About Us | ScientistSQZ SQZ Biotechnologies Company
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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SQZ-PBMC-HPV-10
Solid Tumors
|
Phase 1
Phase 1
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Phase 1 biomarker data presented at ASCO June 4, 2021. Data in abstract noted 4/10 patients had stable disease.
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Latest News
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SQZ Biotechnologies (NYSE:SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, today reported second quarter 2021 financial results and recent portfolio updates.
"This was an exciting quarter for the company as we reported first-in-human data at ASCO for our investigational APC cell therapy, which demonstrated an encouraging safety profile, rapid SQZ manufacturing and early signs of immune activity," said Armon Sharei, Ph.D., Chief Executive Officer at SQZ Biotechnologies. "We continue to execute on our APC and AAC clinical programs in oncology, while also making significant strides across our other important therapeutic areas and in developing our manufacturing platform. The quarter's progress further reinforces the breadth of opportunity for our technology."
Second Quarter 2021 Business and Portfolio Updates
SQZ™ Antigen Presenting Cell ("APC") Platform in Oncology
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Presented initial Phase 1 clinical trial results of SQZ's engineered APC investigational therapy in patients with advanced or metastatic HPV+ tumors at the American Society of Clinical Oncology:
- SQZ-PBMC-HPV was found to be safe and well-tolerated at all dose levels tested and no dose-limiting toxicity or Grade 3 or higher treatment-related SAEs were observed
- Clinical manufacturing feasibility was confirmed with all patient batches produced in less than 24 hours
- Analyses of pre- and post-therapy tumor biopsies indicated increased immune activity in select patients. Four out of six patients with less advanced disease achieved stable disease. One patient who achieved stable disease remained on study for over 10 months
- Completing fourth Phase 1 monotherapy cohort and progressing towards the combination phase of the study with immune checkpoint inhibitors
SQZ™ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology
- Continued progress on eAPC program supports timeline for year-end IND submission to FDA for first clinical candidate. eAPCs incorporate mRNA, which encode multiple activating signals, as well as antigens to potentially enable a more potent CD8 T cell response
SQZ™ Activating Antigen Carriers ("AAC") Platform in Oncology
- Initiating multi-center Phase 1 clinical trial of SQZ-AAC-HPV, the company's red blood cell-derived investigational cell therapy to treat HPV+ tumors
SQZ™ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance
- Preclinical research presented at the Federation of Clinical Immunology Societies demonstrated that the company's engineered TACs can drive antigen-specific immune tolerance through key mechanisms relevant to many complex autoimmune diseases
- SQZ TACs were found to exert potent bystander suppression, showing the ability to suppress pathogenic T cells with different autoantigen specificities. This finding offers a potential pathway to treating autoimmune diseases without inducing broad immunosuppression
SQZ™ Manufacturing and Potential Pipeline Expansion Research
- Manufacturing data presented at the American Society for Gene and Cell Therapy showed that the company's manufacturing platform can process 10 billion cells per minute with greater than 90 percent cell viability, and results from the Phase 1 APC trial further indicate the feasibility of the company's core manufacturing platform to support current therapeutic areas
- First-generation prototype of our point-of-care manufacturing platform is now undergoing internal non-clinical testing
- Preclinical research presented at the International Society for Stem Cell Research demonstrated that the company's Cell Squeeze® technology can rapidly generate neurons with mature markers using optimized, transient mRNA transcription factor expression. Findings indicate potential to direct cell fate for multiple therapeutic applications
Second Quarter 2021 Financial Highlights
- Revenue for the second quarter 2021 was $4.5 million, compared to $6.0 million for the same period last year
- Net loss for the second quarter 2021 was $19.1 million, compared to $10.0 million for the same period last year
- Research and development expenses for the second quarter 2021 were $17.7 million, compared to $12.0 million for the same period last year. The increase was primarily attributable to planned development and manufacturing costs
- General and administrative expenses for the second quarter 2021 were $5.9 million, compared to $4.0 million for the same period last year. The increase was primarily due to an increase in personnel and other corporate-related costs, including stock-based compensation expense and other costs related to operating as a public company
- As of June 30, 2021, the company had cash and cash equivalents of $185.1 million and expects this will be sufficient to fund operating expenses and capital expenditure requirements through the first half of 2023
About SQZ Biotechnologies
SQZ Biotechnologies 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 patient 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 unwanted immune reactions and 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 our financial condition and cash position, manufacturing capabilities, product candidates, preclinical and clinical activities and outcomes, development plans and progress, clinical efficacy, regulatory submissions, therapeutic impact and market opportunities. 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.
