PATRYS LIMITED Annual General Meeting
Roger McPherson, CEO
12 November 2014
ASX: PABSafe Harbour Statement
This presentation contains forward-looking statements that are subject to risks and uncertainties. Such statements involve known and unknown risks that may cause the actual results, performance or achievements of Patrys Limited to be materially different from the statements in this presentation.
Actual results could differ materially depending on factors such as the availability of resources, the results of clinical studies, the timing and effects of regulatory actions, the strength of competition and the effectiveness of the Company's patent protection.
2 Annual General Meeting
November 2014
Key Focus Areas
IgM
o Oncology-focused clinical-stage Company
o Deep pipeline of novel cancer-specific IgM
monoclonal antibodies
o PAT-SM6 moving to next clinical trial
o Out-licensing program for clinical product PAT- SC1
o CAR T cell program
o Diagnostic focus for lead product PAT-SM6
o Network of Internationally-renowned
collaborators
o Experienced Board of Directors and
Management Team
3 Annual General Meeting
November 2014
Experienced & Capable Team
John Read Chairman
Mike Stork Non-Executive Director
Suzy Jones Non-Executive Director
Roger McPherson CEO (Interim), CFO & Company Secretary
Frank Hensel VP Research & Development
Deanne Greenwood Senior Director Business Development
Valentina Dubljevic Senior Director Operations
Stephanie Brändlein Research Group Leader Immunology
o International clinical and business development expertise
o Dedicated R&D team based in Würzburg, Germany
o Experienced in corporate financings, licensing and M&A transactions
o Extensive big biotech & pharma contacts
4 Annual General Meeting
November 2014
Pipeline
Product
(Target)
Discovery
Preclinical
Phase I
Phase 2a
PAT-SM6
(GRP78)
PAT-SM6
(GRP78)
Melanoma Multiple My a Single A tPhase I Completed
Phase I/IIa
Completed 2013
PAT-SM6
(GRP78)
Multiple Myeloma Combination CarfilzomibPhase Ib/IIa
Commence 2015
PAT-LM1
(NONO)
PAT-SC1
(CD55)
PAT-SM3
PAT-SM4
PAT-H12
Solid Tumou Gastric CancerPhase I/IIa
Completed
Out- Licensing
Candidate
5 Annual General Meeting November 2014
FY13 Programme Highlights - I
PAT-SM6:
Phase I/IIa multi-dose multiple myeloma trial:
o Completed Phase I/IIa clinical trial in multiple myeloma in Dec 2013
o Results showed indications of clinical efficacy with 33% of treated patients showing evidence of stable disease (SD) according to the International Myeloma Working Group (IMWG) criteria.
o The patients had a mean time to next therapy of 51 days
o Well tolerated with no serious adverse events (SAEs) or dose limited toxicities being reported at all dose levels tested.
o No evidence of immunogenicity and PAT-SM6 PK half-life of 7 hrs
o Positive results in "individual treatment" patient in combination with Velcade and Revlimid
Preclinical:
o PAT-SM6 showed promise in preclinical combination studies and several additional animal models
o ARC Linkage program underway investigating diagnostic utility of PAT-SM6
Commercial Achievements:
o Granted orphan drug designation in MM by the USA Food and Drug Administration (FDA) and the European Medicines Agency (EMA)
6 Annual General Meeting
November 2014
FY13 Programme Highlights - II
PAT-SC1:o Out-licensing program ongoing focused on Japan, China, South Korea and
India given the incidence of gastric cancer in these populations
PAT-LM1:o Program suspended due to insufficient funds
PAT-SM3, PAT-SM4 and PAT-H12:o Target identification work underway with Monash University based collaborators
Funding:o Raised $7.7 million from rights issue of targeted for $12.5 million
o Current funds focused on PAT-SM6 program
o Based on current plans, funds to second half 2015
7 Annual General Meeting
November 2014
PAT-SM6 & Carfilzomib Trial Timelines
Manufacturing/Paul Ehrlich Institut (PEI):
o Complications in the manufacturing process have resulted in a delay in final PAT-SM6 material being available for the planned combination clinical trial
o The manufacturing problems that have occurred were unforeseeable and have now been resolved
o Due to the delay with availability of final PAT-SM6 material there will also be a delay submitting regulatory documents for approval to PEI
o Finalisation of the protocol for submission to PEI is in progress
Anticipated Timelines
o Expect to submit documents to PEI early 2015 and pending approval recruitment for the clinical trial will begin in Quarter 2, 2015
8 Annual General Meeting November 2014
PAT-SC1 Out-Licensing Program
o A number of potential partners are evaluating PAT-SC1
o One potential partner generated excellent in vivo data with PAT-SC1
o PER.C6® license not available in many regions including India and China, therefore potential partners in these regions may need to generate a new cell line expressing PAT-SC1, for example Chinese Hamster Ovary (CHO)
cell line
9 Annual General Meeting November 2014
CAR T Cell Program
o CAR program underway with European based development company
o CAR constructs have been developed for 2 products in Patrys' pipeline. Cell surface expression has been confirmed and T-cell activation assays are underway
o Feasibility studies are being conducted and if data are positive the collaboration will be extended into 2015
10 Annual General Meeting November 2014
For Further Information
Contact Details:Mr. Roger McPherson, Chief Executive Officer
Ph: +61 3 9670 3273
Email: info@patrys.com
Website: www.patrys.com
|
distributed by
|
