SQZ BIOT Item 8.01 Other Events.
On
Trial Highlights from ESMO IO Abstract 565
? SQZ-PBMC-HPV-101 Phase 1/2 trial has four dose-escalating monotherapy cohorts ranging from 0.5 to 5.0 x10e6 cells per kg ? A total of 18 patients were treated across four cohorts and patients had an average of 3.5 prior lines of systemic cancer therapy ? Across all cohorts the investigational therapy was generally well-tolerated, and no dose-limiting toxicities were observed ? No grade 2 or higher treatment-related severe adverse events, or grade 3 adverse events, were observed in the highest-dose cohort ? In the highest-dose cohort with five patients evaluable, one patient who had been heavily treated with PD-1 inhibitors before entering the trial demonstrated radiographic response as well as substantial increases in CD8 T cell tumor infiltration and PD-L1 expression
The highest-dose monotherapy stage continues enrollment to further characterize the investigational therapy in single agent settings. The combination stage of the trial is enrolling with checkpoint inhibitors targeting the PD-(L)1 and CTLA-4 pathways.
A copy of the press release issued in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information in Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended or the Exchange Act, except as expressly set forth by specific reference in such filing.
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, our platform development, our product candidates, clinical
activities, progress and outcomes, development plans, manufacturing, clinical
safety and efficacy results, therapeutic impact, including the potential impact
of combining SQZ-PBMC-HPV with checkpoint inhibitors, 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
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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
--------------------------------------------------------------------------------
Exhibit Description No. 99.1 Press release issued bySQZ Biotechnologies Company onDecember 2, 2021 104 Cover Page Interactive Data File (embedded with the Inline XBRL document)
--------------------------------------------------------------------------------
© Edgar Online, source
