Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage
biopharmaceutical company developing a novel class of injectable
biologics to selectively engage and modulate disease-specific T
cells directly within the patient’s body, announced today that it
will deliver an oral presentation on its Immuno-STAT™ (Selective
Targeting and Alteration of T cells) platform and biologics as well
as a poster on the company’s bispecific protein, CUE-401, for the
treatment of autoimmune and inflammatory diseases at the Federation
of Clinical Immunology Societies (FOCIS) 2023 Annual Meeting, being
held June 20-23, 2023 in Boston, Massachusetts.
Presentation Details
Oral Presentation
Session: Immuno-oncology and Cell
TherapyTitle: Immuno-STAT Platform: TCR-selective
Engagers for Selective Targeting of IL-2 to Tumor-Specific T
CellsPresenter: Steven Quayle, Ph.D., vice
president and head of Research Biology & Translational
Medicine, Cue BiopharmaDate and
Time: Wednesday, June 21, 2023, 4:45
p.m. – 5:00 p.m. EDT
Dr. Quayle will describe the company’s CUE-100 series of
Immuno-STAT biologics, designed to enable selective targeting of
the immunostimulant cytokine interleukin-2 (IL-2) to tumor specific
T cells for enhanced efficacy and safety profiles. Proof of concept
for this platform has been achieved with clinical data from
CUE-101, the company’s lead candidate. The data has demonstrated
anti-cancer efficacy with a favorable tolerability profile and
supports potential registrational paths for both CUE-101 as a
monotherapy in third line (3L) recurrent/metastatic (R/M) human
papillomavirus (HPV)16+ head and neck squamous cell carcinoma
(HNSCC), and CUE-101 in combination with KEYTRUDA® (pembrolizumab)
in first line (1L) R/M HPV16+ HNSCC. Additionally, Dr. Quayle will
discuss the modularity of the Immuno-STAT platform, which has
enabled rapid generation of additional Immuno-STAT candidates
targeting other tumor antigens, such as mutated KRAS or Wilms’
Tumor 1 (WT1). This includes Cue Biopharma’s second CUE-100 series
candidate, CUE-102, that is being evaluated in a Phase 1 trial for
the treatment of WT1 positive malignancies. Taken together, the
clinical de-risking achieved with CUE-101 supports broad
applications of the Immuno-STAT platform to target diverse
cancers.
Poster Presentation
Session: Exhibit & Poster Opening
ReceptionTitle: CUE-401: A Novel IL-2/TGF-beta
Fusion Protein for the Induction of CD4+ FOXP3+ Regulatory T
CellsPresenter: Rich DiPaolo, Ph.D.,
Professor and Chair, Saint Louis University, High Ridge, Missouri,
U.S.Date and Time: Tuesday, June 20, 2023,
6:00 p.m. – 7:45 p.m. EDT
Cue Biopharma’s collaborator, Dr. DiPaolo, will discuss in vitro
and in vivo data demonstrating the potential of CUE-401, the
company’s novel bispecific protein designed to induce and expand
regulatory T cells (Tregs) for the treatment of T-cell mediated
autoimmune and inflammatory diseases. The ability of CUE-401 to
effectively induce de novo FOXP3-expressing iTregs from both mouse
and human CD4+ T cells – while also expanding existing Tregs – and
suppress autoimmune inflammation represents a novel therapeutic
approach.
About the CUE-100 SeriesThe CUE-100 series
consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC)
molecules along with rationally engineered IL-2 molecules. This
singular biologic is 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-401CUE-401 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.
Cue Biopharma entered into a strategic collaboration and option
agreement with Ono Pharmaceutical Co., Ltd. (“Ono”) in February
2023 to support development of CUE-401.
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 body’s intrinsic immune system as T cell
engagers without the need for ex vivo manipulation or broad
systemic 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 Twitter
at https://twitter.com/CueBiopharma.
Forward-Looking Statements This press
release contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended, that are
intended to be covered by the safe harbor created by those
sections. Such forward-looking statements include, but are not
limited to, those regarding: the company’s beliefs about the
potential benefits of CUE-101 and the CUE 100 series; the company’s
belief that the Immuno-STAT platform stimulates targeted immune
modulation through the selective engagement of disease-relevant T
cells; and the company’s business strategies, plans and prospects.
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”
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 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, 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 COVID-19, including possible effects on the
company’s trials; negative or inconclusive results from the
company’s clinical trials or preclinical studies or serious and
unexpected drug-related side effects or other safety issues
experienced by participants in clinical trials; the Company’s
inability to replicate in later clinical trials any positive data
demonstrated in earlier 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; operations and clinical 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 in 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 ContactMarie CampinellSenior Director,
Corporate CommunicationsCue Biopharma,
Inc.mcampinell@cuebio.com
Media ContactMaya RomanchukLifeSci
Communicationsmromanchuk@lifescicomms.com
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