SQZ-AAC-HPV / STEMCELL Technologies - LARVOL DELTA

ENVOY-001: Study of SQZ-AAC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=5 | Terminated | Sponsor: SQZ Biotechnologies | N=72 ➔ 5 | Trial completion date: Apr 2024 ➔ Nov 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Apr 2024 ➔ Nov 2023; Corporate Decision

Checkpoint inhibition • Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Anal Carcinoma • Oncology • Solid Tumor • 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-AAC-HPV-101: initial data from a phase I dose escalation/expansion study of SQZ-AAC-HPV, a red blood cell-based therapeutic cancer vaccine for HPV16+ solid tumors (SITC 2023) - P1 | "Conclusions SQZ-AAC-HPV treatment was generally well-tolerated and initial efficacy data are encouraging. This presentation may include safety, additional efficacy, and biomarker data from a cut-off proximal to the presentation."

IO biomarker • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD8 • HLA-A

SQZ Biotechnologies Reports Data for Clinical Programs at the Society for Immunotherapy of Cancer Annual Meeting (Businesswire) - P1 | N=72 | NCT04892043 | 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# 693:...Of the five patients treated, one patient experienced a confirmed complete response and two patients experienced stable disease. SQZ-AAC-HPV monotherapy is considered generally safe and well-tolerated at all dose levels."

P1 data • Solid Tumor

SQZ Biotechnologies Reports Second Quarter 2023 Financial Results and Recent Portfolio Updates (Businesswire) - P1 | N=72 | NCT04892043 | Sponsor: SQZ Biotechnologies | "A confirmed complete response (CR), by RECIST 1.1 criteria, was observed in the first patient in the lowest-dose cohort of the SQZ-AAC-HPV-101 Phase 1 clinical trial for HPV16+ solid tumors. Best overall response of stable disease for two additional patients in lowest-dose cohort. Currently enrolling patients for the highest-dose cohort. Interim clinical data is anticipated in the fourth quarter of 2023."

P1 data • Trial status • Oncology • Solid Tumor

SQZ Biotechnologies Provides Update on Collaboration with Roche (Businesswire) - "SQZ Biotechnologies Company...announced that Roche has determined that it will not exercise its option for HPV 16 positive solid tumors under the SQZ-APC-HPV program. SQZ Biotechnologies will regain full clinical development and future commercialization rights for its programs targeting HPV 16 positive tumors. The Company intends to explore potential strategic partnerships to support the advancement of its oncology programs and platforms....SQZ^® enhanced antigen presenting cells (eAPC) candidate has completed enrollment of the highest dose monotherapy cohort in a Phase 1/2 trial, and initial data are anticipated in the second half of 2023....The high dose monotherapy cohort in this trial is currently enrolling, and initial data are anticipated in the fourth quarter of 2023."

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

First Patient With HPV16+ Solid Tumors in SQZ-AAC-HPV Trial Achieves CR (CGTLive) - '"Although early in this trial, we have observed good tolerability among the patients. The confirmed complete response observed in this patient demonstrates the potential of the investigational therapy's intended immunotherapy mechanism,' Richard T. Maziarz, MD..."

Media quote

SQZ Biotechnologies Announces Confirmed Complete Response in HPV16+ Solid Tumor Patient in the Lowest-Dose Cohort of the SQZ-AAC-HPV-101 Clinical Trial (Businesswire) - 'Although early in this trial, we have observed good tolerability among the patients. The confirmed complete response observed in this patient demonstrates the potential of the investigational therapy's intended immunotherapy mechanism,' said Richard T. Maziarz, M.D..."

Media quote

SQZ Biotechnologies Announces Confirmed Complete Response in HPV16+ Solid Tumor Patient in the Lowest-Dose Cohort of the SQZ-AAC-HPV-101 Clinical Trial (Businesswire) - "SQZ Biotechnologies Company...announced that, according to RECIST 1.1 criteria, a confirmed complete response was observed in the first patient in the lowest-dose cohort of the Phase 1 SQZ-AAC-HPV-101 clinical trial. The company has decided to continue to enroll patients in the SQZ-AAC-HPV-101 clinical trial. The second and third patients have also been enrolled in the trial. The company has completed the dose-limiting toxicity period for the lowest-dose cohort. The Study Safety Committee has completed their review and recommends that the company enroll patients in the highest-dose cohort. The company anticipates initial clinical data from the highest-dose cohort by the fourth quarter of 2023."

