Company: ARVN
Filing Date: 2025-05-01
Form Type: 10-Q
Source: 0001655759-25-000085
Chunk: 141

Company: ARVINAS, INC.
Filing Date: 2025-05-01
Form: 10-Q
Item: Part I, Item 8
Chunk 141
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atory research and development work on multiple other undisclosed targets.

Oncology Programs: Vepdegestrant and ARV-393

Estrogen Receptor Program: Vepdegestrant

Vepdegestrant is an investigational orally bioavailable PROTAC protein degrader designed to specifically target and degrade the ER for the treatment of locally advanced or metastatic ER+/HER2- breast cancer. We are co-developing vepdegestrant with Pfizer, pursuant to a collaboration agreement that we and Pfizer entered into in July 2021. We granted Pfizer worldwide co-exclusive rights to develop and commercialize vepdegestrant.

In preclinical studies, vepdegestrant demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a cyclin-dependent kinase, or CDK, 4/6 inhibitor.

We, along with Pfizer, have several ongoing clinical trials of vepdegestrant, and Pfizer has a clinical trial which it plans to add a vepdegestrant combination cohort to, which are summarized below.

•Vepdegestrant is currently under investigation; its safety and effectiveness for these investigational uses have not been established. 

•Defined terms in graph above, not defined elsewhere: CDK4/6i, cyclin-dependent kinase 4/6 inhibitor

•Footnotes in graph: a. Data to be presented at 2025 American Society of Clinical Oncology (May 30 – June 3, 2025); b. The trial (NCT04606446) is currently evaluating Pfizer’s KAT6 inhibitor (PF-07248144) in combination with endocrine therapies following CDK4/6 inhibitor treatments; the trial is being operationalized and funded by Pfizer and will now include a vepdegestrant/KAT6 cohort; c. Clinical trials fully enrolled except for ribociclib combination trial.

In the first quarter of 2025, we, along with Pfizer, announced positive topline results from the Phase 3 VERITAC-2 clinical trial in the estrogen receptor 1-mutant, or ESR1m, population. We and Pfizer plan to present detailed results from the VERITAC-2 Phase 3 clinical trial in a late-breaker oral presentation at the 2025 American