Intellect Neurosciences, Inc. (ILNS)

INTELLECT NEUROSCIENCES

Intellect Neurosciences Inc. (OTCBB: ILNS) is a biopharmaceutical company engaged in the discovery and development of a new breed of innovative "disease-modifying" therapeutic drugs that are designed to slow, arrest and ultimately prevent Alzheimer's disease and other serious neurodegenerative disorders. 

Intellect is focused on neurodegenerative conditions collectively known as proteinopathies such as Alzheimer's, Parkinson's and Huntington disease.  Proteinopathies are caused by amyloidogenic proteins, such as amyloid beta, tau, alpha synuclein and Huntingtin.  Intellect is the first company to develop antibody drug conjugates (ADCs) in which amyloid clearing antibodies are empowered by chemically linking them to molecules that offer neuroprotection, creating a single drug.  The use of ADCs is one way in which Intellect is developing more effective drugs with the recognition that monotherapy may not be effective enough in treating the complex nature of proteinopathies. 

A second approach being pioneered by Intellect, also based on this idea and specifically focused on Alzheimer's disease, is a bi-specific vaccine that targets both beta amyloid and a pathogenic form of tau protein.  In contrast to antibodies that only target beta amyloid and have not yet proven their ability to treat mild to moderate Alzheimer's disease, the dual target vaccine being developed by Intellect has the potential to be used both prophylactically in presymptomatic patients and therapeutically in patients that are symptomatic.

Intellect Neurosciences has its origins in some of the earliest pioneering work that stimulated the development of the potential disease-modifying monoclonal antibodies that several global pharmaceutical companies have been testing as treatments for Alzheimer's disease. The intellectual property resulting from the discovery of how such antibodies could be used as treatments predates competitive strategies such that the pharmaceutical companies developing those drugs, purchased licenses to the technology from Intellect. The company remains ahead of the curve with respect to next-generation therapies, as it has developed multiple distinctive platform technologies that are generating drug candidates for a wide variety of diseases. 

The company developed OX1, a multimodal antioxidant molecule, through preclinical and human safety trials before licensing the program to ViroPharma.  ViroPharma has said it plans to enter Phase 2 clinical trials in patients with Friedreich's Ataxia, an orphan indication, in 2013.  Intellect could receive in excess of $100 million in milestone payments from ViroPharma and, if approved, royalties from sales over many years.

Intellect's preclinical R&D pipeline is based on two proprietary platform technologies, CONJUMAB-A and RECALL-VAX and includes the following drug candidates: 

CONJUMAB-A: Empowered Antibodies for the Treatment of Proteinopathies

N01-OX2 is a first-in-class ADC.  It is a humanized monoclonal antibody specific for beta amyloid protein that is empowered to deliver on-site neuroprotection by its conjugation to melatonin.  The goal of N01-OX2 is to reduce the oxidative stress that leads to cellular inflammation and damage.  N01-OX2 is being developed for the treatment of age-related macular degeneration (AMD), the leading cause of blindness in people over the age of 55. AMD therapies generate $4 billion annually, even though the few approved treatments don't cure the disease and offer only modest improvements in vision for most patients.  N01-OX2 also has potential applications for diabetic retinopathy, glaucoma, traumatic brain injury and Alzheimer's disease.

T01-OX2 is an ADC comprised of a monoclonal antibody selective for oligomeric toxic forms of tau protein and is empowered with neuroprotection by its conjugation to melatonin.  T01-OX2 is expected to reduce tau pathology and has potential for the treatment of Alzheimer's disease, Frontotemporal dementia and also has potential applications to treat ophthalmology indications.

RECALL VAX:  A chimeric peptide vaccine comprised of a human B cell epitope linked to a bacterial T cell epitope to produce highly specific vaccines against one or more amyloidogenic proteins.

