Medivir AB · OMXSTO:MVIR
Medivir AB — Redeye Investor Meeting Göteborg 2019
23 slides from Medivir AB's conference presentation, Mar 28, 2019
Slide 1: Redeye Investor Meeting Göteborg
REDEYE INVESTOR MEETING GÖTEBORG 2019-03-28
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: Medivir – Recent events
Medivir – Recent events • Clinical Development focus on oncology • Birinapant/Keytruda® : completion phase I study – Q4 2018 • Birinapant/Keytruda® : start of phase II study – Q4 2018 • MIV-818: Start of phase I study – Q4 2018 • MIV-828: CD nomination – Q4 2018 • Uli Hacksell appointed as new CEO •
Slide 4: Broad and robust pipeline
Broad and robust pipeline PROJECT & MECHANISM DISEASE AREA RESEARCH PRECLINICAL PHASE I PHASE II PHASE III EXCLUSIVITY Cutaneous T-cell lymphoma (MF) Remetinostat IP: 2034 HDAC INHIBITOR (TOPICAL) Basal cell carcinoma1) IP: 2034 Birinapant Solid tumors IP: 2034 SMAC MIMETIC (INTRAVENOUS) (combo with
Slide 5: Remetinostat for early-stage MF cutaneous T-cell lymphoma
Remetinostat for early-stage MF cutaneous T-cell lymphoma Slide 5
Slide 6: MF-CTCL: orphan blood cancer indication
MF-CTCL: orphan blood cancer indication Cutaneous T-cell lymphoma (CTCL) affects lymphocytes (cells belonging to the immune defense system) located in the skin and typically has a chronic course. • CTCL is a rare form of non-Hodgkin lymphoma primarily present in the skin. Mycosis fungoides (MF) is t
Slide 7: Remetinostat: for treatment of early stage MF-CTCL
Remetinostat: for treatment of early stage MF-CTCL • Remetinostat is a histone deacetylase (HDAC) inhibitor • Remetinostat’s unique chemistry and topical formulation provides for activity in skin and rapid degradation in blood • Approved HDAC inhibitors not used in early- stage MF-CTCL patients • US
Slide 8: Remetinostat: clinical Proof-of-Concept phase II MF-CTCL study
Remetinostat: clinical Proof-of-Concept phase II MF-CTCL study Twelve months phase II data shows reduction in both lesions and severe itch Dose 1% 0.5% 1% 1x/day 2x/day 2x/day n=20 n=20 n=20 Lesion responses1 20% 25% 40% Well tolerated: • No HDAC inhibitor-associated systemic adverse events Patients
Slide 9: Remetinostat: next steps
Remetinostat: next steps • Medivir will further define a planned phase III design based on the requirements clarified by the FDA • One phase III study expected to be sufficient for FDA • Phase III study will enroll treatment-experienced patients • Medivir aims to identify a business partner for the
Slide 10: Birinapant: Uniquely potent against selected solid tumors
Birinapant: Uniquely potent against selected solid tumors Slide 10
Slide 11: Solid tumors: large unmet medical needs
Solid tumors: large unmet medical needs Many patients with solid tumors have few or no options and are in need of effective medicines to extend life. The immuno-oncology medicine Keytruda® on its own is not sufficiently effective in treatment of certain solid tumors. Colorectal cancer indication (CR
Slide 12: Birinapant may benefit patients with inadequate response to immuno-oncology therapies
Birinapant may benefit patients with inadequate response to immuno-oncology therapies • Birinapant, a SMAC mimetic, enables tumor cell death and augments the immune system • Great potential to improve treatment of cancers when combined with immuno-therapy • Ongoing collaboration with Merck for a pha
Slide 13: Birinapant/Keytruda combination - phase I/II study ongoing
Birinapant/Keytruda® combination - phase I/II study ongoing • Dose escalation completed; December 2018: n=19 o One CRC patient has achieved partial response, which had been maintained for over 1 year o Two patients had stable disease for 18 weeks o Safety and tolerability: No concerns o Phase II dos
Slide 14: MIV-818: Nucleotide prodrug for the treatment of liver cancer
MIV-818: Nucleotide prodrug for the treatment of liver cancer Slide 14
Slide 15: Liver cancer focus: HCC and intrahepatic cholangiocarcinoma
Liver cancer focus: hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma • HCC is the third leading cause of cancer-related deaths worldwide o Estimated new cases 2018: Asia: 610,000; US: 42,000; EU: 82,000; Sweden: 550 o Orphan disease in Western markets, but one of fastest gr
Slide 16: MIV-818: prodrug for enhanced efficacy and safety in liver cancer therapy
MIV-818: prodrug for enhanced efficacy and safety in liver cancer (HCC) therapy Troxacitabine MIV-818 Medivir • Clinically active but failed due prodrug • Enhanced activity to systemic dose-limiting technology • Selectivity for cancer toxicities • Improved delivery to the liver Phase I RP2D • Oral a
Slide 17: MIV-828: For acute myeloid leukemia
MIV-828: For acute myeloid leukemia Slide 17
Slide 18: MIV-828: Summary
MIV-828: Summary Acute myeloid leukemia (AML) leads to an overproduction of abnormal immature cells in the bone marrow and prevents development of normal blood cells, which could lead to anemia, bleeding episodes and a high susceptibility for severe infections. • Expected new cases 2018: US: 19,50
Slide 19: MIV-711: Cathepsin K inhibitor with FDA fast track status
MIV-711: Cathepsin K inhibitor with FDA fast track status Slide 19
Slide 20: Osteoarthritis (OA): the most common form of joint disease
Osteoarthritis (OA): the most common form of joint disease • Affects ~240m adults worldwide Cathepsin K protease is involved in the breakdown of collagen I in both bone and collagen II in cartilage • Prevalence increasing due to aging population and obesity epidemic Healthy knee OA knee • Current tr
Slide 21: MIV-711: positive effects on joint structure and signals of benefit
MIV-711: positive effects on joint structure and signals of benefit on clinical symptoms • Study design (MIV-711-201): 3 arms, 26 weeks treatment • Study design (MIV-711-202): 200 mg MIV-711, 26 additional weeks MIV-711-201: Change from baseline vs week 26 Placebo MIV-711 100 mg QD MIV-711 200 mg QD
Slide 22: Summary
Summary Slide 22
Slide 23: Strategic focus on cancer indications with high unmet need
Strategic focus on cancer indications with high unmet need Recent milestones • Birinapant/Keytruda® : completion phase I study – Q4 2018 • Birinapant/Keytruda® : start of phase II study – Q4 2018 • MIV-818: Start of phase I study – Q4 2018 • MIV-828: CD nomination – Q4 2018 Near term value inflectio