SQZ-PBMC-HPV / STEMCELL Technologies - LARVOL DELTA

Final outcomes analysis of the cell product SQZ-PBMC-HPV Phase 1 trial in incurable HPV16+ solid tumors shows improved overall survival in patients with increased CD8+ T cell tumor infiltration. (PubMed, Mol Carcinog) - P1 | "In patients with incurable HPV16+ solid tumors treated with SQZ-PBMC-HPV, an increase in CD8+ T cell density within the tumor parenchyma was associated with superior disease control rate and overall survival. The product composition for patients with increased CD8+ T cell density was enriched for T cells."

Journal • P1 data • Oncology • Solid Tumor • CD8 • GZMB • HLA-A

STEMCELL Technologies Announces Successful Completion of Asset Purchase Agreement with SQZ Biotechnologies Company [Google translation] (Businesswire) - "STEMCELL Technologies is pleased to announce that it has acquired substantially all of the assets of SQZ Biotechnologies Company...This transaction, which was approved today by SQZ shareholders, marks another important milestone for STEMCELL, Canada's largest biotechnology company....Once the SQZ transaction was approved, STEMCELL was able to acquire substantially all of SQZ's assets, including its entire portfolio of more than 400 patents and trademarks, other intellectual property rights such as copyrights and trade secrets, proprietary equipment and its master license from the Massachusetts Institute of Technology."

M&A • Cervical Cancer • CNS Disorders • Gynecologic Cancers • Head and Neck Cancer • Oncology • Parkinson's Disease • Solid Tumor

SQZ-PBMC-HPV-101: Increased overall survival in a subset of patients with recurrent, locally advanced, or metastatic HPV16+ tumors treated with cell-based vaccine, SQZ-PBMC-HPV (SITC 2023) - P1 | "The sub-set of patients who had an increase in CD8 density within the tumor after treatment showed a 3. 5-fold increase in mOS with better control of tumor growth (as measured by clinical response) compared to those without an increase."

Clinical • Metastases • Oncology • CD8 • HLA-A

SQZ Biotechnologies Reports Data for Clinical Programs at the Society for Immunotherapy of Cancer Annual Meeting (Businesswire) - P1 | N=30 | NCT04084951 | Sponsor: SQZ Biotechnologies | "SQZ Biotechnologies Company...presented clinical data for three programs focused on the treatment of Human Papillomavirus 16 positive (HB16+) driven cancers at the Society for Immunotherapy of Cancer Annual Meeting 2023....Poster# 594:...A subset of patients with paired biopsies (6 of 18) showed increased CD8 T cell infiltration when compared to baseline. These patients with increased CD8 T cell infiltration demonstrated an improved overall survival ('OS') when compared to patients with decreased CD8 T cell infiltration. Median OS [95% CI) for Increase in CD8: 606.5 days [314.0, 713.0] compared to median OS [95% CI) for Decrease in CD8: 170.0 days [54.0, 220.0]. SQZ-PBMC-HPV monotherapy is considered generally safe and well-tolerated at all dose levels."

P1 data • Solid Tumor

SQZ-PBMC-HPV-101: Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: SQZ Biotechnologies | Active, not recruiting ➔ Completed | N=200 ➔ 30 | Trial completion date: Jun 2023 ➔ Feb 2023

Checkpoint inhibition • Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion • Trial completion date • Gastrointestinal Cancer • Immune Modulation • Oncology • Solid Tumor • HLA-A

Phase 1 study to determine the safety and dosing of autologous PBMCs modified to present HPV16 antigens (SQZ-PBMC-HPV) in HLA-A*02+ patients with HPV16+ solid tumors. (PubMed, Invest New Drugs) - "SQZ-PBMC-HPV was well tolerated; 5.0 × 10 live cells/kg with double priming was chosen as the recommended Phase 2 dose. Multiple participants exhibited pharmacodynamic changes consistent with immune responses supporting the proposed mechanism of action for SQZ-PBMC-HPV, including patients previously refractory to checkpoint inhibitors."

