Lonza Forms Agreement to Manufacture Acumen Pharmaceuticals’ AD mAb Therapy

Editor's note: this story was originally published on BioPharmInternational.com.

Lonza and Acumen Pharmaceuticals, a clinical-stage biopharmaceutical company specializing in therapeutics that target toxic soluble amyloid beta oligomers (AβOs) for treating Alzheimer’s disease (AD), have formed a collaboration for Lonza to manufacture sabirnetug (ACU193), a monoclonal antibody (mAb) that targets toxic soluble AβOs. Sabirnetug is in clinical development for treating AD and will soon be entering Phase II studies, the companies announced in an April 4, 2024 press release.

Under the agreement, Lonza will manufacture sabirnetug drug substance at its manufacturing facility in Portsmouth, NH. The Portsmouth facility is equipped with 2000-L single-use bioreactors.

“Our collaboration with Acumen showcases our flexibility in enabling innovative biotech companies to advance their innovative therapies on accelerated timelines. We are excited that our new, next-generation single-use manufacturing facility in Portsmouth (US) will be used to manufacture a [C]GMP [current good manufacturing practice] drug substance that could bring new treatment options to patients suffering from Alzheimer’s disease,” said Stefan Egli, global head of Mammalian Biologics, Lonza, in a company press release.

According to the press release, sabirnetug is the first humanized mAb to demonstrate selective target engagement of AβOs in a Phase I first-in-human study. AβOs are known to be an early trigger and persistent driver of AD-associated synaptic dysfunction and neurodegeneration. Sabirnetug operates by preventing toxic AβOs from binding to dendritic spines and by preserving neuronal function, thus addressing an underlying cause of AD, according to the release.

“As we progress into Phase [II] clinical development of sabirnetug as a potentially best-in-class treatment for early AD, we are acutely aware that patients and their families are in urgent need of safe, effective treatment options for this devastating disease. Partnering with Lonza is a critical step to ensure broader access to next-generation AD therapies,” said James Doherty, president and chief development officer, Acumen Pharmaceuticals, in the release.

Further guidance for AD

Regulatory support for the development of AD therapeutics was further advanced this year with the issuance of FDA’s draft guidance on early AD treatment in March 2024 (1). The guidance document is intended to aid sponsors who are in the clinical phases of developing therapeutics for treating the early stages of AD before dementia becomes overt. The March 2024 draft guidance is a revision of the February 2018 guidance; the draft remains open for comments until June 10, 2024.

In the past, enrollment in clinical trials for AD treatments were based on clinical criteria that defined the later stages of AD, and because of this, study subjects “exhibited both the cognitive changes typical of clinically evident AD and the degree of functional impairment associated with overt dementia,” according to FDA’s guidance document. Approved treatments were thus based on that context. However, FDA expects the new draft document to create discussions between the Office of Neuroscience in the Center for Drug Evaluation and Research, the Office of Therapeutic Products in the Center for Biologics Evaluation and Research, sponsors, the scientific community, and the public, where appropriate (1,2).

References

1. FDA. Draft Guidance for Industry, Early Alzheimer’s Disease: Developing Drugs for Treatment (CBER, CDER, March 2024).
2. Haigney, S. FDA Gives Guidance on Developing Treatments for Early Alzheimer’s. PharmTech.com, March 15, 2024.

Source: Acumen Pharmaceuticals