Slide 1: Presentation at BIO 2019
Level 2, 66 Hunter Street Sydney NSW 2000 Tel: (61-2) 9300 3344 Fax: (61-2) 9221 6333 E-mail: pnightingale@biotron.com.au Website: www.biotron.com.au 7 June 2019 The Manager Companies ASX Limited 20 Bridge Street SYDNEY NSW 2000 (15 pages by email) Dear Madam, PRESENTATION AT BIO 2019 The Directors
Slide 2: About Biotron
About Biotron Biotron Limited is engaged in the research, development, and commercialisation of drugs targeting significant viral diseases with unmet medical need. The Company has BIT225 in clinical development for HIV-1, and a promising preclinical program for HBV. In addition, Biotron has several
Slide 3: Biotron Limited (ASX:BIT) BIO2019
BIOTRON LIMITED (ASX:BIT) BIO2019 Philadelphia, PA
Slide 4: Forward Looking Statements
Forward Looking Statements This presentation may contain forward-looking statements with respect to the financial condition, results and business achievements/performance of Biotron Limited (ACN 086 399 144) and certain of the plans and objectives of its management. These statements are statements t
Slide 5: Biotron Limited - Snapshot
Biotron Limited - Snapshot • Spun out from John Curtin School of Medical Research at the Australian National University • Infectious disease focus • Listed on ASX (ASX:BIT) • Pipeline of first-in-class small molecule, viroporin- • Headquartered in Sydney, Australia targeting inhibitors for key viral
Slide 6: Viroporins
Viroporins • Virus-encoded proteins, mainly found in RNA viruses • Form hydrophilic pores in host cell membranes • Involved in key stages of the viral cycle, including: • Virus entry and uncoating, • Transport through cellular compartments, and • Maturation, budding and release of infectious virus •
Slide 7: Pipeline
Pipeline LEAD INDICATION & COMPOUND DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 TARGET PROTEIN HIV-1 Vpu BIT225 Next Generation HIV-1 Vpu (Screening) HCV p7 BIT225 BIT314 HCV p7 (next generation) HBV Screening Potential Leads Dengue M Identified “Pan” Respiratory (incl Corona, Screening rhino, ade
Slide 8: HIV-1 Eradication
HIV-1 Eradication Current antiretroviral drugs do not cure HIV-1 infection • Current end points such as plasma viral load are inadequate • HIV-1 reservoirs set up early, leading to chronic, life-long infection • Not sensitive to current anti-HIV-1 drugs • New mode of actions drugs are needed to erad
Slide 9: BIT225 Targets HIV-1 in Reservoir Cells
BIT225 Targets HIV-1 in Reservoir Cells BIT225 targets HIV-1 Vpu protein, and inhibits assembly and budding of new virus in macrophage reservoirs A B (A) Untreated Controls B) BIT225 treated cells
Slide 10: BIT225-009 Phase 2 HIV-1 Trial
BIT225-009 Phase 2 HIV-1 Trial - Phase 2, 36 subject trial (placebo controlled, double-blinded trial, multisite trial) - HIV-1 positive, treatment-naïve commencing ART - BIT225 (200 mg once daily) or placebo added to treatment for 12 weeks - Completed in 2018 To determine whether BIT225 has a clinic
Slide 11: Results from BIT225-009 Trial
Results from BIT225-009 Trial Data from the BIT225-009 trial indicated that the antiviral effect of BIT225 resulted in: 1. Reduced macrophage-specific immune activation (sCD163) - Via reducing infectious virus within this key reservoir, and/or - Direct effect on HIV-1 Vpu - BIT225 inhibits Vpu funct
Slide 12: Significance of Results of BIT225-009 Trial
Significance of Results of BIT225-009 Trial • Provides evidence of potential benefit over and above current approved antiretroviral drugs (ART) • Evidence of immunological benefits that are not seen in subjects on ART alone • Support ongoing development of BIT225 • As a key component of future eradi
Slide 13: Hepatitis B Virus
Hepatitis B Virus • ~300 million worldwide chronically infected with HBV • Increased risk of significant liver disease, including liver failure and cancer • HBV causes up to 80% of liver cancers • 5 year survival of 15% • >780,000 die every year as a consequence of HBV infection • Current treatments
Slide 14: Hepatitis B Virus
Hepatitis B Virus • Biotron compounds appear to have a novel mechanism of action against HBV • Antiviral activity results in reduction of cccDNA and HBsAg levels in robust cell culture assays Targeting HBV cccDNA is one of the Holy Grails in the race to HBV cure • Lead optimization and selection is
Slide 15: Summary
Summary • Technology core is an antiviral platform with new class of small molecules with broad range of activities • Demonstrated proof of concept of successful targeting of viroporins with BIT225 • Significant value has been created, with completed Phase 2 trials • Solid package of data to support