Slide 1: Biotron Limited - BIO2019, Philadelphia
BIOTRON LIMITED (ASX:BIT) BIO2019 Philadelphia, PA
Slide 2: 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 3: 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 4: 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 5: 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 6: 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 7: 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 8: 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 9: 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 10: 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 11: 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 12: 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 13: 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