncertainties affecting
SELLAS and its development programs. Other risks and
uncertainties of which SELLAS is not currently aware may also
affect SELLAS' forward-looking statements and may cause actual
results and the timing of events to differ materially from those
anticipated. The forward-looking statements herein are made
only as of the date hereof or as of the dates indicated in the
forward-looking statements, even if they are subsequently made
available by SELLAS on its website or otherwise. SELLAS
undertakes no obligation to update or supplement any
forward-looking statements to reflect actual results, new
information, future events, changes in its expectations or other
circumstances that exist after the date as of which the
forward-looking statements were made.
Keytruda® is a registered trademark of Merck Sharp
& Dohme Corp., a subsidiary of Merck & Co., Inc.,
Kenilworth, N.J., USA.
Additional Information about the Proposed Merger involving
Galena Biopharma, Inc. (NASDAQ: GALE) and SELLAS Life Sciences
Group Ltd. and Where to Find It
In connection with the previously disclosed proposed merger
involving Galena Biopharma, Inc. (Galena) and SELLAS Life Sciences
Group Ltd., 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 /information 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 transaction. Information
regarding the special interests of these directors and executive
officers in the proposed merger are included in the proxy statement
/prospectus /information statement referred to above.