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A Portfolio Approach To Developing Neuroprotectants

Cerbella

for Brain Health

NeuroPro

for Brain Health

Business

Alternative Model to Support Healthy Brain Function

competences cerbella_neuropro

Competences

Neurodyn Core Competences

Rx products

GLN-1062 (Galantamine prodrug), transferred to Alpha Cognition Inc. a SPV company founded by Neurodyn in 2016. Asset received FDA approval for treatment of mild to moderate Alzheimer’s dementia, July 2024 – to be marketed as
zunveyl

Progranulin/Granulin development program – ALS first indication

Natural Products

Cerbella for Brain Health

NeuroPro for Brain Health

Licensed to a marketing company co-founded by Neurodyn (2023) LifeSci Brands Inc.

Rx Development

Progranulin/Granulin Development Program

NLS has developed pre-clinical evidence of efficacy of Progranulin & Granulins derived from the full-length molecule, in preclinical models of Parkinson’s Disease*, Alzheimer’s Disease, Amyotrophic Lateral Sclerosis (ALS) and Spinal Muscular Atrophy.

ALS first indication.


*Parkinson’s disease data generated with 3 years support from zunveyl

parkinson
cerbella_neuropro

Progranulin

Potential Therapeutic for Several Neurodegenerative Diseases

What is Progranulin? A neuroprotective protein that has therapeutic potential across several neurodegenerative diseases. It functions as an autocrine neurotrophic factor and increases cell survival signaling pathways.

Progranulin is a highly conserved secreted glycoprotein that is expressed in multiple cell types, both in CNS and peripheral tissues.

Both full length progranulin and individual Granulins have been shown to be important in regulating cell growth, survival, repair, and inflammation.

Why choose ALS as the initial indication for therapy? TDP-43 and FUS are mis-localized to the cytoplasm in the vast majority of ALS cases, and contribute to compromised RNA metabolism, a hallmark of ALS pathology.

Neurodyn’s therapeutic candidates are intended to provide neuroprotection through reduction of TDP-43 & FUS proteinopathies as well as reduction of oxidative and neuroinflammatory stress. We anticipate that these benefits will mitigate the cascade of events that lead to loss of motor neuron function.

Neurodyn and our collaborators have demonstrated that Progranulin and importantly specific Granulins derived from the full-length molecule are able to mitigate TDP-43 pathophysiology.

Graphic: PROTEIN-CODING REGION OF HUMAN GRN GENE-chromosome 17q 21.32 https://nguyen-lab.com/slu/research/

Current Status

Progranulin/Granulin Development Program

Lysosomal

Because lysosomal function is highly disordered in neurodegenerative diseases, including ALS, we hypothesize that this blunts the therapeutic action of progranulin, such that it may be inappropriately or ineffectively processed in the context of the ongoing ALS pathophysiology.

Neuroprotective

For this reason, we are continuing, to develop therapeutic candidates based on granulins and granulin combinations that demonstrate the most potent neuroprotective activity, to circumvent the lysosomal processing stage of mature progranulin.

Optimal

The optimal granulin combinations(s) selected by in vitro evaluation of motor neuron survival, preservation of morphology, and protection from TDP-43 toxicity, as well as their ability to promote protective versus adverse microglial phenotypes, will be selected for in vivo testing.

Evaluate

We will evaluate their ability to mitigate disease development in a mouse model of ALS (TDP-43 transgenic mice) that exhibits a toxic TDP-43 pathology that essentially all ALS patients have.

Testing

Granulin combination(s) that limit disease in vivo will be further progressed for toxicology testing and submission of an investigational new drug application to the FDA – the start of clinical trials.

Success

The success of this development program has the real prospect of providing ALS patients with a truly disease modifying therapy.

Publications

Neurodyn Progranulin

Progranulin is Expressed within Motor Neurons and Promotes Neuronal Cell Survival

Ryan CL, Baranowski DC, Chitramuthu BP, Malik S, Li Z, Cao M, Minotti S, Durham HD, Kay DG, Shaw CA, Bennett HP, Bateman A.

