VIR-5500 / Sanofi, Vir Biotech, Astellas - LARVOL DELTA

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). (ASCO-GU 2026) - P1 | "Pending further clinical validation, available data are suggestive of a generally favorable safety profile, with evidence of meaningful anti-tumor activity, including RECIST responses, and preliminary evidence of durable benefit in a heavily pretreated population with substantial disease burden."

Metastases • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • IFNG • IL6

Pipeline Programs:…VIR-5500 (Businesswire) - "(i) The Company initiated additional Phase 1 dose-expansion cohorts evaluating VIR-5500 at Q3W 800/2000/3500 µg/kg step-up dosing. The first patients were dosed in three monotherapy cohorts evaluating VIR-5500 in taxane naïve metastatic castration-resistant prostate cancer (mCRPC), radioligand therapy naïve mCRPC and radioligand therapy exposed mCRPC, and one combination cohort evaluating VIR-5500 in combination with enzalutamide in early-line mCRPC; (ii) The Company anticipates initiating two additional Phase 1 dose-expansion cohorts, including VIR-5500 in combination with docetaxel in early-line mCRPC and VIR-5500 in combination with darolutamide in metastatic hormone-sensitive prostate cancer; (iii) The Company anticipates initiating pivotal Phase 3 trials in 2027."

New P3 trial • Trial status • Castration-Resistant Prostate Cancer • Hormone Sensitive Prostate Cancer

VIR-5500: "45% ORR, 1 patient with PSA response in treatment for ~300 days"; Prostate cancer (Astellas) - Astellas Corporate Strategic Plan Online Meeting

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer

First Patient Dosed in VIR-5500 T-Cell Engager Trial in Metastatic Prostate Cancer (Targeted Oncology) - "The monotherapy expansion cohort in late-line mCRPC is the first to begin enrollment following monotherapy dose-escalation data that showed a favorable safety profile and promising anti-tumor activity."

Trial status • Prostate Cancer

Vir Biotechnology Announces Closing of Global Strategic Collaboration with Astellas for the Treatment of Prostate Cancer (Businesswire) - "Upon closing, Vir Biotechnology receives a $240 million upfront payment and a $75 million equity investment at a price of $10.36 per share. The Company will also receive a near-term $20 million milestone payment, will split U.S. profit/loss equally with Astellas (50/50), and is eligible to receive up to an additional $1.37 billion in development, regulatory and sales milestones, along with tiered, double-digit royalties on ex-U.S. net sales. Under the terms of Vir Biotechnology's licensing agreement with Sanofi, a portion of certain collaboration proceeds will be shared with Sanofi."

Licensing / partnership • Prostate Cancer

Vir Biotechnology Reports Positive Updated Phase 1 Results for PSMA-targeting, PRO-XTEN® Dual-masked T-Cell Engager VIR-5500 in Patients with Metastatic Prostate Cancer (Vir Biotech Press Release)

P1 data • Castration-Resistant Prostate Cancer

Astellas and Vir Biotechnology Announce Global Strategic Collaboration to Advance PSMA-targeting PRO-XTEN Dual-masked T-Cell Engager VIR-5500 for the Treatment of Prostate Cancer (PRNewswire) - "Astellas to lead commercialization of VIR-5500 in the U.S. with Vir Biotechnology retaining option to co-promote, and Astellas will obtain exclusive rights to commercialize VIR-5500 ex-U.S. Vir Biotechnology will receive $335M in upfront and near-term milestone payments, will split U.S. profit/loss equally with Astellas (50/50), and is eligible to receive up to an additional $1.37B in development, regulatory and sales milestones, along with tiered, double-digit royalties on ex-U.S. net sales."

Licensing / partnership • Prostate Cancer

VIR-5500, a PRO-XTEN dual-masked T-cell engager (TCE) targeting prostate-specific membrane antigen (PSMA), continues to advance through Phase 1 dose escalation as a monotherapy in heavily pre-treated patients with metastatic castration-resistant prostate cancer (mCRPC)… (Businesswire) - "The Company plans to share a comprehensive VIR-5500 data update in late-line patients in the first quarter of 2026."

P1 data • Trial status • Castration-Resistant Prostate Cancer

Vir Biotechnology Announces First Patient Dosed in Part 3 of Phase 1 Trial of PSMA-Targeting PRO-XTEN Dual-Masked T-Cell Engager VIR-5500 in Combination with Androgen Receptor Pathway Inhibitors for the Treatment of Metastatic Prostate Cancer (Businesswire) - "The Phase 1 clinical trial is an open-label, non-randomized study designed to assess the safety, pharmacokinetics and preliminary anti-tumor activity of VIR-5500 in combination with ARPIs in participants with metastatic prostate cancer."

