Arvinas, Inc.

Overview

• Clinical-stage biotechnology company developing PROTAC (proteolysis-targeting chimera)–based targeted protein degraders.
• Core strategy: use PROTACs to remove disease-causing intracellular proteins for oncology and neurology indications, including historically undruggable targets.
• Operates a PROTAC Discovery Engine of discovery tools and platforms to identify, optimize, and validate degraders and targets.
• Business model combines internal clinical programs with collaborations to fund and accelerate development.

PROTAC platform and capabilities

• Mechanism: PROTACs recruit an E3 ligase to tag target proteins for ubiquitin-mediated proteasomal degradation.
• Capabilities:
  • Target selection focused on genetically defined or under‑drugged targets, including transcription factors and scaffolding proteins.
  • E3 KnowledgeBase with proprietary ligands for E3 ligases (VHL, CRBN, IAP, MDM2) and work toward E3s expressed in CNS and tumors.
  • Advanced screening including high‑throughput assays and DNA‑encoded libraries (DEL) adapted for PROTAC design.
  • ANGLE, LEAP, PROTACify: linker evolution, library-enabled PROTAC design, and ternary complex modeling tools.
  • Proteomics for detailed profiling of degradation and selectivity.
  • PIVOT for in vivo PK/PD and efficacy optimization of PROTACs.
• Intellectual property across multiple PROTAC components and targets, including licensed portfolios from Yale and collaborations with Genentech.

Pipeline and programs

• Clinical-stage programs

  • ARV-102: oral LRRK2 degrader intended to cross the blood–brain barrier for Parkinson’s disease (PD) and progressive supranuclear palsy (PSP).
  • ARV-806: PROTAC KRAS G12D degrader targeting KRAS G12D‑mutant cancers (PDAC, colorectal cancer, NSCLC).
  • ARV-393: PROTAC BCL6 degrader for relapsed/refractory non‑Hodgkin lymphoma (including DLBCL).
  • ARV-027: oral polyQ‑AR degrader for spinal bulbar muscular atrophy (SBMA), targeting skeletal muscle.
  • Vepdegestrant (ARV-471): ER degrader for ER+/HER2−, ESR1‑mutated advanced/metastatic breast cancer; NDA accepted with PDUFA date June 5, 2026.

• Preclinical programs

  • ARV-6723: HPK1 degrader with preclinical data showing strong single‑agent activity and synergy with anti‑PD‑1.
  • Pan‑KRAS degrader programs targeting multiple KRAS variants while sparing other RAS isoforms.

• Other programs and corporate changes

  • Luxdegalutamide (ARV-766) and bavdegalutamide (ARV-110): license transitioned to Novartis in 2024; bavdegalutamide programs completed in 2025.

• Notable clinical milestones

  • VERITAC‑2: Phase 3 trial of vepdegestrant in ESR1‑mutant ER+/HER2− breast cancer achieved a positive primary endpoint in the ESR1‑mutant population (PFS improvement); NDA submitted and accepted; PDUFA date set for 2026.
  • ARV‑102: Phase 1 data in healthy volunteers and PD patients demonstrated brain penetration; multiple‑dose cohort ongoing with data anticipated in 2026.
  • ARV‑806: IND filed and dose escalation completed; initial clinical data expected in 2026.
  • ARV‑393: Phase 1 NHL trial ongoing; preclinical data support combination strategies with standard‑of‑care therapies; expansion into combination arms planned in 2026.
  • ARV‑027: Phase 1 in healthy volunteers started in 2026; preclinical target engagement shown in skeletal muscle.

Partnerships, collaborations, and licensing

• Pfizer (vepdegestrant/ARV‑471)

  • Co‑development and co‑commercialization agreement for vepdegestrant worldwide.
  • Upfront payment of $650 million; up to $1.4 billion in contingent milestones.
  • Development costs shared 50/50; commercialization rights managed jointly, with a path to third‑party commercialization as of 2025.

• Genentech (R&D collaboration; Restated Genentech Agreement)

  • Ongoing collaboration with milestone and royalty structures tied to Licensed PROTACs.

