Big picture - Why invest in Genervon Biopharmaceuticals
Genervon Biopharmaceuticals Snapshot
Genervon is a closely held, clinical-stage biopharmaceutical company that is pursuing a new paradigm of drug discovery in the belief that multi-target drug development is the key to curing complex neurological disorders. Genervon discovered a naturally occurring regulator of the development of the human nervous system and has developed and synthesized a cationic, cell-penetrating peptide analog of that regulator. This peptide, which Genervon calls GM6, passes through the human blood-brain barrier and is safe and well-tolerated—as one would expect from a compound endogenous to human biology. GM6 also has been shown to modulate key biomarkers and multiple defective pathways associated with neurodegenerative disorders and to improve clinical outcomes for patients.
Genervon holds more than 80 patents worldwide and is currently planning late-stage clinical trials for GM6 for ALS, PD, AD and MS indications.
Genervon is a closely held, clinical-stage biopharmaceutical company focused on novel treatments for neurodegenerative diseases and disorders.
To date, no effective therapy has been developed for such conditions, but Genervon believes that its new paradigm of drug discovery has unlocked the potential for a wide range of therapeutic and even curative drugs.
It is well-known by now that neurodegenerative diseases and disorders are complex, multifactorial conditions, and that multiple biologic targets must be modulated to affect the disease in question. It is not surprising, then, that the current paradigm of single-target drug development continues to result in clinical trial failures with respect to neurodegenerative conditions. And yet for all this complexity, there is a considerable overlap of common pathways and targets across neurodegenerative diseases. It therefore stands to reason that something that could regulate these common underlying pathways and targets could have dramatic effects across a range of neurodegenerative conditions.
Building on this core hypothesis, in 1996 Genervon discovered what it believes is the naturally occurring regulator of the development of the human nervous system, called the “motoneuronotrophic factor” (MNTF), which is endogenously expressed at its highest levels at week nine of fetal gestation and remains detectable at very low levels in adult tissue. Extensive preclinical testing over many years suggests that MNTF regulates multiple key CNS-related biological functions—including neuronal differentiation, axonal regeneration, reinnervation, and inflammation and apoptosis—providing both neuroprotective and neuro-regenerative therapeutic effects.
Following a multi-year research and drug development effort, Genervon has advanced GM6, a 6-amino-acid active analog peptide of MNTF, into Phase 2 clinical development. Preclinical and clinical data have shown that GM6, which can pass through the blood-brain barrier, is safe and well-tolerated—as one would expect from a compound endogenous to human biology. Moreover, in Phase 2A trials for amyotrophic lateral sclerosis (ALS) conducted at leading research institutions (Massachusetts General and Columbia Presbyterian), as well as in more than two dozen compassionate use or expanded access applications around the world, GM6 has been shown to modulate key biomarkers associated with neurodegenerative disorders and to improve clinical outcomes for patients. Further, bioinformatic analyses have shown that GM6 promotes differential expression of numerous disease-associated genes related to ALS, as well as those related to Parkinson’s Disease (PD), Alzheimer’s Disease (AD) and Multiple Sclerosis (MS), suggesting that GM6 may effectively target the common pathophysiology underlying these conditions. (Click here for a recent press release on Genervon’s ALS strategy)
Genervon holds more than 80 patents worldwide for MNTF, GM6 and related compounds and processes and has obtained an orphan-drug designation and a fast-track designation for GM6 to treat ALS. Genervon is currently planning late-stage clinical trials for GM6 for ALS, PD, AD and MS indications. After 20 years of funding its own research and operations, Genervon is now actively seeking partners to help advance GM6 from a development-stage drug candidate to a marketable therapy for the many victims of neurodegenerative diseases and disorders that desperately need help.
Genervon holds 82 issued U.S. and international patents
The inventions include composition of matter patents which are directed to novel peptides and compositions capable of modulating viability and growth in neuronal cells and to methods of modulating neuronal cell viability and growth employing the novel peptides and compositions of the invention.
The patents include methods for treating neuronal disorders and diseases using motoneuronotrophic factor (MNTF) or its peptide analogs.
The inventions also include methods for inducing differentiation of an embryonic stem cell into a motor neuron using a motoneurontrophic factor (MNTF) or its peptide analogs. The patents further provides a method of enhancing the survival of the differentiated neural cells in long term cell cultures and provide compositions containing MNTF or its peptide analogs for therapeutic use in conjunction with stem cells.
Pipeline - please click here to see the current pipeline
For information on Clinical Trials please click here
For information on Trial Data please click here
For almost 50 years, Mr. Winston Ko, the Chairman and CEO of Genervon Biopharmaceuticals, has embraced entrepreneurial challenges as an investor and developer seeking to make a positive impact. Recognizing the lack of curative therapies for patients suffering from CNS diseases, Mr. Ko commissioned a team of scientists to find a novel endogenous embryonic stage regulator of the human nervous system. His team discovered this critical regulator, and Mr. Ko founded Genervon Biopharmaceuticals to develop a small peptide and active analog of this master regulator for the treatment of neurodegenerative diseases and disorders using a multi-target approach.
Winston Ko, MBA CEO, Chairman of the Board
Dorothy Ko, MS Chief Operating Officer
Raymond Chau, Ph.D. Chief Scientist
Mark Kindy, Ph.D. Director of Scientific Research
Frank Young, M.D. Regulatory Advisor
PC Chan-Yu, Ph.D. Clinical Research
Tony Shum, M.D. Medical Director
Lorraine DeCesare, R.Ph. Clinical Trial Manager
In addition, expert consultants, specialists, and contract research organizations contribute to the ongoing success of Genervon's research and development. The company is dedicated to streamlining the drug development and clinical trial processes through the use of contract research organizations (CROs). This strategy offers the benefits of fast delivery, higher levels of efficiency, and lowered costs associated with drug development.