Under the partnership, Acumen Pharmaceuticals will get access to Halozyme's Enhanze technology for the development of a subcutaneous formulation of the clinical-stage monoclonal antibody (mAb) candidate, ACU193
Acumen and Halozyme sign deal to develop subcutaneous formulation of ACU193 with Enhanze technology. (Credit: National Cancer Institute on Unsplash)
Halozyme Therapeutics has signed a global collaboration and licence agreement with Acumen Pharmaceuticals for the use of Halozyme’s Enhanze drug delivery technology in Alzheimer’s disease (AD).
Enhanze is a proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20). It is designed for rapid subcutaneous drug delivery for a single target.
Under the partnership, Acumen, a biopharmaceutical company, will get access to Halozyme’s Enhanze technology for the development of a subcutaneous formulation of ACU193.
Acumen plans to assess the possible application of Enhanze for ACU193, its clinical-stage monoclonal antibody (mAb) candidate that targets amyloid-β oligomers (AβOs) to treat early AD.
Acumen president and CEO Daniel O’Connell said: “Acumen is a patient-driven organisation, and with the recent momentum of subcutaneous administration of Alzheimer’s therapies, we look forward to being able to provide another treatment option that has the potential to broaden patient access and decrease treatment burden.”
Under the terms of the agreement, the biopharmaceutical firm will pay Halozyme an upfront payment as well as possible milestone payments in the future based on development progress, regulatory approvals, and sales targets.
Additionally, Halozyme will be paid royalties in the single digits on net sales of commercially available medications using Enhanze technology.
Halozyme president and CEO Helen Torley said: “Our collaboration with Acumen for Enhanze reinforces our commitment to provide innovative solutions to improve the patient treatment experience, particularly for such a challenging disease in a large patient population.
“We share Acumen’s view that the Alzheimer’s disease treatment paradigm is at a key inflection point with recent and expected approvals paving a new path for treatment.”
The primary objective of Acumen’s first-in-human, randomised, double-blind, placebo-controlled study was met with positive Phase 1 INTERCEPT-AD trial results.
It showed that ACU193 was generally well-tolerated with a compelling overall safety profile in patients with early AD.
In order to compare the pharmacokinetics (PK) of an intravenous (IV) and subcutaneous version of ACU193, Acumen expects to begin Phase 1 development in human subjects in mid-2024.
With this agreement, Halozyme becomes the 13th licence partner and global collaborator for Enhanze technology.