Genocea Biosciences Inc · OTC:GNCAQ
Genocea Biosciences — 13th Annual Bioprocessing Summit 2021
29 slides from Genocea Biosciences's conference presentation, Aug 19, 2021
Slide 1: GEN-011 PLANET Process: A Robust and Rapidly Scalable Manufacturing Process
GEN-011 PLANET Process: A Robust and Rapidly Scalable Manufacturing Process to Generate Neoantigen- targeted Peripheral T cells (NPTs) 13th Annual Bioprocessing Summit 16 – 19 August 2021 Manish Jain VP, Pharm Sci & Manufacturing
Slide 2: Disclaimer
Disclaimer This presentation contains “forward-looking” statements that are within the meaning of federal securities laws and are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include information concerning our poss
Slide 3: Genocea Biosciences History & Background
Genocea Biosciences History & Background • Located at Cambridge Discovery Park, 100 Acorn Park Drive, Cambridge, MA, USA • Founded in 2006 • By Dr. Darren Higgins, Dr. David A. Sinclair • Public Company: GNCA • IPO, Feb 2014 • ~70 employees • Started as a vaccine company • Now a fully integrated Imm
Slide 4: Genocea at a glance
Genocea at a glance Differentiated Immunotherapies Through Precision Antigen Selection GEN-009 GEN-011 Investigational Personalized Investigational neoantigen immune neoantigen vaccine response profiling cell therapy 4
Slide 5: Genocea focuses on neoantigen immunotherapies for solid tumors
Genocea focuses on neoantigen immunotherapies for solid tumors Pipeline 5
Slide 6: The Trial: a Phase 1/2 study of GEN-011 in patients with refractory solid tumors
Trial Objectives The Trial: a Phase 1/2 study of GEN-011 in patients with refractory solid tumors Targeted Indications Cohort A Trial Objectives Melanoma, NSCLC, SCLC, Multiple low dose • Safety SCCHN, UC, RCC, SqCC skin, (up to12 patients) • Clinical activity SqCCAC • No lymphodepletion • ORR Tumor
Slide 7: Key personalized therapy manufacturing challenges
Key personalized therapy manufacturing challenges Can we identify the right tumor neoantigens? Can we reliably and successfully manufacture each patient’s therapy? Can we scale capacity quickly to serve clinical and commercial demands? Can we deliver commercially attractive COGM and manufacturing cy
Slide 8: Neoantigen selection with ATLAS
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Slide 9: ATLAS: high throughput platform harnessing the immune system for true antigen selection
ATLASTM : high throughput platform harnessing the immune system for true antigen selection Antigen: T cells secrete Transfection of bacterial vectors inflammatory cytokines with plasmids expressing every candidate neoantigen Inhibigen: T cells inhibit cytokine secretion 9
Slide 10: Identification and exclusion of Inhibigens is an important consideration
Identification and exclusion of InhibigensTM is an important consideration for cancer immunotherapies 1,600 Adjuvant only 1,000 Adjuvant only 1,400 Protective vaccine Tumor volume (mm3) Tumor volume (mm3) 800 Inhibigens + Adjuvant 1,200 Protective vaccine + Inhibigen 1,000 600 800 400 600 400 200 20
Slide 11: GEN-011 Neoantigen T cell Therapy
GEN-011 Neoantigen T cell Therapy 11
Slide 12: GEN-011 is designed to overcome limitations of 1st generation solid tumor therapies
GEN-011 is designed to overcome limitations of 1st generation solid tumor therapies Potential GEN-011 Features GEN-011 TIL TCR-T Advantages Targets up to 30 neoantigens to limit tumor escape Avoids Inhibigens that may be detrimental to clinical response Greater efficacy Includes CD4+ and CD8+ neoant
Slide 13: GEN-011 – a new category of neoantigen T cell therapy: NPTs
GEN-011 – studying a new category of neoantigen T cell therapy: ATLAS™-powered neoantigen-targeted peripheral T cells (NPTs) Peripheral blood (leukopak) GEN-011 NPTs Up to 30 neoantigens Neoantigen-specific cell expansion in fully closed single-use vessels Autologous, non-engineered 13
Slide 14: Key cell therapy manufacturing challenges and opportunities
Key cell therapy manufacturing challenges and opportunities Key challenges GEN-011 potential opportunities Can we identify the right tumor • ATLAS enables us to identify the right neoantigens that drive powerful anti- neoantigens? tumor responses Can we reliably and successfully • Reduced patient ma
Slide 15: Manufacturing process design considerations
Manufacturing process design considerations Challenges Strategies • Manufacturing process design robustness to • Develop design boundaries to encompass support patient cell material variability expected variability in patient cell counts and phenotype • Access to representative material for developm
Slide 16: Process design considerations
