Aura Biosciences, Inc. · NASDAQ:AURA
Aura Biosciences — Corporate Update (October 2024)
41 slides from Aura Biosciences's corporate update, Oct 17, 2024
Slide 1: To innovate the future of cancer care to cure patients and preserve organ function
Exhibit 99.2 To innovate the future of cancer care to cure patients and preserve organ function October 17, 2024 1
Slide 2: Legal disclosure
Legal disclosure This presentation contains forward-looking statements, all of which are qualified in their entirety by this cautionary statement. Many of the forward-looking statements contained herein can be identified by the use of forward-looking words such as may , anticipate , believe , could'
Slide 3: Urologic oncology key opinion leaders participating on today's call
Urologic oncology key opinion leaders participating on today’s call Neal Shore, MD, FACS Gary Steinberg, MD, Max Kates, MD Joe Jacob, MD, MCR Carolina Urologic Johns Hopkins Syracuse University FACS Research Center RUSH University 3 3
Slide 4: Aura leadership participating on today's call
Aura leadership participating on today’s call Sabine Brookman- Elisabet de los Pinos, Jill Hopkins, MD Joseph McQuaid, MD Director, Clinical May, MD PhD Chief Medical Officer Development Urologic SVP, Therapeutic Area Founder and CEO And President of R&D Oncology Head Urologic Oncology 4 4
Slide 5: Cancer cases are predicted to increase by 77% by 2050
Cancer cases are predicted to increase by 77% by 2050 as our population ages and 1 grows Large increase in the number of Growing need for function- early-stage cancers requiring preserving, organ-sparing, treatment options with improved local therapies that can benefit-risk profile intercept the cou
Slide 6: Virus-like drug conjugates have the potential to transform early cancer treatment
Virus-like drug conjugates have the potential to transform early cancer treatment Unique tumor selectivity Tumor and mutation-agnostic Targets a key receptor molecule expressed in the >100 cell lines early stages of malignant tumor transformation >15 animal tumor models Dual MOA High potency Targete
Slide 7: AU-011 has a novel dual mechanism of action
VLPs bind to macrophages, B cells, dendritic cells and neutrophils and are capable of stimulating antigen-presenting cells through TLR-4 engagement and NFk-β production Reactive oxygen species disrupts cell membrane and organelles AU-011 has a novel dual mechanism of action Disruption of the tumor c
Slide 8: Bladder cancer: High unmet medical need for function-preserving therapies
Bladder cancer: High unmet medical need for function-preserving organ-sparing therapies most common Conventional bladder cancer treatments are suboptimal th 1 cancer worldwide 9 • Short- and long-term side effects of patients do not • Considerable impact on QoL complete a full course 84% 6 of BCG tr
Slide 9: High risk of recurrence and progression with current treatments for NMIBC
High risk of recurrence and progression with current treatments for NMIBC Low grade – low & intermediate risk High risk papillary disease High risk CIS – BCG unresponsive Progression Adjuvant therapy Adjuvant therapy Adjuvant therapy Intravesical gene therapy 42–84% (Adstiladrin®) BCG TURBT BCG TURB
Slide 10: AU-011 as a potential front-line ablative therapy in NMIBC
Treatment goals Focal treatment with direct tumor cell killing AU-011 as a potential front-line immune Stimulate broad anti-tumor T cell response ablative therapy in NMIBC Front-line early intervention for local disease AU-011 has a dual mechanism of Decreased treatment burden with favorable action
Slide 11: In-office procedure
In-office procedure Local cystoscopic AU-011 administration administration of drug Laser light with standard activation and activation may be cystoscopy needle <5 minutes <10 minutes total laser time optimized for the urology clinic <15 minutes total procedure time Local administration of AU-011 is
Slide 12: Phase 1 trial of AU-011 in bladder cancer
Phase 1 trial of AU-011 in bladder cancer Review of early data from non-light activated and light-activated NMIBC cohorts
Slide 13: Window of opportunity study design
Window of opportunity study: AU-011 administered between scheduled biopsy and standard TURBT Clinical response data up to 21 days; safety data up to 56 days Treatment phase: Feasibility and efficacy Follow-up phase: Safety Day 9 ± 1 (Cohort A) Day 1 Day 2 Day 56 ± 7 Day 14+7 (Cohort B+C) Cystoscopy
Slide 14: Phase 1 trial of AU-011 designed to evaluate safety, feasibility, and mechanism of action