SQZ BIOTECHNOLOGIES COMPANY
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(unaudited)
THREE MONTHS ENDED
JUNE 30,SIX MONTHS ENDED
JUNE 30,2021
2020
2021
2020
Collaboration revenue
$
4,539
$
5,980
$
9,993
$
12,390
Operating expenses:
Research and development
17,682
12,037
32,422
23,905
General and administrative
5,933
4,029
12,054
9,527
Operating expenses
23,615
16,066
44,476
33,432
Loss from operations
(19,076
)
(10,086
)
(34,483
)
(21,042
)
Other income, net
6
100
14
473
Net loss
(19,070
)
(9,986
)
(34,469
)
(20,569
)
Net loss per share attributable to common stockholders, basic and diluted
$
(0.68
)
$
(5.74
)
$
(1.27
)
$
(11.83
)
Weighted-average common shares outstanding, basic and diluted
27,919,647
1,739,114
27,100,817
1,738,353
SQZ BIOTECHNOLOGIES COMPANY
Condensed Consolidated Balance Sheets
(In thousands)
(unaudited)
JUNE 30,
2021DECEMBER 31,
2020Assets
Cash and cash equivalents
$
185,067
$
170,357
Other current assets
4,196
6,474
Total current assets
189,263
176,831
Other assets
49,291
54,310
Total assets
$
238,554
$
231,141
Liabilities and Stockholders' Equity
Current liabilities
43,835
45,193
Long term liabilities
42,015
58,749
Total liabilities
85,850
103,942
Total stockholders' equity
152,704
127,199
Total liabilities and stockholders' equity
$
238,554
$
231,141
View source version on businesswire.com: https://www.businesswire.com/news/home/20210804006127/en/
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Presented initial Phase 1 clinical trial results of SQZ's engineered APC investigational therapy in patients with advanced or metastatic HPV+ tumors at the American Society of Clinical Oncology:
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Bernard Coulie, M.D., Ph.D. and Patrick Vink, M.D. Join Board of Directors
SQZ Biotechnologies (NYSE:SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, today announced the appointments of Bernard Coulie, M.D., Ph.D., and Patrick Vink, M.D., to its board of directors, adding global commercial and clinical development expertise.
"We are thrilled to have Bernard and Patrick join our Board," said Armon Sharei, Ph.D., Chief Executive Officer and Founder of SQZ Biotechnologies. "As we execute on our clinical trials and look to broaden our pipeline to address multiple disease areas with SQZ's novel cell therapies, their experience in the global market and managing clinical development programs will be tremendously valuable."
"Adding these talented leaders to our board strengthens our entry into the clinic and our focus on patient care," said Amy Schulman, Chair of the Board of Directors at SQZ Biotechnologies. "Bernard's and Patrick's healthcare and biotechnology experience will provide valuable support as the company grows. We also want to thank exiting board member Eric Moessinger, Partner at ND Capital, and acknowledge his counsel and support from the early days of SQZ through our public offering."
Bernard Coulie, M.D., Ph.D., has more than 20 years of experience in drug development and company formation and growth. He is currently President & CEO of Pliant Therapeutics. Prior to this role, he cofounded Belgium-based ActoGeniX and served as CEO from 2006 until its acquisition in 2015. Prior to cofounding ActoGeniX, Dr. Coulie held positions with increasing responsibilities in drug discovery and clinical development at Johnson & Johnson Pharmaceutical Research and Development Europe. Dr. Coulie is currently board chair at a biotechnology company in the Netherlands and has held board seats in other companies utilizing a range of technologies.
Patrick Vink, M.D., has over 30 years of experience as a senior executive in the life sciences industry, including broad international expertise. Dr. Vink previously served as Executive Vice President at Cubist, Head of Global Biopharmaceuticals for the Sandoz division of the Novartis Group, Vice President of International Business for Biogen Inc., and Head of Worldwide Marketing, Cardiovascular and Thrombosis at Sanofi-Synthelabo Ltd. He was also a member of the Executive Committee of the European Federation of Pharmaceutical Industries and Associations. Dr. Vink is currently board chair or director in biotechnology companies in Denmark, Switzerland, U.K., and the U.S. and has experience across a range of distinct technology platforms.
