Average Processing Time Per Batch Less Than 6
Hours – a 55% Reduction with Comparable or Improved Product
Metrics
First Clinical Use Planned for SQZ® TACs in
Celiac Disease with IND Submission Anticipated in 1H 2023
Preclinical Data on Hematopoietic Stem Cell
Engineering and Planned Commercial Research-Use-Only System
Presented at ASGCT 2022 Support Potential for Broad Future
Point-of-Care Manufacturing Implementation
R&D Investor Event Featuring
Point-of-Care Manufacturing Platform and Research-Use-Only System,
Tomorrow, May 19, 2022
SQZ Biotechnologies (NYSE: SQZ) announced today that the
company’s first generation, integrated point-of-care (POC) cell
therapy manufacturing system demonstrated superior process
performance and comparable or improved product specifications
relative to current clean room-based processes used in clinical
development. The non-clinical studies showed that the SQZ® POC
system could produce the company’s red blood cell derived SQZ®
Activating Antigen Carrier (AAC) therapeutic candidate for the
treatment of HPV16 positive solid tumors in half the time (under 6
hours), with 90 percent fewer operator hours, while producing
comparable drug product. The system is also compatible with
hematopoietic stem cells and peripheral immune cells, including B
cells, T cells, NK cells, and Monocytes. Data was presented today
at the 2022 American Society for Gene and Cell Therapy (ASGCT)
annual meeting.
“We are tremendously excited with the cell therapy production
data from our prototype point-of-care manufacturing system, which
has the potential to produce cell therapies using a range of cell
types,” said Howard Bernstein, M.D., Ph.D., Chief Scientific
Officer at SQZ Biotechnologies. “Our current clinical manufacturing
process is under 24 hours - comparatively faster than other cell
therapy manufacturing approaches. Our integrated point-of-care
platform represents a further leap with faster production in a
closed system that could eliminate the need for an ISO 7 clean
room. We look forward to its planned first clinical use in our red
blood cell derived SQZ TAC program for celiac disease.”
The company anticipates a SQZ® TAC IND submission for celiac
disease in the first half of 2023. Celiac disease impacts a large
patient population globally and it, like many other diseases, could
benefit from a scalable, decentralized cell therapy manufacturing
model. Manufacturing the first SQZ® TAC clinical candidate on the
SQZ® POC system will further the development of this decentralized
model and support potential future use of the POC system across
disease areas.
The SQZ® POC manufacturing system integrates and automates,
among other things, cell isolation, cell washing, Cell Squeeze®
intracellular delivery technology, and product filling. The system
is designed to process patient material within a closed, single-use
sterile disposable kit. The system architecture offers the
potential to be operated outside of an ISO 7 clean room typically
required of cell therapies—which could ultimately allow cell
therapy manufacturing by SQZ® POC systems in a variety of care
settings.
In addition to the SQZ® POC presentation at ASGCT, preclinical
data were presented on the first study findings of the planned
commercial research-use-only (RUO) microfluidic delivery system.
The RUO presentation highlighted the gentle, yet efficient, nature
of the intracellular delivery system. Data demonstrated the ability
to effectively deliver and express mRNA in unactivated T and NK
cells as well as to gene edit unactivated T cells with limited
impact to viability and downstream function.
Cell Squeeze® gene editing of autologous hematopoietic stem
cells (HSCs) was also presented at the conference. The HSC editing
preclinical data demonstrated that the Cell Squeeze® platform could
efficiently deliver mRNA and RNPs into HSCs, a sensitive cell type
that has been limited previously by toxicity, cargo restrictions,
and scalability using other cell engineering approaches. Analysis
of the Cell Squeeze® processed HSCs determined that their phenotype
was maintained in vitro and in vivo illustrating its broad
potential for use in certain rare and genetic disease
indications.
