PAT-SM6 Overview

Patrys’ second product to enter clinic trials is PAT-SM6, a natural human antibody that binds to multiple types of cancer including solid tumours such as melanoma, breast, colon and pancreatic, as well as blood-based cancers such as multiple myeloma.

Following successful preclinical safety/ toxiciology studies, Patrys advanced PAT-SM6 into a first-in-human clinical trial in melanoma patients. This was a significant milestone for Patrys in a number of ways.

From a treatment perspective, the trial represented a significant opportunity for melanoma patients as PAT-SM6 is a novel antibody that kills cancer in a completely different way to any other treatment available today, such as chemotherapy, which is often ineffective and unsafe. More specifically, PAT-SM6 kills cancer by binding to a protein called GRP78 that is found on the surface of cancer cells but not on the surface of healthy tissues. At least 30 published scientific articles have reported that high levels of GRP78 have been detected in lung, gastric, colonic, oesophageal and liver cancers and melanoma. No other antibody products are known to be in development that target GRP78. GRP78 has been shown by independent researchers to play a key role in promoting tumour progression, metastasis and drug resistance to a variety of therapies.

Given the importance of GRP78 in cancer a product that interrupts the normal functioning of that protein offers real promise to cancer patients. Considering that no other products are in the clinic that target GRP78, this promise is only offered by Patrys' PAT-SM6.

The outcome of the PAT-SM6 trial has broader significance for Patrys as all of the Company’s anti-cancer products come from the same natural human antibody platform. The current clinical trial for PAT-SM6 was completed in February 2012.  Patrys met the primary endpoint of the trial and was able to show that the product was safe when administered as an intravenous single dose.  We are now able to move forward confidently to a multi-dose trial in multiple myeloma patients, and finance dependent a larger trial of patients with melanoma or other solid tumours such as pancreatic and colon cancers.

The success of this clinical result for PAT-SM6 is therefore indicative of the potential value of Patrys’ overall pipeline.

From a technology perspective, PAT-SM6 is the first product advanced to the clinic that has been manufactured using our proprietary natural human antibody production technologies.

Recent PAT-SM6 Milestones

• Approval of clinical trial at the Royal Adelaide Hospital
• Submission of human ethics application
• First two patient cohorts treated with no adverse events reported
• PAT-SM6 melanoma trial progresses to final patient cohort
• PAT-SM6 shows promise in multiple myeloma
• Patrys add second clinical centre for PAT-SM6 trial
• PAT-SM6 antibody detected in patient tumours
• PAT-SM6 shows promise in additional cancer indications
• PAT-SM6 large scale manufacturing reported to scientific community
• Completion of clinical trial

Upcoming PAT-SM6 Events

• Announcement of clinical trial results