About SQZ Biotechnologies
SQZ Biotechnologies 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, and 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 patient 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 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 our corporate governance, product candidates, preclinical and clinical activities, development plans, geographic expansion, clinical safety and efficacy, applicability across disease states 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210701005879/en/
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Results Further Establish Company's Broad Cell Engineering Capabilities and Potential to Direct Cell Fate for Multiple Therapeutic Applications
Findings Presented at 2021 International Society for Stem Cell Research Annual Meeting
SQZ Biotechnologies Company (NYSE:SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, today presented preclinical regenerative medicine data showing that the company's Cell Squeeze® technology can be used to generate neurons from induced human pluripotent stem cells (iPSCs) through the single delivery of an mRNA encoding fate-specifying transcription factor. The new findings build upon recent clinical and pre-clinical research presentations from the company's Oncology and Autoimmune Disease programs and further demonstrates SQZ's broad cell engineering capabilities. The regenerative medicine research was presented at the 2021 International Society for Stem Cell Research virtual annual meeting.
"The ability to precisely stimulate key natural signaling pathways through the delivery of one or multiple transcription factors provides broad cell reprogramming potential that could lead to many new cell therapies and offers a foundation for future regenerative medicines," said Jonathan Gilbert, Ph.D., Vice President and Head of Exploratory Research, SQZ Biotechnologies. "We are excited by these preclinical proof-of-concept data demonstrating that we can rapidly generate neurons with mature markers using optimized, transient mRNA transcription factor expression. This work complements and expands on our earlier published research using SQZ technology to reprogram fibroblasts into iPSCs."i
Common methods to generate specific cell types from iPSCs include sequential treatment of cells using multiple extracellular signaling molecules, a process that can be lengthy, inefficient, and result in variable purity, or using viral vectors, which have the risk of undesirable genomic integration.
Cell Squeeze® technology can generate reprogrammed cells by controlling the magnitude and timing of single or multiple cell programming factors. Specific cells generated with this process have the potential to translate therapeutically due to the rapid process, lack of viral or genetic manipulations, and use of our clinically validated manufacturing.
Major Findings from Cell Reprogramming Research:
- Rapid Induction of Neuronal Differentiation: Within 24 hours after the single squeeze delivery of Neurog2 mRNA, a key neuronal transcription factor, expression of the early neuronal marker TUJ1 was observed. Additionally, two key mature neuronal makers, MAP2 and NeuN, were identified through continued longitudinal observation.
- Potent Target Gene Expression: SQZ scientists developed an optimized mRNA sequence for Neurog2 that showed a 10,000-fold increase in expression of downstream target genes from a single squeeze delivery.
- Multiplexed mRNA Capability: The Cell Squeeze® process also co-delivered two mRNA cargos simultaneously, specifically Neurog2 and puromycin N-acetyltransferase, a commonly used enzyme for cell purification. Mature neuronal marker expression and contrast images showed the selective survival of the induced cells, demonstrating that multiple functional mRNAs can be delivered into iPSCs.
- Maintaining Cell Health: SQZ investigators demonstrated that the Cell Squeeze process alone does not disrupt normal iPSC gene and protein expression. Findings verified that 24 hours after processing the iPSCs through a SQZ™ chip, there was no significant difference in the expression of 32 common housekeeping genes as well as no disruption in pluripotent marker gene and protein expression.
Together these data show the potential of the Cell Squeeze® technology to rapidly reprogram cells for regenerative medicine applications.
Poster Presentation Details
Title: Microfluidic cell squeezing enables the in vitro generation of induced neurons from human pluripotent stem cells through non-viral transcription factor delivery
Abstract Number: 318
Poster Session: Poster Session 3, New Technologies; Wednesday, June 23, 2021, 12:00 PM - 1:00 PM EDTAbout SQZ Biotechnologies
SQZ Biotechnologies 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, and 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 patient 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 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, applicability across disease states, 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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i Sharei A, et al. A vector-free microfluidic platform for intracellular delivery. PNAS February 5, 2013 110 (6) 2082-2087; https://doi.org/10.1073/pnas.1218705110View source version on businesswire.com: https://www.businesswire.com/news/home/20210623005188/en/
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Engineered TACs Prevented Hyperglycemia in Type 1 Diabetes Models by Deletion of Target T Cells and Increase of Regulatory T Cells that Exerted Potent Bystander Suppression
Data Presented at Federation of Clinical Immunology Societies
SQZ Biotechnologies Company (NYSE:SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, is presenting preclinical results from the company's Tolerizing Antigen Carrier (TAC) program demonstrating that its engineered TACs can drive antigen-specific immune tolerance through key mechanisms relevant to many complex autoimmune diseases. In models of Type 1 diabetes (T1D), SQZ™ TACs were able to delete antigen-specific T cells, without causing non-specific immune suppression, ultimately preventing hyperglycemia. Importantly, SQZ TACs increased antigen-specific regulatory T cells (Tregs) that exerted potent bystander suppression, showing the ability to suppress pathogenic T cells with different autoantigen specificities. Together, these results suggest that SQZ TACs are a versatile platform for inducing antigen-specific immune tolerance. The data will be presented on Thursday at the 2021 Federation of Clinical Immunology Sciences (FOCIS) annual meeting.