Process design considerations MDDC Preparation Rapid Expansion (REP) • Professional APCs • Activator • Cytokines/media Antigen Specific Expansion (ASE) • Vessel for expansion • Vessel for expansion • 2-step • Starting Cell # • APCs (maturation, ratio) • T cells (co-culture/separate) • Neoantigens (p
Slide 17: Manufacturing process design Case Study 1: APCs
Manufacturing process design Case Study 1: APCs • Do we need professional APCs for optimal expansion? 10 • Assessed the requirement for monocyte-derived dendritic cells 8 (MDDC) to drive antigen-specific T cell expansion Fold expansion 6 • T cell cultures containing MDDCs exhibited most significant
Slide 18: Manufacturing process design Case Study 2: T cells during ASE
Manufacturing process design Case Study 2: T cells during ASE • Should CD4+ and CD8+ T cells be co-cultured or cultured separately? 3.5 • Assessed the impact of CD4+ or CD8+ T cell co-culture on antigen-specific T Total CD4 CD8 cell yield 3 • Co-culture of CD4+ or CD8+ T cells does 2.5 not negativel
Slide 19: Manufacturing process design Case Study 3: T cells to APC ratio
Manufacturing process design Case Study 3: T cells to APC ratio • How critical is the ratio of T cells to APC for antigen specific expansion? Fold Expansion T cells to APC ratio needs to be optimized to achieve higher fold expansion Ratio 1 Ratio 2 Ratio 3 Genocea Data on File 19
Slide 20: Robust and rapidly scalable manufacturing process with single-use technology
Robust and rapidly scalable manufacturing process with single-use technology Peripheral blood Phenotypic cell sort (leukopak) GEN-011 Process Peripheral blood ensures starting cell material T cells rapidly obtained from every patient, dramatically expanding accessible patient population Up to 30 ver
Slide 21: GEN-011 delivers billions of NPTs
GEN-011 delivers billions of NPTs Contains an average of Pure T cell drug product 3.3 billion T cells 10 10 Non-T cells 1% T cell number 10 9 CD3+ T cells 99% CD3+ T cells Non-T cells 10 8 Pre-expansion cells GEN-011 Mean across development runs with cancer patient and healthy donor material 21
Slide 22: GEN-011: CD4+ and CD8+ memory T cells for anti-tumor efficacy
GEN-011: CD4+ and CD8+ memory T cells for anti-tumor efficacy, persistence and proliferation Both T cell subsets are Desired T cell memory phenotype represented 100 % Frequency 75 CD8+ 38% 50 + CD4 62% 25 0 Naive Terminal Memory memory (Cm+Em) (TEMRA) Data represent mean across cancer patients and h
Slide 23: Majority of GEN-011 NPTs are specific for ATLAS-identified neoantigens
Majority of GEN-011 NPTs are specific for ATLAS- identified neoantigens Relevant Antigens Irrelevant Antigens Mitogen Activation Marker 2 Activation Marker1 Proportion of positive 96% 6% control (Mitogen) 23
Slide 24: GEN-011 NPTs are highly functional and cytotoxic
GEN-011 NPTs are highly functional and cytotoxic An average of 16,000 cells per T cells are potently million are secreting cytokines in cytolytic against target response to stimulation neoantigens CD8 100 + Specific Neoantigens CD4 80 Unpulsed Control + % Cytotoxicity 60 Negative control 40 20 0 16:
Slide 25: GEN-011 NPTs exhibit greater neoantigen activity and potency compared to TIL
GEN-011 NPTs exhibit greater neoantigen activity and potency compared to TIL T cells are activated appropriately Neoantigen-specific T cells upon neoantigen stimulation secrete abundant IFNg 80 CD8 25000 + % Activation marker upregulation 20000 60 IFNg pg/mL 15000 40 10000 20 5000 0 0 1 GEN-011 TIL
Slide 26: GEN-011 NPTs have an unparalleled breadth of neoantigen coverage
GEN-011 NPTs have an unparalleled breadth of neoantigen coverage GEN-011 targets up to 30 neoantigens 89% Recent selected TIL data show successful amplification to only 4% of antigens included in the process1 Recent conventional TIL data show responses to an average of 6% of the predicted neoantigen
Slide 27: Supply chain considerations
Supply chain considerations Challenges Strategies • Logistics for patient cell material and samples • Bulletproof chain-of-custody and identify committed supply chain partners and carriers • Sourcing of key reagents, raw materials and components • Define requirements with FDA and work proactively wi
Slide 28: Summary
Summary • GEN-011 is an autologous, neoantigen-targeted peripheral T cell (NPT) therapy candidate with potential advantages over TIL and TCR-T approaches • GEN-011 is produced by the PLANET process which is a robust and rapidly scalable manufacturing process • GEN-011 NPTs target up to 30 relevant n
Slide 29: Acknowledgments
Acknowledgments The patients and their families who consented to participate in our pre-clinical studies and clinical trial Our Clinical Trial Partners Development and Manufacturing partners Our Scientific Collaborators Our Investors The Incredible Team at 29
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