Vir Biotechnology, Inc. · NASDAQ:VIR
Vir Biotechnology — Technical Presentation (May 2026)
10 slides from Vir Biotechnology's technical presentation, May 6, 2026
Slide 1: Preliminary Phase 1 Dose Escalation Results of VIR-5500 in mCRPC
Preliminary Phase 1 Dose Escalation Results of VIR-5500 (AMX-500), a Dual-Masked PRO-XTEN® T-cell Engager, in Metastatic Castration Resistant Prostate Cancer (mCRPC) Johann S. de Bono,1 María Dolores Fenor de la Maza,2 Valentina Boni,3 Joaquin Mateo,4 Anthony M. Joshua,5 Inaki Eguren-Santamaría,6 Fa
Slide 2: VIR-5500-V101 First in Human Phase 1 Study
VIR-5500-V101 First in Human Phase 1 Study VIR-5500 (PSMA) No Dose Limiting Toxicities; CRS Mainly Grade 1, Despite No Prophylaxis Q3W Cohort 800/1500/3000 µg/kg 12% (7/58) Grade ≥ 3 TRAEs, Limited CRS 50% (29/58) primarily seen in the first cycle, Mostly Grade 1 (Fever Only),1 and No DLTs2 99% PS
Slide 3: VIR-5500-V101 Phase 1 Study, Part 1 Monotherapy Dose Escalation
VIR-5500-V101 Phase 1 Study, Part 1 Monotherapy QW and Q3W Dose Escalation VIR-5500 (PSMA) All Dose Escalation Cohorts have Cleared DLT (N=58) QW Dose Escalation (N=26) Q3W Dose Escalation (N=32) Eligibility Criteria: 1000 2000 3000 µg/kg (N=4) 1000 2000 4000 µg/kg w/ Prophylactic Steroids (
Slide 4: Late-line mCRPC Population
Late-line mCRPC Population VIR-5500 (PSMA) VIR-5500 Baseline Characteristics VIR-5500 NCT05997615 N = 58 Median age, years (range) 68 (49-81) Prior lines of therapy (Any Setting) Study & Enrollment Details Number, Median (Min, Max) 4 (2, 7) Heavily pre-treated participants: Prior Taxane, n (%) 55 (9
Slide 5: VIR-5500 Observed to be Well-Tolerated with a Favorable Safety Profile
VIR-5500 Observed to be Well-Tolerated with a Favorable Safety Profile VIR-5500 12% Grade ≥ 3 TRAEs, Limited CRS, Mostly Grade 1 (Fever Only), and No DLTs (PSMA) Limited High-Grade Events & Treatment Discontinuations Low Grade CRS in Doses ≥3,000 µg/kg Q3W (N=22) TEAEs in any Participant n (%) (N=58
Slide 6: Dose Response Relationship with Infrequent Low-Grade CRS
Dose Response Relationship with Infrequent Low-Grade CRS VIR-5500 Deeper PSA Declines & Confirmed PSA Responses at Higher Doses (PSMA) 100 Maintenance Dose Cohorts < 400 μg/kg QW PSA Best % Change from Baseline (PCWG3)^ 400 - 2000 μg/kg QW 400 - 2000 μg/kg Q3W ≥ 3000 μg/kg QW ≥ 3000 μg/kg Q3W 50 0 -
Slide 7: Deep PSA Declines Observed as Early as Cycle 1 Day 8
Deep PSA Declines Observed as Early as Cycle 1 Day 8, VIR-5500 Evidence of Concordant RECIST Responses in Evaluable Patients (PSMA) PSA-Evaluable Participant Dosed at ≥ 3000 ug/kg Q3W Doses ≥ 3000 µg/kg Q3W Any PSA Decline 88% (15/17) PSA50 82% (14/17) PSA90 53% (9/17) PSA99 29% (5/17) ORR (RECIST v
Slide 8: Significant RECIST Response in Large Liver Lesions with a PSA90 Response
Significant RECIST Response in Large Liver Lesions with a PSA90 Response Q3W cohort 800/2000/3500 µg/kg VIR-5500 RECIST Baseline Week 9 PSA 403 ng/mL PSA 44 ng/mL 94% Best PSA Decline Case Study Detail: • 75-year-old male • High disease burden; liver and 2 Liver Lesions lymph-nodes (no bone lesions)
Slide 9: Complete Response in Diffuse Lesions with prior RLT, with a PSA99 Response
Complete Response in Diffuse Lesions with prior RLT, with a PSA99 Response VIR-5500 RECIST PSMA/CD3 Duplex IHC Q3W Cohort 1000/2000/4000 µg/kg Baseline Week 5 with Prophylactic Steroids PSMA membrane H-score 140 PSMA membrane H-score 0 No malignancy identified Baseline Week 9 100% tumor PSMA+ PSA 10
Slide 10: Preliminary Evidence of Tolerability and Anti-Tumor Activity with VIR-5500
Preliminary Evidence of Tolerability and Anti-Tumor Activity with VIR-5500, VIR-5500 (PSMA) a PRO-XTEN PSMA-Targeted, Protease-Activated, Dual Masked T-cell Engager ® • Phase 1 study of VIR-5500 supports proof-of-concept for PRO-XTEN® masking technology, largely abrogating CRS toxicity that is prima
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