On July 31, 2023 Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) reported that the U.K. Innovative Licensing and Access Pathway Steering Group, which consists of The All Wales Therapeutics and Toxicology Centre (AWTTC), The Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC), has awarded an Innovation Passport to vepdegestrant (ARV-471), an investigational PROTAC ER degrader, for the treatment of patients with estrogen receptor (ER)+/ human epidermal growth factor receptor (HER)2- locally-advanced breast cancer or metastatic breast cancer (Press release, Arvinas, JUL 31, 2023, View Source [SID1234633532]).
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The Innovation Passport is the entry point for the Innovative Licensing and Access Pathway (ILAP). The goal of ILAP is to accelerate the time to market facilitating patient access to medicines in the U.K. The Innovation Passport application is the first step in the ILAP process, which activates the Medicines and Healthcare products Regulatory Agency (MHRA) and its partner agencies, including the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC) and to develop a roadmap for regulatory and development milestones.
"This esteemed acknowledgment underscores our commitment to advancing medicine and delivering transformative solutions for patients," said John Houston, Ph.D., president and chief executive officer at Arvinas. "Arvinas is hopeful our investigational PROTAC ER degrader, vepdegestrant, will have the potential to be an endocrine therapy backbone for ER+/HER2-breast cancer."
"The Innovation Passport designation opens the door for Pfizer and Arvinas to discuss access considerations for potential future indications for vepdegestrant," said Chris Boshoff, M.D., Ph.D., chief oncology research and development officer and executive vice president at Pfizer. "We look forward to an ongoing dialogue with regulators, health technology assessment agencies and other partners, supporting a timely review as we aim to bring this potential medicine to patients as quickly as possible."
Multiple Phase 1, 2, and 3 studies with vepdegestrant are enrolling globally, including the VERITAC-2 Phase 3 2L/3L clinical trial of vepdegestrant as a monotherapy for the treatment of patients with ER+/HER2- metastatic breast cancer, which is anticipated to complete enrollment in 2024. Arvinas and Pfizer recently initiated the study lead-in of the VERITAC-3 Phase 3 trial of vepdegestrant and palbociclib as a first-line treatment in patients with ER+/HER2- locally advanced or metastatic breast cancer. The study lead-in will identify the dose of palbociclib for the randomized portion of the study. The companies also plan to submit additional data from the Phase 1b combination trial with palbociclib at a medical congress during the second half of 2023.
About ILAP
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) launched ILAP at the start of 2021 in order to accelerate the development and access to promising medicines in the early stages of development. The pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with MHRA and other stakeholders. Other benefits of ILAP include access to a range of development tools, such as the potential for a 150-day accelerated Marketing Authorization Application (MAA) assessment, rolling review and a continuous benefit risk assessment. More information about ILAP can be found here.
About vepdegestrant (ARV-471)
Vepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with early and locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Use of vepdegestrant in the ongoing and planned clinical trials will continue to monitor and evaluate patient safety and anti-tumor activity.
In preclinical studies, vepdegestrant demonstrated up to 97% ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed increased anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits.