Patrys' CEO Presents at Asia Biotech Invest 2014
2014-06-04 · Patrys Ltd. · original patrys.com ↗
Investor Presentation Dr. Marie Roskrow, CEO & Managing Director June 2014 ASX: PAB Safe 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 Patrys in 2014 3 o ASX-listed microcap ($25M) Company o Oncology-focussed & clinical-stage o Deep pipeline of novel cancer-specific IgM monoclonal antibodies o Treasure-trove of novel cancer targets o Significant intellectual property portfolio o Network of Internationally-renowned collaborators o Experienced Board of Directors and Management Team o Headquarters in Melbourne, Australia. R&D centre in Würzburg, Germany IgM Technology Overview 4 61% IgM 12% IgA 27% IgG 40,000 MAbs Captured Proprietary antibody capture technology 99.90% IgM 0.10% IgG Spleen / lymph nodes isolated from multiple patients >300 MAbs Passed Screening Tests approx. 99.9% are IgM’s 14 products evaluated to date Pipeline 5 Product (Target) Discovery Phase I Preclinical PAT-SM6 (GRP78) PAT-LM1 (NONO) PAT-SC1 (CD55) PAT-SM6 (GRP78) PAT-SM3 PAT-NM1 Phase I Completed Phase I/IIa Completed 2013 Phase I/IIa Completed Out- Licensing Candidate Phase 2a Melanoma Multiple Myeloma Single Agent Solid Tumours Gastric Cancer Multiple Myeloma Combination Carfilzomib PAT-SM6 (GRP78) Phase I/IIa Commence 2014 PAT-SM6 Patrys’ Lead Antibody: PAT-SM6 PAT-SM6: o IgM isotype, λ-light chain o Isolated from stomach cancer patient o Targets tumour specific epitope on GRP78 o Binds also to oxidised LDL and VLDL Mode of Action: o Internalisation upon binding of oxidised LDL & GRP78PAT-SM6 o Internalisation triggers apoptosis In vivo & In vitro Reactivity: o Effective in multiple xenograft models o Expression data show specific expression in wide range of tumours incl. melanoma and myeloma 7 Multiple Myeloma - Opportunity Multiple Myeloma – Opportunity o Cancer of the plasma cells in bone marrow. Cells grow out of control and form tumours in solid bone, cause damage to other organs o Estimated to be more than 220,000 cases worldwide and incidence increasing o 5 year survival of ~30% o Market expected to increase from ≈$8B (2013) to >$15B (2018) o Market currently dominated by 3 products: • Revlimid (net sales $4.28B 2013) • Velcade (net sales $3.77B 2013) • Kyprolis® (carfilzomib) (net sales $272M 2013) o Several MAbs currently in clinical development but none approved to date. Likely to be used in combination therapies o Significant interest in MM from both large pharmaceutical and biotechnology companies 8 Multiple Myeloma – Pathology 9 o Abnormal plasma cells (myeloma cells) secrete lots of “useless” antibodies (M proteins) o Myeloma cells crowd out other blood cells resulting in anaemia, thrombocytopenia (bleeding) and leucopenia (infections) o Monoclonal gammopathy detected by electrophoresis o Abnormal proteins (Bence Jones) detected in urine Multiple Myeloma – Presentation 10 o Bone disease and hypercalcaemia o Abnormal protein deposits o Bone marrow failure Therapies for Multiple Myeloma 11 Proteosome inhibitors o Bortezomib (Velcade) o Carfilzomib (Kyprolis) IMIDs o Lanalidomide (Revlimid) o Pomalyst (Pomalidomide) o Thalidomide Chemotherapeutics o Melphalan o Cisplatin o Cyclophosphamide o Doxorubicin Stem cell transplantation o Autologous o Allogeneic Clinical studies o Small molecules o Antibodies, peptides o Immunotherapeutics Daratumumab (Genmab/Janssen Biotech,Phase II) Elotuzumab (BSM/Abbott, Phase III) BHQ880 (Novartis, Phase 1b/II) CD138 toxin- conjugated (BT062, Biotest AG, Phase I/IIa) PAT-SM6 (Patrys, Phase I/IIa) GRP78 Antibodies in all stages of clinical development MOR 202 (MorphoSys/Celgene, Phase I/IIa) Antibodies in Clinical Trials for MM 12 Phase I/IIa PAT-SM6 Monotherapy Trial 13 o 12 patients treated with 4 doses PAT-SM6 in 4 dose cohorts (0.3mg/kg, 1mg/kg, 