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.