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Intellect Neurosciences Issues Letter To Shareholders

Tau Programs:

Tau immunotherapy is gaining traction in the Alzheimer's field, and it has potential applications for many orphan indications, such as the many types of frontotemporal dementia, among other tauopathies.

TauC3 is a monoclonal antibody that uniquely targets a shortened form of tau protein known as ∆ tau that nerve cells produce after exposure to Aß. ∆ tau forms fibrils much faster than full-length tau and has been demonstrated to be a precursor of tangles commonly found in the brains of AD patients, as well as in the spectrum of diseases classified as frontotemporal dementias. The experiments we are conducting with our collaborators at UCI aim to validate ∆ tau as a therapeutic target and establish the potential of TauC3 for the treatment of AD and other tauopathies.  As recently announced, we have initiated in vivo studies from which we anticipate data in the third quarter of 2013. If positive, we could develop TauC3 either as a single molecule or antibody-drug conjugate using the CONJUMAB platforms.

TOC-1 is a monoclonal antibody that selectively targets yet another pretangle form of tau known as oligomeric tau. Oligomeric tau are small aggregates of tau that are thought to be extremely toxic and occur very early in Alzheimer's disease and other tauopathies. We currently are working toward re-engineering TOC-1 to produce a more druggable form of the molecule. This work is being undertaken in collaboration with two separate contract research organizations in Switzerland and China.  

Patent news

Tau patents: Intellect has established its position as a leader in tau immunotherapy with the publication of two Tau patent applications, which are accessible on the Internet: Patterson et al. 2011 Antibodies Selective for Pathological Tau Timers and Prefibrillar Tau Oligomers and their use in Treatment, Diagnosis and Monitoring of Tauopathies, published March 3 rd 2012 under Publication No. WO 2012/1493653 and Chain, 2011: Treatment of Tauopathies, WO 2012/106363 published November 15, 2012. We have received a Written Report in each case, but we do not generally respond to such reports that are non-binding until there is an action from a foreign patent office during the national phase filings based on the PCT applications. We plan to enter the national phase filings next summer.

ANTISENILIN patents: 

For reasons that are unclear to us, Johnson & Johnson and Pfizer are continuing in their opposition to our ANTISENILIN patent in Europe, having responded quite aggressively to our appeal notice and submissions even after the bapineuzumab Phase 3 results were announced. We are considering our response and strategy leading up to the Oral Hearings in Munich, which we anticipate will be scheduled for early next year.  Meanwhile, we are waiting for an Official Action from the EPO with regard to our pending divisional patent application that aims to overcome the formalistic objections raised in the opposition. If the EOP grants us a patent on this second application, the opposition becomes moot.

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