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Progranulin Modulates Zebrafish Motoneuron Development in Vivo and Rescues Truncation Defects Associated with Knockdown of Survival Motor Neuron 1

Chitramuthu BP, Baranowski DC, Kay DG, Bateman A, Bennett HP

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Progranulin Gene Delivery Protects Dopaminergic Neurons in a Mouse Model of Parkinson’s Disease

Van Kampen JM, Baranowski D, Kay DG

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Neurotrophic Effects of Progranulin In Vivo in Reversing Motor Neuron Defects Caused by Over or Under Expression of TDP-43 or FUS

Chitramuthu BP, Kay DG, Bateman A, Bennett HP

Read More
Progranulin Gene Delivery Reduces Plaque Burden and Synaptic Atrophy in a Mouse Model of Alzheimer’s Disease

Van Kampen JM, Kay DG

Read More

Natural Products

Cerbella for Brain Health

NeuroPro for Brain Health

Licensed to a marketing company co-founded by Neurodyn (2023) LifeSci Brands Inc.

cerbella neuropro
cerbella Carmichael OT, Pillai S, Shankapal P, McLellan A, Kay DG, Gold BT, Keller JN. A Combination of Essential Fatty Acids, Panax Ginseng Extract, and Green Tea Catechins Modifies Brain fMRI Signals in Healthy Older Adults. J Nutr Health Aging. 2018;22(7):837-846. doi: 10.1007/s12603-018-1028-2. PMID: 30080229.

Cerbella

What makes Cerbella® different?

Employs amplified absorption technology, increasing brain bioavailability.
Highest purity and potency available on the market.
Proprietary composition & standardized concentration of ginsenosides (8%).
Fortified with green tea catechins and Omega 3 fatty acids.
Clinical validation of improved brain function by fMRI

Clinical Study Exceptional Results *
Cerbella had the following benefits in aging individuals:
elevated attention levels, and improvement of short-term memory.
increased many aspects of cognitive function, specifically executive functions
faster mental processing speed and generally more efficient brain function
most importantly no adverse events

Comments from the Pennington researchers that stand out:
The fact that so many aspects of cognition are elevated in response to Cerbella is intriguing and suggests that Cerbella may have an impact on multiple cognitive domains in elderly individuals.

it is likely that the blend of ingredients in Cerbella results in overall improvements in neuronal efficiency *
* The study was conducted by the Pennington Biomedical Research Center at Louisiana State University at Baton Rouge, recognized as a world leader in Nutritional research.

neuropro

NeuroPro

High purity 10% triterpenoid saponins (ginsenosides)

Ginseng claims:

scavenge free radicals (Kitts et al., 2000) and activates endogenous antioxidant enzymes in vivo (Gillis, 1997).
prevents neuronal cell loss in models of ischemia (Wen et al., 1996), hypoxia (Seong & Kim, 1997), glutamate toxicity (Kim et al., 1998), and ALS (Gillis, 1997).
inhibits dopaminergic depletion induced by methamphetamine in vivo (Oh et al., 1996).
afford mitochondrial protection, energy restoration and inhibition of apoptosis (Zhang et al., 2011).
activates insulin-like growth factor-I receptor (IGF-IR) signaling pathway (Xu et al., 2009).

Team

Leadership Team

Ken Cawkell
Ken Cawkell

Director, CEO

Ken has been involved in technology industries within public, private and venture capital markets as a professional advisor and as a principal and investor for over 35 years, principally as the co-founder Cawkell Brodie LLP, a Vancouver-based law firm. He is a founder and CEO of Neurodyn Life Sciences Inc., a private biotech company focused on developing natural based products to promote brain health and healthy ageing. Ken is also a founder, director and officer of Alpha Cognition Inc., a Vancouver-based biopharmaceutical company with a portfolio of innovative, product candidates targeting Alzheimer’s and other neurodegenerative diseases.

kcawkell@neurodyn.ca
+ 1 604 619 0990

Denis Kay
Denis Kay, MSc, PhD

Director, CSO

Denis is a co-founder of Neurodyn Life Sciences (NLS), and has acted as NLS’s Chief Scientific Officer since that time. Also a co-founder of Alpha Cognition Inc., he assumed the role of Chief Scientific Officer at ACI in 2017. He brings more than 30 years of experience in the development and characterization of animal models of neurological diseases, and 7 years of early-stage Central Nervous System clinical development experience. At NLS he was responsible for overseeing the development of Cerbella and its clinical evaluation. He is a grant recipient of the Michael J. Fox Foundation, the USAMRMC, and has received funding from numerous Government agencies for research and product development programs.

dgkay@neurodyn.ca
+ 1 902 314 0776