Phase 2b trial met key clinical objectives and is
being discontinued early by the sponsor
SELLAS Life Sciences Group Inc., (Nasdaq:SLS) (SELLAS) today
announced that the sponsor-principal investigator, after taking
into account that key clinical development objectives were met as
well as other regulatory considerations, and in agreement with
SELLAS, determined to terminate early the Phase 2b independent
investigator-sponsored clinical trial (IST) of trastuzumab
(Herceptin®) +/- nelipepimut-S (NeuVax™) in HER2 1+/2+ breast
cancer patients. In this Phase 2b study, Herceptin® was provided
under a Clinical Trial Supply Agreement by Genentech, Inc.
The decision to early terminate this Phase 2b study was based
in part on the previously announced recommendation of the
independent Data Safety Monitoring Board (DSMB) to further advance
the development of the NeuVax + Herceptin combination for the
triple negative breast cancer (TNBC) patient population. Data from
the Phase 2b has been submitted for presentation at a major medical
conference that will take place during the second half of 2018.
“We wish to thank our patients and their families for their
participation in this trial. Based on data demonstrating that
this combination therapy has the potential to become an important
therapeutic option for TNBC patients facing a life-threatening
disease and for whom current options in the adjuvant setting are
extremely limited, we have determined, in consensus with SELLAS, to
close out the current study,” stated COL (ret) George E.
Peoples, MD, FACS, Founder and Director of Cancer Insight, LLC and
study Principal Investigator. “We look forward to supporting
SELLAS’ interactions and discussions with regulatory
bodies.”
SELLAS conducted this week two advisory meetings with global
experts in regulatory affairs and breast cancer clinical
development in order to determine the optimal path for further
development of the NeuVax + Herceptin combination in TNBC in a
pivotal setting and engagement with the U.S. Food and Drug
Administration (FDA) and European Medicines Agency (EMA).
As previously announced, a pre-specified interim analysis of
safety and efficacy conducted by the DSMB, demonstrated a
clinically meaningful and statistically significant difference
between the TNBC cohort of patients and the control arm with a
hazard ratio of 0.26, p-value = 0.023, in favor of the NeuVax +
Herceptin combination compared to Herceptin alone. The analysis
also showed an adverse event profile with no notable differences
between treatment arms and no additional cardiotoxicity in the
NeuVax + Herceptin arm. Based on these positive results, the DSMB
recommended to expeditiously seek regulatory guidance from the FDA
for further development of the combination of NeuVax + Herceptin in
TNBC, a population with a large unmet medical need.
“We agree with Dr. Peoples’ decision to close this Phase 2b
study earlier than planned and it is a priority to advance the
development program for NeuVax + Herceptin in TNBC. Indeed, we have
initiated the necessary steps for prompt engagement with the
regulatory authorities for their guidance on the expeditious
development of this combination therapy, as exemplified by the
clinical and regulatory advisory board meetings we just conducted
during this year’s ASCO meeting,” said Nicholas J. Sarlis, MD,
PhD, FACP, Executive Vice President and Chief Medical Officer
of SELLAS.
Providing their impressions from the discussion of the Phase 2b
study data during the Clinical Advisory Board meeting at the ASCO
conference, Debu Tripathy, MD, Professor and Chairman, Department
of Breast Medical Oncology, The University of Texas - MD Anderson
Cancer Center, mentioned that “in early stage TNBC the benefit of
chemotherapy in the adjuvant setting is incomplete and leaves room
for improvement. Further, to date, targeted therapies have not
proven effective for TNBC. Targeting HER2 as an immune therapy
target with the Herceptin plus NeuVax combination in HER2 1+/2+
TNBC makes sense biologically, especially considering the baseline
presence of activated cellular immunity components in most patients
with this tumor type,” while Prof. Dr. med. Volkmar Müller, MD,
PhD, Professor and Deputy Director, Department of Gynecology,
University Clinic of Hamburg-Eppendorf, Germany commented, “The
data from the Phase 2b study of Herceptin + NeuVax are promising in
the TNBC cohort. SELLAS’ decision to pursue clinical and regulatory
strategies with this combination in TNBC based on the current
findings is justified, due to the high unmet need, low number of
competing trials in the maintenance/adjuvant setting and
feasibility of a pivotal Phase 3 study design whereby a
relapse-based endpoint could be reached with confidence.” Neither
Prof. Tripathy nor Prof. Dr. med. Müller participated in the NeuVax
+ Herceptin Phase 2b study.
SELLAS also announced that it has appointed Jeffrey S. Weber,
MD, PhD, as Chairman of its SAB. In his new role, together with the
other members of the Company’s SAB, Dr. Weber will strengthen the
Company’s capacities to drive, position and prioritize pipeline
development with key focus on two assets, galinpepimut-S and
nelipepimut-S (NeuVaxTM).