Phase 1 trial of AU-011 for bladder cancer designed to evaluate safety, feasibility, and mechanism of action Single dose window of opportunity study in NMIBC all-comers Histopathological assessment completed at time of standard of care TURBT Part 1 (n=5) Part 2 (n=~10) AU-011 alone AU-011 + focal li
Slide 15: Patient population: AUA risk classification and grade at screening
Patient population: AUA risk classification and grade at screening Drug + light: Patient A2 Drug + light: Patient B1 High-risk Drug + light: Patient A4 Drug only: Patient 3 Drug + light: Patient B3 Intermediate- Drug only: Patient 4 Drug + light: Patient B2 risk Drug + light: Patient A3 Drug + light
Slide 16: Phase 1 trial of AU-011 designed to evaluate safety, feasibility, and mechanism of action
Phase 1 trial of AU-011 for bladder cancer designed to evaluate safety, feasibility, and mechanism of action Single dose window of opportunity study in NMIBC all-comers Histopathological assessment completed at time of standard of care TURBT Part 1 (n=5) Part 2 (n~10) AU-011 alone AU-011 + focal lig
Slide 17: Drug only: Treatment schedule
Drug only without light activation (n=5) TURBT Drug only: Treatment schedule Pathology Total dose: 100 µg • 50 µg into base of tumor Day 2 Day 1 • 50 µg into lamina propria • Evidence of non-invasive • Urologist performs TURBT to urothelial carcinoma include injected lesion • Sample sent to central
Slide 18: Drug only without light activation: Safety data
Drug only without light activation (n=5) Safety Data Event Grade Number of patients Adverse events (related to study drug) None None 0/5 Drug only: Adverse events (related to injection or laser procedure) Safety data 1 1/5 Hematuria • First in human in bladder – safety cohort as required by • No tre
Slide 19: Phase 1 trial of AU-011 designed to evaluate safety, feasibility, and mechanism of action
Phase 1 trial of AU-011 for bladder cancer designed to evaluate safety, feasibility, and mechanism of action Single dose window of opportunity study in NMIBC all-comers Histopathological assessment completed at time of standard of care TURBT Part 1 (n=5) Part 2 (n~10) AU-011 alone AU-011 + focal lig
Slide 20: Cohorts A–C: Single-dose drug with light activation
Cohort A–C: Single-dose drug with light activation (n=~10) TURBT Cohorts A–C: Single-dose drug with light activation Treatment schedule Pathology Cohort A: Day 9 ± 1 Cohort A: Day 1 Day 2 Day 3–7 Cohort B/C: Day 14+7 • 50 µg into base of tumor • 50 µg into lamina propria • Evidence of non-invasive •
Slide 21: Cohort A + B: Safety data
a Cohort A + B: Single-dose drug with light activation (n=7) Event Grade Number of patients Adverse events (related to study drug) Cohort A + B: Nocturia 1 1/7 Single-dose drug with Urinary urgency 1 1/7 light activation Adverse events (related to injection or laser procedure) 1 1/7 Hematuria Safety
Slide 22: Efficacy data: Ta low-grade tumors
Efficacy data: Ta low-grade 4/5 low-grade target tumors demonstrate complete response to AU-011 c d Patient A1 Patient A3 Patient A4 Patient B2 Patient C1 Single Multiple Multiple Multiple Multiple (Multiple at TURBT) Screening diagnosis Ta low-grade Ta low-grade Ta low-grade (2024) Ta low-grade Ta
Slide 23: Strong evidence of immune-mediated mechanism of action
• 100% (7/7) of target tumors showed infiltration of effector CD8+ T and CD4+ cells, as early as 7 days after laser activation Light-activated cohorts a (A + B): • 100% (7/7) of non-target tumors (in the five patients with available immune staining) showed T cell infiltration, supportive of a bladde
Slide 24: Complete clinical response confirmed with histopathologic evaluation: Patient A1
Complete clinical response visualized at time of TURBT confirmed with Patient A1 histopathologic evaluation 64-year-old Caucasian male Evidence of clinical complete response by Screening diagnosis: (2023) absence of tumor cells, as well as immune Immune • Single activation, after single dose treatme
Slide 25: Summary of pre-and-post treatment pathology: Patient A1
Summary of pre-and-post treatment pathology: Single low-grade target lesion and two non-target lesions Patient A1 64-year-old Caucasian male Pre-treatment pathology Post-treatment pathology Target lesion: Clinical complete response Screening diagnosis: (2023) Local pathology: Central pathology: • Si
Slide 26: Patient A1: focal distribution, necrosis, and positive immune staining
H&E CD3 Patient A1: AU-011 focal distribution, necrosis, and positive immune staining (target lesion) CD4 CD8 Post-treatment No central pathology read available for pre-treatment; block lost at site. Cohort A: H&E, hematoxylin and eosin.Clinicaltrials.gov identifier: NCT05483868; AU-011-102 26 Singl
