Phase 1/2 basket trial of lead clinical
candidate, galinpepimut-S (GPS), plus
Keytruda® (pembrolizumab) ongoing; Phase 3 registrational
study for GPS monotherapy in acute myeloid leukemia (AML)
planned
SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the
“Company”), a clinical-stage biopharmaceutical company focused on
the development of novel cancer immunotherapies for a broad range
of cancer indications, today announced that its Board of Directors
is conducting a review of strategic options focusing on maximizing
shareholder value. The Company has engaged Cantor Fitzgerald &
Co. to act as its strategic and financial advisor for this process.
“We are committed to identifying a strategic plan which will
enhance shareholder value while allowing for the acceleration of
our development programs, so that our novel immunotherapeutics, GPS
and NPS, may benefit cancer patients,” commented Angelos M.
Stergiou, M.D., ScD h.c., President and Chief Executive Officer of
SELLAS.
The Company plans to explore a wide range of strategic
alternatives that include, among others, a sale of the Company,
business combination, merger or reverse merger with another
company, strategic investment/financing, or a funded collaboration
or partnership which would allow the Company to continue with its
current business plan of advancing the clinical development of its
lead product candidates, GPS and NPS.
SELLAS recently initiated a Phase 1/2 prospective multi-arm
(‘basket’ type), open-label, multi-institutional, U.S.-only
clinical study of GPS in combination with Merck & Co., Inc.’s
anti-PD-1 therapy, pembrolizumab (Keytruda®). The ongoing study is
investigating GPS’s effects on the rate of morphological partial to
complete response conversion in patients with AML on
hypomethylating agents and on the overall response rate in adult
patients with ovarian cancer, TNBC, small cell lung cancer, and
colorectal cancer with measurable metastatic disease. The study is
being led by Drs. Richard Maziarz of Oregon Health and Science
University and Roisin O’Cearbhaill of Memorial Sloan Kettering
Cancer Center.
The Company also has planned a Phase 3 prospective open-label,
randomized, controlled, global, registration-enabling clinical
study of GPS monotherapy versus predefined investigator’s choice
best available maintenance therapy in adult patients with AML who
have achieved their morphological second complete response (with or
without complete platelet count recovery; CR2/CR2p) following
successful second-line antileukemic therapy. This study is being
led by Drs. Hagop Kantarjian of MD Anderson Cancer Center and Gert
Ossenkoppele of Amsterdam University Medical Center (VUMC) and the
HOVON network.
The Company’s second clinical candidate, NPS, is being developed
for TNBC. The Company is currently engaged in discussions with the
FDA regarding trial design for a Phase 3 registrational study in
TNBC.
The Company has not set a timeline for this process and there
can be no assurance that a transaction will be entered into or
consummated or, if a transaction is undertaken, as to its terms,
structure or timing. The Company does not expect to discuss or
disclose further developments regarding the strategic process
unless and until its Board of Directors has approved a specific
action or otherwise determined that further disclosure is
appropriate or required by law.
Keytruda® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J.,
USA, and is not a trademark of SELLAS. The manufacturer of this
brand is not affiliated with and does not endorse SELLAS or its
products.
About SELLAS Life Sciences Group, Inc.
SELLAS is a clinical-stage biopharmaceutical company focused on
novel cancer immunotherapeutics for a broad range of cancer
indications. SELLAS’ lead product candidate, GPS, is licensed from
Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor
1 (WT1) protein, which is present in an array of tumor types. GPS
has potential as a monotherapy or in combination to address a broad
spectrum of hematologic malignancies and solid tumor indications.
SELLAS has a Phase 3 clinical trial planned (pending funding
availability) for GPS in AML and is also studying GPS in
combination with pembrolizumab in multiple indications. SELLAS has
received Orphan Drug designations for GPS from the FDA and the
European Medicines Agency (EMA) for AML, malignant pleural
mesothelioma (MPM), and multiple myeloma (MM); GPS has also
received Fast Track designation for AML, MPM and MM from the FDA.
SELLAS’ second product candidate, NPS, is a HER2-directed cancer
immunotherapy being investigated for the prevention of the
recurrence of breast cancer after standard of care treatment in the
adjuvant setting. NPS has received Fast Track status designation by
FDA for the treatment of patients with early stage breast cancer
with low to intermediate HER2 expression, otherwise known as HER2
1+ or 2+, which includes TNBC patients, following standard of
care.
Forward-Looking Statements This press
release contains forward-looking statements. All statements other
than statements of historical facts are “forward-looking
statements,” including those relating to future events. In some
cases, forward-looking statements can be identified by terminology
such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,”
“should,” “project,” “believe,” “estimate,” “predict,” “potential,”
“intend,” or “continue” and other words or terms of similar
meaning. These statements include, without limitation, statements
related to the Company’s plans to explore strategic alternatives,
the potential outcome and benefits of a strategic transaction or a
financing, and the further development of GPS and NPS, including
the timing of clinical results, the potential time to market for
GPS and NPS, the potential results from a clinical trial and
interactions with the U.S. Food and Drug Administration. These
forward-looking statements are based on 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 the Company’s ability to identify
potential strategic and financial transactions and to complete any
transactions it pursues, whether SELLAS will be able to realize the
expected benefits from a strategic review or a strategic
transaction, immune-oncology product development and clinical
success thereof, the uncertainty of regulatory approval, the
uncertainty of finding potential partners for product candidate
development, and other risks and uncertainties affecting SELLAS and
its development programs as set forth under the caption “Risk
Factors” in Exhibit 99.1 in its Current Report on Form 8-K filed on
July 18, 2018 and in its other SEC filings. 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. 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.
For more information on SELLAS, please visit
www.sellaslifesciences.com.
Investor ContactsWill O’ConnorStern Investor
Relations, Inc.212-362-1200ir@sellaslife.com
Barbara Wood, JDSELLAS Life Sciences
Group646-979-3728bwood@sellaslife.com
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