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June 30, 2017

AgeneBio Receives Grant from Alzheimer’s Drug Discovery Foundation for Drug-Discovery Program to Delay the Onset of Alzheimer’s Dementia

Novel GABA_A program targets hippocampal overactivity that leads to neurodegeneration and cognitive decline in Alzheimer’s disease patients

Baltimore, MD, June 28, 2017 — AgeneBio, a pharmaceutical company developing innovative therapeutics for unserved patients battling neurodegeneration, today announced that the Company has received an additional $750,000 grant from the Alzheimer’s Drug Discovery Foundation (ADDF). The grant will support drug development of AgeneBio’s novel GABA_A discovery program to treat mild cognitive impairment due to Alzheimer’s disease (MCI due to AD) and delay the onset of Alzheimer’s dementia. MCI due to AD is an intermediate stage between normal cognition and Alzheimer’s dementia in which memory and cognitive abilities are markedly worse than expected for a person’s age. Approximately 80% of patients with MCI due to AD progress to Alzheimer’s dementia within seven to 10 years. This is the third grant awarded to AgeneBio from the ADDF.

“AgeneBio’s GABA_A discovery program is a novel approach to delaying the onset of Alzheimer’s dementia by targeting the marked hippocampal overactivity that is present during MCI due to AD,” said Sharon Rosenzweig-Lipson, PhD, AgeneBio’s Vice President of Research and Development and the Primary Investigator on studies supported by this grant. “We are very grateful to the ADDF, a leader in supporting Alzheimer’s research, for its long-term support and confidence in our science. We have made significant progress in advancing the chemistry of our GABA_A program and look forward to furthering our program with this support.”

Howard Fillit, MD, Founding Executive Director and Chief Science Officer of the ADDF, said: “We are pleased to provide long-term support to AgeneBio for its novel approach to treating hippocampal overactivity, which occurs in the early stages of Alzheimer’s.”

AgeneBio’s portfolio of drug discovery work is based on the research of its founder and Chief Scientific Officer, Michela Gallagher, PhD, Krieger-Eisenhower Professor of Psychological and Brain Sciences and Principal Investigator of the Neurogenetics and Behavior Center at Johns Hopkins University.

For the last five years, AgeneBio has partnered with Hager Biosciences, a leading preclinical-stage drug discovery organization with innovative medicinal chemistry capabilities, to advance the chemistry of its GABA_A discovery program. With this funding, Dr. Rosenzweig-Lipson and the team from Hager will continue to advance this discovery program to target hippocampal overactivity, which prior research suggests is a major contributor to neurodegeneration and cognitive decline in patients with MCI due to AD. This program is designed to enhance the activity of GABA at the GABA_A alpha-5 (a5) receptor, which improves memory function under conditions of aging and hippocampal overactivity in preclinical testing.

“As the GABA_A program continues to progress, we are very optimistic about its potential to address MCI due to AD and delay the onset of Alzheimer’s dementia,” said AgeneBio President and CEO Jerry McLaughlin. “While we are in the early stages of development, we envision the potential for GABA_A to positively impact this medical crisis facing millions of patients and their families. We are honored to continue our valued relationship with the ADDF and to be a part of its vital work to find effective Alzheimer’s therapies.”

About GABA_A Drug Discovery Program

AgeneBio’s novel GABA_A α5 small molecule program is in discovery stage with potential to address unmet needs for several diseases of the central nervous system including MCI due to AD, autism and schizophrenia. The GABA_A α5 Positive Allosteric Modulator (PAM) program targets hippocampal overactivity, which prior research suggests is a major contributor to cognitive decline and MCI due to AD. GABA functions as an inhibitory neurotransmitter thus limiting overactivity of neurons. With a high density of GABA_A α5 receptors in the hippocampus, compounds that act as GABA_A α5 PAMs are well positioned to attenuate and control hippocampal overactivity. This discovery program is designed to enhance the activity of GABA at the GABA_A  a5 receptor, which improves memory function in preclinical testing under conditions of hippocampal overactivity and aging. Proof of biology studies demonstrate that GABA_A α5 PAMs from multiple structural classes occupy GABA_A α5 receptors in the hippocampus and improve memory impairment in aged animals.

About MCI due to AD, the Pre-Dementia Stage of Alzheimer’s Disease
MCI due to AD is a clinical condition between normal aging and early Alzheimer’s dementia characterized by impaired memory. There is no treatment for MCI due to AD, sometimes referred to as the pre-dementia stage of Alzheimer’s disease, and most patients progress to Alzheimer’s dementia within seven to 10 years. Today 5.6 million Americans and 25 million people globally suffer from MCI due to AD, and this population will double by 2030. By age 85, one of every three people will have Alzheimer’s disease. Alzheimer’s disease currently costs Medicare and Medicaid $150 billion in direct medical costs annually, which are expected to exceed $1 trillion by 2050. Data from the Alzheimer’s Association suggests that a five-year delay in the onset of Alzheimer’s dementia could reduce its prevalence by more than 40%.

About the Alzheimer’s Drug Discovery Foundation (ADDF)
Funding provided by the Alzheimer Drug Development Foundation, Inc. (ADDF).  ADDF catalyzes and funds drug discovery and drug development for cognitive aging and Alzheimer’s disease.  To learn more about ADDF, visit the website at: www.alzdiscovery.org.

About Hager Biosciences

Hager Biosciences is a leading preclinical-stage drug discovery organization based on innovative medicinal chemistry capabilities. Hager’s main mission is to become a preferred partner to pharmaceutical and biotech firms by providing therapeutic leads through out-licensing for unmet medical needs. Through effective collaboration, fostering and leadership of cross-functional scientists, Hager Biosciences has contributed significantly to the pipelines of several big pharma and biotech research organizations. Overall, Hager’s team authored/co-authored a combined total of more than 65 journal articles, and they hold more than 65 US or World Intellectual Property Organization patents.

About AgeneBio

AgeneBio, Inc., is a development-stage CNS biopharmaceutical company developing innovative therapeutics aimed at preserving and restoring brain function for unserved patients afflicted with neurological and psychiatric diseases. AgeneBio’s novel pipeline of therapies is based on decades of research at Johns Hopkins University and leading research centers worldwide showing that overactivity in the hippocampus contributes to cognitive impairment and drives neurodegeneration if not controlled. This overactivity is a characteristic feature of mild cognitive impairment due to Alzheimer’s disease (MCI due to AD), the symptomatic pre-dementia stage of Alzheimer’s disease. If approved, AgeneBio’s Phase 3-ready lead candidate AGB101 will be the first and only therapeutic targeting hippocampal overactivity and potentially the first therapeutic to slow progression to and delay the onset of Alzheimer’s dementia. AgeneBio also has a novel GABA_A alpha-5 small molecule program in discovery stage with therapeutic potential for a spectrum of untreated conditions including MCI due to AD, autism and schizophrenia. Learn more at www.agenebio.com and follow us on Twitter @AgeneBio.

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Jennifer Guinan | Sage Strategic Marketing | 610.410.8111 | Jennifer@sagestrat.com