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The Focused Interferon Therapeutics (FIT) platform is a proprietary
targeted antibody-interferon fusion technology with potential broad
application in oncology -
This asset purchase adds two innovative early-stage drug candidates to
Spectrum’s existing pipeline and advances the oncology strategy
HENDERSON, Nev.–(BUSINESS WIRE)–Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical
company focused on novel and targeted oncology therapies, announced
today the closure of an asset purchase and license agreement with
ImmunGene, Inc., a privately held biotechnology company. The deal
includes an exclusive license for the intellectual property related to
the FIT antibody-interferon fusion technology drug delivery platform
originally developed by scientists at UCLA.
The license also includes two novel assets derived from this platform.
The first asset is an antibody-interferon fusion molecule directed
against CD20 (Anti–CD20-IFNα). This drug candidate is in Phase 1
development for treating relapsed or refractory non-Hodgkin lymphoma,
including diffuse large b-cell lymphoma patients where a considerable
unmet medical need exists. Research for this program received financial
support through the Therapy Acceleration Program® of The Leukemia &
Lymphoma Society, Inc. (LLS), and an LLS research grant to UCLA. The
second asset is an antibody-interferon fusion molecule directed against
GRP94, a target for which currently there are no existing approved
therapies. It has the potential for treating both solid and hematologic
malignancies.
“The FIT platform that we’ve acquired today represents a new class of
biotherapeutics which may have the potential to make the administration
of an antibody-interferon fusion protein feasible and allows Spectrum to
harness this powerful immune activating cytokine,” said Francois Lebel,
M.D., F.R.C.P.C., Chief Medical Officer of Spectrum Pharmaceuticals. “In
pre-clinical models, anti–CD20-IFNα has been shown to have significant
proapoptotic activity. Anti–CD20-IFNα is essentially a 2-pronged attack
whereby both CD20 and IFNAR signaling pathways can be activated to
induce tumor cell apoptosis. Although IFNα has potent biologic
activities against B-cell malignancies, its clinical utility has been
curtailed by systemic toxicities. Preclinical results suggest that
anti–CD20-IFNα fusion proteins have an improved therapeutic index, while
still exhibiting the ability to eradicate tumor cells.”
Originally developed by scientists at UCLA and licensed to Spectrum by
UCLA Technology Development Group, the FIT platform fuses interferon
with various monoclonal antibodies targeting various tumor antigens.
Interferons are highly potent and well-established anticancer cytokines
but have been associated with significant dose-related side effects. The
FIT technology may be able to maintain the potency and efficacy of
interferon while reducing toxicity traditionally associated with
interferon therapy. FIT therapies have potential application as single
agents or in combination with other therapies, such as checkpoint
inhibitors.
“Adding a promising platform and two early stage assets is consistent
with our commitment to serving the needs of cancer patients by
developing innovative drugs for unmet need,” said Joe Turgeon, President
and CEO of Spectrum Pharmaceuticals. “We are aggressively building
a robust oncology pipeline anchored by our late-stage assets, poziotinib
and ROLONTIS.”
Under the terms of the agreement, Spectrum will pay an upfront cash
payment of approximately $3 million, up to $156 million in development
and sales milestones, and royalties on net sales in the high-single
digits.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biopharmaceutical company focused on
acquiring, developing, and commercializing novel and targeted drug
products, with a primary focus in hematology and oncology. Spectrum has
a strong track record of successfully executing across the
biopharmaceutical business model, from in-licensing and acquiring
differentiated drugs, clinically developing novel assets, successfully
gaining regulatory approvals, and commercializing in a competitive
healthcare marketplace. Spectrum has a late-stage pipeline with novel
assets that serve areas of unmet need. This pipeline has the potential
to transform the company in the near future.
About UCLA Technology Development Group
UCLA Technology Development Group (TDG) serves as a campus-wide gateway
to Innovation, Research and Entrepreneurship. TDG promotes UCLA
innovation, research, teaching and entrepreneurship to benefit society,
creates economic value to support UCLA’s scholarly and educational
missions and the State of California, and leads UCLA’s research
community to bring innovation to market.
Notice Regarding Forward-looking Statements – Certain statements in
this press release may constitute “forward-looking statements” within
the meaning of the United States Private Securities Litigation Reform
Act of 1995, as amended to date. These forward-looking statements relate
to a variety of matters, including, without limitation, statements that
relate to Spectrum’s business and its future, including the Company’s
ability to successfully develop the FIT therapies, the potential
applications for the FIT therapies, including as single agents or in
combination with other therapies and, in the case of the anti-body
interferon fusion molecule directed against GRP94, its potential for
treating both solid and hematologic malignancies, the ability of the FIT
therapies to meet currently unaddressed medical needs and the size of
the potential markets, the feasibility of administering
antibody-interferon fusion proteins clinically, the future potential of
Spectrum’s existing drug pipeline, and other statements that are not
purely statements of historical fact. These forward-looking statements
are based on management’s current beliefs, expectations and assumptions
and are subject to significant risks and uncertainties. Investors are
cautioned not to place undue reliance on any such forward-looking
statements. All such forward-looking statements speak only as of the
date they are made, and Spectrum undertakes no obligation to update or
revise these statements, whether as a result of new information, future
events or otherwise. Although Spectrum believes that the expectations
reflected in these forward-looking statements are reasonable, these
statements involve many risks and uncertainties that may cause actual
results to differ materially from what may be expressed or implied in
these forward-looking statements, including, without limitation, the
uncertainties inherent in new product development, including clinical
trial results and additional analysis of existing pre-clinical and
clinical data, the possibility that Spectrum’s new and existing drug
candidates, including poziotinib, ROLONTIS and the FIT therapies, may
not ultimately prove to be safe or effective, and the possibility that
Spectrum’s new and existing drug candidates, if approved, may not be
more effective, safer, or more cost efficient than competing drugs. For
a further discussion of risks and uncertainties that could cause actual
results to differ from those expressed in these forward-looking
statements, as well as risks relating to the business of Spectrum in
general, see the risk disclosures in the Annual Report on Form 10-K of
Spectrum for the year ended December 31, 2018, and in subsequent reports
on Forms 10-Q and 8-K and other filings made with the SEC by Spectrum.
SPECTRUM PHARMACEUTICALS, INC.® and ROLONTIS®
are registered trademarks of Spectrum Pharmaceuticals, Inc and
its affiliate. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals’
logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other
trademarks are the property of their respective owners.
© 2019 Spectrum Pharmaceuticals, Inc. All Rights Reserved
Contacts
Shiv Kapoor
Vice President, Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com