ASGCT POINT-OF-CARE MANUFACTURING DATA
HIGHLIGHTS
- Average processing time per batch run reduced by 55 percent,
from 12 hours 45 minutes to 5 hours 45 minutes
- Required person-hours reduced by 90 percent, from 150 hours to
15 hours
- Batches showed comparable attributes, including drug and
adjuvant content, cell purity, and interferon gamma secretion (a
measure of T cell activation)
ASGCT RESEARCH-USE-ONLY (RUO) SYSTEM
DATA HIGHLIGHTS
- RUO system demonstrated robust CRISPR-Cas9 editing in
unactivated human T cells, and efficient delivery and expression of
mRNA to unactivated T and NK cells
- The gentle nature of the RUO system’s intracellular delivery
mechanism resulted in limited impact to T cells. Unactivated T
cells retained their unactivated phenotype and demonstrated similar
activation and expansion compared to untreated samples
- In contrast, electroporation of unactivated T cells resulted in
spontaneous increases in pro-inflammatory cytokine transcripts and
secretion, independent of TCR engagement
ASGCT HEMATOPOIETIC STEM CELL (HSC)
DATA HIGHLIGHTS
- Cell Squeeze® technology efficiently delivered mRNA and RNPs
into HSCs; 90 percent of HSCs expressed transferred mRNA, and high
editing rates were achieved using B2M and CCR5 targeting RNPs
- HSC phenotype was maintained following Cell Squeeze® treatment
compared to controls as determined by microarray analysis, CFC
assay, and NBSGW mouse engraftment study
- Cell Squeeze® treated HSCs could be transferred immediately
following treatment, and demonstrated superior engraftment versus
electroporation
R&D INVESTOR EVENT
DETAILS
The company will host a live R&D Investor event with
optional virtual participation on Thursday, May 19, 2022, beginning
at 4:05 p.m. ET. Onsite and virtual participants can register in
advance by completing the registration form on the event website:
https://investorday.sqzbiotech.com/. Following the event, a webcast
replay will be made available on the company’s investor website:
investors.sqzbiotech.com.
ASGCT PRESENTATION TITLES AND
TIMING
SQZ Point-of-Care Manufacturing Presentation Title: A
Decentralized and Integrated Manufacturing System for the Rapid and
Cost-Effective Production of Cell Therapy Drug Products SQZ
Presenter: Maisam Dadgar Session Title: Cell Therapy
Product Engineering, Development or Manufacturing Abstract
Number: 1171 Date & Time: Wednesday, May 18, 2022,
from 5:30-6:30 PM
STEMCELL TECHNOLOGIES Immune Cell Engineering Poster
Presentation Title: A New Benchtop System for Simple and
Versatile Introduction of Macromolecules into Human Lymphocytes by
Microfluidic Squeezing STEMCELL Presenter: Eric Ouellet,
Ph.D. Session Title: Synthetic/Molecular Conjugates and
Physical Methods for Delivery II Abstract Number: 997
Date & Time: Wednesday, May 18, 2022, from 5:30-6:30
PM
SQZ Hematopoietic Stem Cell Research Presentation Title:
Rapid, Gentle, and Scalable Engineering of Hematopoietic Stem Cells
Using Vector-Free Microfluidic Cell Squeeze® Technology SQZ
Presenter: Murillo Silva, Ph.D. Session Title: Cell
Therapy Product Engineering, Development or Manufacturing
Abstract Number: 1176 Date & Time: Wednesday, May
18, 2022, from 5:30-6:30 PM
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.
About STEMCELL Technologies
STEMCELL Technologies supports life sciences research with more
than 2,500 specialized reagents, tools, and services. STEMCELL
offers high-quality cell culture media, cell separation
technologies, instruments, accessory products, educational
resources, and contract assay services that are used by scientists
performing stem cell, immunology, cancer, regenerative medicine,
and cellular therapy research globally. To learn more and receive
future announcements about the RUO system in development, visit
www.stemcell.com/RUOsystem.
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, regulatory submissions, platform development,
product candidates, preclinical and clinical activities, progress
and outcomes, development plans, manufacturing capabilities,
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
statements, whether as a result of new information, the occurrence
of current events, or otherwise, unless required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220518005306/en/
SQZ CONTACTS MEDIA John
Lacey 781-392-5514 john.lacey@sqzbiotech.com INVESTORS Michael Kaiser 857-760-0398
michael.kaiser@sqzbiotech.com STEMCELL CONTACTS MEDIA Dominika Nackiewicz
public.relations@stemcell.com
SQZ Biotechnologies (NYSE:SQZ)
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