Arvinas and Pfizer have been awarded an Innovation Passport designation for vepdegestrant by the UK Innovative Licensing and Access Pathway Steering Group for the treatment of oestrogen receptor (ER)+/ human epidermal growth factor receptor (HER) 2- locally advanced or metastatic breast cancer.
An Innovation Passport serves as an entry point for the Innovative Licensing and Access Pathway (ILAP), which accelerates the drug’s time to market and facilitates patient access in the UK.
Vepdegestrant is an investigational oral proteolysis targeting chimeras (PROTAC) oestrogen receptor protein degrader. It is being co-developed and commercialised by Arvinas and Pfizer as part of a collaboration agreement announced in July 2021.
According to the deal, both companies will equally share development costs, commercialisation expenses, and profits.
“The Innovation Passport designation opens the door for Pfizer and Arvinas to discuss access considerations for potential future indications for vepdegestrant,” said Pfizer’s executive VP Chris Boshoff in a press release.
There are multiple clinical trials investigating vepdegestrant as a monotherapy for patients with ER+/HER2- advanced or metastatic breast cancer. The Phase III monotherapy trial VERITAC-2 (NCT05654623) is expected to complete enrolment in 2024.
The drug is also being studied in combination therapy trials such as the recently initiated Phase III VERITAC-3 trial (NCT05909397) with vepdegestrant and Pfizer’s Ibrance (Palbociclib), and the Phase Ib/II clinical trial with Carrick Therapeutics’ samuraciclib, which is expected to start in H2 2024.
According to GlobalData, the parent company of Pharmaceutical Technology, vepdegestrant is expected to generate $1.3bn in global sales in 2029.