JCR Pharmaceuticals Announces That Acumen Pharmaceuticals Has Exercised its Exclusive Option to Develop Therapeutic Candidates for Alzheimer’s Disease, Enabled by J-Brain Cargo® Technology Platform

- Strategic partnership, announced in July 2025, utilizes JCR’s J-Brain Cargo^® to develop a novel blood-brain barrier-penetrating therapy targeting a pathological driver of Alzheimer’s disease

- Option exercise puts Acumen’s Enhanced Brain Delivery (EBD™) program on track for IND filing in mid-2027

HYOGO, Japan--(BUSINESS WIRE)--JCR Pharmaceuticals Co., Ltd. (TSE 4552; JCR), a global specialty biopharmaceutical company dedicated to developing therapies for rare and genetic diseases, today announced that Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) exercised its exclusive option to develop, manufacture, and commercialize, on a global basis, up to two candidates for development in the treatment of Alzheimer’s disease (AD), enabled by JCR’s proprietary blood-brain barrier (BBB)-penetrating technology platform, J-Brain Cargo^®.

The partnership, announced in July 2025, focuses on developing a BBB-penetrating treatment for AD that combines JCR’s J-Brain Cargo^® with Acumen’s amyloid beta oligomer (AβO)-selective antibodies, which target toxic soluble AβOs, a key pathological driver in the onset and progression of AD. The collaborative program aims to demonstrate the feasibility of applying J-Brain Cargo^® in delivering sabirnetug, Acumen’s targeted immunotherapy drug candidate, and other AβO-selective antibodies across the BBB to slow the progression of AD pathology. Earlier this year, Acumen presented non-clinical data from a mouse model of AD at the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders, which demonstrated that using AβO-selective antibodies with J-Brain Cargo^® technology increased brain exposure while preserving target engagement as demonstrated by AβO selectivity. Acumen plans to file an investigational new drug application for this program in mid-2027.

Under the terms of the agreement, JCR will receive an option payment with Acumen’s decision to exercise its exclusive option to develop, manufacture, and commercialize, on a global basis, up to two candidates from the collaboration. JCR will also be eligible to receive future milestone payments of up to USD 40 million related to development, and up to USD 515 million related to sales, for a total of up to USD 555 million (approximately JPY83.2 billion converted at the exchange rate of JPY 150 to USD). In addition, JCR is entitled to receive tiered royalties based on net sales for any products that emerge from the collaboration.

“We're pleased that our strategic partner, Acumen Pharmaceuticals, opted to exercise its exclusive option to develop, manufacture, and commercialize, on a global basis, up to two candidates for the treatment of Alzheimer’s disease,” said Hiroyuki Sonoda, Ph.D., President and Chief Scientific Officer of JCR Pharmaceuticals. “Acumen continues to progress the collaborative development program in Alzheimer’s disease, and the non-clinical data that Acumen reported earlier this year are truly encouraging. By combining our J-Brain Cargo^® platform with Acumen’s novel, AβO-selective antibodies, we aim to overcome the challenge of delivering biologics to the brain to potentially improve the ability to treat AD safely and effectively.”

“As we build on the strength of our sabirnetug program, we’re pleased to exercise our exclusive option to develop, manufacture, and commercialize, on a global basis, up to two candidates for the treatment of Alzheimer’s disease,” said Daniel O’Connell, Chief Executive Officer of Acumen Pharmaceuticals. “By pairing our AβO-selective antibody expertise with JCR’s blood-brain barrier-penetrating technology, J-Brain Cargo^®, we have the potential to deliver a next-generation therapeutic which could further expand and enhance the treatment paradigm for people living with Alzheimer’s disease. We look forward to sharing updates when they are available.”

AD is a progressive neurodegenerative disorder affecting more than 50 million people globally and is a leading form of dementia. One of its defining pathological hallmarks is the accumulation of Aβ in the brain, which are believed to trigger a cascade of events leading to neuronal damage, cognitive decline, and memory loss.¹ Delivering biologics across the BBB remains a fundamental obstacle to effectively treating the disease.

