Intellect Neurosciences Inc. (fka ILNS)

[montanus]

Lonza to make antibody conjugates for preclinical trials

By Gareth MacDonald+
01-Oct-2012

Lonza to make preclinical trial supplies of an antibody-drug conjugate (ADC) at its facility in Visp, Switzerland

Lonza will use its facility in Visp, Switzerland to make preclinical trial supplies of an antibody-drug conjugate (ADC) being developed by Intellect Neurosciences.
The candidate drug in question - IN-NO1-OX2 or Conjumab-A - combines one of Intellect’s beta amyloid protein targeting Antisenilin antibodies with a small molecule neuroprotective compound.

Under the contract, Switzerland-based Lonza will combine the core antibody with various neuroprotective compounds from its own library for further assessment by Intellect and several unnamed ‘specialised' contract research organisations (CROs).

Work on the project has already begun according to Stefan Stoffel, Lonza head of chemical manufacturing operations, who said: "We have already generated a detailed road map for the optimisation and manufacture of Conjumab-A, and are excited to be associated with this entirely novel and promising application for antibody-drug conjugates."

ADC development

The decision to develop and produce the candidate ADCs in Visp fits with plans Lonza outlined in August when it said making more high-tech, high-value pharmaceutical products and ingredients at the plant was key to increasing its competitiveness.

At the time recently appointed COO Beat In-Albon – who was called in to handle the ‘Visp Challenge ’ – said: “The focus will be on process production, process optimisation as well as the introduction of higher margin, new technology products.”

While it is hard to say how significant the Intellect contract is for Lonza – no financial terms were disclosed – the deal does underline the interest top tier contract manufacturing organisations (CMOs) have in ADC development and manufacture.

In recent years Lonza, SAFC, Goodwin Biotechnology and Piramal have invested in this type of manufacturing , while – in July – French firm Novasep invested €3m to add ADC production capacity at its plant in Le Mans.


http://www.in-pharmatechnologist.com/Processing/Lonza-to-make-antibody-conjugates-for-preclinical-trials


Pipeline activities:
Tue, Oct 16, 2012 9:35 AM EDT

Our antibody-drug conjugate platform, CONJUMAB, provides potential development of two independent antibody-based products from the same starting material, our compound, IN-N01. Our recent agreement with Lonza, with whom we signed a letter of intent, was an important step in the development of our first ADC, CONJUMAB-A. We are excited to have reached a point at which Lonza is now manufacturing the preclinical materials for the drug optimization and drug selection program, and look forward to testing these compounds in the near future. With sufficient financial resources, we could reasonably expect to file two INDs within two years, one for CONJUMAB-A initially focused on age-related macular degeneration and a second for IN-N01 for a second indication such as familial Alzheimer's disease or traumatic brain injury, both of which could qualify as orphan diseases.

Patent news:

We remain determined to secure our ANTISENILIN patents still under review by the USPTO and hopeful that this can be accomplished over the next few months. The demonstration using biomarkers that bapineuzumab reduces amyloid plaque and neurodegeneration in the brain of Alzheimer's patients provides compelling new evidence in support of the ANTISENILIN platform technology. Similarly, we plan to continue with the appeal process that we initiated in February to overcome the challenge to our patents in Europe.
We were disappointed by the failure of one of our global pharmaceutical licensees to pay the $2 million milestone payment triggered by the issuance of our patent by the USPTO on May 8, 2012 eventually leaving us no option except to pursue our claim in the courts. The action of our licensee in this regard is unconscionable and, in my opinion at least, an affront to the pharmaceutical industry that desperately needs to foster rather than thwart innovation at a time that global pharmaceutical companies are substantially reducing their internal R&D and relying more and more on companies such as Intellect Neurosciences to provide the next generations of high value therapeutics. The community at large should be aghast that a small company such as ours needs to divert attention and limited resources from its critically important mission of developing disease modifying therapies for Alzheimer's and other serious neurological diseases.

http://finance.yahoo.com/news/intellect-neurosciences-issues-letter-shareholders-133500792.html


Intellect Neurosciences Announces New Findings Supporting Its Tau Oligomer Selective TOC-1 Monoclonal Antibody for the Treatment of Alzheimer's Disease
By GlobeNewswire, November 06, 2012, 09:35:00 AM EDT


NEW YORK, Nov. 6, 2012 (GLOBE NEWSWIRE) -- Intellect Neurosciences, Inc. (OTCBB:ILNS), a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment of Alzheimer's and other neurological diseases, announced today scientists at Northwestern University have published new findings on its tau oligomer selective TOC-1 monoclonal antibody. These new data explain a phenomenon concerning the role of aggregated oligomeric tau as an inhibitor of fast axonal transport (FAT). FAT is the mechanism by which newly synthesized membrane and other proteins made in the nerve cell body essential for neuronal membrane function and maintenance are provided to the synapse.

