Sqz Biotechnologies Company · OTC:SQZB
Sqz Biotechnologies — Corporate Update (December 2021)
31 slides from Sqz Biotechnologies's corporate update, Dec 9, 2021
Slide 1: SQZ-PBMC-HPV-101 Clinical Program Updates at ESMO Immuno-Oncology Congress 2021
SQZ-PBMC-HPV-101 Clinical Program Updates at ESMO Immuno-Oncology Congress 2021 Conference Call and Webcast December 9th, 2021
Slide 2: Forward Looking Statements and Legal Disclaimers
Forward Looking Statements and Legal Disclaimers This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forwa
Slide 3: Welcome to the SQZ Conference Call and Webcast
Welcome to the SQZ Conference Call and Webcast SQZ-PBMC-HPV-101 Clinical Program Updates at ESMO Immuno-Oncology Congress 2021
Slide 4: Agenda
Agenda Welcome Micah Zajic, Chief Business Officer SQZ Oncology Portfolio Armon Sharei, PhD, Chief Executive Officer and Founder SQZ-PBMC-HPV-101 Phase 1/2 Trial Highest-Dose Cohort Findings Jong Chul Park, MD, Massachusetts General Hospital Monotherapy Summary & Clinical Development Ricardo Zwirtes
Slide 5: Agenda
Agenda Welcome Micah Zajic, Chief Business Officer SQZ Oncology Portfolio Armon Sharei, PhD, Chief Executive Officer and Founder SQZ-PBMC-HPV-101 Phase 1/2 Trial Highest-Dose Cohort Findings Jong Chul Park, MD, Massachusetts General Hospital Monotherapy Summary & Clinical Development Ricardo Zwirtes
Slide 6: An exciting milestone for the SQZ APC approach in solid tumors
An exciting milestone for the SQZTM APC approach in solid tumors Biomarkers support expected APC mechanism Clinical and immune response in heavily treated patient Motivates program expansion with systemic combos and eAPCs Manufacturing data highlights rapid production Additional clinical data readou
Slide 7: SQZ Technology Can Underpin a New Generation of Cell Therapies
SQZ™ Technology Can Underpin a New Generation of Cell Therapies Universe of Possible SQZ™ Cell Therapies Hematology Oncology Solid Tumors Autoimmune Infectious Disease Regenerative Medicine SQZ™ Technology Potentially enables engineering of many previously challenging biologies Robust process allows
Slide 8: Engineering Antigen Presentation in a Natural Way to Direct the Immune System
Engineering Antigen Presentation in a Natural Way to Direct the Immune System 1. Antigen (What to target) Antigen presenting cells (APCs) show peptide antigen on MHC-I and MHC-II that T cells look at using their T cell receptors (TCR) 2. Context (Activation vs. Tolerance) Once a T cell’s TCR is enga
Slide 9: Diverse Pipeline: Synergistic in Execution yet Independent in Mechanism
Diverse Pipeline: Synergistic in Execution yet Independent in Mechanism 9 PLATFORM CELL SOURCE / CARGO INDICATION PRE-CLINICAL PHASE 1/2 ONCOLOGY SQZ APCs PBMC + Peptide H&N, Cervical, Anal Other Solid Tumors SQZ AACs RBC + Peptide + Adjuvant H&N, Cervical, Anal KRAS mut Solid Tumors Other Solid Tum
Slide 10: The Therapeutic Potential and Historical Challenges of Driving CD8 Tumor Responses
The Therapeutic Potential and Historical Challenges of Driving CD8 Tumor Responses Responders Progressors …However, there has been limited success in the vaccine field to date. The only approved cell-based cancer vaccine did not induce T cell infiltration into tumor centers in a Phase 2 neoadjuvant
Slide 11: SQZ APCs are Designed to Overcome Historical Challenge of CD8 T cell Activation
SQZTM APCs are Designed to Overcome Historical Challenge of CD8 T cell Activation Squeezed Antigen SQZTM APC vs. Cross-Presentation Potency Data: Cell Squeeze® mediated cytosolic delivery demonstrated 1000x More Efficient CD8 Activation versus cross-presentation in dendritic cells % CD8 T Cell Activ
