Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage
biopharmaceutical company developing a novel class of therapeutic
biologics to selectively engage and modulate disease-specific T
cells, today announced the strategic prioritization of its
autoimmune programs and organizational restructuring to strengthen
operational efficiencies while enabling its encouraging oncology
survival data to continue to mature.
“We have made substantial progress advancing the
development of our autoimmune program CUE-401 through our
partnership with Ono Pharmaceutical, Co., Ltd. and demonstrable
preclinical progress advancing CUE-501, our program for depleting
autoreactive B cells,” said Daniel Passeri, chief executive
officer of Cue Biopharma. “I believe each of these
autoimmune programs has the potential to address multiple diseases
and create near-term and intermediate value creation opportunities.
While we plan to focus our resources on our novel autoimmune
programs, we intend to preserve the potential value of our clinical
oncology programs by retaining requisite clinical capabilities to
enable maturation of clinical survival data in the current ongoing
Phase 1 trials of CUE-101 and CUE-102. As such, we are actively
pursuing third party support through partnerships and
collaborations to further develop these programs. We believe the
strategic measures we are taking will strengthen operational
efficiencies and extend our capital runway.”
Through strategic realignment and prioritizing
autoimmune programs, along with associated organizational
restructuring, Cue Biopharma expects to reduce its fiscal year 2025
operating expenses by approximately 25%, to a projected annual cash
burn, based upon current assumptions, of approximately $30 million.
Cue Biopharma continues to pursue additional partnership support to
further improve operational efficiencies and decrease capital
requirements.
To achieve its strategic objectives, Cue Biopharma
has realigned its workforce requirements resulting in an
approximately 25% reduction of staff across research, development
and general and administrative resources. This workforce
realignment along with the implementation of focused operational
efficiencies is expected to extend the company’s cash runway into
mid-year 2025.
About CUE-401CUE-401, partnered
with Ono Pharmaceutical Co., Ltd., is a preclinical, bispecific
fusion protein designed to induce and expand regulatory T cells
(Tregs) through the delivery of transforming growth factor beta
(TGF-β) and interleukin 2 (IL-2) with therapeutic potential across
a range of T-cell mediated autoimmune and inflammatory
diseases.
About CUE-501CUE-501 is a
bispecific designed to selectively harness the protective
anti-viral T cell repertoire (virus-specific T cells, or VSTs) and
redirect them to target and deplete B cells. Deploying a biologic
to selectively redirect “killer” T cells, while avoiding the
systemic engagement and activation of all T cells, to accomplish T
cell-mediated B cell depletion addresses the important mechanism of
autoimmune diseases and may offer significant advantages over
current cell therapy-based strategies and bispecifics.
About the CUE-100 Series The
CUE-100 series consists of Fc-fusion biologics that present two
signals to T cells. Signal #1 is a tumor-specific peptide linked to
a major histocompatibility complex (pMHC) to enable selectivity and
specificity. Signal #2 is a rationally engineered interleukin 2
(IL-2) molecule to trigger T cell activation. These singular
biologics are anticipated to selectively target, activate and
expand a robust repertoire of tumor-specific T cells directly in
the patient’s body. The binding affinity of IL-2 for its receptor
has been deliberately attenuated to achieve preferential selective
activation of tumor-specific effector T cells while reducing the
potential for effects on regulatory T cells (Tregs) or broad
systemic activation, potentially mitigating the dose-limiting
toxicities associated with current IL-2-based therapies.
About CUE-101 and the Phase 1
TrialCUE-101 is Cue Biopharma’s lead clinical drug
candidate from the CUE-100 series of interleukin 2 (IL-2)-based
biologics. It is designed to activate and expand HPV16
tumor-specific T cells by presenting the HPV E7 protein to the
HPV-specific T cell receptor. CUE-101 is currently being evaluated
in a fully enrolled Phase 1 open label, dose escalation and
expansion study, for the treatment of HPV16+ driven
recurrent/metastatic head and neck squamous cell carcinoma in
second line (2L) and beyond patients as a monotherapy, and as a
first line (1L) therapy in combination with pembrolizumab
(KEYTRUDA®).