3mg/kg and 6mg/kg/dose) evaluated at day +36 (end of trial) • 10 male, 2 female: median age 71 yrs • Received average 5 prior lines of therapy o PAT-SM6 safe in all patients. No dose limiting toxicity (DLT), no related serious adverse events (SAE) and no related adverse event grade ≥ 4 o No evidence of immunogenicity. PK analysis showed half-life of 7 hrs o PAT-SM6 specifically targets MM cells in vivo and stimulates significant immune responses o 4/12 patients had stable disease (day +36 post treatment) with a significant reduction in protein M levels in the peripheral blood o Patients who received prior treatment with proteasome inhibitors responded best to PAT-SM6 o Mean time to next therapy is 51 days (clinically significant). Two patients had stable disease for >130 days post treatment o 10/11 patients responded positively to drugs that they had previously been resistant to (i.e. PAT- SM6 makes cancer cells more sensitive to other drugs) Next Steps for PAT-SM6 14 o Execute new Phase I/II combination trial in relapsed / refractory MM: • Trial to be sponsored by Onyx Pharmaceuticals (Amgen) • PAT-SM6 in combination with carfilzomib (Kyprolis), 2nd generation proteasome inhibitor approved in USA July 2012 • Patrys to provide PAT-SM6 (large-scale GMP production currently ongoing) o Trial to be conducted in Germany under leadership of Professor Dr. Hermann Einsele (University Hospital, Würzburg) o Patrys retains worldwide rights to PAT-SM6 PAT-LM1 PAT-LM1 Antibody & Target 16 PAT-LM1: o IgM isotype, λ-light chain o Isolated from a lung cancer patient o Targets tumour-specific epitope of surface- expressed NONO (non-POU-domain-containing octomer binding protein) Mode of Action: o NONO mainly found in nucleus: involved in transcriptional & post-transcriptional gene regulation o Unknown mechanism-of-transport to cell membrane In Vivo & In Vitro Reactivity: o Effective in several xenograft models o Expression data show specific expression in a wide range of tumors incl. lung, pancreas, colon, leukaemias Crystal structure of NONO with PSPC1 Passon et al PNAS 2012 17 PAT-LM1 Preclinical Lung Squamous Cell Carcinoma Colon Adenocarcinoma + control - control PAT-LM1 Esophagus Squamous Cell Carcinoma Breast Ductal Adenocarcinoma PAT-LM1 binds C1q, suggestive of CDC IHC staining with PAT-LM1 on tumour tissues PAT-LM1 reduced tumour volume & induced cell-death Apoptotic cells Regression Necrosis Control tumor LM-1 treated tumor Cyto- keratin H&E B) Histology on excised tumoursA) Individual (symbols) and mean (bar) tumor volume (200µg) (n=10 per group) Control tumor PAT-LM1 treated tumor Cyto- keratin H&E OD655 0 0.05 0.1 0.15 0.2 0.25 0.3 0.35 0.4 20μg 10μg 5μg 1μg 0.5μg LM1 without C1q coating with 5μ/ml C1q coating Apoptotic cells Regression Necrosis Control tumor LM-1 treated tumor Cyto- keratin H&E B) Histology on excised tumoursA) Individual (symbols) and mean (bar) tumor volume (200µg) (n=10 per group) Control tumor PAT-LM1 treated tumor Cyto- keratin H&E Lung cancer xenograft 18 2014 Key Milestones Key Milestone Projected Timing (CY) PAT-SM6: o Final data from MM trial o Complete GMP manufacturing o Commence combination Phase I/II MM trial with Onyx (Amgen) o Preclinical data published 1Q, 2014 1H, 2014 2014 2014 PAT-LM1: o Commence manufacturing and scale-up work / Toxicology o Preclinical data published 2Q, 2014 1H, 2014 PAT-SC1: o Preclinical & clinical trial (gastric cancer) data published o Out-licensing deal 1Q, 2014 2014 Discovery Abs: o Target work on PAT-SM3 & 3 other early stage antibodies 2014 For Further Information Contact Details: Dr. Marie Roskrow, Chief Executive Officer / Managing Director Mr. Roger McPherson, Chief Financial Officer Ph: +61 3 9670 3273 Email: [email protected] Website: www.patrys.com
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