SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS”), a
late-stage clinical biopharmaceutical company focused on the
development of novel cancer immunotherapies for a broad range of
cancer indications, and 3D Medicines Inc. (“3DMed”), a China-based
biopharmaceutical company developing next-generation
immuno-oncology drugs, today announced that they have entered into
an Exclusive License Agreement granting rights to 3DMed to develop
and commercialize SELLAS’ lead late-stage clinical candidate,
galinpepimut-S (GPS), as well as its next generation heptavalent
immunotherapeuatic, GPS+, which is at preclinical stage, across all
therapeutic and diagnostic uses in the Greater China territory
(mainland China, Hong Kong, Macau and Taiwan). SELLAS retains
sole rights to GPS and GPS+ outside of the Greater China area.
Potential payments to SELLAS under the agreement could total $202
million in license fees and milestone payments, not including
future royalties.
GPS is an innovative potentially first-in-class
WT1-targeting artificially engineered synthetic heteroclitic
immunotherapeutic in development for hematological malignancies and
solid tumors characterized by an overexpression of the WT1 (Wilms
Tumor Protein) antigen. In 2020, SELLAS commenced a Phase 3
clinical trial (the REGAL study) of GPS in patients with acute
myeloid leukemia (AML) who have reached second complete
remission.
“This agreement represents an important
achievement for SELLAS as we continue to progress our clinical
development program for GPS. We are excited to collaborate with
3DMed on the development and commercialization of GPS in China.
3DMed, an ambitious biopharmaceutical company with development,
registration and commercialization capabilities with a focus on
developing next-generation immuno-oncology drugs and an experienced
team, is a wonderfully complementary partner in bringing the
potential of GPS to patients in Greater China. The collaboration
begins to put in place essential elements designed to expand the
reach of GPS outside the United States, following potential
regulatory approvals," said Angelos Stergiou, MD, ScD h.c.,
President and Chief Executive Officer of SELLAS. “The
completion of this agreement, amid the COVID-19 pandemic, shows the
execution strength of our team. We are also pleased to have
strengthened our balance sheet with the non-dilutive upfront
license fee of $7.5 million with other potential milestones over
the next several months.”
“We are very pleased to execute this exclusive
license agreement of GPS and GPS+ in the Greater China area with
SELLAS,“ said John Gong, M.D., Ph.D., Chairman and Chief Executive
Officer of 3DMed. “GPS and GPS+ are innovative therapeutics and,
with growing need for new treatments, GPS’ potential use as a
monotherapy as well as in combination with our Envafolimab, an
innovative subcutaneous PD-L1 antibody which we have just filed for
marketing approval in China, could create significant value for
both 3DMed and SELLAS. This partnership highly reflects the vision
of 3DMed to help patients with cancer to live longer and better. We
believe that the addition of the GPS and GPS+ assets to our
clinical portfolio is an important synergistic and strategic step
for 3DMed as this partnership will expand our company’s therapeutic
area expertise and improve our competitiveness.”
Under the financial terms of the agreement:
- SELLAS could potentially receive up
to $202 million in license and milestone payments during the course
of the collaboration, not including future royalties.
- SELLAS will receive payment of an
upfront license fee of $7.5 million payable this quarter and is
eligible to receive potential near-term milestones totaling up to
an additional $8.0 million.
- SELLAS is entitled to receive
royalties on Chinese sales on a tiered basis, dependent on sales
levels, ranging from the high single to low double-digit
percentage.
- 3DMed will be responsible for the
costs of all development and regulatory activity for Greater
China.
Torreya acted as a financial advisor to SELLAS.
About
Galinpepimut-S
Galinpepimut-S (GPS) is an innovative and
potentially first in class heteroclitic immunotherapy targeting
Wilms Tumor 1 (WT1) which is ranked as the #1 cancer antigen by the
National Cancer Institute. GPS consists of a mixture of four
peptide fragments derived from the WT1 whole-length protein, two of
which are artificially mutated by design utilizing the heteroclitic
technology principle, aiming at optimal immunogenicity and
mitigation of immune tolerance by the vaccinated host. GPS
targets 25 carefully selected and validated WT1 antigenic epitopes
and is applicable across the majority of HLA types on a global
scale. GPS has an off-the-shelf lyophilized formulation and is
administered subcutaneously to patients. GPS is optimally
positioned either as a maintenance monotherapy in various clinical
settings where the residual disease burden after prior debulking is
very low, such as complete remission status in AML, or in
combination with other therapeutic agents, most notably immune
checkpoint inhibitors. In clinical trials, GPS has shown, both as
monotherapy and in combination with checkpoint inhibitors, high
rates of induction of immunogenicity and the abiitiy to delay
disease relapse with an overall low incidence of adverse events,
mainly low grade local inoculation reactions, and is currently
being evaluated in a Phase 3 clinical trial as monotherapy for AML
patients who are in second complete remission and in Phase 1 and
Phase 2 studies in combination with checkpoint inhibitors. GPS was
granted Orphan Drug Product Designations from the U.S. Food and
Drug Administration (FDA), as well as Orphan Medicinal Product
Designations from the European Medicines Agency, in AML, malignant
pleural mesothelioma (MPM), and multiple myeloma (MM), as well as
Fast Track Designation for AML, MPM, and MM from the FDA.
About SELLAS Life Sciences Group, Inc.
SELLAS is a late-stage clinical
biopharmaceutical company focused on the development of 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 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’
second product candidate, nelipepimut-S (NPS), is a HER2-directed
cancer immunotherapy with potential 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 triple
negative breast cancer patients, following standard of care.
For more information on SELLAS, please
visit www.sellaslifesciences.com.
About 3D Medicines, Inc.
3D Medicines, Inc. is a biopharmaceutical
company at the stage of late clinical development and early
commercialization. With the concept “Help people with cancer live
longer and better,” aiming for the future long-term survival of
tumor patients, 3D Medicines focuses on the development of
differentiated next-generation immuno-oncology drugs, to help
cancer patients live longer with better quality of life. 3D
Medicines has built a pipeline with both innovative biological and
small-molecule anti-tumor drugs, and a professional team with
global development, registration and commercialization
capabilities. For more information, please visit
www.3d-medicines.com.
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 for further
development of and regulatory plans for GPS, including the timing
of clinical results and the potential for GPS as a drug development
candidate. 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 COVID-19 pandemic and its
impact on the Company’s clinical plans and business strategy, 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 as set forth under the caption
“Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March
13, 2020 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.
Investor ContactsAdam HoldsworthPCG
Advisory917-497-9287adamh@pcgadvisory.com
Investor RelationsSELLAS Life Sciences Group,
Inc.917-438-4353info@sellaslife.com
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