RV03 is a first-in-class bi-specific vaccine targeting both beta amyloid and delta tau.  Delta tau is a shorter form of the tau protein.  It is especially toxic to nerve cells and precedes the formation of neurofibrillary tangles.  RV03 has potential for the treatment of Alzheimer's disease and Frontotemporal dementia. 

DANIEL CHAIN


Chairman of the Board/Director/CEO, Intellect Neurosciences

Daniel G. Chain, Ph.D., Chief Executive Officer. Dr. Chain formed Intellect in April 2005 and has served as our Chief Executive Officer since October 2005. In July 1999, Dr. Chain founded Mindset Biopharmaceuticals USA, Inc., a biopharmaceutical development stage company, and Mindset Ltd., an Israeli research and development subsidiary of Mindset Biopharmaceuticals USA. In 2001, Dr. Chain founded MindGenix Inc., a contract drug testing company, as a subsidiary of Mindset Biopharmaceuticals USA. He served as Chief Executive Officer of Mindset Biopharmaceuticals USA from July 1999 until October 2005, when he resigned as the Chief Executive Officer of Mindset Biopharmaceuticals USA and joined Intellect. Dr. Chain continues to serve Mindset BioPharmaceuticals USA and MindGenix as president of both companies. Under his employment agreement with us, he is permitted to spend up to 5% of his time in his capacity of president of Mindset Biopharmaceuticals and Mindgenix. Dr. Chain is the author of several scientific research publications in peer-reviewed journals in various fields. Dr. Chain's interest in biology of the human brain led to his invention of antibody-based therapies being developed for the prevention and treatment of Alzheimer's disease and to the invention of insulin sensitizers being developed to increase glucose utilization in the aging brain as a method to improve age-related cognitive impairment. Dr. Chain is a member of the Society for Free Radical Biology and Medicine, a member of the Royal Society of Medicine and the Society for Neuroscience. Dr. Chain obtained his B.Sc., with honors, in Biochemistry from the Institute of Biology in London and obtained his Ph.D. in Biochemistry from the Weizmann Institute of Science in Israel. He trained as a post-doctoral research fellow at the Center for Neurobiology and Behavior at Columbia University College of Physicians and Surgeons in New York. Dr. Chain is qualified to be a director of the Company based on his prior experience as a CEO and a director of biotechnology companies.

http://www.forbes.com/profile/daniel-chain/

PLATFORM TECHNOLOGIES

Intellect's preclinical R&D pipeline is based on four proprietary platform technologies: ANTISENILIN^Ò, CONJUMAB™, OLIGOTOPE™ and RECALL-VAX™

ANTISENILIN®: Free-end Specific Amyloid Beta Antibodies for Treatment of AD
 
IN-N01 is a humanized a high-affinity, stabilized, IgG4 therapeutic antibody that binds the amino terminus of amyloid beta without binding to the amyloid precursor protein (APP).
 
Antibodies exist in several isoforms; IgG1 antibodies have the strongest potential to induce inflammation while IgG4 has the lowest potential. IN-N01 is designed to promote the clearance of monomeric, oligomeric and plaque forms of amyloid beta, which accumulate in the brains of Alzheimer's patients or following traumatic brain injury and in the retina of the eye in patients with age-related macular degeneration, diabetic neuropathy and glaucoma.
 
CONJUMAB™: Empowered Antibodies for the Treatment of Proteinopathies
 
CONJUMAB-A is a first-in-class antibody drug conjugate for treatment of proteinopathies. IN-N01 has been empowered to deliver on-site neuroprotection by its conjugation to melatonin. Melatonin is a potent free radical scavenger and is an inhibitor of beta amyloid aggregation and previously shown to counteract the neurotoxicity associated with amyloid beta. Compounds based upon CONJUMAB-A are designed to reduce the oxidative stress and promote clearance of beta amyloid that is central to cellular inflammation and damage.
 
