ImmunoBrain Checkpoint Awarded $5 Million US NIA Grant for Phase 1b Alzheimer’s Disease Proof-of-Mechanism Study of Anti-PD-L1 IBC-Ab002

NEW YORK, Friday August 27, 2021 – ImmunoBrain Checkpoint Inc. (“IBC”) an innovative biopharmaceutical company developing potential disease-modifying immune therapies that harness the power of the immune system to help protect and repair the brain to combat neurodegenerative diseases, announced today that the National Institute on Aging (NIA) of the US National Institutes of Health (NIH) has awarded the Company a grant totaling $5 million over three years to support a first-in-human clinical study of IBC-Ab002, for the treatment of Alzheimer’s disease.

IBC-Ab002 is a proprietary anti-PD-L1 antibody developed and engineered with differentiating characteristics tailored to treat Alzheimer’s disease, based on a unique mechanism of action that has the potential to arrest, slow-down or even stop Alzheimer’s disease progression. Its development is based on studies carried out at the Weizmann Institute of Science, Israel, demonstrating that the immune system is needed for the maintenance of healthy brain function and repair, but may be impaired in patients with Alzheimer’s disease. IBC-Ab002 aims to empower the immune system to help defeat the disease and, thereby, to change the disease course and slow-down its progression.

In pre-clinical studies, treatment with an anti-PD-L1 antibody has been shown to reduce both amyloid-beta and tau, two key toxic proteins, alteration in the inflammatory milieu of the brain, preservation of synapses and neurons, and improvement in cognition as measured by learning/memory tests.

The phase 1b safety and proof-of-mechanism study of IBC-Ab002 in patients with mild Alzheimer’s disease is expected to start in the first half of 2022 in the UK, the Netherlands and in Israel. In addition to the NIA funding, the study will be funded in part by a grant received from the Alzheimer’s Association under the 2020 Part the Cloud + Bill Gates Partnership Grant Program.

Dr. Eti Yoles, IBC’s Chief Operating Officer, said: “We are grateful to the NIA for this vote of confidence in our novel approach. IBC is committed to finding a therapy that will bring relief to the millions of patients struggling with Alzheimer’s disease and their families.”

Dr. Jesse Cedarbaum, IBC’s Chief Medical Officer, said: “Aging is the major risk factor for the development of Alzheimer’s disease. With aging comes the seemingly paradoxical phenomena of ‘inflammaging’ and ‘immune exhaustion and senescence’. IBC-Ab002 is an antibody that has been designed with the goal of rebalancing the immune system to provide neuroprotection against Alzheimer’s disease and perhaps other neurodegenerative disorders. After a rigorous review process by scientists, clinicians, and key opinion leaders, we thank the NIA for its recognition that augmenting the body’s natural defenses could be an important avenue for treating Alzheimer’s disease.”

Professor Michal Schwartz, IBC’s Chief Scientific Officer, said: “Seeing the robustness of the effect in so many animal models, and on both symptoms and disease pathology, reinforces my optimism that we have the potential to activate a general mechanism needed for brain repair that will overcome many of the unique complexities of Alzheimer’s disease. I am very grateful to the NIA for its belief in and support of our novel therapy.”

Dr. Philip Scheltens, Director of the Alzheimer Center at the VU University Medical Center in Amsterdam and Principal Investigator for the planned clinical study, said: “I am pleased that the NIA recognizes the innovative approach of IBC, supporting its progress to the clinic. I am confident that these funds will help the IBC team to progress its therapeutic target through the clinical study here at Amsterdam UMC.”

There are no approved therapies for Alzheimer’s disease that have been shown to have a major impact on the clinical course of the disease. If successful, IBC’s therapy will be a first-of-its kind approach with the potential to change the course of Alzheimer’s disease and arrest its progression. The success of IBC’s approach would lead to better understanding of how the immune system helps protect the brain, would contribute to the understanding of the biology of Alzheimer’s disease, and could ignite a new era in developing therapies to combat this family of devastating diseases.

About ImmunoBrain Checkpoint

ImmunoBrain Checkpoint (IBC) is a biopharmaceutical company focused on developing novel disease-modifying immune therapies to combat neurodegenerative diseases, and in particular, Alzheimer’s disease. IBC’s IP platform emerged from the laboratory of Professor Michal Schwartz and licensed from Yeda, the commercialization arm of the Weizmann Institute of Science in Israel. IBC’s technology is based on more than 20 years of studies by Schwartz’s team, who pioneered the idea that the brain engages in a life-long dialogue with the immune system for its maintenance and repair, and that this communication is compromised in aging and Alzheimer’s disease. Schwartz’s team’s results in preclinical studies indicate that loosening the restraints from the immune system using antibodies that target inhibitory immune checkpoints (commonly expressed by exhausted immune cells), can rewire brain/immune communication, and thereby protect the brain from functional loss.

Previously, IBC received a $500,000 grant from the ALS Association to pursue a novel immunotherapeutic approach to treat ALS and identify optimal immune-checkpoint pathways to target, a $1,000,000 grant from the Alzheimer’s Association under the 2020 Part the Cloud + Bill Gates Partnership Grant Program, and additional support from the Israel Innovation Authority. www.immunobrain.com

About IBC-Ab002

IBC’s therapeutic approach seeks to harness the body’s own immune mechanism of repair to optimize the communication between the body and the brain. IBC-Ab002 is a proprietary antibody developed by IBC’s team led by Drs. Eti Yoles and Carol David, specifically optimized for IBC’s therapeutic mechanism of action. It is designed to transiently inhibit the activity of certain immune system molecules that act as “checkpoints” to restrain the activity of the immune system, and thereby enable a neuroprotective immunological cascade to combat the effects of neurodegenerative proteinopathy. In preclinical studies, anti-PD-L1 treatment was found to be effective in five different animal models of Alzheimer’s disease, including both amyloid and tau transgenic mice. In these studies, anti-PD-L1 antibody treatment reduced both cognitive deficits and toxic pathological proteins that accumulate in the brain.

IBC-Ab002 has also been engineered to have an improved safety profile relative to other antibodies with respect to inducing immune-mediated adverse effects. IBC plans to start its phase 1b clinical trial in the first half of 2022 in patients with early Alzheimer’s disease.

Disclaimer: Research reported in this press release will be supported by the National Institute On Aging of the National Institutes of Health under Award Number R01AG071810. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health

For more information, please contact info@immunobrain.com

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