Medivir Ab · OMXSTO:MVIR
Medivir Ab — Investor Presentation (December 2019)
24 slides from Medivir Ab's investor presentation, December 2019
Slide 1: Corporate Presentation December 2019
CORPORATE PRESENTATION DECEMBER 2019
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: An oncology-focused development company set for growth
An oncology-focused development company set for growth Proprietary nucleotide-prodrug platform • Multiple opportunities for breakthrough oncology products • Spearheaded by MIV-818 and MIV-828 Advanced clinical programs for partnering/out-licensing • Remetinostat, Birinapant and MIV-711 The company •
Slide 4: Nucleotide-prodrug projects
Nucleotide-prodrug projects Slide 4
Slide 5: The nucleotide-prodrug concept: A versatile source of new oncology products
The nucleotide-prodrug concept: A versatile source of new oncology products • By combination of “prodrug tail” and a nucleotide, a tunable uptake in target cell/tissue can be achieved. • Once in the cancer cell, the prodrug is cleaved and an active nucleotide metabolite is formed. • This concept has
Slide 6: MIV-818: A liver-targeted nucleotide
MIV-818: A liver-targeted nucleotide • MIV-818 is an oral prodrug of the clinically effective troxacitabine • 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 incorp
Slide 7: MIV-818: A nucleotide-prodrug for primary liver cancer
MIV-818: A nucleotide-prodrug for primary liver cancer Current treatment options for hepatocellular carcinoma (HCC) provide little benefit. Because of the liver targeting and the mechanism of action, MIV-818 may provide an outstanding efficacy and safety profile. May be ideal as stand alone treatmen
Slide 8: Preclinical evidence for MIV-818 liver targeting
Preclinical evidence for MIV-818 liver targeting • MIV-818 exhibited substantial liver targeting by preferential formation of the active TRX-TP metabolite in liver of rats • The liver targeting of the TRX-TP metabolite was 100-fold higher for MIV-818 than for troxacitabine Compound Route Dose Liver
Slide 9: MIV-818 shows efficacy in preclinical HCC models
MIV-818 shows efficacy in preclinical HCC models Inhibition of tumour growth in mouse HCC Inhibition of patient-derived HCC cell lines in vitro xenograft models in vivo A : 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 In h ib itio n o f P D C s ( n = 1 5 ) D o s in g (p o B ID x 5 d
Slide 10: MIV-818: enhanced anti-tumor effect in combination with sorafenib
MIV-818: enhanced anti-tumor effect in combination with sorafenib in preclinical HCC models DNA damage (pH2AX) and hypoxia in mouse HCC B : C o m b in a t io n w it h M IV -8 1 8 a n d s o r a f e n ib in H e p G 2 m o d e l tumor model HepG2 1600 D o s in g p e rio d Vehicle MIV-818 V e h ic le + V
Slide 11: 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 effect, measured as DNA damage, observed in liver biopsies from tumor tissue in MIV-818 treated patients. Normal liver tissue does not appear to have been affected • This tumor selective effect was observed at low levels o
Slide 12: MIV-818 study design
MIV-818 study design Phase Ia • Intrapatient dose escalation Phase I RP2D • Objective: Establish the start-dose for phase Ib • A total of nine patients included • Start-dose for phase Ib determined Phase Ia (n=9) Phase Ib (n≤24) Phase Ib Intrapatient dose escalation Interpatient dose escalation • Cl
Slide 13: Potential role for MIV-818 in HCC treatment
Potential role for MIV-818 in HCC treatment Early stage disease currently treated with surgery, transplantation or chemo embolization Drug therapy in advanced disease provides 2-3 months of extended life expectancy: • 1st line therapy; sorafenib or lenvatinib • 2nd line therapy; several immuno-oncol
Slide 14: MIV-828 for acute myeloid leukemia
MIV-828 for acute myeloid leukemia Profile of MIV-828 • Nucleotide prodrug given intravenously • Active metabolite shown to have potent anti-leukemic activity in preclinical in vivo AML models • Increased activity and reduced susceptibility to pharmacologic resistance mechanisms of prodrugs • Precli
Slide 15: Assets for partnering
Assets for partnering Slide 15
Slide 16: Three advanced clinical-stage assets for partnering
Three advanced clinical-stage assets for partnering • The phase III ready remetinostat – a topical HDAC inhibitor for cutaneous T-cell lymphoma (MF-CTCL) and potentially basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). • The bivalent SMAC mimetic birinapant – currently in one combinatio
Slide 17: Remetinostat for MF-CTCL
Remetinostat for MF-CTCL • Formulated as gel for topical administration • Strong phase II efficacy and safety data • US-orphan drug designation for MF-CTCL • EOP2 discussions with FDA clarified that: o One placebo-controlled phase III study sufficient for approval o Co-primary endpoint required to d
Slide 18: Birinapant for solid tumors
Birinapant for solid tumors • Birinapant enables tumor cell death and augments the immune system. Has great potential to improve cancer therapy in combination with other treatments • Ongoing phase I study in head and neck cancer in combination with radiation • Phase II combination study with Merck’s
Slide 19: MIV-711 for osteoarthritis
MIV-711 for osteoarthritis (OA), the most common form of joint disease Successful placebo controlled phase II study of MIV-711 in OA: • MIV-711 showed significant effects on joint structure (bone and cartilage) after 26 weeks. • Trends favoured MIV-711 over placebo on knee pain and function. • Safet
Slide 20: Corporate information and milestones
Corporate information and milestones Slide 20
Slide 21: Corporate information
Corporate information • Founded in 1988 • Listed on Nasdaq Stockholm • Market cap around 590 million SEK, cash position at Q2-19: 192 million SEK • Has developed two drugs from idea to market: Xerclear and Olysio • Has established over 20 partnerships that generated over 400 million USD • Current fo
Slide 22: Experienced leadership
Experienced leadership Linda Basse, MD; PhD; CMO Abbott, Topo Target,Genmab, Zealand Uli Hacksell, PhD; CEO Astra, ACADIA, Cerecor Rikard Höse, MD; Med Dir. Karolinska University Hospital, Novartis Christina Herder, PhD; COO Pharmacia, Biovitrum Fredrik Öberg, PhD; CSO Uppsala University Magnus Chri
Slide 23: 2019 milestones
2019 milestones MIV-818: POC in phase Ia Q2 2019 New organization in place Q3 2019 Birinapant Head & Neck cancer phase I study started Q4 2019 Birinapant/Keytruda®: phase II futility analysis Q4 2019 MIV-818: Planned start of phase Ib Q4 2019 Slide 23
Slide 24: Key company goals 2020
Key company goals 2020 Drug development activities Business development activities MIV-818 • Continued intense partnering efforts with • Completing the phase Ib study remetinostat, birinapant and MIV-711 • Initiating discussions with FDA and EMA • Strengthened outreach to Asian pharmaceutical • Fina