Vir Biotechnology, Inc. · NASDAQ:VIR
Vir Biotechnology — EASL ILC 2021 Hepatitis B Data Call
20 slides from Vir Biotechnology's conference presentation, Jun 28, 2021
Slide 1: EASL ILC 2021 Hepatitis B Data Call
Vir Biotechnology, Inc. EASL ILC 2021 Hepatitis B Data Call A WORLD WITHOUT INFECTIOUS DISEASE June 25, 2021 Exhibit 99.1
Slide 2: Legal Disclaimers
Legal Disclaimers © 2021 Vir Biotechnology, Inc. Forward-Looking Statements Statements in this presentation that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding the expected success, cost, and tim
Slide 3: Vir Clinical Development Pipeline
Disease Area Product Candidate Treatment/ Prophylaxis Pre-clinical Phase 1 Phase 2 Phase 3 Authorized Collaborator COVID-19 Sotrovimab* Treatment Sotrovimab + bamlanivimab Treatment Sotrovimab* Prophylaxis VIR-7832 Treatment HBV VIR-2218 Treatment VIR-2218 + PEG-IFN-⍺ Treatment VIR-3434 Treatment VI
Slide 4: Chronic HBV: Our Approach to Functional Cure
Chronic HBV: Our Approach to Functional Cure We believe that chronic HBV (CHB) is a viral disease resulting in immune dysfunction We believe that chronic HBV infection results in immune dysfunction via the expression of a large amount of HBV antigens, which act to suppress the immune system We belie
Slide 5: Chronic HBV: HBV T cells become dysfunctional in infected mice
Chronic HBV: HBV T cells become dysfunctional in infected mice Isogawa M, et al. PLoS Pathog 2013; 9(7):e1003490 © 2021 Vir Biotechnology, Inc. Transgenic HBV mouse Core-only expressing mouse HBV T cell HBV T cell
Slide 6: Chronic HBV: Reversal of Functional Cure Via Immunosuppression
Chronic HBV: Reversal of Functional Cure Via Immunosuppression Seto W, et al. J Clin Oncol 2014; 32(33): 3736-43 © 2021 Vir Biotechnology, Inc. functionally cured patient (HbsAg < LLOQ) rituximab-containing chemotherapy + =
Slide 7: Vir's Broad HBV Functional Cure Portfolio
Vir’s Broad HBV Functional Cure Portfolio © 2021 Vir Biotechnology, Inc. VIR-2218 Phase 2 Data Potential Best-In-Class siRNA as “backbone” of therapy Substantial, Durable, and Dose Dependent Reduction of HBsAg through 48 weeks1 Ongoing / Planned Combination Trials Currently in Phase 2 PEG-IFN-⍺ Star
Slide 8: EASL ILC 2021: Vir Abstracts
A Phase 1 study evaluating the neutralizing, vaccinal monoclonal antibody VIR-3434 in participants with chronic hepatitis B virus infection Safety and antiviral activity of VIR-2218, an X-targeting RNAi therapeutic, in participants with chronic hepatitis B infection: week 48 follow-up results Prelim
Slide 9: VIR-2218 HBsAg Response through Week 48
VIR-2218 20 mg Week HBsAg (IU/mL) VIR-2218 100 mg VIR-2218 50 mg VIR-2218 200 mg 10000 1000 10 100 10000 1000 10 100 0 4 8 12 16 20 24 28 32 36 40 44 48 0 4 8 12 16 20 24 28 32 36 40 44 48 Higher VIR-2218 Dose Levels Associated With a More Sustained Response through Week 48 With only 2 doses, at Wee
Slide 10: ESC+ Decreases Off-target Activity
ESC+ Decreases Off-target Activity Enhanced stabilization chemistry plus (ESC+)* decreases off-target seed-mediated binding while maintaining on-target activity and is hypothesized to improve the hepatic safety profile. MRNA, microRNA; siRNA, small interfering RNA; UTR, untranslated region 1. Janas
Slide 11: No Dose-Dependent Changes in Post-Treatment ALT Levels through Week 48