Journal • P1 data • Oncology • Solid Tumor • CD8 • HLA-A • PD-L1

[VIRTUAL] A Phase 1, Dose Escalation and Dose Expansion Study of SQZ PBMC HPV as Monotherapy and in Combination with Atezolizumab in HLA-A*02+ Patients with HPV16+ Recurrent, or Metastatic Solid Tumors. (SITC 2020) - P1 | "No formal statistical hypothesis testing will be performed. Results N/A Conclusions N/A"

Clinical • Combination therapy • Monotherapy • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • CD8 • IFNG

Preliminary biomarker and safety results of SQZ-PBMC-HPV at RP2D in monotherapy and combination with checkpoint inhibitors in HLA A*02+ patients with recurrent, locally advanced, or metastatic HPV16+ solid tumors (ESMO-IO 2022) - P1 | "Pts also receiving atezolizumab or ipilimumab are dosed IV q3w. This report will be the first to summarize the PD and safety endpoints for pts receiving SQZ-PBMC-HPV + ICI therapy. Conclusions Building on encouraging earlier monotherapy response data with SQZ-PBMC-HPV, this monotherapy and ICI combination data will further elucidate the impact of this therapeutic vaccine's mechanism and evaluate its place in patient treatment."

Biomarker • Checkpoint inhibition • Clinical • IO biomarker • Monotherapy • Oncology • Solid Tumor • CD8 • HLA-A • PD-L1

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 (ESMO-IO 2022) - P1, P1/2 | "Background SQZ-eAPC-HPV (eAPC) is an autologous, cell based, HLA-genotype agnostic HPV therapeutic cancer vaccine that leverages clinical and manufacturing experience from the SQZ-PBMC-HPV clinical candidate (NCT04084951). Conclusions eAPC explores the impact of multiplexed mRNA-based engineering of a cancer vaccine. As of the data cut-off for this abstract (17Aug22), it is thus far well tolerated."

Clinical • P1/2 data • Cervical Cancer • Oncology • Solid Tumor • CD86 • IL12A

SQZ-PBMC-HPV-101: Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=200 | Active, not recruiting | Sponsor: SQZ Biotechnologies | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2022 ➔ Mar 2023 | Trial primary completion date: Nov 2022 ➔ Mar 2023

Checkpoint inhibition • Combination therapy • Enrollment closed • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Immune Modulation • Inflammation • Oncology • Solid Tumor • HLA-A

SQZ Biotechnologies and Collaborators Publish Technology Review on SQZ APCs and Effective CD8 T Cell Activation (Businesswire) - P1 | N=200 | NCT04084951 | Sponsor: SQZ Biotechnologies | "'Activation of CD8 T cells through MHC-I antigen presentation is a promising approach and is being tested in the SQZ-PBMC-HPV-101 clinical trial where we’ve seen increases in CD8 T cell tumor infiltration and clinical benefit in a refractory patient with HPV16-mediated cancer. We look forward to potentially building on these early results through combination with various immunomodulatory drugs, such as checkpoint inhibitors'....Enabling MHC-I Presentation and Multi-Dimensional Immune Engineering: SQZ’s approach has demonstrated preclinically dramatic improvements in potential CD8 T cell activation as well as synergy with next generation immuno-oncology drugs such as PD-1 IL2v."

P1 data • Preclinical • Oncology • Solid Tumor

SQZ Biotechnologies Announces Strategic Prioritization of SQZ Enhanced Antigen Presenting Cells Program; Armon Sharei to Step Down as Chief Executive Officer (Businesswire) - "At European Society of Medical Oncology—Immuno-Oncology (ESMO-IO) Congress 2022, the company will present the latest clinical data from the company’s Antigen Presenting Cells (APC) program clinical candidate, SQZ-PBMC-HPV, including high dose monotherapy and combination therapy. The company will also present initial cohort 1 data from its ongoing COMMANDER-001 Phase 1/2 (SQZ-eAPC-HPV) trial at ESMO-IO."

