Genervon Biopharmaceuticals LLC

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January 28, 2013 Issue

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Genervon Biopharmaceuticals is Well Positioned for Growth

Two ongoing CNS Phase 2 Clinical Trials and an additional pipeline of ten Phase 2 ready indications. Its novel first-in-class, human endogenous embryonic stage master regulator peptide drugs are for the nervous system.

Winston Ko
CEO
Mr. Winston Ko is the Chairman and CEO of Genervon Biopharmaceuticals.

About Genervon Biopharmaceuticals LLC

www.genervon.com

Genervon has discovered a novel, endogenous, embryonic stage family of nine, first-in-class, human master regulators peptide drugs of the nervous system and has 46 Composition of Matter and Use patents. One of the master regulators, GM600, has two ongoing Phase 2 clinical trials and an additional pipeline of ten indications Phase 2 ready.

Genervon scientists have confirmed that one of the master regulator peptides, GM600, regulates over 4,000 genes. They have mapped out the ALS mechanisms of action (MOA’s). GM600 controls and modulates over thirty known and significant ALS genes with positive effects, through at least eight pathways, potentially more, concurrently, systemically and dynamically, and up to twenty-two biological functions, including neurogenesis, neural development, neuronal signaling, neural transport, etc. Their master regulator peptide drug modulates not one but more than thirty ALS mutant genes with, not a cocktail of drugs, but one peptide drug.

GM604 also proved to be very effective in the disease modification of ALS animal models with mutant SOD1 genes and Wobbler mice models. It led to improved clinical scores in SOD1 mice. Moreover, GM604 delayed the onset of ALS symptoms by 27%, extended life by 30% and delayed the median clinical score deterioration time in ALS mice by 41%.

GM604 also provided neuroprotection against soluble inflammatory factors from ALS human patients' Cerebral Spinal Fluid (CSF) in vitro by 175%.

GM604 dramatically increased the survival life span by 500% (6 fold from 7-14 weeks to 55-65 weeks) and increased preservation of motoneurons by 160% (2.6 fold) in a Wobbler Mice Model for motoneuron diseases similar to ALS.

The discovery of endogenous, embryonic stage, human master regulators is changing the drug development paradigm from hitting a single gene/pathway to a comprehensive and dynamic, multi-factorial approach to treat complex Central Nervous System (CNS) disorders and systemic diseases. Genervon is at the forefront of a drug development paradigm shift that is beginning to be appreciated.

Genervon Biopharmaceuticals, LLC is an innovative clinical stage biopharmaceutical company providing breakthrough biological drugs for unmet medical needs.

Biopharmaceuticals

Central and Peripheral Nervous Systems

Genervon Biopharmaceuticals LLC

1055 E. Colorado Blvd., Fifth Floor
Pasadena, CA 91106
323-721-5500
www.genervon.com

info@genervon.com
 

Genervon - Print Version


 

Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – January 28, 2013

CEOCFO: Mr. Ko, what is the basic concept at Genervon Biopharmaceuticals?
Mr. Ko: Back in the 1990s, I founded Genervon Biopharmaceuticals with the goal of finding a cure for those who are suffering from CNS diseases because it is the most difficult part of the world’s unmet medical needs.

CEOCFO: What is so difficult about it? Why is it in that category?
Mr. Ko: CNS diseases involve the interplay of a highly complex, multi-factorial process of many non-dominant effectors in an interwoven dynamic network. It requires a new class of disease modification bio-drugs for the unmet need of serious and life threatening CNS diseases. I have to confess, it is very difficult to break from the classic paradigm of single target drug development, which has been prevailing in the scientific community and the pharmaceutical industry up to today. Genervon’s core insight and hypothesis back in the early 1990s is that embryonic stage master regulators for nervous system development are multi-factorial and are able to correct inadvertent errors in fetal development. Thus, they are life sustaining and potentially therapeutic for adults.

CEOCFO: What is your approach? How do you look at it, and how have you come up with something that is different?

Mr. Ko: We had to develop two novel proprietary technology platforms. The first is Protein Bands Selection by Function to find the fetal signal regulators. The second is In Silico Analysis to find active sites, e.g., we can identify the active sites of the Epogen. We also had to become experts in embryonic development, biologic systems, signaling and master regulator systems, genetics, genomics and mechanisms of action in multi-factorial processes.

CEOCFO: What have you developed so far? Where are you in the research?
Mr. Ko: Our discoveries after over fifteen years of leading-edge research in human embryonic development, utilizing our proprietary technology platforms, include a protein we call MNTF, its gene sequence and its chromosome location. Within the MNTF protein, we identified a family of nine embryonic stage, human, multi-factorial master regulators which govern nervous system development, protection and correction. These master regulators are highly expressed in week 9 of embryonic development, a time of incredible intricacies, but truly remarkable consistency as well. Genervon has developed one of the nine master regulators named GM600 for disease modification of CNS and neurodegenerative diseases and disorders. GM600 penetrates the Blood Brain Barrier (BBB) and activates many appropriate genes through multiple pathways to induce anti-inflammatory, anti-apoptotic, anti-oxidative and regenerative effects. GM600 is able to restore healthy nerve function. 

