On October 23, 2023 Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug delivery technology that leverages a patient’s own biology to deliver rare disease therapeutics, reported the successful completion of its acquisition of EryDel S.p.A., a privately-held, late-stage biotech company (Press release, Quince Therapeutics, OCT 23, 2023, View Source [SID1234636259]). Quince’s newly acquired Phase 3 lead asset, EryDex, targets a rare neurodegenerative disease, Ataxia-Telangiectasia (A-T). Currently, there are no approved treatments for A-T and the market represents a $1+ billion estimated peak sales opportunity globally. EryDex utilizes a highly differentiated and proprietary technology platform for autologous intracellular drug encapsulation (AIDE), which is designed to optimize the biodistribution of dexamethasone sodium phosphate (DSP; a pro-drug) by using an A-T patient’s own red blood cells to deliver the sustained therapeutic over a once monthly treatment period.

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"The successful closing of the EryDel acquisition is an exciting step forward in fulfilling our vision to build a leading rare disease biotechnology company," said Dirk Thye, M.D., Quince’s Chief Executive Officer. "We are dedicated to developing treatments utilizing our proprietary AIDE technology platform that hold the potential to help children and families affected by rare and debilitating diseases such as A-T. Quince’s priority is to advance the Phase 3 clinical trial of EryDex to evaluate its safety and efficacy for the treatment of A-T, then expand our development efforts into other potential indications that leverage our proprietary AIDE technology platform."

Quince is well-capitalized into 2026 and intends to focus its development expertise and financial resources toward advancing a single global Phase 3 NEAT (Neurologic Effects of EryDex on Subjects with A-T) clinical trial, which is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the neurological effects of EryDex on patients with A-T. Enrollment for the Phase 3 NEAT trial is expected to begin in the second quarter of 2024. The company plans to enroll approximately 86 A-T patients aged six to nine years-old and approximately 20 additional A-T patients aged 10 years or older. This pivotal clinical trial will be conducted under a Special Protocol Assessment (SPA) that has been agreed with the U.S. Food & Drug Administration (FDA), which should allow for the submission of a New Drug Application (NDA) following completion of this single study, assuming positive results.

Quince’s integrated senior leadership team holds extensive development, clinical, regulatory, and commercial expertise, and includes:

Dirk Thye, M.D. – Chief Executive Officer and member of Quince’s Board of Directors
Charles Ryan, J.D., Ph.D. – President
Guenter R. Janhofer, M.D., Ph.D. – Chief Medical Officer
Brendan Hannah, M.B.A. – Chief Business Officer and Principal Financial Officer
Giovanni Mambrini, MSc – Chief Technology Officer
Thomas Sabia, M.B.A. – Chief Commercial Officer
Pamela Williamson, RAC, FRAPS, M.B.A. – Head of Regulatory Affairs
EryDel’s former Chief Executive Officer, Luca Benatti, Ph.D., also joins Quince’s Board of Directors.

The acquisition of EryDel was completed with no upfront cash payment, using a stock-for-stock exchange and potential downstream milestone cash payments. EryDel stockholders now own 15.2% of Quince’s outstanding shares and may be issued up to an additional 725,036 shares of the company’s common stock (equal to 16.6% of Quince’s currently outstanding shares – inclusive of the shares issued) upon the first anniversary of the transaction closing. EryDel stockholders also will be entitled to up to $485 million in potential total downstream cash payments, including up to $5 million in development milestones, $25 million at NDA acceptance, $60 million in approval milestones, and $395 million on market and sales milestones, with no royalties paid to EryDel stockholders. The transaction includes the assumption of EryDel’s $13 million (€10 million in principal) European Investment Bank (EIB) loan with scheduled payments beginning in the second half of 2026.