Slide 12: SQZ APC Approach to Direct Endogenous T Cells Against Solid Tumors
SQZTM APC Approach to Direct Endogenous T Cells Against Solid Tumors Lead APC Candidate: SQZ-PBMC-HPV-101 Peripheral blood mononuclear cells (PBMCs) engineered with HPV16 E6 and E7 synthetic long peptide cargo
Slide 13: Agenda
Agenda Welcome Micah Zajic, Chief Business Officer SQZ Oncology Portfolio Armon Sharei, PhD, Chief Executive Officer and Founder SQZ-PBMC-HPV-101 Phase 1/2 Trial Highest-Dose Cohort Findings in Advanced Solid Tumors Jong Chul Park, MD, Massachusetts General Hospital Monotherapy Summary & Clinical De
Slide 14: SQZ-PBMC-HPV-101 Evaluated in Advanced, Heavily Pretreated Patients
SQZ-PBMC-HPV-101 Evaluated in Advanced, Heavily Pretreated Patients Confirmed HPV16+ recurrent or metastatic cancers, progressed after at least 1 available standard therapy Heavily pretreated patient population at study entry, with median 4 prior lines of therapy across cohorts (n=18) All patients i
Slide 15: SQZ-PBMC-HPV-101 was Well-Tolerated At All Dose Levels
SQZ-PBMC-HPV-101 was Well-Tolerated At All Dose Levels; No Related Grade ≥3 AEs at Highest Dose 1Grade 3 anemia. 2Grade 2 cytokine release syndrome (CRS). 3AEs of medical concern related to SQZ-PBMC-HPV mechanism of action (CRS, IRR). M=millions, SP=single-prime, DP=double-prime, AE=adverse events S
Slide 16: Potential Proof-of-Concept for SQZ-PBMC-HPV-101 in anti-PD-1 Refractory Patient
Potential Proof-of-Concept for SQZ-PBMC-HPV-101 in anti-PD-1 Refractory Patient 52-year-old man with squamous cell carcinoma of the oropharynx. Large primary lesion with significant symptom burden Initial diagnosis 3.7 years ago, with 6 prior lines of systemic therapy including carbo/5FU/pembro and
Slide 17: Patient 17: Immune Markers in Tumor Further Demonstrate APC Mechanism At Work
Patient 17: Immune Markers in Tumor Further Demonstrate APC Mechanism At Work Pre-treat Post-treat CD8 TIL Increase CD8 PanCK CD8 Cells/mm2 HLA-I Increase HLA-I H-Score (0-300) PD-L1 Increase PD-L1 % of PD-L1+ Tumor Cells Pre-treat Post-treat Pre-treat Post-treat Case Study: Patient 17 Influx of CD8
Slide 18: Patient 17: Evidence of HPV Antigen-Specific Tumor Targeting
Patient 17: Evidence of HPV Antigen-Specific Tumor Targeting Proportion of HPV16 E6 High-Expressing Cells Meaningfully Decreases After APC Treatment RNA ISH Assay Proportion of HPV16 E7 High-Expressing Cells Meaningfully Decreases After APC Treatment RNA ISH Assay Substantial reduction in frequency
Slide 19: Agenda
Agenda Welcome Micah Zajic, Chief Business Officer SQZ Oncology Portfolio Armon Sharei, PhD, Chief Executive Officer and Founder SQZ-PBMC-HPV-101 Phase 1/2 Trial Highest-Dose Cohort Findings Jong Chul Park, MD, Massachusetts General Hospital Monotherapy Summary & Clinical Development Ricardo Zwirtes
Slide 20: Summary: Lead APC Candidate Induced Immune, Clinical Responses in Certain Post-CPI Patients
Target Lesion Response SD SD CR Survival (days)* 492+ 467+ 105+ RMH 1 0 1 Pre Post Pre Post Pre Post Patient 2 7 17 Dose 0.5 e6/kg 2.5 e6/kg 5.0 e6/kg (DP) Summary: Lead APC Candidate Induced Immune, Clinical Responses in Certain Post-CPI Patients 2x 6x 8x Safety and Tolerability Favorable safety an
Slide 21: SQZ-PBMC-HPV-101 Clinical Plan and Milestones
