Company: ARVN
Filing Date: 2025-02-11
Form Type: 10-K
Source: 0001655759-25-000016
Chunk: 80

Company: ARVINAS, INC.
Filing Date: 2025-02-11
Form: 10-K
Item: Item 1
Chunk 80
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 and preliminary anti-tumor activity of ARV-393 as a single agent in adult patients with relapsed/refractory NHL. We plan to disclose preliminary data from this ongoing Phase 1 clinical trial in patients with NHL in 2025.

We plan to present preclinical data of ARV-393 in combination with standard of care biologic agents and small molecule inhibitors in high grade and aggressive diffuse large B-cell lymphoma in vivo models at the American Association for Cancer Research, or AACR, Annual Meeting in the second quarter of 2025. 

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Additional information regarding our preclinical and clinical progress with ARV-393 is included below in "Item 1. Business—Our Clinical Stage Programs—Oncology Programs—Hematology Program: ARV-393".

Neuroscience Program: ARV-102

ARV-102 is our first oral PROTAC protein degrader in development to treat neurodegenerative diseases. In preclinical studies, ARV-102 has been shown to cross the blood-brain barrier and degrade LRRK2, which is a large multidomain scaffolding kinase. In human genetics, increased activity and expression of LRRK2 are genetically involved in the pathogenesis of neurological diseases including progressive supranuclear palsy, or PSP, and Parkinson’s Disease, or PD. We are currently conducting two ongoing clinical trials with ARV-102, a Phase 1 clinical trial in healthy volunteers and a Phase 1 clinical trial in patients with PD.

In the second quarter of 2024, we received health authority approval to initiate the multiple ascending dose, or MAD, portion of the ongoing Phase 1 clinical trial of ARV-102 in healthy volunteers, and we initiated the MAD portion of this clinical trial in the third quarter of 2024. We completed enrollment of this MAD cohort in the first quarter of 2025.

We completed enrollment in the single ascending dose, or SAD, portion of the Phase 1 clinical trial of ARV-102 in healthy volunteers in the third quarter of 2024. We plan to present SAD data from the ongoing Phase 1 clinical trial in healthy volunteers in an oral session at the Alzheimer’s Disease/Parkinson’s Disease (AD/PD) conference in Vienna, Austria in the second quarter of 2025.

In the fourth quarter of 2024, we initiated dosing in the SAD portion of the Phase 1 clinical trial with ARV-102 in patients with PD. We expect to complete enrollment