CONJUMAB-A is being developed for the treatment of age-related macular degeneration (AMD), the leading cause of blindness in people over the age of 55. CONJUMAB-A also has potential applications for diabetic retinopathy, glaucoma, traumatic brain injury, and Alzheimer's disease.
 
OLIGOTOPE™: Protein oligomer selective antibodies and methods of making them using chemically cross-linked stabilized aggregates as immunogens

TOC-1, our first compound utilizing the OLIOGOTOPE platform, is a murine monoclonal antibody selective for neurotoxic tau oligomers or aggregates considered to be the earliest pathogenic form of tau. Intellect plans to test TOC-01 as potential therapeutic for Alzheimer's disease and other tauopathies such as Frontotemporal dementia.
http://www.faqs.org/sec-filings/121015/Intellect-Neurosciences-Inc_10-K/#b
 
TauC3 specifically targets the neoepitope that is formed following cleavage of intact tau protein by proteolytic enzymes known as "executioner" caspases. This pathological process is stimulated by an accumulation of amyloid beta in the brain of Alzheimer's patients. It is believed that the smaller cleaved tau, referred to as delta tau, is especially toxic and prone to form tangles inside nerve cells and occurs early in the pathogenesis of the disease so antibody-mediated removal of delta tau would be expected to prevent the irreversible damage to nerve cells.
http://globenewswire.com/news-release/2013/02/07/521841/10020964/en/Intellect-Neurosciences-Initiates-in-vivo-Proof-of-Concept-Studies-in-a-Preclinical-Alzheimer-s-Model-for-Its-TauC3-Monoclonal-Antibody.html
 
 
RECALL VAX™: Chimeric peptide vaccine platform incorporating bacterial and human epitopes to target neoepitopes in pathological proteins
 
RV03, our first compound generated on the RECALL-VAX platform, is a first-in-class bi-specific vaccine targeting both beta amyloid and delta tau. Delta tau is a shorter form of the tau protein. It is especially toxic to nerve cells and precedes the formation of neurofibrillary tangles. RV03 has potential for the treatment of Alzheimer's disease and Frontotemporal dementias.
http://www.faqs.org/sec-filings/121015/Intellect-Neurosciences-Inc_10-K/#b
 

INTERNAL PIPELINE

One program under the RECALL-VAX platform has yielded two AD vaccine drug candidates, RV01 and RV02. RECALL-VAX™ has the potential to delay or prevent the development of Alzheimer's in those who are at risk by stimulating patients' immune systems to produce antibodies that clear amyloid betas and prevent further accumulation and deposition. Many view a vaccine of this nature, which is analogous to a flu shot, as the ultimate quest in Alzheimer's research.

Additionally,  CONJUMAB-A is Intellect's newly introduced platform technology for a novel class of therapeutics for treatment of Alzheimer's disease and other proteinopathies based on antibody-drug conjugates (ADCs).  The new ADC- based technology has the potential to improve on current methods of passive immunotherapy by increasing clearance of amyloid proteins while delivering potent cytoprotective molecules to sites of damage in the brain and other organs.  CONJUMAB-A is designed to reduce inflammation caused by amyloidosis while avoiding vasogenic edema, a side effect of plaque dissolution that occurs in some patients.   The company's lead CONJUMAB-A candidate is IN-N01-OX2, a non-activating, stabilized IgG4 humanized antibody specific for beta amyloid protein conjugated to melatonin, which is a naturally occurring molecule with potent anti-oxidant and anti-fibrillogenic properties. 