SQZ-PBMC-HPV-101 Clinical Plan and Milestones SQZ-PBMC-HPV-101 at 5.0M cells/kg dose was endorsed by study DSMB to move into PD-(L)1 & CTLA-4 combination stages, with no dose escalation required in combination cohorts The highest dose cohort is still enrolling to further evaluate efficacy of SQZ-PBM
Slide 22: Encouraging Results Reinforce Broader Potential Across Indications
Encouraging Results Reinforce Broader Potential Across Indications SQZTM APCs Squeezed with KRAS G12D or G12V Elicited Functional CD8 T Cell Responses ~100,000 patients per year in U.S. have KRAS G12D and G12V mutations Spans multiple tumor types, including pancreatic, colorectal and some lung cance
Slide 23: Agenda
Agenda Welcome Micah Zajic, Chief Business Officer SQZ Oncology Portfolio Armon Sharei, PhD, Chief Executive Officer and Founder SQZ-PBMC-HPV-101 Phase 1/2 Trial Highest-Dose Cohort Findings Jong Chul Park, MD, Massachusetts General Hospital Monotherapy Summary & Clinical Development Ricardo Zwirtes
Slide 24: SQZ APCs + Systemic Combinations
SQZTM APCs + Systemic Combinations Improve T cell function in the tumor microenvironment Induce inflammation to improve tumor access Path to early line combinations with established treatments SQZTM eAPCs Integrated Combination Function Enhance T cell priming Polyclonal T cell response to expand add
Slide 25: Synergistic Combination Potential With Systemic Therapeutic Modalities
Synergistic Combination Potential With Systemic Therapeutic Modalities *Presented at SITC 2020 in SQZ Poster and Roche Oral Presentation Preclinical data* demonstrated synergistic potential of SQZTM APCs in combination with Roche PD1-IL2v I-O Combinations SQZTM APCs and cisplatin chemotherapy combin
Slide 26: Anticipated Clinical Translation of Multi-functional eAPCs
Anticipated Clinical Translation of Multi-functional eAPCs eAPC IND targeted by end of 2021 SQZTM eAPC CD86 1 3 Signals CD8 T Cell SQZ eAPC IL-2 IL-12 TCR MHC-I Five mRNAs as cargo Broader antigen repertoire in mRNA potentially increases addressable population 2-3x Addition of co-stimulatory factors
Slide 27: Agenda
Agenda Welcome Micah Zajic, Chief Business Officer SQZ Oncology Portfolio Armon Sharei, PhD, Chief Executive Officer and Founder SQZ-PBMC-HPV-101 Phase 1/2 Trial Highest-Dose Cohort Findings Jong Chul Park, MD, Massachusetts General Hospital Monotherapy Summary & Clinical Development Ricardo Zwirtes
Slide 28: Robust Autologous Cell Therapy Manufacturing in <24 Hours for Phase 1/2 Patients
Robust Autologous Cell Therapy Manufacturing in <24 Hours for Phase 1/2 Patients Current Cell Therapy Production Patient Leukapheresis Day 1 SQZ Process <24-hours Day 2 QC and Batch Release Day 2-8 Administration to Patient ~1 week Median manufacturing time was 17 hours for SQZ-PMBC-HPV-101 and allo
Slide 29: Agenda
Agenda Welcome Micah Zajic, Chief Business Officer SQZ Oncology Portfolio Armon Sharei, PhD, Chief Executive Officer and Founder SQZ-PBMC-HPV-101 Phase 1/2 Trial Highest-Dose Cohort Findings Jong Chul Park, MD, Massachusetts General Hospital Monotherapy Summary & Clinical Development Ricardo Zwirtes
Slide 30: Summary & 2022 Oncology Portfolio Outlook
Summary & 2022 Oncology Portfolio Outlook APC platform progress supports broader development for HPV+ solid tumors and expansion to new antigens Patient 17 illustrated differentiated clinical impact potential of SQZ™ APC program Increased CD8 TIL and PD-L1 expression underscores potential CPI synerg
Slide 31: Questions & Answers
Questions & Answers SQZ-PBMC-HPV-101 Clinical Program Updates at ESMO Immuno-Oncology Congress 2021
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