P1 data • P1/2 data • Oncology • Solid Tumor

COMMANDER-001: A Phase 1/2, First-in-Human, Multicenter, Open Label Study of SQZ-eAPC-HPV as Monotherapy and with Pembrolizumab in Patients with HPV16+ Recurrent, Locally Advanced, or Metastatic Solid Tumors (Trial in Progress) (SITC 2022) - P1/2 | "SQZ-eAPC-HPV is an improved 2nd generation product, with no HLA restrictions, that builds on the clinical and manufacturing experience with the 1st generation SQZ-PBMC-HPV product. Preconditioning is not required, and the study will be primarily conducted out-patient. Trial Registration NCT05357898 Ethics Approval The study is registered on clinicaltrials.gov and was approved by the Ethics Board of all institutions listed as recruiting."

Clinical • Monotherapy • P1/2 data • Oncology • Solid Tumor • CD8 • CD86 • IL12A • IL2

SQZ-PBMC-HPV-101: Preliminary 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 (ESMO-IO 2021) - P1 | "Legal entity responsible for the study SQZ Biotechnologies. Funding SQZ Biotechnologies."

Clinical • IO biomarker • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • CD8 • PD-L1

SQZ Biotechnologies Reports Third Quarter 2022 Financial Results and Recent Portfolio Updates (Businesswire) - "Third Quarter 2022 and Recent Portfolio Updates - SQZ® Antigen Presenting Cell ('APC') Platform in Oncology: (i) Continued enrollment of high dose monotherapy and combination with checkpoint inhibitors in the Phase 1/2 (SQZ-PBMC-HPV-101) trial; (ii) Anticipate additional monotherapy data in the highest-dose cohort and initial, interim data for patients in combination with checkpoint inhibitors."

Trial status • Oncology • Solid Tumor

SQZ Biotechnologies Receives FDA Fast Track Designation for its Lead Cell Therapy Candidate for the Treatment of HPV16+ Tumors (Businesswire) - "SQZ Biotechnologies...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the company’s lead cell therapy candidate, SQZ-PBMC-HPV, for the treatment of HPV16+ advanced or metastatic solid tumors."

Fast track designation • Oncology • Solid Tumor

[VIRTUAL] Initial results of a first-in-human, dose escalation study of a cell-based vaccine in HLA A*02+ patients (pts) with recurrent, locally advanced or metastatic HPV16+ solid tumors: SQZ-PBMC-HPV-101. (ASCO 2021) - P1 | "These antigen presenting cells (APC) were matured with CpG7909 and were not genetically modified . SQZ-PBMC-HPV-101 demonstrated clinical feasibility of the Cell Squeeze technology and favorable tolerability of engineered APCs . The study allows for the characterization of the immunogenicity of engineered APCs in humans . Preliminary results warrant the testing in combination with CPI ."

Clinical • P1 data • Inflammation • Oncology • Solid Tumor • CD8

SQZ Biotechnologies Announces Lead Cell Therapy Candidate Induced Radiographic, Symptomatic and Immune Response as Monotherapy in Post-Checkpoint HPV+ Solid Tumor Patient (Businesswire) - P1/2, N=200; NCT04084951; Sponsor: SQZ Biotechnologies; "SQZ Biotechnologies Company...presented interim results from the highest-dose cohort of its ongoing Phase 1/2 clinical trial of lead Antigen Presenting Cell (APC) therapy candidate targeting Human Papillomavirus positive (HPV16+) solid tumors at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress. Of the five patients in this cohort evaluable for efficacy, one checkpoint refractory head-and-neck cancer patient showed a radiographic response and symptomatic improvement. The target lesion demonstrated a complete response at both radiographic assessments. At the most recent assessment, the major oropharyngeal lesion demonstrated continued improvement upon physical examination; however, a new dermal lesion was detected. The investigational therapy was well-tolerated, and no dose-limiting toxicities were observed as of October 8, 2021."

