Medivir Ab · OMXSTO:MVIR
Medivir Ab — Investor Presentation (October 2020)
27 slides from Medivir Ab's investor presentation, October 2020
Slide 1: Cancerforskning i frontlinje – Temadag EPB
CANCERFORSKNING I FRONTLINJE – TEMADAG EPB STOCKHOLM OCTOBER, 2020
Slide 2: Important notice
Important notice You must read the following before continuing. The following applies to this document and the information provided in this presentation by Medivir AB (publ) (the “Company”) or any person on behalf of the Company and any other material distributed or statements made in connection wit
Slide 3: Table of content
Table of content Slide 3
Slide 4: Table of content
Table of content 1. Executive summary 2. MIV-818 o Mode of action and preclinical data o Clinical development o Potential indications 3. Other assets 4. Milestones and summary Slide 4
Slide 5: Executive summary
Executive summary Proprietary clinical asset • MIV-818 – A liver directed nucleotide prodrug • In phase Ib clinical development Founded: 1988 • Opportunities for breakthrough oncology indications Listed: Nasdaq Stockholm Location: Stockholm The company Cash position: c. SEK 95M1) • Building on an ex
Slide 6: Focused clinical program
Focused clinical program Nucleotide prodrug Indication Research Preclinical Phase I Exclusivity MIV-818 Liver cancer IP : 2035 Multiple programs for partnering/out-licensing Compound Mechanism Indication Phase I Phase II Phase III Exclusivity Remetinostat Topical HDAC MF-CTCL1) IP : 2034 SCC BCC Bir
Slide 7: MIV-818 Mode of action and preclinical data
MIV-818 Mode of action and preclinical data Slide 7
Slide 8: MIV-818: A liver-directed nucleotide
MIV-818: A liver-directed nucleotide • MIV-818 is an oral prodrug • Once absorbed from the GI-tract, MIV-818 is transported to the liver • The prodrug is taken up by liver cancer cells and converted into troxacitabine triphosphate (TRX-TP) • TRX-TP is incorporated into DNA and causes double-strand D
Slide 9: Troxacitabine - Background
Troxacitabine - Background • Developed by Shire Biochem Inc. and SGX pharmaceuticals • Nucleoside analogue with anticancer activity • Administration route, intravenous injection • More than 700 patients have received the drug in phase I/II/III trials • In a 48 patient phase I/II trial in AML, 5 pati
Slide 10: Preclinical evidence for MIV-818 liver targeting
Preclinical evidence for MIV-818 liver targeting Compound Route Dose Liver TRX-TP/Plasma (µmol/kg) TRX (AUC ratio) Troxacitabine (TRX) iv 80 <0.016 MIV-818 oral 80 1.9 • MIV-818 exhibited substantial liver targeting by preferential formation of the active TRX-TP metabolite in liver of rats • MIV-818
Slide 11: MIV-818 shows efficacy in preclinical HCC models
MIV-818 shows efficacy in preclinical HCC models Inhibition of tumor growth in mouse HCC Inhibition of patient-derived HCC cell lines in vitro xenograft models in vivo In h ib itio n o f P D C s ( n = 1 5 ) M IV - 8 1 8 d o s e -r e s p o n s e in H e p G 2 m o d e l 100 D o s in g (p o B ID x 5 d )
Slide 12: MIV-818: enhanced anti-tumor effect in combination with MKI in preclinical HCC models
MIV-818: enhanced anti-tumor effect in combination with MKI in preclinical HCC models C o m b in a t io n w it h M IV - 8 1 8 a n d s o r a fe n ib (N = 8 ) C o m b in a t io n o f M IV - 8 1 8 a n d L e n v a t in ib (N = 1 0 ) D o s in g p e rio d D o s in g p e rio d 1600 1600 V e h ic le V e h i
Slide 13: Summary
Summary • Preclinical evidence of increased liver targeting with MIV-818 vs i.v. troxacitabine • MIV-818 has demonstrated efficacy in multiple preclinical HCC models • Pharmacodynamic markers for DNA-damage e.g. phosphorylation of histone 2AX (pH2AX) • Evidence of activity in hypoxic regions of tumo
Slide 14: MIV-818 Clinical development
MIV-818 Clinical development Slide 14
Slide 15: MIV-818: Phase Ia objectives
