Cue Biopharma Granted FDA Fast Track Designation for CUE-101 for the Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
October 04 2022 - 8:00AM
Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage
biopharmaceutical company developing a novel class of injectable
biologics designed to selectively engage and modulate
tumor-specific T cells directly within the patient’s body,
announced today that the U.S. Food and Drug Administration (FDA)
has granted Fast Track designation to CUE-101, its lead clinical
drug candidate from the CUE-100 series of interleukin 2
(IL-2)-based biologics, for the treatment of patients with human
papilloma virus (HPV16+) recurrent/metastatic head and neck
squamous cell carcinoma (R/M HNSCC) as a monotherapy and in
combination with pembrolizumab (KEYTRUDA®).
“We are very pleased to have received Fast Track designation
from the FDA for CUE-101. This designation not only underscores the
large unmet need for patients with R/M head and neck cancer who
currently rely on available non-targeted therapies, but also
highlights the potential of CUE-101 to provide a significant
clinical benefit,” said Dr. Matteo Levisetti, senior vice
president, Clinical Development of Cue Biopharma. “To date in its
Phase 1b clinical trials, CUE-101 has demonstrated a favorable
tolerability profile and single-agent anti-tumor activity in
monotherapy as well as encouraging anti-tumor clinical activity in
combination with pembrolizumab, supporting the potential to improve
overall survival (OS) for these patients. We look forward to
providing periodic updates and remain committed to advancing the
development of CUE-101 to provide patients with a potentially more
effective and better tolerated treatment option. We anticipate
initiating a registrational trial for CUE-101 monotherapy by
mid-2023.”
Fast Track is a process designed to facilitate the development
and expedite the review of drug candidates to treat serious
conditions and fulfill an unmet medical need. A therapeutic
candidate that receives Fast Track designation may be eligible for
more frequent interactions with the FDA to discuss the therapeutic
candidate’s development plan. Therapeutic candidates with Fast
Track designation may be eligible for accelerated approval and
priority review if supported by clinical data.
CUE-101 is currently being evaluated in a Phase 1b trial
(NCT03978689) as a monotherapy for the treatment of second line and
beyond patients with HPV16+ R/M HNSCC and as a first-line treatment
in a Phase 1 dose escalation and expansion trial in combination
with KEYTRUDA® for the same patient population.
About HPV+ Recurrent or Metastatic Head and Neck
CancerHuman papilloma virus (HPV)-positive cancers account
for more than 20,000 deaths each year in the U.S. and Europe. The
majority of these cancers are driven by HPV16 which carries the E7
antigen targeted by CUE-101. Despite treatment with current
standard of care, the majority of patients with metastatic disease
will experience recurrence, significantly affecting quality of life
and often leading to untimely death.
About CUE-101CUE-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 two signals or “cues” to T
cells. Signal #1 incorporates the HPV E7 protein, harbored by
HPV-induced cancer cells, to provide selectivity through
interaction with the HPV-specific T cell receptor. Signal #2
consists of an engineered IL-2 variant to stimulate the activity of
T cells. To date, Cue Biopharma has established initial proof of
concept with CUE-101 as a monotherapy and believes that the CUE-100
series has the potential to treat multiple cancer indications.
CUE-101 is currently being evaluated for the treatment of HPV16+
driven R/M HNSCC as a monotherapy and in combination with
pembrolizumab (KEYTRUDA®).About Cue
BiopharmaCue Biopharma, a clinical-stage biopharmaceutical
company, is developing a novel class of injectable biologics to
selectively engage and modulate tumor-specific T cells directly
within the patient’s body to transform the treatment of cancer. The
company’s proprietary platform, Immuno-STAT™ (Selective
Targeting and Alteration of T cells) is designed to harness
the body’s intrinsic immune system without the need for ex vivo
manipulation.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-1010 and the CUE 100 series; the
Company’s projections regarding the timing for clinical trial
initiation; 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
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“should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,”
“project,” “estimate,” “anticipate,” “strategy,” “future,” “likely”
or other comparable terms, although not all forward-looking
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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; 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,
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partners; the company’s ability to obtain adequate financing to
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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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