Aura Biosciences, Inc. · NASDAQ:AURA
Aura Biosciences — AAO 2023
19 slides from Aura Biosciences's conference presentation, Nov 1, 2023
Slide 1: A Phase 2 Trial of Belzupacap Sarotalocan for Choroidal Melanoma
A Phase 2 Trial of Belzupacap Sarotalocan, Monday, 11:54AM - a Targeted Investigational Therapy 12:01PM PST Session: PA069 for Choroidal Melanoma Location: WEST 2006 via Suprachoroidal Administration 1
Slide 2: Bel-sar is a VDC with a Novel Dual Mechanism of Action
Bel-sar is a VDC with a Novel Dual Mechanism of Action Reactive oxygen species disrupts cell membrane and organelles Light Activated Drug Bel-sar* Bel-sar is a novel VDC that consists of a VLP conjugated to ~200 molecules of phthalocyanine dye Kines et al; Cancer Immunology Research, May 2021 Mechan
Slide 3: Bel-sar is a Novel Targeted Therapy in Development for Choroidal Melanoma
Bel-sar is a Novel Targeted Therapy in Development for the Treatment of Choroidal Melanoma Bel-sar is Delivered by Simple Light Activation with Standard Suprachoroidal Injection Goals of Treatment Ophthalmic Laser Local tumor control suprachoroidal Preservation of vision 3-4h No radiation morbidity
Slide 4: Ph 2 Trial – Dose Escalation and Expansion with Suprachoroidal Administration
Ph 2 Trial – Dose Escalation and Expansion with Suprachoroidal Administration Patient Population Representative of Early-Stage Disease: Indeterminate Lesions and Small Choroidal Melanoma Endpoint Endpoint Definitions Trial Design – Enrollment Complete (n=22) Growth in Tumor Height Tumor Progression
Slide 5: High Tumor Control Rates Observed – Durable at 12 Months Follow Up
High Tumor Control Rates Observed – Durable at 12 Months Follow Up Dose Response: >90% completed 12 Months Subtherapeutic vs Therapeutic Regimen Total Patients Tumor Control Dose/Regimen (n) Rate 100% Subtherapeutic Regimens 80% 80% Single dose up to 2 cycles 10 20% (2/10) % Subjects with Tumor Cont
Slide 6: High Tumor Control Rates Observed – Durable at 12 Months Follow Up
High Tumor Control Rates Observed – Durable at 12 Months Follow Up Dose Response: >90% completed 12 Months Subtherapeutic vs Therapeutic Regimen Total Patients Tumor Control Dose/Regimen (n) Rate 100% Subtherapeutic Regimens 80% 80% Single dose up to 2 cycles 10 20% (2/10) % Subjects with Tumor Cont
Slide 7: High Tumor Control Rates Observed – Durable at 12 Months Follow Up
High Tumor Control Rates Observed – Durable at 12 Months Follow Up Dose Response: >90% completed 12 Months Subtherapeutic vs Therapeutic Regimen Total Patients Tumor Control Dose/Regimen (n) Rate 100% Subtherapeutic Regimens 80% 80% Single dose up to 2 cycles 10 20% (2/10) % Subjects with Tumor Cont
Slide 8: High Tumor Control Rates Observed – Durable at 12 Months Follow Up
High Tumor Control Rates Observed – Durable at 12 Months Follow Up Dose Response: >90% completed 12 Months Subtherapeutic vs Therapeutic Regimen Total Patients Tumor Control Dose/Regimen (n) Rate 100% Subtherapeutic Regimens 80% 80% Single dose up to 2 cycles 10 20% (2/10) % Subjects with Tumor Cont
Slide 9: High Tumor Control Rates Observed: Change from Baseline in Tumor Thickness
High Tumor Control Rates Observed in Ph 3 Population Treated with Therapeutic Regimen Subtherapeutic Regimens (n=10) Change from Baseline in Tumor Thickness Over 12 Months Change from Baseline in Tumor Thickness (mm) Treatment Follow-up Timeframe Timeframe Patients who had documented growth at entry
Slide 10: High Tumor Control Rates Observed: Population Treated with Therapeutic Regimen