The Company has applied for a patent for its CONJUMAB-A technology. Intellect has the exclusively license to certain patents granted by the USPTO to NYU School of Medicine and the University of South Alabama Research Foundation specifically covering the use of melatonin for the treatment of Alzheimer's disease and other types of amyloidosis. The CONJUMAB-A platform is applicable to a broad range of diseases including, Alzheimer's, Parkinson's, Huntington's, Age-Related Macular Degeneration, Glaucoma, Cerebral Angiopathy, Frontotemporal Dementia, Progressive Supranuclear Palsy, Pick's disease, Cortical Basal Degeneration and Peripheral Amyloidosis.



http://www.intellectns.com/internal-pipeline
 

CORPORATE PRESENTATIONS

May, 2012

http://content.stockpr.com/intellectns/media/d58aaf7b67c66fcf7837102deeddaa6a.pdf


OneMedForum San Francisco 2012
January 11-14, 2012

http://ir.stockpr.com/intellectns/upcoming-events/view/143/onemedforum-2012

 

FINDING THE ANSWER TO ALZHEIMER'S

http://ir.stockpr.com/intellectns/videos
http://www.youtube.com/watch?v=STmiIVCFskA

 

MILESTONE PAYMENT

Intellect Neurosciences Sues Pfizer Over $2 Million Milestone Payment

The lawsuit has been in the making since the U.S. Patent and Trademark Office issued Intellect a patent in May covering the company's ANTISENILIN® monoclonal antibody platform technology for the treatment and prevention of Alzheimer's disease.  The patent is a fundamental component of a licensing agreement between Intellect and an unnamed major pharma.  Intellect believes that the allowance of the patent triggered a milestone payment of $2 to Intellect, but the big drug maker does not agree.

As with many licensing agreements, names are not disclosed as part of non-disclosure agreements, so gleaning the name of the global pharma from the news was impossible, but not too difficult to track-down.  First, an article published through Accesswire on July 15 offered commentary in saying,

"A news story from Reuters reports that the findings offer a bit of evidence that the drug, bapineuzumab, which is being developed jointly by Pfizer Inc, Irish drugmaker Elan, and Johnson & Johnson is having a desired effect. The news comes on the heels of a report from BioMedReports, a news portal which revealed for the first time on Tuesday that several big pharmaceutical companies originally licensed the drug's technology platform from Intellect Neurosciences (ILNS.OB) after the company's founder and chairman, Dr. Daniel G. Chain discovered and protected the humanized monoclonal antibody."

"Intellect recently announced that it has granted a royalty-bearing license to Wyeth and Elan Pharma International Ltd. (Elan) regarding patents and patent applications related to antibodies and methods of treatment for Alzheimer's disease including a co-exclusive license to Bapineuzumab under the ANTISENILIN(R) patents."

Since Pfizer bought Wyeth for $68 billion, "connecting-the-dots" lead to a common thread of the lawsuit being against Pfizer (NYSE: PFE) as the defendant in the lawsuit is unnamed and Elan's (NYSE: ELN) name doesn't seem to be under and NDA.  

A search with the New York State Supreme Court systeme confirmed that Pfizer is the defendant in the case that was filed on September 21, 2012.

The due diligence was not really necessary as the web search revealed Pfizer, but it did provoke the thought that Intellect probably has a licensing agreement with Johnson & Johnson (NYSE: JNJ) related to ANTISENILIN as well.

Commenting on the lawsuit, Daniel Chain, Ph.D., chairman and CEO of Intellect, said, "The idea that this global pharmaceutical company would attempt to withhold payment of a milestone payment stipulated in a license contract should be exceptionally distressing to every patent holder, especially small biopharmaceutical companies the size of Intellect Neurosciences, whose ability, in this case, to conduct critically important Alzheimer's research is dependent on receiving such payments from its licensees.  After exhausting all non-litigious options to secure our $2 million milestone payment, we realized we have no option save pursuing payment via the courts."

The patent discloses therapeutic antibodies to treat or delay onset of Alzheimer's disease and is based on discoveries that stimulated development of monoclonal antibodies that several global pharmaceutical companies have tested as treatments for Alzheimer's disease. The antibodies specifically bind to the ends of the beta amyloid protein without binding to the amyloid precursor protein (APP), which has important advantages compared to antibodies that do not have this feature, according to Intellect's press release today.

LAWSUIT

ANTISENILIN®

UPCOMING EVENTS