Company: ARVN
Filing Date: 2025-05-01
Form Type: 10-Q
Source: 0001655759-25-000085
Chunk: 147

Company: ARVINAS, INC.
Filing Date: 2025-05-01
Form: 10-Q
Item: Part I, Item 8
Chunk 147
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 90% decrease of bis(monoacylglycerol)phosphate in urine, a biomarker of lysosomal function; data for this endpoint in the MAD cohort is pending.

•In CSF, ARV-102 induced dose-dependent LRRK2 reduction, with greater than 50% LRRK2 reduction at single doses of greater than or equal to 60 mg and repeated doses of greater than or equal to 20 mg.

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Other Programs: ARV-806 and bavdegalutamide (ARV-110)

Kirsten rat sarcoma, or KRAS, is one of the most frequently mutated human oncogenes, is commonly altered in pancreatic, colorectal, and lung cancers, among others, and is associated with poor prognosis and resistance to standards of care. G12D is the most common mutation of the KRAS protein. ARV-806, our PROTAC KRAS G12D degrader, is a potent small molecule degrader of KRAS G12D and is designed to eliminate, rather than inhibit, KRAS G12D and, in preclinical studies, ARV-806 was 30-fold more potent than an inhibitor in vitro and provided additional aspects of differential biology contributing to its potent and broad antitumor effect in vivo. In addition, in the preclinical setting, ARV-806 demonstrated high potency and selectivity, with robust antitumor activity through dose-responsive degradation of KRAS G12D in KRAS G12D mutated cancers, including pancreatic and colorectal cancers. 

We filed an investigational new drug application with the U.S. Food and Drug Administration, or FDA, for ARV-806 in the first quarter of 2025 and received a safe-to-proceed letter from the FDA in the second quarter of 2025. We expect to initiate a first-in-human Phase 1 clinical trial of ARV-806 in patients with solid tumors harboring KRAS G12D mutations in the second half of 2025.

Bavdegalutamide is an investigational orally bioavailable PROTAC protein degrader designed to target and degrade the androgen receptor, or AR, for the treatment of men with metastatic castration resistant prostate cancer. Clinical trials for bavdegalutamide (ARV-110-101 and ARV-110-103) were completed in the second quarter of 2025, and we are winding down the bavdegalutamide program.

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