Slide 27: Complete clinical response confirmed with histopathologic evaluation: Patient A3
Complete clinical response visualized at time of TURBT confirmed with Patient A3 histopathologic evaluation 72-year-old Hispanic male Screening diagnosis: (2024) • Multiple AU-011 • Ta low-grade (<3 cm) injection • No CIS Screening AUA risk classification: Intermediate Initial diagnosis: (2019) Biop
Slide 28: Summary of pre-and-post treatment pathology: Patient A3
Summary of pre-and-post treatment pathology: Single low-grade target lesion and two non-target lesions Patient A3 Pre-treatment pathology Post-treatment pathology 72-year-old Hispanic male Target lesion: Clinical complete response Screening diagnosis: (2024) Central pathology: Central pathology: • M
Slide 29: Patient A3: focal distribution, necrosis, and positive immune staining
Patient A3: AU-011 focal distribution, necrosis, and positive immune staining (target lesion) H&E CD3 CD4 CD8 Pre-treatment Post-treatment H&E, hematoxylin and eosin. Cohort A: Clinicaltrials.gov identifier: NCT05483868; AU-011-102. 29 Single-dose drug with light activation
Slide 30: Patient A3: generation of secondary lymphoid follicles
H&E: Pre-treatment CD4: Pre-treatment Patient A3: Post-treatment generation of secondary lymphoid follicles and increase in CD3, CD4, and CD8 infiltration CD4: Post-treatment H&E: Post-treatment H&E, hematoxylin and eosin. Cohort A: Clinicaltrials.gov identifier: NCT05483868; AU-011-102. 30 Single-d
Slide 31: Efficacy data: Ta high-grade tumors demonstrated immune response
Efficacy data: Ta high-grade 3/3 high-grade tumors demonstrated immune response to AU-011 Patient A2 Patient B1 Patient B3 Single Single Multiple Screening diagnosis Ta high-grade Ta high-grade Ta high-grade Screening AUA High Intermediate High risk classification AU-011 dose/ 100 µg 100 µg 100 µg d
Slide 32: Summary
Summary % aura
Slide 33: AU-011 demonstrated a favorable safety profile with robust clinical and immunological response
AU-011 demonstrated a favorable safety profile with robust clinical and immunological response in early data readout of ‘all-comers’ NMIBC patients Tumor shrinkage Favorable Rapid Immune Development and clinical safety profile activation plan response Only Grade 1 Drug-Related 100% of patients showe
Slide 34: Appendix
Appendix % aura
Slide 35: Anti-tumor immunity: Treating beyond the target
Anti-tumor immunity: Treating beyond the target Preclinical development
Slide 36: Evidence of secondary follicles supportive of local adaptive immune response
Evidence of secondary (activated) follicles in tumor stroma supportive of local adaptive immune response Where does AU-011 fit in the cancer immunity cycle and the TME sub-cycle? Photoactivation of AU-011 generates ROS, resulting in necrotic cell death of tumor cells bound by AU-011. This releases t
Slide 37: Role of CD4+ and CD8+ T-cells in TC-1 syngeneic murine tumor model
Role of CD4+ and CD8+ T-cells at time of treatment and time of tumor rechallenge in the TC-1 syngeneic murine tumor model Depletion at the time of treatment Depletion at the time of rechallenge Implant TC-1 Implant TC-1 Rechallenge with 3 3 Tumor volume: 50mm Tumor volume: 50mm tumor cells tumor cel
Slide 38: Syngeneic mouse bladder tumor model
Tumor growth Syngeneic mouse tumor bladder model • MB49 model in C57BL/6 mice 1400 Control • N = 8–10/group Robust pre-clinical anti-PD-1 1200 AU-011 Anti-PD-1 anti-PD-1 + AU-011 1000 activity in bladder • Mouse equivalent of pembrolizumab • 100 µg administered 3 times every 3 days (IP) 800 cancer b
Slide 39: Patient A1: Immunohistochemistry
Patient A1: Single-dose drug with light activation Immunohistochemistry Target lesion Non-target lesion A Non-target lesion B Stain Pre-treatment Post-treatment Pre-treatment Post-treatment Pre-treatment Post-treatment NA Absent NA Absent NA Absent AU-011 NA Present NA Absent NA Absent Necrosis NA N
Slide 40: Patient A3: Immunohistochemistry
Patient A3: Single-dose drug with light activation Immunohistochemistry Target lesion (biopsy) Target lesion (TURBT) Non-target lesion A Non-target lesion B Post- Post- Post- Post- Stain Pre-treatment Pre-treatment Pre-treatment Pre-treatment treatment treatment treatment treatment Absent Present Ab
Slide 41: Secondary (activated) lymphoid follicle: Patient A3
Secondary (activated) lymphoid follicle: Patient A3 Capable of generating tissue-specific, adaptive immune responses 72-year-old Hispanic male Screening diagnosis: (2024) • Multiple • Ta low-grade (<3 cm) • No CIS • Secondary lymphoid follicles form ectopically at sites of Screening AUA risk classif