"The holy grail for effectively treating autoimmune diseases is the ability to precisely target autoreactive T cells without inducing broad immunosuppression," said Howard Bernstein, M.D., Ph.D., chief scientific officer at SQZ Biotechnologies. "We are very excited to see our TACs induce multiple mechanisms of antigen-specific tolerance with long lasting effects. We believe the ability of our TACs to increase regulatory T cells capable of bystander suppression may enable the development of differentiated therapies for complex autoimmune diseases."
Critical to the development of tolerogenic therapies for many autoimmune diseases is the ability to regulate both autoreactive CD4 (helper) T cells and CD8 (killer) T cells, which are often involved in the attack seen on healthy cells in autoimmune diseases. These preclinical studies tested SQZ TACs in multiple models of T1D.
Major Findings from Autoimmune Disease Models:
- Disease Suppression: Engineered TACs significantly delayed onset of disease to a median of 65 days compared to 8 days in controls of a T1D model driven by pathogenic CD4 T cells. All doses were administered within the first 4 days of disease induction. In another T1D model where disease was driven by pathogenic CD8 T cells, the TACs prevented onset of T1D for all animals. All doses were administered within the first 2 days of disease induction.
- Reduction of Disease Driving T Cells: TACs reduced frequency of disease driving CD4 T cells in the pancreas 5-fold and decreased the secretion of proinflammatory cytokine interferon gamma – a major driver of disease in this model – by 126-fold. The engineered TACs also reduced disease driving CD8 T cells in the pancreas by 60-fold and decreased secretion of proinflammatory cytokine interferon gamma by 375-fold. In addition, there was a nearly 4-fold increase in antigen-specific apoptotic CD8 T cells in the pancreas.
- Increase in Regulatory T Cells: In the T1D model driven by pathogenic CD4 T cells, antigen-specific Tregs in the pancreas increased by approximately 5-fold and the suppressor cytokine IL-10 by about 6-fold.
- Bystander Suppression: In a model where both pathogenic CD4 and CD8 T cells were present, treatment with TACs encapsulating CD4 antigen alone increased frequency of antigen-specific Tregs by 3.5-fold, reduced the number of CD8 T cells of a different autoantigen specificity by 10-fold, and decreased interferon gamma secretion by 9-fold – displaying strong bystander suppression.
These robust preclinical data demonstrate that SQZ TACs can restore T cell tolerance to self-antigens through multiple mechanisms and highlight the broad potential of the SQZ platform to enable antigen-specific immunotherapies for complex autoimmune disease.
Poster Presentation Details
Title: SQZ™ TAC Cell Therapy Platform Induces Antigen-Specific Tregs and Prevents Onset of Diabetes in Adoptive Transfer Model
Abstract Number: Th128
Poster Session: Thursday, June 10, 2021 - 4:45 PM - 5:30 PM PDTAbout Type 1 Diabetes
Nearly 1.6 million Americans are living with Type 1 Diabetes (T1D), including about 1.4 million adults and 200,000 children and adolescents (<20 years). Five million people in the U.S. are expected to have T1D by 2050. A separatee CDC study of T1D cases in youth showed that 60 percent of diagnoses occur between the ages of 5 and 14. Worldwide incidence is 15 patients diagnosed per every 100,000 people. There is no cure for T1D, and it requires chronic disease management through exogenous insulin therapy, insulin analogs and adjunctive treatments for glycemic control. The life expectancy for T1D patients is 10–15 years less than the healthy population due to hypoglycemia events and long-term risks of cardiovascular complications, neuropathy, kidney damage, and retinopathy. There remains significant unmet need for disease-modifying therapeutics that address the autoimmune-mediated attack of beta cells as a driving factor of disease pathogenesis.
About SQZ TACs
SQZ TACs are a red blood cell-derived cell therapy candidate being developed as an antigen-specific immune tolerance platform. The platform is designed to leverage the natural process of RBC clearance by professional antigen presenting cells (APCs) in the lymphoid organs, where they engulf aged RBCs and present their components to CD4 and CD8 T cells. This physiological mechanism is tolerogenic by default, instructing the immune system to not mount an attack. SQZ TACs are generated by squeezing RBCs with disease-specific antigen and are made to appear aged. SQZ TACs are designed to be rapidly engulfed in vivo by patient's professional APCs and to act as a "Trojan horse" to drive high quantities of antigen through the tolerogenic RBC clearance process, inducing tolerization of the patient's T cell and antibody responses against the specific target.
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, applicability across disease states, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210609005273/en/
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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.
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