Doses of Autologous Cell Therapy Manufactured
in Under 24 Hours and Available to Patients in Approximately One
Week
Clinical Trial Findings Presented at the
American Society of Clinical Oncology Annual Meeting
SQZ Biotechnologies Company (NYSE: SQZ), focused on unlocking
the full potential of cell therapies for multiple therapeutic
areas, today presented initial results from its ongoing Phase 1
clinical trial of SQZ-PBMC-HPV demonstrating that the
investigational cell therapy is safe and well-tolerated and can
stimulate immune responses in certain patients with advanced or
metastatic Human Papillomavirus positive (HPV16+) tumors. The trial
also showed that the company’s clinical stage manufacturing process
of its autologous cell therapy is fast and reliable. The
monotherapy stage trial data of the company’s first Antigen
Presenting Cell (APC) platform candidate was presented at the 2021
American Society of Clinical Oncology (ASCO) annual meeting; poster
presentation 2536.
“Our vision is to make cell therapies that are safe and
available with rapid turnaround times, allowing access to patients
who need them,” said Oliver Rosen, M.D., chief medical officer at
SQZ Biotechnologies. “The company’s first-in-human data of a
cell-based therapeutic vaccine are encouraging and an important
first step towards validation of our directed immunity approach.
Within this small trial of patients with very advanced disease,
four patients who had progressed after multiple prior therapies
achieved stable disease. These early outcomes, combined with
encouraging safety data and fast clinical-scale manufacturing
times, support our plans to initiate the trial’s safety combination
phase with immune checkpoint inhibitors.”
Safety & Tolerability
A primary outcome measure in the monotherapy dose escalation
phase of the trial is safety and tolerability. Findings from the
trial show that SQZ-PBMC-HPV was safe and well-tolerated at all
tested dose levels with patients receiving 2 to 10 doses. No
dose-limiting toxicities were observed.
“Overall, SQZ-PBMC-HPV has been safe and well tolerated by
patients, even advanced patients as we have seen in this study,”
said study author Antonio Jimeno, M.D., Ph.D., Professor of
Medicine, Oncology and Otolaryngology, University of Colorado
School of Medicine, and Co-Leader, Development Therapeutics
Program, University of Colorado Cancer Center. “I look forward to
completing the single agent portion of the trial and advancing into
the combinations of SQZ-PBMC-HPV with immunotherapies.”
There were no grade 3 or higher treatment related serious
adverse events (SAEs). In one patient, a grade 2 cytokine release
syndrome and immune-related reaction was observed. A related grade
3 adverse event (AE, anemia) was observed in another patient.
Manufacturability
Manufacturing feasibility is a secondary outcome measure in the
monotherapy phase of the trial. All patient batches were produced
under current good manufacturing practice regulations, met
specifications, and yielded multiple cryopreserved doses in less
than 24 hours.
The findings show that doses of SQZ-PBMC-HPV were released and
available for administration approximately one week from the time a
patient’s cells were drawn. Antigen presentation was confirmed in
all patient batches independent of individual patient medical
history or prognostic score.
Patient Characteristics & Immune Response
Biomarkers
The clinical trial enrolled patients with HPV16+ cancers
progressing after unlimited prior lines of therapy. The 12 enrolled
patients had very advanced disease:
- Median number of prior cancer treatments was four with one
patient having received seven prior treatments
- Eleven patients previously treated with an immune checkpoint
inhibitor (ICI)
- Six of the 12 patients had a Royal Marsden Hospital (RMH) score
of 2. (RMH scores range from 0-to-3, with scores of 2 and higher
predicting poor prognosis and short life expectancy)
Despite the treatment refractory status of the enrolled
patients, 4 out of 6 patients with RMH scores less than 2,
reflecting less advanced disease, achieved stable disease as best
overall response. Two of these patients showed an increase in CD8
tumor infiltrating lymphocytes (TILs), an important biomarker in
immune-oncology therapy development.
The study authors highlighted two patients – Patients 2 and 7
detailed below – which suggested that less advanced patients with
lower tumor burden, such as patient two, might have a higher
likelihood of clinical benefit.
- Patient 2: Enrolled 3-and-half years after diagnosis and had a
best overall response of progressive disease with ICI therapy. The
patient had an RMH score of 1 and low tumor burden. She achieved
stable disease while on the SQZ-PBMC-HPV-101 trial and remained on
study for over 10 months. Image analysis of the central tumor 28
days after the first dose showed a 2-fold increase in CD8 TILs on
treatment compared to baseline
- Patient 7: Enrolled 1 year after diagnosis and had a partial
response with chemotherapy in combination with ICI therapy but then
progressed. He achieved stable disease after treatment on the
SQZ-PBMC-HPV-101 trial and remained on study for three months.
Image analysis of the central tumor showed a 6-fold increase in CD8
TILs on treatment compared to baseline
The company is now actively enrolling patients in the last
monotherapy highest-dose cohort of the Phase 1 trial. These results
will inform the dosage approach for the combination therapy phase
of the clinical trial with immune checkpoint inhibitors.
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 is available on-demand via the
ASCO virtual meeting website.
SQZ-PBMC-HPV-101 Trial Design
SQZ-PBMC-HPV 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 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 DLT window of 28 days
and the definition of a recommended phase 2 dose. The planned
safety combination phase of the study will include SQZ-PBMC-HPV 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
focused on unlocking the full potential of cell therapies to
benefit patients with cancer, autoimmune and infectious diseases.
The company’s proprietary Cell Squeeze® technology offers the
unique ability to deliver multiple biological materials into many
patient cell types to engineer what we believe can be a broad range
of potential therapeutics. Our goal is to create well-tolerated
cell therapies that can provide therapeutic benefit for patients
and 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 approach could change the way people think
about 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 in 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 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 Media Contact: John Lacey Corporate
Communications john.lacey@sqzbiotech.com 781-392-5514
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