Mr. Rob Hutchison reports

BIOASIS PROVIDES SCIENTIFIC UPDATES ON ITS TRANSCEND PROGRAMS

Bioasis Technologies Inc. has results from its Her2+ brain tumour model with its lead therapeutic, MTfp-TZM. The company has also provided a scientific update relating to other programs.

The Bioasis neuro-oncology program

Bioasis has completed efficacy and other tests using Her2+ brain tumour animal models using its lead BBB (blood-brain barrier) delivery vectors melanotransferrin (MTf) and melanotransferrin-peptide (MTfp) to deliver the anti-cancer drug, trastuzumab (TZM), across the BBB. Fusion proteins comprising the cancer drug trastuzumab (TZM or Herceptin) and MTf (MTf-TZM) or MTfp (MTfp-TZM) were used. The purpose of these studies was to answer specific questions and provide data relating to taking MTfp-TZM into clinical trials. As a result of the combined studies and with the benefit of the full collection of data, the Bioasis board of directors supports moving MTfp-TZM to an IND (investigational new drug) and into clinical trials.

The recent results revealed that MTfp-TZM showed increased activity against Her2+ brain tumours when compared with other Transcend/trastuzumab conjugates that Bioasis has previously tested. MTfp-TZM reduced the size and number of brain tumours in the animal models and showed improved activity levels outside the brain compared with TZM alone. Statistically significant increased animal survival rates were also observed compared with the controls. An additional dose titration study confirmed tolerance at levels equal to that of current dosing in humans.

Chief executive officer Rob Hutchison commented: "We're very pleased with the latest results of the MTf-and MTfp-trastuzumab studies. MTfp-TZM met or exceeded our objectives, with the key data confirming the enhanced activity of the fusion protein, and as a result, our board of directors has placed a high priority on moving MTfp-TZM into the clinic. Until submissions are made to clinical regulators and to scientific publications, Bioasis will not be releasing quantitative data from the studies, but may do so at an appropriate time in the future."

The Bioasis lysosomal storage disease (LSD) program

In late 2014, Bioasis initiated a study using an animal model of lysosomal storage disease with Dr. Maurizio Scarpa and the Brains for Brain Foundation in Padova, Italy. The purpose of the study is to investigate the ability of Bioasis's Transcend BBB transport technology to deliver to the central nervous system the therapeutic enzyme required to correct the neurological disorder Mucopolysaccharidosis type II (MPS II), or Hunter syndrome. The study aims to determine whether a therapeutic quantity of idursulphase (I2S) can be delivered to the brain using Bioasis's Transcend fusion proteins, MTf-I2S and the MTfp-I2S, and whether the fusion proteins can restore normal function after intravenous administration.

The company is pleased to report that the portion of the study performed in live animals is now complete and that the histopathology analyses are currently under way. Early results indicate that the animals given the fusion protein MTfp-I2S had levels of glycosaminoglycan similar to those seen in the liver of wild-type (normal) mice. Glycosaminoglycan levels are elevated in liver cell lysosomes of MPS II-diseased mice.

The Bioasis siRNA program

On March 16, 2015, Bioasis announced the results of an ischemic stroke model performed using the Transcend peptide carrier, MTfp, coupled to a siRNA. In this study, the company demonstrated that the MTfp-siRNA therapeutic was successfully transported across the BBB, reduced the volume of the brain infarct and improved overall brain function as determined by neurological scoring.

The ischemic stroke model was undertaken as a proof-of-concept study due to the clear data readout this model provides. The goal of this study was to provide a therapeutic efficacy study to support licensing of MTfp to interested gene therapy companies for the treatment of CNS diseases such as Parkinson's disease and amyotrophic lateral sclerosis (ALS).

The Bioasis-Medimmune neuropathic pain program

Studies conducted by MedImmune LLC have produced data that illustrate certain desirable characteristics of the Bioasis peptide carrier, MTfp. To validate the peptide (MTfp) licensing model, MedImmune was provided with the amino acid sequence of MTfp. Using the MTfp sequence, MedImmune designed and manufactured a fusion protein comprising MTfp coupled to an antibody that targets a pain receptor in the brain. In an animal model, the fusion successfully crossed the BBB and also showed greater pain reduction than the currently used therapeutic.

Up to 5 per cent of the injected dose of the MTfp-antibody fusion entered the brain and showed peak transport at 24 hours. Active transport into the brain of between 3 and 4 per cent continued for more than 12 days. In contrast, the full-length MTf-antibody fusion showed a peak of brain exposure at approximatively two hours, which decreased afterward, exhibiting a half-life in plasma of five days. Importantly, administration of either MTf-antibody or MTfp-antibody fusion or conjugate produced a greater degree of analgesia in the neuropathic pain model when compared with administration of the antibody alone. Analgesia is dependent on the antibody entering the CNS.

Mr. Hutchison stated: "These results with MedImmune are of great importance for Bioasis and its licensing business model. We now know that the MTfp amino acid sequence can be provided to a licensee and the licensee will be able to build the sequence into its therapeutics with relative ease and with low manufacturing costs. In addition, the increased half-life observed with the MTfp transport vector results in a much higher exposure of the therapeutic in the brain, a key consideration for our potential licensing partners."

About Transcend

Transcend is Bioasis's proprietary platform for the delivery of therapeutics across the BBB to address unmet medical needs in the treatment of metastatic brain cancers as well as neurodegenerative and metabolic diseases. The BBB represents the single greatest challenge in treating neurological disorders. The ability to effectively and selectively breach the BBB offers the opportunity for Bioasis to deliver therapeutics into the brain. Transcend was originally based on MTf (melanotransferrin or p97) where the full-length protein was conjugated to therapeutic molecules. Recently, Bioasis identified a family of peptides within MTf that facilitate receptor-mediated transcytosis. The lead peptide carrier was used in the work reported above.

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