CEOCFO: What have you done with what you have found so far?
Mr. Ko: In order for you to understand the depth and substance of our discoveries, I can tell you a portion of the data we have collected over the years.

Spinal Cord Injury Studies: decreased lesion volume by 53%. Sciatic Nerve Gap Studies: increased motoneurons crossing 8mm gap by 150%. Wobbler Mice Studies (motoneurons degeneration model): increased survival life span by 500% and increase preservation of motor neurons by 160%. ALS SOD1 Mice Studies: delayed median clinical score by 41%, delayed symptoms by 27% and delayed death by 30%. Multiple Sclerosis studies: improved clinical score by 270%, reduced lesions in the brain by 68% and the spinal cord by 67%.  Parkinson’s Disease studies: increased monoamines and metabolite levels including dopamine, DOPAC and HVA in the brain by 600%, improved movements by 250%, improved behavioral score by 250% and preserved neurons in Substantia Nigra by 300%. Stroke Studies: reduced infarct volume by 56% (PMCAO in rats) and 73% (MCAO in mice); increased neurogenesis by 75%; decreased neurological deficit by 52%; reduced apoptosis by 65% and reduced inflammation by 75%. Our Stroke and PD clinical trials are in Phase 2 now.

The European Patent Office notified Genervon less than a month ago of its intention to grant a European patent on Methods of Treating Neuronal Disorders using MNTF peptides and analogs thereof. That will bring the portfolio of Genervon’s Composition of Matters and Use patents to 46.

CEOCFO: Has your approach to find master regulators been tried in the past or is the whole idea itself novel to Genervon?
Mr. Ko: Science and medical students who study System Biology 101 know that the human body is an interwoven, dynamic network and a holistic organism. The idea of a multi-factorial approach to treat complicated diseases is not novel but is a major paradigm shift. Single target drugs have been the dominating tradition and mindset dictating scientific research and drug development for the last several decades. In the last several years, there have started to be isolated voices calling for the drug development of multi-factorial signal/regulator peptides to make homeostasis possible, to influence nerve control of all internal organs and to deal with systemic diseases.

CEOCFO: Have the medical communities caught up with what you figured out at Genervon?
Mr. Ko: The discovery of endogenous, embryonic stage human master regulators by Genervon is changing the drug development paradigm from hitting a single gene/pathway to a comprehensive and dynamic, multi-factorial approach to treat complex CNS and neuro-degenerative diseases. Genervon is at the forefront of a drug development paradigm shift that is beginning to be appreciated.

CEOCFO: What about funding? It is always difficult, but particularly when you are taking more of a maverick approach. How far can your current funding take Genervon Biopharmaceuticals?
Mr. Ko: You are right. Mavericks cannot fight the system. I needed to stay focused in order to achieve my goals. I decided to bear all the risk of discovery and drug development and self-fund the company. A side benefit is that after more than fifteen years I still control 100% of the company. Our company is unique and unconventional.

CEOCFO: How do you deal, on a personal level, with the frustration of knowing that you have something that could really be game changing, and life changing, but it is such an arduous process to get it into use and for it to be accepted in any form?
Mr. Ko: Drug discovery and drug development cannot be hurried. For example, the Wobbler mice we worked with usually die after 7 weeks. With our drug, they lived for more than 65 weeks at MUSC. Instead of being frustrated about the time it took to finish the studies, I am pleased. The study of growing motoneurons across an 8 mm gap of the axotomized sciatic nerves with hundreds of animals at Johns Hopkins took us more than three years. Anyone who has counted motoneurons growth knows the pain.

CEOCFO: What are your next steps the next year or so?
Mr. Ko: Right now we have two ongoing Phase 2 clinical trials for ischemic stroke and Parkinson’s Disease indications. We also have a pipeline of ten more indications ready for Phase 2. I decided for the first time we will welcome partnerships with other companies, for them to license one indication each and to work with us to get clinical trials finished and file for NDA applications.

CEOCFO: Why should investors and people in the business community be paying attention to Genervon?
Mr. Ko: Simply put, investors are fifteen years closer to payback time. Master regulator are a new class of drugs. Our game changing, first-in-class master regulator peptide drugs for systemic diseases is a once in a lifetime investment opportunity that is available now for a limited time only.

CEOCFO: Do you have any final thoughts?
Mr. Ko: The reason why I accepted your invitation is because I hope your esteemed publication may be able to bring the Genervon message to the CEOs of the pharmaceutical industry.

CEOCFO: We have many readers that follow the bio industry, because we talk to many companies in your industry. It is definitely an area that people take a look at to know what is going on.
Mr. Ko: I am hopeful your online magazine will be able to bring our message to your audience. Only CEOs have the vision, courage and authority to be an internal corporate champion to implement paradigm shifting technology.

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“Genervon has discovered a novel, endogenous embryonic stage family of nine, first-in-class human master regulators peptide drug of the nervous system and has 46 Composition of Matter and Use patents. One of the master regulators, GM600, has two ongoing Phase 2 clinical trials and an additional pipeline of ten indications Phase 2 ready. Only CEOs have the vision, courage and authority to be an internal champion to implement paradigm shifting technology.”- Winston Ko

“Only CEOs have the vision, courage and authority to be an internal corporate champion to implement paradigm shifting technology.”

- Winston Ko

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