200 150 100 50 0 VIR-2218 20 mg Week Alanine Aminotransferase (U/L) HBeAg- HBeAg+ 200 150 100 50 0 0 4 8 12 16 20 24 28 32 36 40 44 48 VIR-2218 100 mg VIR-2218 50 mg 0 4 8 12 16 20 24 28 32 36 40 44 48 VIR-2218 200 mg No Dose-Dependent Changes in Post-Treatment ALT Levels through Week 48 No grade >1
Slide 12: VIR-2218 With and Without PEG-IFNα
VIR-2218 With and Without PEG-IFNα Open-label study to evaluate the safety and antiviral activity of VIR-2218 alone or in combination with PEG-IFNα in non-cirrhotic, HBeAg-negative and positive adults with chronic HBV infection on NRTI therapy Participants will be followed for safety and antiviral e
Slide 13: VIR-2218 with Pegylated Interferon Alfa-2a Mediated HBsAg Decreases from Baseline
VIR-2218 with Pegylated Interferon Alfa-2a Mediated HBsAg Decreases from Baseline All participants on nucleos(t)ide reverse transcriptase inhibitors (NRTI) therapy. Study is ongoing, N values at each timepoint per cohort are indicated below the graph HBsAg, hepatitis B surface antigen; PEG-IFNα, peg
Slide 14: Early On-Treatment Data
Early On-Treatment Data “We hypothesize that knocking down HBV antigens will remove the block on the immune system, and in the setting of an immune modulator, result in immune control” We believe that this VIR-2218+ PEG-IFNα data suggests that treatment with an siRNA could help unlock the potential
Slide 15: VIR-3434: An Engineered Human Antibody Against HBsAg
© 2021 Vir Biotechnology, Inc. VIR-3434: An Engineered Human Antibody Against HBsAg with Multiple Potential Mechanisms of Action cccDNA, covalently closed circular DNA; intDNA, integrated DNA; SVPs, subviral particles; HBsAg, hepatitis B surface antigen; PEG-IFNα, pegylated interferon alfa VIR-3434
Slide 16: VIR-3434-1002 Phase 1 Design
VIR-3434-1002 Phase 1 Design In Part B, 8 participants per cohort were randomized 6:2 to receive a single dose of VIR-3434 or placebo by SC injection Blinded preliminary safety, tolerability, and HBsAg data up to 4 weeks post-dose are presented for Part B cohorts evaluating low doses of 6 mg and 18
Slide 17: Preliminary PK of VIR-3434 After Single SC or IV Dose in Healthy Volunteers
Preliminary PK of VIR-3434 After Single SC or IV Dose in Healthy Volunteers VIR-3434 was generally well tolerated in healthy volunteers following single doses of up to 3000 mg; AEs were generally mild, and no AEs led to study discontinuation The bioavailability and half-life following SC administrat
Slide 18: VIR-3434 Mediated HBsAg Decreases from Baseline
VIR-3434 Mediated HBsAg Decreases from Baseline Most participants rapidly achieved ≥ 1 log10 IU/mL decline in HBsAg The largest reductions in HBsAg were in the 18 mg cohort, who also had higher baseline HBsAg levels Full analysis of VIR-3434 PK and HBsAg:VIR-3434 complex disposition is ongoing All p
Slide 19: VIR-3434 Next Steps
VIR-3434 Next Steps Higher single doses of VIR-3434 are being evaluated Patients with higher baseline HbsAg are being evaluated NRTI-naïve patients will be evaluated Multiple and higher doses of VIR-3434 will be evaluated in combination with VIR-2218 in the MARCH trial MARCH, Monoclonal Antibody siR
Slide 20: 2H:2021 Anticipated Catalysts
2H:2021 Anticipated Catalysts © 2021 Vir Biotechnology, Inc. COVID-19 HBV HIV Sotrovimab (mAb) BLA (Early Treatment, COMET-ICE, IV) File Sotrovimab (mAb) EMA rolling review (Early Treatment, COMET-ICE, IV) Complete Sotrovimab (mAb) Phase 2 (Early Treatment, COMET-PEAK, IM) Data VIR-7832 (mAb) Phase
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