The paper, titled, "Tau oligomers and tau toxicity in neurodegenerative disease," was written by Lester Binder, Ph.D., the Abbott Laboratories, Duane and Susan Burnham Research Professor of Genetic and Molecular Medicine, at Northwestern University. It appeared in the recent edition of Biochemistry Society Transactions.

"The inhibition of FAT requires a small stretch of amino acids termed phosphatase-activation domain, or PAD. Using a PAD-specific antibody, TNT1 and Tau oligomer selective antibody TOC-1, Dr. Binder's research group was able to demonstrate the PAD is more exposed in oligomeric tau leading to dissociation of the microtubules in diseased neurons. This leads to an increase in FAT inhibition and represents an early event in AD pathogenesis. These findings support our belief, shared by several global pharmaceutical companies with whom we are in discussions, that TOC-1 has important therapeutic potential," stated Daniel Chain, PhD, chairman and CEO of Intellect.

Intellect previously obtained development and commercialization rights to TOC-1 under an exclusive license agreement with Northwestern University and plans to develop it for the treatment of Alzheimer's disease (AD) and other tauopathies.

Dr. Chain will speak about Intellect's TOC-1 program at the International Drug Discovery Science and Technology (IDDST) conference November 8-10 in Nanjing, China.

Intellect Neurosciences, Inc. develops innovative approaches aimed at arresting or preventing Alzheimer's disease and other neurodegenerative diseases especially focused on proteinopathies. Intellect's pipeline includes therapeutic vaccines, antibodies and neuroprotective antibody drug conjugates. For more information, please visit www.intellectns.com.

The Intellect Neurosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=14741

Safe Harbor Statement Regarding Forward-Looking Statements:

The statements in this release and oral statements made by representatives of Intellect Neurosciences relating to matters that are not historical facts (including, without limitation, those regarding future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Intellect's product candidates and the sufficiency of Intellect's cash and other capital resources) are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that actual performance or results could materially differ, that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, or Intellect's ability to fund such efforts with or without partners. Intellect undertakes no obligation to update any of these statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly, any forward-looking statements should be read in conjunction with the additional risks and uncertainties detailed in Intellect's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in Intellect's Annual Report on Form 10-K (file no. 333--128226), filed on October 15, 2012.

CONTACT: Jules AbrahamJQA Partners, [e-mail]

http://www.nasdaq.com/article/intellect-neurosciences-announces-new-findings-supporting-its-tau-oligomer-selective-toc-1-monoclonal-antibody-for-the-treatment-of-alzheimers-disease-20121106-00803#.UOaT-W9FVHk


Daniel Chain Sues Pfizer for $2M

Posted in: Articles, biotechnology, neurological | October 17, 2012 at 6:32 am
Intellect Neurosciences has filed a breach of contract suit against Pfizer Inc. for failing to make a $2 million milestone payment for rights to its Alzheimer’s disease technology.
Intellect Neurosciences was founded by CEO Daniel Chain, who laid the groundwork for the technology in dispute with Pfizer during his tenure at Mindset, a Jerusalem-based startup.
Intellect contends that the licensing fee was triggered when the U.S. Patent and Trademark Office issued the company a patent on May 8 that covers its Antisenilin monoclonal antibody platform technology for the treatment and prevention of Alzheimer’s disease.
“It’s a distressing situation for us, a small company, to go head-to-head with a major company,” Intellect Neurosciences Chairman and CEO Daniel Chain said in a report to The Pink Sheet. The milestone payment “was clear, black and white in the agreement.”
Intellect Neurosciences’ patent discloses therapeutic antibodies to treat or delay onset of Alzheimer’s disease. The antibodies bind to both ends of the beta amyloid protein without binding to the amyloid precursor protein.
Following the recent American Neurology Association annual meeting, Chain posted an Oct. 9 personal perspective on the conference on the company’s homepage. “As the dust settles after the initial disappointing results from four major Alzheimer’s Phase III trials,” he concludes, the ANA “offered glimmers of light that renewed hope. The presenters and expert panelists conveyed a strong sense that Intellect is correct in its belief beta amyloid (Aß) plays a central and causative role in the pathogenesis of Alzheimer’s disease and that immunotherapy represents a realistic path forward. The next-generation drugs will have an improved probability of success because of the lessons we have learned.”


http://www.bioisrael.com/daniel-chain-sues-pfizer-for-2m