SQZ-eAPC-HPV / STEMCELL Technologies - LARVOL DELTA

COMMANDER-001: Study of SQZ-eAPC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=20 | Terminated | Sponsor: SQZ Biotechnologies | N=60 ➔ 20 | Trial completion date: Mar 2024 ➔ Nov 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Mar 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

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

COMMANDER-001: 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 (SITC 2023) - P1/2 | "Recommended phase 2 dose is expected to be declared in 2023. The presentation will include safety, preliminary efficacy, and pharmacokinetic/pharmacodynamic data from a cut-off proximal to presentation."

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

SQZ Biotechnologies Reports Data for Clinical Programs at the Society for Immunotherapy of Cancer Annual Meeting (Businesswire) - P1/2 | N=60 | NCT05357898 | 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# 692:...Completed enrollment for highest-dose cohort of monotherapy dose escalation trial. Observed BOR of Stable Disease in 40 Percent (8 of 20) of Treated Patients. SQZ-eAPC-HPV monotherapy is considered generally safe and well-tolerated at all dose levels."

Enrollment status • P1/2 data • Solid Tumor

COMMANDER-001: Study of SQZ-eAPC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=60 | Active, not recruiting | Sponsor: SQZ Biotechnologies | Recruiting ➔ Active, not recruiting

Checkpoint inhibition • Combination therapy • Enrollment closed • Metastases • Monotherapy • Oncology • Solid Tumor

SQZ Biotechnologies Reports Second Quarter 2023 Financial Results and Recent Portfolio Updates (Businesswire) - "SQZ® Enhanced Antigen Presenting Cell ('eAPC') Platform in Oncology: Completed enrollment for highest-dose cohort of monotherapy dose escalation trial. On track to report interim clinical data for the middle- and highest-dose monotherapy cohorts in the third quarter of 2023."

P1/2 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

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 Biotechnologies Receives FDA Fast Track Designation for its eAPC Therapeutic Candidate for Treatment of HPV16+ Tumors and Presents Clinical Data for Multiple Programs at the European Society for Medical Oncology Immuno-Oncology Congress (Businesswire) - P1/2 | N=60 | COMMANDER-001 (NCT05357898) | Sponsor: SQZ Biotechnologies | "SQZ Biotechnologies Company...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the company’s Enhanced Antigen Presenting Cell (eAPC) candidate for the treatment of HPV16+ advanced or metastatic solid tumors....The company also presented clinical data from its ongoing Antigen Presenting Cells (APC) and eAPC clinical trials at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress. Data also demonstrated that its APC and eAPC therapeutic candidates were well-tolerated among patients treated in its trials. Manufacturing of the cell product took less than 24 hours, and the median viability of all lots, in both clinical trials, was greater than 90 percent."

Fast track designation • P1/2 data • 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) - "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

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 Biotechnologies Presents Cell Squeeze Manufacturing Platform, Linked Antigen mRNA Preclinical Research, and COMMANDER-001 Phase 1/2 Clinical Trial in Progress Poster at Society for Immunotherapy of Cancer Annual Meeting (Businesswire) - "-SQZ Biotechnologies...will present preclinical research demonstrating the potential of its Cell Squeeze® technology to multiplex engineer a diverse set of cell types, including hematopoietic stem cells (HSCs) and induced pluripotent stem cells (iPSCs), to potentially support the creation of new therapeutic candidates....The company will also present a COMMANDER-001 Phase 1/2 Trial in Progress poster demonstrating how its Enhanced Antigen Presenting Cell (eAPC) therapeutic candidate is designed to leverage the delivery of five mRNAs encoding for proteins stimulating the key T cell activation signals required to generate an immune response against tumors, including membrane-bound IL-2 and IL-12. By presenting all three canonical signals, the eAPC approach can potentially amplify the T cell response."

P1/2 data • Preclinical • Oncology • Solid Tumor

SQZ Biotechnologies Reports Third Quarter 2022 Financial Results and Recent Portfolio Updates (Businesswire) - "Continued enrollment for the monotherapy stage of the COMMANDER-001 Phase 1/2 (SQZ-eAPC-HPV) trial. Anticipate initial cohort 1 data by the end of 2022."

P1/2 data • Oncology • Solid Tumor

Study of SQZ-eAPC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: SQZ Biotechnologies

Checkpoint inhibition • Combination therapy • Monotherapy • New P1/2 trial • Immune Modulation • Inflammation • Oncology • Solid Tumor

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

SQZ Biotechnologies Announces FDA Clearance of Investigational New Drug (IND) Application for SQZ-eAPC-HPV, a Novel mRNA-based Cell Therapy for the Treatment of HPV16 Positive Solid Tumors (Businesswire) - "SQZ Biotechnologies Company...announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for SQZ-eAPC-HPV, authorizing the company to proceed with initiating a Phase 1/2 clinical trial of the novel cell therapy candidate. The company plans to initiate its COMMANDER-001 Phase 1/2 clinical trial of SQZ-eAPC-HPV in patients who have HPV16+ solid tumors, including head and neck, cervical, and anal cancers, and have progressed following standard therapies."

IND • Anal Carcinoma • Cervical Cancer • Genito-urinary Cancer • Head and Neck Cancer • Solid Tumor