“We are very proud to expand Jeff’s role on the Company’s SAB.
Jeff is a leading expert in cancer immunotherapeutics, with broad
advisory experience to biopharmaceutical companies in the
immuno-oncology field and has a proven leadership track in academic
centers. His insights and ability to coordinate and collaborate
with our SAB members and our scientific and clinical leadership
will help us to more efficiently develop our peptide
immunotherapeutic vaccines candidates,” said Dr. Sarlis. “Having
worked with Jeff as a member of our SAB over the past 2 years, we
are delighted to strengthen our collaboration,” added Dr.
Sarlis.
Dr. Weber currently serves as Co-Director of the Melanoma
Program at the New York University (NYU)-Langone Perlmutter Cancer
Center and Deputy Director of the Center. Prior to this position,
he was Head of the Melanoma Center of Excellence at H. Lee Moffitt
Cancer Center. Earlier in his career, Dr. Weber worked as a Senior
Investigator in the Surgery Branch of the National Cancer Institute
(NCI) at the National Institutes of Health (NIH) and before that
served as Chief of Medical Oncology at the University of Southern
California (USC)’s Keck School of Medicine. He is a member of the
Editorial Boards at Journal of the National Cancer Institute,
Clinical Cancer Research, Human Gene Therapy and Journal of
Immunotherapy and has served on or chaired numerous NCI study
sections. Dr. Weber has published more than 180 articles in the top
peer-reviewed journals, including New England Journal of Medicine
and Nature Medicine. Dr. Weber was the recipient of the Bob
Chandler Courage Award from the USC, of a K24 Mid-Career Mentor
Award from NIH, has been recognized as one of the “Best Doctors in
America” for over a decade and was the OncLive Giants of Cancer in
Melanoma for 2016. He was also the first investigator to
demonstrate that PD-1 inhibitors had encouraging activity in
resected melanoma patients.
“I am delighted to become the Chairman of the Scientific
Advisory Board of SELLAS and honored to work together with my
colleagues at the SAB to meaningfully support the company’s quest
to change the field by innovative approaches to vaccinate patients
using immunogenic peptides for the treatment of cancer,” commented
Dr. Weber.
Herceptin® is a registered trademark of Genentech, Inc. 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
SELLAS is a clinical-stage biopharmaceutical company focused on
novel cancer immunotherapeutics for a broad range of cancer
indications. SELLAS’ lead product candidate, galinpepimut-S (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
Phase 3 clinical trials planned (pending funding availability) for
GPS in two indications, acute myeloid leukemia (AML) and malignant
plural mesothelioma (MPM) and is also developing GPS as a potential
treatment for multiple myeloma and ovarian cancer. SELLAS
plans to study GPS in up to four additional indications.
SELLAS has received Orphan Drug designations from the U.S.
Food and Drug Administration (FDA) in AML, MPM, and multiple
myeloma, as well as the European Medicines Agency, for GPS in
AML and MPM; GPS also received Fast Track designation for AML and
MPM from the FDA. NeuVax™ (nelipepimut-S), a HER2-directed
cancer immunotherapy, is also being investigated for the prevention
of the recurrence of breast cancer after standard of care treatment
in the adjuvant setting. NeuVax™ has received Fast Track status
designation by the FDA for the treatment of patients with early
stage breast cancer with low to intermediate HER2 expression,
otherwise known as HER2 1+ or 2+, following standard of care.
For more information on SELLAS, please visit
www.sellaslifesciences.com.
Forward-Looking Statements
This press release contains forward-looking statements.
You can identify such forward-looking statements by the use of the
words “expect,” “will,” “anticipate,” “estimate,” “plan” and other
words of similar import. The forward-looking statements in this
press release include, but are not limited to, statements related
to the potential of nelipepimut-S (NeuVaxTM) as a therapeutic
option for TNBC, the ability to further clinical development of
NeuVax, Dr. Weber’s impact in his new role on the SAB, the general
development of the Company’s product candidate pipeline and the
effects of the Company’s approach to cancer treatment. 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 immune-oncology product development
and clinical success thereof, the uncertainty of regulatory
approval, and other risks and uncertainties affecting SELLAS and
its development programs. These risks and uncertainties are
described more fully in SELLAS’ Annual Report on Form 10-K and
other filings with the Securities and Exchange Commission. Other
risks and uncertainties of which SELLAS is not currently aware may
also affect SELLAS’ forward-looking statements. 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.
Investor Contact:Will O’ConnorStern Investor Relations,
Inc.212-362-1200ir@sellaslife.com
David Moser, JDSELLAS Life Sciences Group,
Inc.813-864-2571info@sellaslife.com
Source: SELLAS Life Sciences Group, Inc.
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