Kazia Therapeutics Ltd · NASDAQ:KZIA
Kazia Therapeutics — Novogen — Investor Presentation (April 2017)
21 slides from Kazia Therapeutics's investor presentation, Apr 10, 2017
Slide 1: An emerging oncology drug developer with two clinical-stage programs
An emerging oncology drug developer with two clinical-stage programs Novogen Limited April 2017 NRT NVGN
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties and other factors that could cause the actual
Slide 3: Corporate Overview | Novogen's Transformation
Corporate Overview | Novogen’s Transformation Enhanced Pipeline GDC-0084 in-licensed from Genentech in October 2016 Under development for Glioblastoma (primary brain cancer) Completed phase I human trial in 47 patients Phase II human trial to start in 2017 Open IND with US FDA, strong IP protection,
Slide 4: Experienced New Management Team
Dr James Garner Chief Executive Officer & Managing Director Physician / MBA; Extensive pharma drug development experience Dr Gordon Hirsch Chief Medical Officer Physician / MBA; Twenty years of pharmaceutical industry experience Dr Peng Leong Chief Business Officer Eighteen years of business develop
Slide 5: Expertise | Global Scientific Advisory Board
Expertise | Global Scientific Advisory Board Professor Sir Murray Brennan Dr Karen Ferrante Professor Peter Gunning Professor Alex Matter New York Boston Sydney Singapore Former head of oncology research at Novartis Led team that discovered Gleevec® (imatinib), one of the first targeted therapies fo
Slide 6: Strategy | Accelerating Value Realisation
Strategy | Accelerating Value Realisation Partner with big pharma for late-stage development to bring to market Bring in under-valued assets from other pharmaceutical companies Conduct focused clinical trials Identify optimal patient groups Understand safety and dosing Engage with external experts I
Slide 7: Portfolio | Diversified Pipeline – Two Assets in Human Trials
Portfolio | Diversified Pipeline – Two Assets in Human Trials Lead Optimisation Preclinical Proof-of-Concept IND-Enabling Tox & CMC Phase I Clinical Trials Phase II Clinical Trials Patent Expiry SBP TRXE-002-1 Cantrixil 2035 SBP TRXE-009 Trilexium 2035 PI3K GDC-0084 2032 Ovarian Cancer Solid Tumours
Slide 8: GDC-0084 | How it Works
GDC-0084 | How it Works PI3K A central biochemical control mechanism in the growth of cells PI3K ACTIVATED PI3K INHIBITED TUMOUR GROWTH TUMOUR INHIBITION 85 – 90% of glioblastoma cases have PI3K ‘switched on’ GDC-0084 switches off PI3K activation, arresting growth of tumour cells >50% of patients at
Slide 9: Comparators | US-based PI3K Companies
Comparators | US-based PI3K Companies Single asset company with one PI3K inhibitor in phase I human trials US$ 122 million Market Cap One PI3K inhibitor in phase II human trials, one other drug in phase III, and two in animal testing US$ 600 million Market Cap One PI3K inhibitor in phase II human tr
Slide 10: GDC-0084 | What Makes it Different
GDC-0084 | What Makes it Different One PI3K inhibitor is already a marketed drug, providing validation for the approach Others PI3K inhibitors are in human trials against a wide range of cancer types GDC-0084 inhibits all the four main types of PI3K, whereas Zydelig mainly targets just one type GDC-
Slide 11: GDC-0084 | Unmet Need in Brain Cancer
GDC-0084 | Unmet Need in Brain Cancer Lung 14 million cancer cases per annum Breast Colon Prostate Stomach No clear cause or strong risk factors 3-4 months untreated survival 12-15 months average survival with treatment Any age, but most common in 60s Five-year survival 3 – 5% ( breast cancer: 90%)
Slide 12: GDC-0084 | Promising Human Trial Data
Efficacy Signals GDC-0084 | Promising Human Trial Data Safety Phase I safety trial conducted by Genentech 47 patients enrolled with advanced brain cancer Most common adverse events were mouth ulcers and increase in blood sugar (common effects of PI3K inhibitors) No evidence of liver, bone marrow, ki
Slide 13: GDC-0084 | Phase II Study Starting 2H 2017
GDC-0084 | Phase II Study Starting 2H 2017 Debulking surgery prior to study entry Radiotherapy + temozolomide Maintenance temozolomide Maintenance GDC-0084 R Phase II study design to target first-line patients, following surgery and radiotherapy Patients in United States, Australia and other countri
Slide 14: GDC-0084 | Longer-Term Expansion Opportunities
GDC-0084 | Longer-Term Expansion Opportunities Glioblastoma Metastatic brain cancer Other types of cancer Best opportunity to run a focused clinical program Fastest path to market Up to 10 times as many patients as glioblastoma Potential to expand use of GDC-0084 after a successful launch in gliobla
Slide 15: TRXE-002-1 (Cantrixil) | How it Works
TRXE-002-1 (Cantrixil) | How it Works Tumor cancer stem cells daughter cells Chemo-therapy Recurrence Data courtesy of Prof Gil Mor, Yale University Ovarian cancer tumours contain a mixture of different cell types Chemotherapy is not very active against ‘cancer stem cells’ Cancer stem cells importan
Slide 16: TRXE-002-1 | Unmet Need in Ovarian Cancer
Cause of death for 1 in 100 women 10% of cases are primarily genetic in origin TRXE-002-1 | Unmet Need in Ovarian Cancer Lung 14 million cancer cases per annum Breast Colon Prostate Stomach >60% of patients have disease spread at diagnosis 80% of patients are over 50 years of age Five-year survival
Slide 17: TRXE-002-1 | Significant Progress in Months
TRXE-002-1 | Significant Progress in 12 Months Feb – Jul 2016 Conduct of IND-enabling CMC and toxicology studies Aug – Sep 2016 Review of Investigational New Drug (IND) Application by US FDA, with successful approval after 30 day review period Oct – Nov 2016 Activation of clinical sites Shipping of
Slide 18: TRXE-002-1 | Human Clinical Trials Started in December 2016
TRXE-002-1 | Human Clinical Trials Started in December 2016 Trial Sites ~6 hospitals in United States and Australia Investigators are generally specialist gynaecological oncologists with clinical trial experience Patient Population Women with confirmed ovarian cancer Resistant or refractory to at le
Slide 19: Laboratory Research | Reprioritisation of ATM Projects
Laboratory Research | Reprioritisation of ATM Projects ATM-3507 (Anisina) Program Terminated – April 2017 Under development since 2013 Novel approach to targeting the structural components of cancer cells, based on research from UNSW Animal studies showed unfavourable balance of activity and toxicit
Slide 20: Milestones | Rich Series of Value-Driving Activities in 2017
Milestones | Rich Series of Value-Driving Activities in 2017 GDC-0084 (phase II study in brain cancer) Transfer of IND with US FDA Transfer of responsibility for intellectual property Completion of manufacture of capsules for trial Consultation with FDA to confirm approach Submission and approval of
Slide 21: Tel:(+61) 9472 4101 Email:[email protected]
Tel:(+61) 02 9472 4101 Email:[email protected]