SQZ Biotechnologies Receives FDA Fast Track Designation for its Lead Cell Therapy Candidate for the Treatment of HPV16+ Tumors
28 4월 2022 - 5:45AM
Business Wire
Designation Creates Potential to Bring
Important New Therapy to Patients Earlier
SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full
potential of cell therapies for multiple therapeutic areas, today
announced that the U.S. Food and Drug Administration (FDA) has
granted Fast Track Designation for the company’s lead cell therapy
candidate, SQZ-PBMC-HPV, for the treatment of HPV16+ advanced or
metastatic solid tumors.
Fast Track Designation is designed to accelerate the development
and review of treatments for serious and life-threatening diseases
where no treatment currently exists or where the treatment in
discovery may be better than what is currently available.
“We are thrilled to receive FDA Fast Track Designation for our
SQZ® Antigen Presenting Cells product candidate,” said Armon
Sharei, Ph.D., Chief Executive Officer and Founder at SQZ
Biotechnologies. “This designation adds to our exciting clinical
data presented at ESMO-IO last year where we first demonstrated the
potential of our Cell Squeeze® technology to drive clinical benefit
while maintaining favorable tolerability. The FDA Fast Track
program can potentially expedite future review processes and
accelerate the registrational path for SQZ-PBMC-HPV.”
Data presented at the ESMO Immuno-Oncology Congress 2021 has
shown that the company’s lead APC cell therapy candidate induced
radiographic, symptomatic and immune response as monotherapy in a
post-checkpoint HPV16+ solid tumor patient. The company continues
to enroll patients in its highest dose monotherapy cohort and is
simultaneously enrolling patients for combination therapy in the
company’s Phase 1/2 SQZ-PBMC-HPV-101 clinical trial.
SQZ-PBMC-HPV-101 Trial Design
SQZ-PBMC-HPV is being evaluated in a Phase 1/2 clinical trial
for the treatment of HPV16+ advanced or metastatic solid tumors.
Patients must be positive for the human leukocyte antigen serotype
HLA-A*02. The investigational candidate, which targets E6 and E7
oncoproteins, is being studied as a monotherapy and in combination
with immuno-oncology agents. The study’s primary outcome measures
in the monotherapy and combination phases of the trial include
safety and tolerability. Antitumor activity is a secondary outcome
measure in both the monotherapy and combination stages of the
trial, and manufacturing feasibility is a secondary outcome measure
in the monotherapy phase of the trial. The monotherapy phase of the
study includes escalating dose cohorts with a dose-limiting
toxicity (DLT) window of 28 days and is designed to identify a
recommended phase 2 dose. The planned combination phase of the
study will include SQZ-PBMC-HPV and checkpoint inhibitors. DLT will
be measured over 42 days.
About Human Papillomavirus Positive Cancers
Human papillomavirus (HPV) is one of the most common viruses
worldwide and certain strains persist for many years, often leading
to cancer. According to the Centers for Disease Control (CDC), in
the United States HPV+ tumors represent 3% of all cancers in women
and 2% of all cancers in men, resulting in over 39,000 new cases of
HPV+ tumors every year. HPV infection is larger outside of the
U.S., and according to the International Journal of Cancer, HPV+
tumors account for 4.5% of all cancers worldwide resulting in
approximately 630,000 new cases every year. According to the CDC,
HPV infection plays a significant role in the formation of more
than 90% of anal and cervical cancers, and most cases of vaginal
(75%), oropharyngeal (70%), vulval (70%) and penile (60%)
cancers.
About SQZ Biotechnologies
SQZ Biotechnologies Company is a clinical-stage biotechnology
company focused on unlocking the full potential of cell therapies
for patients around the world and has active programs in oncology,
autoimmune and infectious diseases, as well as additional
exploratory initiatives to support future pipeline growth. The
company’s proprietary Cell Squeeze® technology offers the unique
ability to deliver multiple biological materials into many cell
types to engineer what we believe can be a broad range of potential
therapeutics. With demonstrated production timelines under 24 hours
and the opportunity to eliminate preconditioning and lengthy
hospital stays, our approach could significantly broaden the
therapeutic range and accessibility of cell therapies. The
company’s first therapeutic applications seek to generate
target-specific immune responses, both in activation for the
treatment of solid tumors and infectious diseases, and in immune
tolerance for the treatment of autoimmune diseases. For more
information, please visit www.sqzbiotech.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained that do not relate to matters of
historical fact should be considered forward-looking statements,
including without limitation statements relating to regulatory
designations, events and presentations, platform development,
product candidates, preclinical and clinical activities, progress
and outcomes, development plans, manufacturing, clinical safety and
efficacy results, therapeutic potential, market opportunities and
disease prevalence. These forward-looking statements are based on
management's current expectations. Actual results could differ from
those projected in any forward-looking statements due to several
risk factors. Such factors include, among others, risks and
uncertainties related to our limited operating history; our
significant losses incurred since inception and expectation to
incur significant additional losses for the foreseeable future; the
development of our initial product candidates, upon which our
business is highly dependent; the impact of the COVID-19 pandemic
on our operations and clinical activities; our need for additional
funding and our cash runway; the lengthy, expensive, and uncertain
process of clinical drug development, including uncertain outcomes
of clinical trials and potential delays in regulatory approval; our
ability to maintain our relationships with our third party vendors
and strategic collaborators; and protection of our proprietary
technology, intellectual property portfolio and the confidentiality
of our trade secrets. These and other important factors discussed
under the caption "Risk Factors" in our most recent Annual Report
on Form 10-K and other filings with the U.S. Securities and
Exchange Commission could cause actual results to differ materially
from those indicated by the forward-looking statements. Any
forward-looking statements represent management's estimates as of
this date and we undertake no duty to update these forward-looking
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Certain information contained in this press release relates to
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version on businesswire.com: https://www.businesswire.com/news/home/20220427006000/en/
Media John Lacey 781-392-5514
john.lacey@sqzbiotech.com
Investors Michael Kaiser
857-760-0398 michael.kaiser@sqzbiotech.com
SQZ Biotechnologies (NYSE:SQZ)
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