P1/2 data • Oncology • Solid Tumor

SQZ Biotechnologies Lead Cell Therapy Candidate Generated Monotherapy Clinical Response Correlated with Substantial CD8 T Cell Tumor Infiltration in HPV+ Solid Tumor at Highest Dose (Businesswire) - P1/2, N=200; NCT04084951; Sponsor: SQZ Biotechnologies; "In an abstract published today by the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress, taking place December 8-11, the company reported that a highly treatment experienced patient in the highest-dose cohort demonstrated a radiographic response in conjunction with substantial increases in CD8 T cell tumor infiltration and PD-L1 expression – both markers of tumor inflammation...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."

P1/2 data • Oncology • Solid Tumor

SQZ Biotechnologies Announces Independent DSMB Recommendation to Advance Lead Cell Therapy Candidate Into Combination With Checkpoint Inhibitors (Businesswire) - "Abstract Title: SQZ-PBMC-HPV-101: Preliminary 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. Lead Author: Jong Chul Park..."

Oncology • Solid Tumor

SQZ Biotechnologies Announces Independent DSMB Recommendation to Advance Lead Cell Therapy Candidate Into Combination With Checkpoint Inhibitors (Businesswire) - "SQZ Biotechnologies...announced that the independent Data and Safety Monitoring Board (DSMB) for the Phase 1/2 clinical trial SQZ-PBMC-HPV-101 has recommended that the trial advance into the combination stage with checkpoint inhibitors...Data from the highest dose monotherapy cohort has been accepted for oral presentation at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress being held December 8-11, 2021...The combination stage of the trial is now open for enrollment and will include checkpoint inhibitors targeting the PD-(L)1 and CTLA-4 pathways."

DSMB • P1/2 data • Oncology • Solid Tumor

[VIRTUAL] A Phase 1, Dose Escalation and Dose Expansion Study of SQZ PBMC HPV as Monotherapy and in Combination with Atezolizumab in HLA-A*02+ Patients with HPV16+ Recurrent, or Metastatic Solid Tumors. (SITC 2020) - P1 | "No formal statistical hypothesis testing will be performed. Results N/A Conclusions N/A"

Clinical • Combination therapy • Monotherapy • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • CD8 • IFNG

SQZ Biotechnologies Initial First-In-Human Data Demonstrates Investigational Cell Therapy is Safe and Can Stimulate Immune Responses in Certain Patients with Advanced or Metastatic HPV16+ Tumors (Businesswire) - P1, N=200; NCT04084951; Sponsor: SQZ Biotechnologies; "SQZ Biotechnologies...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....A primary outcome measure in the monotherapy dose escalation phase of the trial is safety and tolerability...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)."

P1 data • Oncology • Solid Tumor

SQZ Biotechnologies to Present First Clinical Data at the American Society of Clinical Oncology Annual Meeting from Ongoing Phase 1 Study in Patients with Advanced or Metastatic HPV+ Tumors (Businesswire) - P1, N=200; NCT04084951; Sponsor: SQZ Biotechnologies; "SQZ Biotechnologies Company...will present safety and tolerability, manufacturing, and antitumor activity data from its ongoing Phase 1 clinical trial of SQZ-PBMC-HPV-101 in patients with advanced or metastatic Human Papillomavirus Positive tumors at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 4-8...'SQZ-PBMC-HPV-101 has been well-tolerated at all tested dose levels and demonstrated signals of increased immune activity. Importantly, we are also presenting evidence that we can efficiently and reproducibly manufacture our investigational therapy at scale, potentially making it more accessible to patients in need'."

Commercial • P1 data • Oncology • Solid Tumor

SQZ Biotechnologies to Present New Data on Rapid Cell Therapy Manufacturing Capabilities and Advantages in Cell Performance at ASGCT 2021 (Businesswire) - "SQZ Biotechnologies...announced today that it will present new data on the company’s scaled cGMP cell therapy manufacturing program at the 2021 American Society for Gene and Cell Therapy Virtual Annual Meeting (ASGCT) from May 11-14....The company is delivering its first investigational drug (SQZ-PBMC-HPV) utilizing this core technology for its Phase 1 clinical trial in patients with Human Papillomavirus positive (HPV+) tumors."

P1 data • Oncology • Solid Tumor