SQZ Biotechnologies to Present New Enhanced APC Platform Preclinical Findings and ENVOY-001 Phase 1/2 Clinical Trial in Progress Poster at the American Association for Cancer Research 2022 Annual Meeting

Rhea-AI Summary

SQZ Biotechnologies Company (NYSE: SQZ) announced the presentation of new preclinical findings on its enhanced antigen presenting cell (eAPC) platform at the American Association for Cancer Research (AACR) Annual Meeting on April 8-13, 2022. The eAPC platform effectively delivers multiple mRNA, enhancing CD8 T cell responses against various diseases, including HPV. The FDA granted IND clearance for SQZ-eAPC-HPV, its first therapeutic candidate targeting HPV16+ solid tumors. Additionally, a Trial in Progress presentation will detail the ENVOY-001 Phase 1/2 trial of SQZ-AAC-HPV in patients with HPV-related tumors.

Positive

• Presentation of new preclinical findings on the eAPC platform demonstrating the ability to enhance CD8 T cell responses against diseases.
• FDA granted IND clearance for SQZ-eAPC-HPV, expanding the therapeutic scope for HPV16+ solid tumors.
• Upcoming presentation of ENVOY-001 Phase 1/2 trial results indicating ongoing clinical progress.

Negative

• None.

WATERTOWN, Mass.--(BUSINESS WIRE)-- SQZ Biotechnologies Company (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, today announced that it will present new preclinical findings on the company’s enhanced antigen presenting cell (eAPC) platform at the American Association for Cancer Research (AACR) Annual Meeting on April 8-13, 2022 in New Orleans, Louisiana. The new eAPC work demonstrates the company’s Cell Squeeze^® platform’s ability to deliver multiple mRNA simultaneously into important immune cells – monocytes, B cells, T cells, and NK cells – generating eAPCs with specific antigens and costimulatory factors that are designed to drive strong CD8 T cell responses against targeted diseases.

“By simultaneously engineering the three fundamental signals involved with T cell activation, SQZ eAPCs can potentially drive powerful, targeted immune responses against a variety of diseases,” said Howard Bernstein, M.D., Ph.D., Chief Scientific Officer at SQZ Biotechnologies. “Our preclinical data at AACR demonstrates that our eAPCs can significantly enhance CD8 T cell responses to a variety of disease antigens – including Cytomegalovirus, Influenza, and Human Papillomavirus. The versatility of our approach has the potential to further enable rapid evolution of the platform for a variety of diseases by using mRNA to encode other antigens or T cell activation signals.”

In January, the FDA gave IND clearance for SQZ-eAPC-HPV, the company’s first eAPC therapeutic candidate, for use in patients who have HPV16+ solid tumors. SQZ eAPCs are intended to build on the promising preliminary monotherapy results from our SQZ APC candidate by expanding the addressable patient population and directly incorporating combination-like functionality.

In addition to the new eAPC preclinincal data, a Trial in Progress poster presentation of the ENVOY-001 Phase 1/2 clinical trial will be delivered by Victoria Villaflor, M.D., City of Hope Medical Center. The presentation will summarize the ENVOY-001 study design of SQZ-AAC-HPV, the company’s first AAC clinical candidate being investigated in patients with HPV16+ recurrant, locally advanced, or metastatic solid tumors.

AACR eAPC Poster

Title: Co-delivery of antigen-encoding mRNA and signal 2/3 mRNAs to PBMCs by CellSqueeze^® technology generates SQZ^® eAPCs that prime CD8 T cells in humanized mouse model
Presenter: Scott Loughhead, PhD, SQZ Biotechnologies
Session Date and Time: Tuesday Apr 12, 2022 9:00 AM - 12:30 PM
Poster Board Number: 19
Abstract Number: 2853

AACR Trial in Progress Presentation

Title: ENVOY-001: A phase 1, multicenter, open-label study of SQZ-AAC-HPV as monotherapy and in combination with immune checkpoint inhibitors in HLA-A*02+ patients with HPV16+ recurrent, locally advanced, or metastatic solid tumors.
Presenter: Victoria M. Villaflor, MD, City of Hope Medical Center
Session Date and Time: Wednesday, April 13 from 9:00 am - 12:30 pm ET
Poster Section: 35
Abstract Number: 7645

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. SQZ-eAPC-HPV is the company’s first eAPC clinical candidate, and it is being evaluated in a Phase 1/2 clinical trial (COMMANDER-001) for the treatment of HPV16+ advanced or metastatic solid tumors. The investigational candidate is being studied as a monotherapy and in combination with an immune checkpoint inhibitor.

About SQZ-AAC-HPV

SQZ^® Activating Antigen Carriers (AACs) are designed to transport tumor-specific antigens and adjuvant using engineered red blood cells (RBCs) to a patient’s own professional antigen presenting cells (APCs). The APCs can then activate CD8 killer T cells that travel to tumor sites and attack specific diseased cells. SQZ-AAC-HPV is the company’s first AAC clinical candidate, and it is being evaluated in a Phase 1/2 clinical trial (ENVOY-001 or SQZ-AAC-HPV-101) for the treatment of HPV16+ advanced or metastatic solid tumors. The investigational candidate is being studied as a monotherapy and in combination with immune checkpoint inhibitors.

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 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.

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 platform development, our product candidates, preclinical and clinical activities, progress and outcomes, development plans, manufacturing, clinical safety and efficacy results, therapeutic impact, 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 Annual Report on Form 10-K, as updated by our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021 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.

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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Media

John Lacey

781-392-5514

john.lacey@sqzbiotech.com



Investors

Michael Kaiser

857-760-0398

michael.kaiser@sqzbiotech.com

Source: SQZ Biotechnologies Company

FAQ

What are the new findings presented by SQZ Biotechnologies at the AACR Annual Meeting?

SQZ Biotechnologies presented preclinical findings showing that their eAPC platform can enhance CD8 T cell responses against various diseases.

What is the significance of the IND clearance for SQZ-eAPC-HPV?

The IND clearance allows SQZ Biotechnologies to initiate clinical trials for their first eAPC therapeutic candidate targeting HPV16+ solid tumors.

When will the ENVOY-001 Phase 1/2 trial presentation take place?

The ENVOY-001 Phase 1/2 trial presentation will occur on April 13, from 9:00 am to 12:30 pm ET at the AACR Annual Meeting.

What diseases does the SQZ eAPC platform target?

The SQZ eAPC platform is designed to target diseases by enhancing immune responses, specifically against HPV, Cytomegalovirus, and Influenza.

What is the potential market impact of SQZ's eAPC technology?

SQZ's eAPC technology has the potential to create targeted immune responses which could significantly impact the treatment of solid tumors and infectious diseases.