Oncology Drug Development

Transcription

1 Oncology Drug Development Presentation to BioShares Biotech Summit 2018 Queenstown, NZ 27 July 2018 ASX: KZA NASDAQ: KZIA

2 Oncology remains the largest and fastest-growing sector of the global pharmaceutical market Forecast Share of Total Market in % 16% Oncology Bubble Size = Forecast Market Size in % 12% 10% 8% Antirheumatics Antidiabetics 6% Antivirals Bronchodilators Antihypertensives Vaccines Sensory organs 4% MS Immunosuppressants 2% Antihyperlipidaemics Anti-fibrinolytics Anti-coagulants Anti-bacterials Dermatologicals 0% -5% 0% 5% 10% 15% Source: Evaluate Pharma, World Preview 2015 & Outlook to 2020 Forecast Sales Growth, CAGR 1

3 Oncology commands the largest share of capital investment and licensing and M&A dealflow Capital Investment Licensing Transactions Acquisitions Share of VC, IPO and FOPO funding, Share of licensing transaction value, Share of acquisitions by value, Oncology Oncology Oncology 26% 32% 30% Source: BIO, Emerging Therapeutic Company Investment and Deal Trends (2016) 2

4 However, oncology is one of the most challenging indications, with low LOA, and high R&D costs Likelihood of Approval (from Phase I) Median Cost of Development 0% 10% 20% 30% Hematology Infectious Disease Ophthalmology Other Metabolic Gastroenterology Allergy Endocrine Respiratory Urology Autoimmune Neurology Cardiovascular Psychiatry Oncology 1,600 1,400 1,200 1, US$ million Source: Amplion, Clinical Development Success Rates, ; Office of Health Economics, The R&D Cost of a New Medicine,

5 Kazia has implemented a strategy of developing high-quality oncology assets from external sources Identify Value Build Value Realise Value Bring in undervalued assets from other pharmaceutical companies $ Conduct focused clinical trials Identify optimal patient groups Understand safety and dosing Engage with external experts Proceeds of outbound licensing reinvested in earlier-stage assets Partner with big pharma for latestage development to bring to market Reduce cycle time and accelerate returns: 2-4 years to get to value inflection Improve portfolio strength: access the best global innovation Mitigate risk: bring in assets which already partially de-risked 4

6 Our license of GDC-0084 from Genentech has helped us build a promising mid-clinical oncology pipeline Preclinical Phase I Phase II Phase III GDC-0084 PI3K / mtor Inhibitor Licensed from Genentech in October 2016 Glioblastoma Multiforme (GBM) (Kazia-sponsored) Potential future studies and collaborations Potential future studies and collaborations TBD TBD TRX-E (Cantrixil) Ovarian Cancer (Kazia-sponsored) 5

7 Other companies have built successful businesses around in-licensed oncology products (NASDAQ: TSRO) (NASDAQ: PBYI) (NASDAQ: CLVS) 3 2 US$ billion $2.4 billion 3 2 US$ billion $2.2 billion 3 2 US$ billion $2.5 billion 1 $360 million 1 $440 million 1 $291 million 0 IPO (2012) Current 0 IPO (2012) Current 0 IPO (2011) Current Dec 2010 Jun 2012 Licenses rolapitant from Schering-Plough Licenses niraparib from Merck Oct 2011 Sep 2016 Licenses neratinib from Pfizer Submits NDA for neratinib Jun 2011 Jun 2016 Licenses rucaparib from Pfizer Submits NDA for rucaparib Oct 2015 Submits NDA for rolapitant Dec 2016 Submits NDA for niraparib Source: Bloomberg; Company SEC Filings; Crunchbase 6

8 7 There is a rich field of high-quality oncology assets available for partnering from Big Pharma

9 1. Differentiation of target assets is key 212 PI3K inhibitors, but only one is brain-penetrant 100% 80% 60% 40% Non- Oncology (39) Oncology (173) Discontinued / No Development (79) Discovery (54) No Published Evidence of Crossing Blood-Brain Barrier or Off- Target Toxicity (38) GDC-0084 Completed phase I clinical study in glioblastoma (n=47) Strong preclinical data package Strong theoretical rationale for development (PI3K disordered in ~90% of glioblastoma cases) 20% Ph I (17) Ph II (15) Marketed (2) Crosses BBB (1) Only brain-penetrant PI3K inhibitor in development for brain cancer 0% Ph III (6) PI3K Inhibitors Oncology Clinical Source: Thompson Reuters Cortellis Competitor Intelligence 8

