Upon conclusion of the deal, Quince will fund the EryDex through the Phase 3 clinical trial under special protocol assessment (SPA) with the FDA for an anticipated NDA submission
Quince Therapeutics to acquire EryDel. (Credit: National Cancer Institute on Unsplash)
Biotechnology company Quince Therapeutics has agreed to acquire late-stage biotech company EryDel and its Phase 3 asset, EryDex, which targets ataxia-telangiectasia (A-T) disease.
EryDel has developed an autologous intracellular drug encapsulation (AIDE) technology and has EryDex that targets A-T, a rare fatal paediatric neurological disease with no approved treatments.
The drug has already received orphan drug status to treat A-T from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).
Upon completion of the deal, EryDel stockholders will own roughly 16.7% of the merged business and be eligible for up to $485m in milestone payments without any royalties for the research, regulatory, and commercial phases of the business.
Under the terms of the agreement, EryDel will operate as a wholly-owned subsidiary of Quince Therapeutics and will retain its corporate and manufacturing presence in Italy.
Quince Therapeutics CEO Dirk Thye said: “We are highly enthusiastic and optimistic about our acquisition of this unique drug/device combination technology platform and promising late-stage clinical asset to drive Quince’s next stage of growth.
“EryDel’s proprietary AIDE technology enables the autologous intracellular encapsulation and delivery of dexamethasone in a controlled, slow-release manner that has the potential to allow chronic administration of steroids over many months or years with a favourable safety profile.”
Upon closing of the deal, Quince will fund the EryDex through the Phase 3 clinical trial under special protocol assessment (SPA) with the FDA for an anticipated New Drug Application (NDA) submission. It will also support European regulatory activities.
Additionally, the biotechnology company will enrol the first patient in the global Phase 3 trial of EryDex in the second quarter of 2024.
EryDel CEO Luca Benatti said: “Quince’s effort will be supported by the encouraging Phase 3 data generated from EryDel’s prior international study of EryDex, which demonstrated a significant delay in disease progression in A-T patients and further supported more than 10 years of safety data.
“Quince is well-positioned to advance EryDel’s differentiated AIDE technology and development of our lead asset EryDex to deliver innovative treatments to patients in need.”
The transaction, which has been unanimously authorised by the boards of directors of both businesses, is expected to conclude in the third quarter of 2023. It is subject to certain regulatory clearances and other closing conditions.