P1 data • Trial status • Oncology • Solid Tumor

ENVOY-001: Study of SQZ-AAC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: SQZ Biotechnologies | Active, not recruiting ➔ Recruiting

Checkpoint inhibition • Combination therapy • Enrollment open • Metastases • Monotherapy • Immune Modulation • Inflammation • Oncology • Solid Tumor • HLA-A

ENVOY-001: Study of SQZ-AAC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=72 | Active, not recruiting | Sponsor: SQZ Biotechnologies | Recruiting ➔ Active, not recruiting

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

SQZ Biotechnologies Announces Strategic Prioritization of SQZ Enhanced Antigen Presenting Cells Program; Armon Sharei to Step Down as Chief Executive Officer (Businesswire) - "SQZ Biotechnologies...announced the strategic prioritization of its clinical portfolio to concentrate on the development of its second-generation enhanced Antigen Presenting Cells (eAPC) cell therapy program, focused on HPV16 positive recurrent, locally advanced, or metastatic solid tumors....The company will transition its first-generation Antigen Presenting Cells (APC) therapy to its second-generation enhanced Antigen Presenting Cells therapy and has initiated switching select APC sites to the eAPC clinical trial....Additionally, the company will pause its APC, Activating Antigen Carrier (AAC) and Tolerizing Antigen Carrier (TAC) programs. This portfolio prioritization allows the company to deliver data readouts for the SQZ® eAPC program’s highest-dose monotherapy cohort, which the company anticipates in mid-2023. The company will continue to explore partnerships and collaborations for its earlier stage assets and programs, including TAC..."

Commercial • Licensing / partnership • P1/2 data • Oncology • Solid Tumor

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. (AACR 2022) - P1 | "Murine AAC-HPV treatment was also shown to be synergistic with cisplatin combinations...The second part of the study will assess the safety of SQZ-AAC-HPV when combined with nivolumab 360 mg q3w and/or ipilimumab 3 mg/kg q3w x4 or 1 mg/kg q6w when combined with nivolumab... N/A"

Checkpoint inhibition • Clinical • Combination therapy • IO biomarker • Monotherapy • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • CD8 • HLA-A • IFNG

SQZ Biotechnologies Presents New eAPC Preclinical Data Demonstrating That Multiplexed mRNA Engineering of Immune Cells Increases Killer T Cell Activity In Vivo (Businesswire) - "SQZ Biotechnologies...shared enhanced antigen presenting cell (eAPC) preclinical data demonstrating that delivery of multiple mRNAs encoding for disease-specific antigens together with immune stimulators (CD86 costimulatory factor and membrane bound IL-2 and IL-12 cytokines) had a synergistic effect that substantially increased killer T cells in humanized mouse models. The preclinical data, presented at the American Association for Cancer Research (AACR) 2022 Annual Meeting, showed this in vivo enhancement can be seen with a variety of disease antigen mRNAs across a range of HLA types....Beyond eAPC preclinical advances, a SQZ AAC phase 1/2 clinical trial in progress presentation to be delivered on April 13."

Preclinical • Trial status • Oncology • Solid Tumor

SQZ Biotechnologies Reports Full Year 2021 Financial Results and Recent Portfolio Updates (Businesswire) - "SQZ® APC, eAPC, and AAC Clinical Data for HPV+ Solid Tumors Anticipated Second Half 2022"

Clinical data • Oncology • Solid Tumor

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 (Businesswire) - "SQZ Biotechnologies Company... 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....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."

Clinical protocol • Preclinical • Oncology • Solid Tumor

Study of SQZ-AAC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1; N=72; Recruiting; Sponsor: SQZ Biotechnologies; Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Clinical • Combination therapy • Enrollment open • Monotherapy • Immune Modulation • Inflammation • Oncology • Solid Tumor • HLA-A

Study of SQZ-AAC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1; N=72; Not yet recruiting; Sponsor: SQZ Biotechnologies

Checkpoint inhibition • Clinical • Combination therapy • Monotherapy • New P1 trial • Immune Modulation • Inflammation • Oncology • Solid Tumor