The next step is to ensure that sufficient product purity can be achieved, which has not been an issue previously. That will then move the company to the final toxicology studies with the purified antibody at the end of this year with clinical studies expected to start in around 12 months time.
Patrys CEO James Campbell said that the company has received very strong interest from Australian oncologists keen on trialing PAT-DX1 due to its highly novel mechanism of action. PAT-DX1 is naturally attracted to tumours, has been shown to cross the blood-brain-barrier, and strangely enters the cell nucleus and interrupts the DNA damage repair process which destabilises tumour growth, particularly in tumours with genetic mutations.
Whilst the Phase I study will be primarily designed to show safety, patients will be those with solid tumours who can be expected to benefit from the treatment. Of interest will be not just the compound's effect on tumours and therapeutic outcomes, but also if evidence of the compound crossing the blood brain barrier and entering the tumour cell nucleus can be established, supporting the data from animal studies.
PAT-DX1 crosses the blood-brain-barrier using the 'nuceloside transporter protein' ENT2 which is highly conserved across animals and humans according to Campbell.
In May Patrys appointed Dr Rebecca Tunstall as Vice President of Corporate Development. Dr Tunstall has a strong background in co-ordinating clinical studies, having formerly been head of clinical trials management in Australia at GlaxoSmithKline.
The successful completion of the engineering run of PAT-DX1 (pending meeting final purity specifications in coming weeks) is a significant milestone for Patrys. Manufacture of PAT-DX1 has been more difficult than other more traditional monoclonal antibodies, including PAT-DX3 which is following the lead compound and is more of a standard antibody compound. (PAT-DX1 comprises of two of the binding domains, joined together, of the original deoxymab antibody.)
Patrys is capitalised at $47 million with $12 million in funds at the end of March.
Bioshares recommendation: Speculative Buy Class B
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