High Tumor Control Rates Observed in Ph 3 Population Treated with Therapeutic Regimen Aura Biosciences, Inc. Protocol AU-011-202 Exctraction 9/18/2023 Data Cut 3 Aug 2023 Subtherapeutic Regimens (n=10) Open-Label Data Review Active Growth and 3 Cycle Regimens (n=10) Figure Tumor Thickness Change or
Slide 11: Ph 2 Interim Data Demonstrated Statistically Significant Tumor Growth Arrest
Ph 2 Interim Data Demonstrated Statistically Significant Tumor Growth Arrest Successful Treatment with 3 Cycle Regimen in Ph 3 Eligible Tumors with Active Growth Change in Tumor Growth (mm/yr) (n=8) Rate of Tumor Growth (mm/yr) P < 0.0001 + 0.383 - 0.001 August 3, 2023, data on file Aura Biosciences
Slide 12: Goal for Bel-sar: Eliminate Malignant Cells in the Choroid and Preserve Vision
Goal for Bel-sar: Eliminate Malignant Cells in the Choroid and Preserve Vision Similar to Current Clinical Practice with Radiotherapy - Local Tumor Control May Equate to a Local Cure Many early-stage melanomas have Bel-sar targets mostly the (Unchanged Tumor Height) a small component of melanoma mal
Slide 13: Goal for Bel-sar: Eliminate Malignant Cells in the Choroid and Preserve Vision
Goal for Bel-sar: Eliminate Malignant Cells in the Choroid and Preserve Vision Phase 3 Eligible Patient after treatment lesion shows fibrosis and no growth 12 months Similar to Current Clinical Practice with Radiotherapy - Local Tumor Control May Equate to a Local Cure Wk Wk Baseline Wk 4 Wk 8 Wk 12
Slide 14: Goal for Bel-sar: Eliminate Malignant Cells in the Choroid and Preserve Vision
Goal for Bel-sar: Eliminate Malignant Cells in the Choroid and Preserve Vision Phase 3 Eligible Patient after treatment lesion shows fibrosis and no growth 12 months Similar to Current Clinical Practice with Radiotherapy - Local Tumor Control May Equate to a Local Cure Wk Wk Baseline Wk 4 Wk 8 Wk 12
Slide 15: Kaplan-Meier Analysis Simulation of Key Primary & Secondary Endpoint with Ph 2 Data
Kaplan-Meier Analysis Simulation of Key Primary & Secondary Endpoint with Ph 2 Data Time to Tumor Progression Time to Composite Endpoint Progression-Free Probability Progression-Free Probability Log-rank test Log-rank test p=0.0012 p=0.0023 Subtherapeutic up to 2 cycles (n=10) Subtherapeutic up to 2
Slide 16: 90% Visual Acuity Preservation Despite 80% of Patients at High Risk for Vision Loss
90% Visual Acuity Preservation Despite 80% of these Patients being at High Risk for Vision Loss >90% patients completed . 12 months Aura Biosciences, Inc. Protocol AU-011-202 Exctraction 9/18/2023 Data Cut 3 Aug 2023 Total Vision Vision Open-Label Data Review Median Change in BCVA in Ph3 Eligible Po
Slide 17: Safety Supports Potential First Line Treatment in Early-Stage Disease
Safety Supports Potential First Line Treatment in Early-Stage Disease Ongoing Ph 2 Safety Outcomes with SC Administration Adverse Event Radiotherapy* Bel-Sar+ Surgeries secondary to AEs+ (e.g., Cataracts) 40%+ 0% All Treated Subjects (n=22) Drug/Laser Related Adverse Events Grade I Grade II Grade II
Slide 18: Randomized Controlled Global Ph 3 Trial
Randomized Controlled Global Ph 3 Trial 18
Slide 19: SPA Agreement with FDA Supports Global Ph 3 Trial Design
SPA Agreement with FDA Supports Global Ph 3 Trial Design Fast Track and Orphan Designations SPA Agreement 80 µg bel-sar treatment arm (n=40) 15 Month Primary Efficacy Analysis Randomize 40 µg bel-sar treatment arm (2:1:2) (n=20) Sham control arm (n=40) Enrollment (N=~100) Primary Endpoint First Key