SQZ Biotechnologies Company (NYSE: SQZ), a cell therapy company
developing novel treatments for multiple therapeutic areas, will
present safety and tolerability, manufacturing, and antitumor
activity data from its ongoing Phase 1 clinical trial of
SQZ-PBMC-HPV-101 in patients with advanced or metastatic Human
Papillomavirus Positive tumors at the 2021 American Society of
Clinical Oncology (ASCO) Annual Meeting, taking place June 4-8.
“These early data demonstrate the feasibility of our Cell
Squeeze® technology and how it can potentially change the way the
field thinks about cell therapies,” said Armon Sharei, Ph.D., Chief
Executive Officer and Founder of SQZ Biotechnologies. “In this
small number of patients whose cancer was very advanced,
SQZ-PBMC-HPV-101 has been well-tolerated at all tested dose levels
and demonstrated signals of increased immune activity. Importantly,
we are also presenting evidence that we can efficiently and
reproducibly manufacture our investigational therapy at scale,
potentially making it more accessible to patients in need.”
The Phase 1 clinical trial data of SQZ-PBMC-HPV-101 being
presented at ASCO includes three of the four planned monotherapy
dose-escalating patient cohorts. Enrollment and evaluation of the
monotherapy in the highest-dose cohort is ongoing. In the next
stage of the trial, it is planned to combine SQZ-PBMC-HPV-101 with
immune checkpoint inhibitors. The study’s primary outcome measures
in the monotherapy stage of the trial are safety, tolerability, and
the definition of the recommended phase 2 dose. Secondary outcome
measures include antitumor activity and manufacturing
feasibility.
Trial Highlights from ASCO Abstract 2536
Design, Safety, Tolerability and Patient Demographics
- SQZ-PBMC-HPV was given IV q 3 weeks on an outpatient basis and
patients did not receive a prior conditioning regime
- The median number of lines of prior therapy was four, and all
but one patient had previously received an immune checkpoint
inhibitor
- SQZ-PBMC-HPV-101 was well-tolerated at all dose levels tested
with patients receiving between two to 10 doses
- No dose-limiting toxicity or Grade 3 or higher
treatment-related SAEs were observed
Manufacturing
- All batches of SQZ-PBMC-HPV-101 demonstrated HPV-specific CD8 T
cell activation in vitro after thawing, and batch size allowed for
treatment at the assigned dose regimen
- Quick and efficient manufacturing with all patient batches
produced in less than 24 hours
- Investigational doses were released and available for
administration approximately one week from the time a patient’s
cells were drawn
Outcome and Biomarker
- Four patients achieved stable disease
- One patient who achieved stable disease remained on study for
42 weeks
- Preliminary analyses on pre- and post-therapy tumor biopsies
indicated increased immune activity in select patients
Poster Presentation Details
Title: Initial Results of a first-in-human, dose
escalation study of a cell-based vaccine in HLA A* 02+ patients
with recurrent, locally advanced or metastatic HPV16+ solid
tumors
First Author: Antonio Jimeno, M.D., Ph.D., University of
Colorado Cancer Center
Abstract Number: 2536
Poster Session: Developmental Therapeutics --
Immunotherapy
Date and Time: A copy of the poster will be available
on-demand starting Friday, June 4, 2021 at 8:00 am ET via the ASCO
virtual meeting website.
SQZ-PBMC-HPV-101 Trial Design
SQZ-PBMC-HPV-101 is being evaluated in a Phase 1 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 stages of the trial include
safety, tolerability, and to define a recommended phase 2 dose.
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 stage
of the trial. The monotherapy phase of the study includes
escalating dose cohorts with DLT measured over 28 days. The planned
safety combination phase of the study will include SQZ-PBMC-HPV-101
and checkpoint inhibitors that have previously received regulatory
approval. DLT will be measured over 42 days in the safety
combination phase.
About Human Papillomavirus Positive Cancers
Human papillomavirus (HPV) is one of the most common viruses
worldwide and certain strains persist for many years 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 is a clinical-stage biotechnology company
developing transformative cell therapies for patients with cancer,
infectious diseases, and other serious conditions. Using its
proprietary technology, SQZ Biotechnologies offers the unique
ability to deliver multiple materials into many patient cell types
to engineer what we believe can be an unprecedented range of
potential therapeutics for a variety of diseases. SQZ
Biotechnologies has the potential to create well-tolerated cell
therapies that can provide therapeutic benefit for patients and to
improve the patient experience over existing cell therapy
approaches. With accelerated production timelines under 24 hours
and the opportunity to eliminate preconditioning and lengthy
hospital stays, our goal is to use the SQZ™ approach to establish a
new paradigm for cell therapies. Our first therapeutic applications
aim to leverage the potential to generate target-specific immune
responses, both in activation for the treatment of solid tumors and
immune tolerance for the treatment of unwanted immune reactions and
autoimmune diseases. For more information, please visit
www.sqzbiotech.com.
Forward Looking Statement
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 upcoming events
and presentations, our product candidates, preclinical and clinical
activities, development plans, clinical safety and efficacy,
regulatory compliance, and therapeutic impact. 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 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 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 SQZ undertakes no duty to update these
forward-looking statements, whether as a result of new information,
the occurrence of current events, or otherwise, unless required by
law.
Certain information contained in this press release relates to
or is based on studies, publications, surveys and other data
obtained from third-party sources and our own internal estimates
and research. While we believe these third-party sources to be
reliable as of the date of this press release, we have not
independently verified, and we make no representation as to the
adequacy, fairness, accuracy, or completeness of any information
obtained from third-party sources.
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SQZ Biotechnologies IR Contact:
investors@sqzbiotech.com
SQZ Biotechnologies Media Contact: John Lacey Corporate
Communications john.lacey@sqzbiotech.com 781-392-5514
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