Aura Biosciences, Inc. · NASDAQ:AURA
Aura Biosciences — ASRS 2021
12 slides from Aura Biosciences's conference presentation, October 2021
Slide 1: A Phase 2 Trial of AU-011 for Indeterminate Lesions and Small Choroidal Melanoma
A P HASE 2 T RIAL OF AU-011, AN I NVESTIGATIONAL , V IRUS -L IKE D RUG C ONJUGATE (VDC) FOR THE T REATMENT OF P RIMARY I NDETERMINATE L ESIONS AND S MALL C HOROIDAL M ELANOMA (IL/CM) USING S UPRACHOROIDAL A DMINISTRATION Prithvi Mruthyunjaya, MD, MHS Associate Professor of Ophthalmology and Radiatio
Slide 2: Disclosures
DISCLOSURES Consultant: Funding: • Alcon • Arix Biosciences (P30-026877) • Aura Biosciences • Castle Biosciences Patent provisional • The Cancer League • PCT Application Serial No. • Retina Research Foundation/ US2021/015830 The Macula Society AU-011 is an investigational compound and is not current
Slide 3: On behalf of the AU-011 Program Investigator Group
On behalf of the AU-011 Program Investigator Group Dr. Carol Shields Dr. Ivana Kim Dr. Brian Marr Philadelphia, PA Boston, MA New York, NY Dr. Hakan Demirci Ann Arbor, MI Dr. Tara McCannel Los Angeles, CA Dr. Antonio Capone Jr. Royal Dr. Abdhish Bhavsar Dr. Amy Schefler Minneapolis, MN Dr. Chris Ber
Slide 4: Slide 4
Slide 5: AU-011 Is a First in Cancer Molecule: Targeted to Preserve Vision
AU-011 IS A FIRST IN CANCER MOLECULE: TARGETED TO PRESERVE VISION Viral Like Drug Conjugates (VDCs) VDCs bind to specifically modified HSPGs VDCs are activated with an ophthalmic laser on the tumor cell surface with multivalent generating singlet oxygen that disrupts the binding tumor cell membrane,
Slide 6: AU-011 Has a Novel Dual Mechanism of Action
AU-011 HAS A NOVEL DUAL MECHANISM OF ACTION AU-011 Causes Acute Tumor Cell Necrosis: VDC deliver hundreds of IRDye700DX molecules that upon light activation generate singlet oxygen causing disruption of the membrane of the tumor cell And Immune Activation: Damaged tumor cells release neoantigens
Slide 7: Phase 2 Study Objectives
PHASE 2 STUDY OBJECTIVES intravitreal To assess safety and efficacy of AU-011 via suprachoroidal (SC) injection to treat primary indeterminate lesions and small choroidal melanomas A dose escalation phase is ongoing to suprachoroidal establish the maximum safe and well tolerated dose and treatment
Slide 8: Suprachoroidal Administration Can Optimize Delivery to the Posterior Segment
SUPRACHOROIDAL ADMINISTRATION CAN OPTIMIZE DELIVERY TO THE POSTERIOR SEGMENT Ocular Ocular Exposure After After IVT or SC 1 Exposure IVT or Injection SC Injection 20000 IVT AU-011 Concentration (ng/mL) SC 15000 Intravitreal (IVT) injection Suprachoroidal (SC) injection 10000 Optimize therapeutic i
Slide 9: Phase 2 Suprachoroidal Study
PHASE 2 S UPRACHOROIDAL STUDY Open Label Dose Escalation Phase Single Dose Cohorts - Completed Status: 14 subjects enrolled to date 20 μg 40 μg 40 μg x 1 Laser x 1 Laser x 2 Lasers Added option for a 3rd cycle to Cohort 5 Based on safety to date added Cohort 6: Cohort 1 Cohort 2 Cohort 3 (n=1)
Slide 10: Phase 2 Suprachoroidal Delivery of AU-011 – Demonstrated Favorable Safety Profile to Date
PHASE 2 S UPRACHOROIDAL DELIVERY OF AU-011 – DEMONSTRATED FAVORABLE SAFETY PROFILE TO DATE Preliminary results All Treated Subjects (n=13) Treatment Related Adverse Events Grade I Grade II Grade III Total Majority of AEs were transient and resolved Anterior chamber cell/ inflammation 23.1% 0.0% 0
Slide 11: AU-011 Suprachoroidal Safety and Next Steps
AU-011 SUPRACHOROIDAL SAFETY AND NEXT STEPS Suprachoroidal administration may improve the therapeutic index and optimize treatment parameters, compared to intravitreal administration Favorable safety profile to date • Preliminary Phase 2 safety data supports the continued dose escalation to an 8
Slide 12: Stanford Ocular Oncology Service – Thank you!
STANFORD O CULAR O NCOLOGY S ERVICE Orbital Ocular Pediatric Intraocular Systemic Eyelid surface Tumors Tumors cancers and Tumors Tumors Retinoblastoma Melanoma the eye Prithvi Mruthyunjaya, MD, MHS Director Thank Andrea Kossler, MD Director, Orbital Oncology you! Ben Erickson, MD Albert Wu, MD ocul