About CUE-102 and the Phase 1
TrialCUE-102 is Cue Biopharma’s second lead clinical drug
candidate from the CUE-100 series of interleukin 2 (IL-2)-based
biologics. It is designed to activate and expand Wilms’ Tumor 1
(WT1)-specific T cells by presenting the WT1 peptide to the WT1-
specific T cell receptor. WT1 is a well-recognized onco-fetal
protein known to be over-expressed in a number of cancers,
including solid tumors and hematologic malignancies. CUE-102 is
being evaluated in a Phase 1 open label, two-part dose escalation
and expansion study, for patients with late-stage colorectal,
gastric/gastroesophageal junction, pancreatic and ovarian cancers
that express WT1.
About Cue BiopharmaCue
Biopharma, a clinical-stage biopharmaceutical company, is
developing a novel class of injectable biologics to selectively
engage and modulate disease-specific T cells directly within the
patient’s body. The company’s proprietary platform, Immuno-STAT™
(Selective Targeting and Alteration of T cells) and biologics are
designed to harness the curative potential of the body’s intrinsic
immune system through the selective modulation of disease-specific
T cells without the adverse effects of broad systemic immune
modulation.
Headquartered in Boston, Massachusetts, we are
led by an experienced management team and independent Board of
Directors with deep expertise in immunology and immuno-oncology as
well as the design and clinical development of protein
biologics.
For more information please
visit www.cuebiopharma.com and follow us
on X and LinkedIn.
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Such forward-looking statements include, but are not limited to,
those regarding: the company’s belief regarding the potential
benefits and applications of its drug candidates and programs; the
near-term and intermediate value creation potential of its
autoimmune programs; the company’s intention to preserve the value
of its oncology programs; the company’s business strategies, plans
and prospects, including those related to the prioritization of
CUE-401 and CUE-501, partnering opportunities and the potential
benefits of the company’s program prioritization and realignment
and workforce reduction on its burn rate; and the company’s
projections regarding its annualized capital requirements, cash
burn rate, cash burn rate reductions, 2025 cash burn rate,
workforce reductions and cash runway. Forward-looking statements,
which are based on certain assumptions and describe the company’s
future plans, strategies and expectations, can generally be
identified by the use of forward-looking terms such as “believe,”
“expect,” “may,” “will,” “should,” “would,” “could,” “seek,”
“intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,”
“strategy,” “future,” “likely,” “promise” or other comparable
terms, although not all forward-looking statements contain these
identifying words. All statements other than statements of
historical facts included in this press release regarding the
company’s strategies, prospects, financial condition, operations,
costs, plans and objectives are forward-looking statements.
Important factors that could cause the company’s actual results and
financial condition to differ materially from those indicated in
the forward-looking statements include, among others, the company’s
ability to shift its focus to its autoimmune assets and achieve the
cost savings that it is projecting; the company’s limited operating
history, limited cash and a history of losses; the company’s
ability to achieve profitability; potential setbacks in the
company’s research and development efforts including negative or
inconclusive results from its preclinical studies or clinical
trials or the company’s ability to replicate in later clinical
trials positive results found in preclinical studies and
early-stage clinical trials of its product candidates; serious and
unexpected drug-related side effects or other safety issues
experienced by participants in clinical trials; its ability to
secure required U.S. Food and Drug Administration (“FDA”)
or other governmental approvals for its product candidates and the
breadth of any approved indication; adverse effects caused by
public health pandemics, including possible effects on the
company’s operations and clinical trials; delays and changes in
regulatory requirements, policy and guidelines including potential
delays in submitting required regulatory applications to the FDA;
the company’s reliance on licensors, collaborators, contract
research organizations, suppliers and other business partners; the
company’s ability to obtain adequate financing to fund its business
operations in the future and ability to continue as a going
concern; the company’s ability to maintain and enforce necessary
patent and other intellectual property protection; competitive
factors; general economic and market conditions and the other risks
and uncertainties described in the Risk Factors and Management's
Discussion and Analysis of Financial Condition and Results of
Operations sections of the company’s most recently filed Annual
Report on Form 10-K and any subsequently filed Quarterly Report(s)
on Form 10-Q. Any forward-looking statement made by the company in
this press release is based only on information currently available
to the company and speaks only as of the date on which it is made.
The company undertakes no obligation to publicly update any
forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise.
Investor Contact Marie
Campinell Senior Director, Corporate CommunicationsCue
Biopharma, Inc.mcampinell@cuebio.com
Media ContactJonathan
PappasLifeSci Communicationsjpappas@lifescicomms.com
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