• Novartis (luxdegalutamide ARV‑766 and AR‑V7 asset)

  • May 2024 license closing with upfront cash of $150 million; up to $1.01 billion in potential milestones and royalties on net sales.
  • Novartis holds exclusivity for luxdegalutamide.

• Yale University (Amended Yale License)

  • Broad exclusive worldwide license to PROTAC field with upfront payments and ongoing milestones, collaboration payments, and royalties; term extends through relevant patent expirations.

• Strategy: select collaborations to accelerate development while retaining rights to advance certain products independently or with other partners.

Intellectual property

• Patent portfolio (as of December 31, 2025)

  • ARV‑102 (LRRK2): three patent families covering ARV‑102 and related degraders; issued patents expiring 2041–2044; additional applications expiring 2044–2045.
  • ARV‑806 and KRAS G12D: composition‑of‑matter and method filings with expiries 2044–2045.
  • ARV‑393 (BCL6): composition‑of‑matter patents and additional families for combinations/formulations; expiries 2042–2045.
  • ARV‑027 (polyQ‑AR): U.S. and foreign patents with expiries 2037–2044.
  • Vepdegestrant (ARV‑471): composition‑of‑matter, methods, and formulations with expiries 2037–2046.
  • ARV‑6723 (HPK1): composition‑of‑matter patents with expiries 2044–2045.

• PROTAC platform IP

  • VHL (Yale‑licensed), CRBN (Cereblon), IAP, and MDM2 E3 portfolios with patents expiring in the 2030s.
  • Co‑owned families with Yale covering PROTAC composition‑of‑matter with expiries through the early‑to‑mid 2040s.

• Genentech collaboration IP

  • Restated agreement includes rights to Licensed PROTACs with milestone and royalty terms; expiries aligned with last‑to‑expire patent claims through the 2040s.

• Trade secrets and know‑how protected by confidentiality agreements supplement the patent estate.

Manufacturing and operations

• No internal manufacturing facilities; relies on contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) for active drug substance and finished drug product.
• Some partnerships designate external suppliers for commercial supply, including Pfizer for vepdegestrant.
• Active supply arrangements exist with external manufacturers across several programs (ARV‑102, ARV‑393, ARV‑806, vepdegestrant, ARV‑027).

Regulatory and development path

• Development pathway includes IND‑enabling work, cGMP manufacturing, IRB approvals, Phase 1–3 trials, NDA submissions, and potential expedited designations (Fast Track, Breakthrough, Priority Review, Accelerated Approval).

• Program highlights:

  • Vepdegestrant NDA accepted; PDUFA date June 5, 2026; VERITAC‑2 showed PFS improvement versus fulvestrant in the ESR1‑mutant population.
  • KRAS G12D and other oncology programs progressing through Phase 1/2.
  • ARV‑102 supports CNS‑targeted indications with biomarker and pharmacology data.

• International considerations include EMA pathways and country‑specific regulatory, pricing, and reimbursement dynamics.

Financial highlights and milestones

• Collaboration payments and milestones

  • Pfizer: $650 million upfront for vepdegestrant with up to $1.4 billion in additional milestones; 50/50 development cost sharing.
  • Novartis: $150 million upfront for luxdegalutamide and related assets with up to $1.01 billion in potential milestones and royalties.
  • Yale Amended License: upfront and related payments of $14.95 million at signing plus a $5.0 million payment in June 2025 and additional collaboration‑based milestones and royalties.

• Patent and portfolio scale (as of Dec 31, 2025)

  • 71 issued U.S. patents
  • 318 granted foreign patents
  • 620 pending patent applications (118 U.S., 502 foreign)

• Key regulatory milestone: VERITAC‑2 Phase 3 results in the ESR1‑mutant population with an NDA submission and an FDA PDUFA date in June 2026.

Summary

Arvinas develops PROTAC‑based targeted protein degraders for oncology and neurology using a proprietary Discovery Engine and a broad patent estate. The company advances multiple clinical and preclinical programs while partnering with industry leaders to fund development and commercialize lead assets, with a major regulatory milestone (PDUFA date) for vepdegestrant scheduled for June 5, 2026.