- Designation Represents Potential to Bring Important New Therapy
to Patients Earlier
- Stable Disease Observed in Two Out of Four Evaluable Patients
in eAPC Phase 1/2 Trial Including a Pronounced Pharmacodynamic
Response in a Patient with Prolonged Stable Disease
- Interim Results from Ongoing SQZ® eAPC Phase 1/2 Trial Showed
Favorable Safety Data and Investigational Therapy was Generally
Well Tolerated
- Median Drug Viability of Greater than 90 Percent for Both SQZ®
eAPC and SQZ® APC Clinical Trials
SQZ Biotechnologies Company (NYSE: SQZ) today announced that the
U.S. Food and Drug Administration (FDA) has granted Fast Track
Designation for the company’s Enhanced Antigen Presenting Cell
(eAPC) candidate 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.
The SQZ® eAPC platform is the company’s second-generation cell
therapy platform which simultaneously delivers five different
mRNAs—each encoding for a different protein which plays a part in
stimulating key T cell activation signals required to generate an
immune response against tumors—to four different cell types.
The company also presented clinical data from its ongoing
Antigen Presenting Cells (APC) and eAPC clinical trials at the
European Society for Medical Oncology Immuno-Oncology (ESMO-IO)
Congress. Data also demonstrated that its APC and eAPC therapeutic
candidates were well-tolerated among patients treated in its
trials. Manufacturing of the cell product took less than 24 hours,
and the median viability of all lots, in both clinical trials, was
greater than 90 percent.
In the SQZ® eAPC clinical trial, scans showed stable disease as
the best overall response for two out of four evaluable patients in
low dose Cohort 1. A positive ELISpot response for the E7 antigen
was observed in one of these patients and correlated with prolonged
stable disease. This patient remains on treatment.
“Receiving FDA Fast Track Designation underscores the
significant potential of our SQZ® eAPC candidate, which is designed
to generate an even more powerful immune response than our APC
candidate,” said Marshelle Smith Warren, M.D., Chief Medical
Officer at SQZ Biotechnologies. “The initial safety and
tolerability data presented at ESMO-IO today supports our recent
portfolio prioritization decision to focus on our eAPC program. In
addition to the clean safety profile, we were pleased to observe
stable disease in two of the four evaluable patients in the eAPC
trial. The team is working diligently to add more eAPC sites to our
study to achieve our goal of a highest-dose monotherapy data
readout by the middle of 2023.”
Major Findings from Clinical
Research:
Poster #183P: COMMANDER-001: Initial safety data from a
phase I/II dose escalation/expansion study of SQZ-eAPC-HPV, a
cell-based mRNA therapeutic cancer vaccine for HPV16+ solid
tumors
- All patients in Cohort 1 completed the 28-day dose limiting
toxicity (DLT) period without experiencing a DLT. No related
serious adverse events were reported
- Of the four patients enrolled in Cohort 1, two patients (50%)
experienced a best overall response of stable disease, including
one patient who had a pronounced pharmacodynamic response with
prolonged stable disease
- Cell collection to product release took approximately 1 week.
One year’s worth of SQZ-eAPC-HPV, the maximum amount of drug able
to be administered on study, was able to be manufactured for all
patients in Cohort 1
- Median viability of all lots was 94%
Poster #191P: Preliminary biomarker and safety results of
SQZ-PBMC-HPV at recommended phase II dose (RP2D) in monotherapy and
combination with checkpoint inhibitors in HLA A*02+ patients with
recurrent, locally advanced, or metastatic HPV16+ solid tumors
- Data suggests SQZ-PBMC-HPV is capable of stimulating an
anti-tumor immune response in a subset of patients. As observed in
patient 17 (presented at ESMO-IO 2021), increased CD8 tumor
infiltration in conjunction with a reduction of E6 (and E7)
expressing cells in the presence of elevated MHCI expression is
consistent with a biomarker signature of antigen-specific
killing
- SQZ-PBMC-HPV is considered safe and well-tolerated at RP2D both
in monotherapy and in combination with checkpoint inhibitors. The
safety profile consisted of mostly low grade (grades 1 and 2)
non-specific AEs, only one patient experienced serious adverse
events (unrelated to SQZ-PBMC-HPV), and no dose-limiting toxicities
observed
- All batches produced under cGMP yielding multiple cryopreserved
doses in <24hrs with about 1 week collection-to-release time.
Product characterization confirmed antigen presentation and high
viability in all patient batches
About SQZ-eAPC-HPV SQZ® Enhanced Antigen Presenting Cells
(eAPC) are derived from peripheral blood mononuclear cells (PBMCs),
which are primarily composed of monocytes, T cells, B cells, and NK
cells, and engineered with various mRNA encoding for multiple
target antigens and immuno-stimulatory signals, including CD86 and
membrane-bound IL-2 and IL-12. The company has presented
preclinical findings showing that SQZ® eAPCs have generated robust
T cell responses in human in vitro and in vivo models.
Additionally, it was demonstrated preclinically that HPV16-encoding
mRNA delivery to PBMCs stimulated CD8+ T cells across a range of
HLA haplotypes, supporting eAPC clinical development in broader
HPV16+ patient populations.
COMMANDER-001 Trial Design SQZ-eAPC-HPV is being
evaluated in a Phase 1/2 clinical trial (COMMANDER-001) for the
treatment of HPV16+ advanced or metastatic solid tumors. The
clinical candidate, which targets E6 and E7 oncoproteins, is being
studied as a monotherapy and in combination with pembrolizumab, an
immune checkpoint inhibitor. The study consists of two parts. The
first part is designed to assess safety and tolerability of
multiple doses of SQZ-eAPC-HPV in treatment-experienced patients,
following a dose-escalation scheme for monotherapy, and a dose
de-escalation for the combination with pembrolizumab. The second
part of the study will assess clinical response of SQZ-eAPC-HPV in
combination with pembrolizumab in immune checkpoint inhibitor
treatment-naïve patient populations.
About SQZ-PBMC-HPV
SQZ-PBMC-HPV is the company’s Antigen Presenting Cell (APC)
autologous cell therapy clinical candidate and is derived from
peripheral blood mononuclear cells (PBMCs), primarily composed of
monocytes, T cells, B cells, and NK cells, and engineered with
tumor specific E6 and E7 peptide antigens. It received FDA fast
track designation in April 2022. In December 2021, the company
presented clinical data at the European Society for Medical
Oncology Immuno-Oncology (ESMO-IO) congress that included a
checkpoint refractory head-and-neck cancer patient who demonstrated
a radiographic, symptomatic, and immune response in the monotherapy
cohort of the Phase 1/2 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 phases 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. Patient enrollment is expected to be
discontinued by the end of the year with a transition to the
currently enrolling COMMANDER-001 trial featuring the
second-generation SQZ® eAPC candidate for the treatment of HPV16+
advanced or metastatic solid tumors.
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 is a
clinical-stage biotechnology company focused on unlocking the full
potential of cell therapies. 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. 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 events and presentations, the timing and
outcome of the company’s clinical trials, clinical safety and
efficacy of its therapeutic candidates, strategic prioritization,
manufacturing capabilities, and Fast Track Designation. 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; our ability to continue as a
going concern; our ability to successfully execute or achieve the
benefits of our strategic prioritization and other cost saving
measures; 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 Quarterly Report on Form 10-Q,
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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version on businesswire.com: https://www.businesswire.com/news/home/20221206005194/en/
SQZ Biotechnologies Investor and Media Relations: Mike
Kaiser michael.kaiser@sqzbiotech.com 857-760-0398
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