VIR-5525 / Vir Biotech, Sanofi - LARVOL DELTA

Vir Biotechnology Announces First Patient Dosed in Phase 1 Clinical Trial of EGFR-Targeting PRO-XTEN Dual-Masked T-Cell Engager VIR-5525 for the Treatment of Solid Tumors (Businesswire) - "Vir Biotechnology...announced that the first patient has been dosed in the Company’s Phase 1 clinical trial evaluating VIR-5525....VIR-5525 will be evaluated for the treatment of a variety of EGFR-expressing solid tumors in areas of high unmet need such as non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), and cutaneous squamous cell carcinoma (cSCC). The Phase 1 clinical trial (NCT06960395) is a first-in-human open-label, non-randomized study designed to assess the safety, pharmacokinetics, and preliminary anti-tumor activity of VIR-5525 as a monotherapy and in combination with pembrolizumab....The first patient dosing of VIR-5525 triggers a $75 million milestone payment as part of the Company's 2024 exclusive worldwide license agreement with Sanofi....The payment will be recognized as a research and development expense in the third quarter of 2025."

Financing • Trial status • Colorectal Cancer • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=450 | Recruiting | Sponsor: Vir Biotechnology, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Vir Biotechnology Provides Corporate Update and Reports First Quarter 2025 Financial Results (Businesswire) - "Pipeline Programs:...Solid Tumors:...The Company plans to initiate a Phase 1 study of VIR-5525, its PRO-XTEN dual-masked EGFR-targeting TCE, in the second quarter of 2025, to evaluate its potential across a number of solid tumor indications."

New P1 trial • Solid Tumor

Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=450 | Not yet recruiting | Sponsor: Vir Biotechnology, Inc.

New P1 trial • Oncology • Solid Tumor

Vir Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2024 Financial Results (Businesswire) - "...The Company plans to initiate a Phase 1 study of VIR-5525, its dual-masked EGFR-targeting TCE, in the first half of 2025, evaluating its potential across a number of solid tumor indications."

New P1 trial • Solid Tumor

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