J-Brain Cargo^® is JCR’s proprietary platform that enables the systemic delivery of biotherapeutics to the central nervous system (CNS) through a mechanism known as receptor-mediated transcytosis. The technology has been clinically validated with IZCARGO™, the first approved drug in Japan to use the platform, for the treatment of a lysosomal storage disorder with CNS involvement. With broad potential to deliver a wide range of biologic therapies across the BBB, J-Brain Cargo^® is a versatile platform for advancing treatments for complex CNS conditions, including neurodegenerative diseases. The J-Brain Cargo^® technology platform has a well-established safety profile through several non-clinical studies, clinical trials and marketing experience in Japan.

The impact of this announcement on JCR's consolidated financial results for the fiscal year ending March 31, 2027, has already been factored into the current earnings forecast.

About Alzheimer’s Disease
Alzheimer’s disease is a progressive neurodegenerative disorder affecting more than 50 million people globally and is a leading cause of dementia. One of its defining pathological features is the accumulation of amyloid-beta (Aβ) in the brain, and increasing evidence highlights soluble Aβ oligomers as a particularly neurotoxic species that are thought to trigger a cascade of events leading to neuronal damage, cognitive decline, and memory loss.¹

About the J-Brain Cargo^® Platform Technology
JCR Pharmaceuticals has developed a proprietary blood-brain barrier-penetrating technology, J-Brain Cargo^®, to bring biotherapeutics into the central nervous system. The first drug developed based on this technology is IZCARGO™ (INN: pabinafusp alfa), which was approved in Japan for the treatment of a lysosomal storage disorder (LSD). With J-Brain Cargo^®, JCR seeks to address the unresolved clinical challenges of LSDs by delivering the enzyme to both the body and the brain.

About JCR Pharmaceuticals Co., Ltd.
JCR Pharmaceuticals Co., Ltd. (TSE 4552) is a global specialty pharmaceutical company that develops treatments that go beyond rare diseases to solve the world’s most complex healthcare challenges. We continue to build upon our 50-year legacy in Japan while expanding our global footprint into the U.S., Europe, and Latin America. We improve patients’ lives by applying our scientific expertise and unique technologies to research, develop, and deliver next-generation therapies. Our approved products in Japan include therapies for the treatment of growth disorder, MPS II (Hunter syndrome), Fabry disease, acute graft-versus host disease, and renal anemia. Our investigational products in development worldwide are aimed at treating rare diseases including MPS I (Hurler, Hurler-Scheie and Scheie syndrome), MPS II, MPS IIIA and B (Sanfilippo syndrome type A and B), and more. Our core values – Putting people first, Forging our own path, Always advancing, and Committed to excellence – mean that the work we do benefits all our stakeholders, including partners, patients and employees. We strive to expand the possibilities for patients while accelerating medical advancement at a global level. For more information, please visit JCR’s global website: https://jcrpharm.com/.

About Sabirnetug (ACU193)
Sabirnetug (ACU193) is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble amyloid beta oligomers (AβOs), which are a highly toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques. Soluble AβOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function, and induce neurodegeneration. By selectively targeting toxic soluble AβOs, sabirnetug aims to address the hypothesis that soluble AβOs are an early and persistent underlying cause of the neurodegenerative process in Alzheimer’s disease (AD). Sabirnetug has been granted Fast Track designation for the treatment of early AD by the U.S. Food and Drug Administration and is currently being evaluated in a Phase 2 study in patients with early AD.

About Acumen Pharmaceuticals, Inc.
Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AβOs, in its ongoing Phase 2 clinical trial ALTITUDE-AD (NCT06335173) in early symptomatic AD, following positive results in its Phase 1 trial INTERCEPT-AD. Acumen is investigating a subcutaneous formulation of sabirnetug using Halozyme’s proprietary ENHANZE^® drug delivery technology. Acumen is also collaborating with JCR Pharmaceuticals to develop an Enhanced Brain Delivery™ (EBD™)-enabled therapy for Alzheimer’s disease utilizing a transferrin-receptor-targeting blood-brain barrier-penetrating technology. The company is headquartered in Newton, Mass. For more information, visit www.acumenpharm.com.

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Reference

1. Sadigh-Eteghad S, Sabermarouf B, Majdi A, Talebi M, Farhoudi M, Mahmoudi J. Amyloid-beta: a crucial factor in Alzheimer's disease. Med Princ Pract. 2015;24(1):1-10. www.doi.org/10.1159/000369101.