10 2. Assets need to be partially-validated GDC-0084 had shown encouraging data in phase I Safety Efficacy Signals Phase I safety trial conducted by Genentech 47 patients enrolled with advanced glioma (grade 3/4); average of three prior lines of therapy Most common adverse events were oral mucositis and hyperglycemia (common effects of PI3K inhibitors) No evidence of liver, bone marrow, kidney toxicity, or mood disturbances Data presented at American Society for Clinical Oncology annual meeting in Chicago, June 2016 Arresting Tumour Growth Potentially Delaying Progression Slowing Tumour Metabolism GDC % Achieved stable disease 21% Remained on study for >3 months 26% Showed metabolic partial response on FDG-PET Comparison 21-52% in studies of Avastin in similar patients Median progression-free survival of 1 month* Potentially better predictor of clinical response than MRI * Taal et al., Lancet Oncology (2015): ORR and mpfs of Lomustine in 2L GBM were 2/41 (5%) and 1 months, respectively (n = 46) Schwarzenberg J, et al. Clin Cancer Res; 20(13);

11 3. Assets must target an unserved medical need Direct competition with Big Pharma is unattractive CASE STUDY: EVOLUTION OF MELANOMA TREATMENT Dacarbazine Interferon Complex, rapidly-evolving, and increasingly effective standard of care, with participation by multiple pharmaceutical companies makes melanoma a challenging indication Source: Kieger Report, Oncology Spring / Summer

12 Not everything responds well to IO therapies Immunologically Hot Immunologically Cold High infiltrate of non-functional CD8+ T-cells Low infiltrate of CD8+ T-cells Melanoma Lung Colorectal Gastric Ovarian Brain High potential for immuno-oncology therapies Likely to remain the focus of targeted therapies and new modalities 11

13 Most cancers are disaggregating to niche indications Lung Cancer Proportion of Cases 100% 80% 60% 40% 20% Unknown / Other NSCLC PIK3CA HER2 ALK BRAF EGFR KRAS Large Cell Squamous Non-Small Cell Small Cell ALK Inhibitors 2% of lung cancer cases 3 marketed products > $1 billion category 0% Source: Kantar Health 12

14 4. Development should focus on future partnership Top 10 Pharma companies own ~77% of the market WW Oncology Sales (US$, millions) 0 5,000 10,000 15,000 20,000 25,000 30,000 Share 2014 CAGR F Key Products 32.6% 2% % 11% 2020F 4.8% 22% 11.0% 4% 3.8% 18% 5.2% 9% 3.8% 14% 1.8% 24% 0.6% 50% 3.8% 9% Source: Company Websites; Evaluate Pharma, World Preview 2015 & Outlook to % 13

15 Number of Deals Projected Payment in USD M Clinical proof-of-concept is the key value driver Deals happen at all stages of development 60 but late-stage deals are most valuable Phase I Phase II Phase III Source: Thompson Reuters Cortellis Competitor Intelligence Discovery Phase I Phase II Phase III Current Status 14

16 Transaction values can provide remarkable ROI May Oncology M&A Deals in oncolytic virus; preclinical $1.0B June ,204 Oncology Licensing and Partnering Deals in pegylated recombinant IL-10; phase III February 2018 $1.6B $244 billion Aggregate value of Oncology Deals in tyrosine kinase inhibitor; phase II/III March 2018 $1.7B $9.0B Source: Clarivate Analytics; Kazia analysis CAR-T; (Celgene phase I) 15

17 Key Takeaways A licensing-driven strategy, focused on isolating particular components of the drug development value chain, is a viable approach to oncology drug development 1. Differentiation of target assets is key 1 2. Assets need to be partially validated 3. Assets must target an unserved medical need 4. Development should focus on future partnerships 4 16

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