MIV-818: Phase Ia objectives Primary objectives • To assess safety and tolerability of escalating doses of MIV-818 in patients with Hepatocellular carcinoma (HCC), Intra hepatic cholangiocarcinoma (iCCA), or metastatic liver disease and to establish the phase Ib start dose Key secondary and explorat
Slide 16: MIV-818: Selective effect signal in liver cancer in phase Ia
MIV-818: Selective effect signal in liver cancer in phase Ia • Clear signs of cell death, measured as DNA damage, observed in liver biopsies from tumor tissue in MIV-818 treated patients • The tumor selective effect is an early proof-of-concept of the intended liver-directed effect in patients Pre-d
Slide 17: MIV-818: Conclusions from phase Ia
MIV-818: Conclusions from phase Ia • Adverse events were generally mild and the few severe adverse events were reversible • Only low levels of MIV-818 and acceptable exposure to troxacitabine were observed in blood after two treatment cycles • Liver biopsies showed selective DNA damage in tumor tiss
Slide 18: MIV-818: Phase Ib study conduct and objectives
MIV-818: Phase Ib study conduct and objectives Study conduct: Classic 3+3 dose escalation study in HCC, iCCA and liver metastatic disease patients Part A will be conducted as a monotherapy and Part B as add-on to SoC Six sites: 4 sites in United Kingdom and 2 in Belgium Objectives: Primary: Establis
Slide 19: MIV-818: Clinical development plan in advanced liver cancer
MIV-818: Clinical development plan in advanced liver cancer Phase Ib -Part A Phase Ib - Part B Phase Ib monotherapy Phase Ib add-on to SoC (n=up to 30) (n=up to 30) Next phase add-on to SoC Interpatient dose escalation Interpatient dose escalation Example: MIV-818 + SoC vs. Placebo + SoC 3+3 design
Slide 20: The liver cancer therapeutics market
The liver cancer therapeutics market Slide 20
Slide 21: Potential target populations
Potential target populations US 5EU 7MM/8MM • iCCA and HCC are indications with Intrahepatic CCA (iCCA) cancer in the liver Diagnosed incident cases 5,000 5,500 12,5001 Diagnosed prevalent cases 7,000 8,000 18,0001 • iCCA and HCC are orphan indications • Company has received orphan HCC designation f
Slide 22: Global market for HCC and Colorectal cancer
Global market for HCC and Colorectal cancer HCC Sales Forecast ($m) Colorectal Cancer Sales Forecast ($m) 3 500 12 000 3 000 10 000 2 500 8 000 2 000 ($m) ($m) 6 000 1 500 4 000 1 000 2 000 500 0 0 2018 2025 2018 2025 US EU5 JP China US EU5 Japan China • HCC sales in 8 major markets are estimated to
Slide 23: MIV-818 has a unique profile
MIV-818 has a unique profile • Unique profile vs approved drugs in iCCA, HCC and CRC • DNA-breaking, small-molecular approach, which selectively reaches all tumour cells irrespective of genetic cause. • The orally administered prodrug MIV-818 is directed to the liver providing both efficacy and safe
Slide 24: Other assets
o 3 ssets > . 9 a “3? ee “Other a
Slide 25: Multiple programs for partnering/out-licensing
Multiple programs for partnering/out-licensing Compound Mechanism Indication Phase I Phase II Phase III Exclusivity Remetinostat Topical HDAC MF-CTCL1) IP : 2034 SCC BCC Birinapant SMAC mimetic HNCC2) IP : 2034 MIV-711 Cathepsin K OA3) IP : 2034 inhibitor 1) Indications: basal cell carcinoma, squamo
Slide 26: Partnering deals executed in 2020
Partnering deals executed in 2020 • Preclinical research deal with Tango Therapeutics • Entered into a license agreement for Chinese rights with Yuanmai Biotech with our product Xerclear® for labial herpes • Option agreement with a biotech company for an undisclosed preclinical research project Slid
Slide 27: Executive summary
Executive summary Proprietary clinical asset • MIV-818 – A liver directed nucleotide-prodrug • In phase Ib clinical development, Founded: 1988 • Data from part A expected in Q1-2021 Listed: Nasdaq Stockholm Location: Stockholm The company Cash position: c. SEK 95M1) • Building on an experienced lead