Trial status • Castration-Resistant Prostate Cancer

AMX-500-001: Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer (clinicaltrials.gov) - P1 | N=390 | Recruiting | Sponsor: Vir Biotechnology, Inc. | Phase classification: P1/2 ➔ P1 | N=215 ➔ 390

Enrollment change • First-in-human • Phase classification • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Vir Biotechnology Announces Encouraging Safety and Efficacy Data in Ongoing Dose Escalation Trials for Dual Masked T-Cell Engager VIR-5500 in mCRPC (Businesswire) - P1 | N=215 | NCT05997615 | Sponsor: Amunix | "The study has enrolled 18 participants with significant disease burden who have received 3 to 6 prior lines of therapy...Early efficacy data show encouraging signs of prostate-specific antigen (PSA) responses, and PSA reductions were observed in 100% (12/12) of participants after an initial dose ≥120 µg/kg. PSA50 response was confirmed in 58% (7/12) of participants receiving a first dose ≥120 µg/kg...Preliminary data show a promising safety profile, with no dose-limiting toxicities observed up to 1000 µg/kg without prophylactic corticosteroids. Safety findings showed minimal grade 1 or 2 CRS (17% and 11%, respectively) and no grade 3 or greater CRS at any dose."

P1 data • Castration-Resistant Prostate Cancer

Vir Biotechnology Reports Third Quarter 2024 Financial Results and Provides Corporate Update (Vir Biotech Press Release) - "The Company plans to share initial clinical data for VIR-5500 in the first quarter of 2025."

P1 data • Castration-Resistant Prostate Cancer

Vir Biotechnology Announces Closing of Exclusive Worldwide License Agreement With Sanofi for Multiple Potential Best-in-Class Clinical-Stage T-Cell Engagers (Businesswire) - "Vir Biotechnology...announced that the exclusive worldwide license agreement with Sanofi announced on August 1, 2024, has closed following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The agreement provides Vir with an exclusive worldwide license to three clinical-stage masked T-cell engagers (TCEs) with potential applications in a range of cancers and exclusive use of the proprietary PRO-XTEN masking platform for oncology and infectious disease....The clinical-stage assets Vir is licensing under the agreement are: (i) SAR446309 is a dual-masked HER2-targeted TCE in phase 1 clinical study including participants with metastatic treatment resistant HER2+ tumors such as breast and colorectal cancers; (ii) SAR446329 is a dual-masked PSMA-targeted TCE in phase 1 clinical study including participants with metastatic castration-resistant prostate cancer; (iii) SAR446368 is a dual-masked EGFR targeted TCE with an active IND."

Licensing / partnership • Breast Cancer • Colorectal Cancer • Metastatic Castration-Resistant Prostate Cancer

Vir Biotechnology Acts on Expanded Strategy of Powering the Immune System Through Exclusive Worldwide License Agreement with Sanofi for Multiple Potential Best-in-Class Clinical-Stage T-cell Engagers (Businesswire) - "Across its portfolio of clinical assets, below are anticipated upcoming catalysts: (i) SAR446309: Phase 1 monotherapy and combination study data expected in the second half of 2025; (ii) SAR446329: Phase 1 monotherapy study data expected in the second half of 2025; (iii) SAR446368: Phase 1 study to begin enrollment in the first quarter of 2025 or sooner."

New P1 trial • P1 data • Metastatic Castration-Resistant Prostate Cancer • HER-2

Vir Biotechnology Acts on Expanded Strategy of Powering the Immune System Through Exclusive Worldwide License Agreement with Sanofi for Multiple Potential Best-in-Class Clinical-Stage T-cell Engagers (Businesswire) - "Vir Biotechnology...announced that it has entered into an exclusive worldwide license agreement with Sanofi for three clinical-stage masked T-cell engagers (TCEs) and exclusive use of the protease-cleavable masking platform for oncology and infectious diseases, acquired by Sanofi from Amunix Pharmaceuticals. The clinical-stage assets include SAR446309 (AMX-818), a dual-masked HER2-targeted TCE; SAR446329 (AMX-500), a dual-masked PSMA-targeted TCE; and SAR446368 (AMX-525), a dual-masked EGFR-targeted TCE....As part of the strategic agreement with Sanofi, key employees with extensive scientific and development expertise in TCEs, and in-depth experience using the masking platform technology, will join Vir upon receipt of Hart-Scott-Rodino (HSR) Act clearance....Pursuant to this agreement, Sanofi will receive an upfront payment and is eligible to receive future development, regulatory and commercial net sales-based milestone payments and tiered royalties on worldwide net sales."

Licensing / partnership • Solid Tumor

Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Metastatic Castration Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1/2 | N=215 | Recruiting | Sponsor: Amunix, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Metastatic Castration Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1/2 | N=215 | Not yet recruiting | Sponsor: Amunix, a Sanofi Company

Metastases • New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor