Medivir Ab · OMXSTO:MVIR
Medivir Ab — Investor Day (October 2021)
33 slides from Medivir Ab's investor day presentation, Oct 14, 2021
Slide 1: ProHearings 14 October 2021
PROHEARINGS 14 OKTOBER, 2021
Slide 2: Today's presenters
Today’s presenters Interim CEO, Chief Scientific Officer Chief Financial Officer Magnus Christensen Fredrik Öberg Slide 2
Slide 3: 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 4: Table of content
Table of content 1. Executive summary 2. Partnerships 3. MIV-818 4. Upcoming milestones 2021 Slide 4
Slide 5: Executive summary
Executive summary Slide 5
Slide 6: Executive summary
Executive summary Proprietary clinical asset MIV-818 Founded: 1988 • MIV-818 – A liver directed nucleotide prodrug Listed: Nasdaq OMX • MIV-818 has received Orphan drug designation (ODD) by EMA and FDA Location: Stockholm for the treatment of hepatocellular carcinoma (HCC) Cash position: SEK 248M1)
Slide 7: Focused clinical program and partnered assets
Focused clinical program Nucleotide prodrug Indication Preclinical Phase I Phase II Exclusivity MIV-818 Liver cancer IP : 2035 Partnered assets in clinical development Compound Mechanism Indication Phase I Phase II Partner Exclusivity Birinapant SMAC mimetic Solid tumors IP : 2034 (IGM-9427) Multipl
Slide 8: Analysts covering Medivir
Analysts covering Medivir Richard Ramanius, Redeye Ulrik Trattner, Carnegie Investment Bank Ingrid Gafanhao, Kempen Joe Pantginis, H.C. Wainwright & Co Slide 8
Slide 9: Partnerships
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Slide 10: Delivering on our partnering strategy
Delivering on our partnering strategy Asset Date Partner(s) Type of deal Potential future revenues Xerclear Feb 2020 SYB Out-licensing Royalties Undisclosed target Feb 2020 Undisclosed biotech Option Option fee USP-1 March 2020 Tango Therapeutics Out-licensing Milestones and royalties Birinapant Dec
Slide 11: Birinapant - Licensing agreement with IGM Biosciences
Birinapant - Licensing agreement with IGM Biosciences Triple Negative Breast Cancer Model (MDA-MB-231) • IGM is a clinical-stage biotechnology company focused on creating and 1500 IGM-8444 Birinapant developing engineered IgM antibodies IGM-8444 + Birinapant Tumor volume (mm3) 1000 Vehicle • Birinap
Slide 12: MIV-818 – for the treatment of liver cancer
MIV-818 – for the treatment of liver cancer Slide 12
Slide 13: Hepatocellular carcinoma (HCC) is a growing market
Hepatocellular carcinoma (HCC) is a growing market • Continued very high unmet medical need in HCC HCC: Combination therapies drive growth $5.3B o Despite recent advances in treatment of HCC, there is still a large group of patients that do not respond to or are intolerant to current treatments • Th
Slide 14: MIV-818 – Introduction
MIV-818 – Introduction MIV-818 stable in intestine to reach liver Cancer cells • Novel nucleotide prodrug inhibiting DNA- replication of tumor cells, targeting cancer cells in the liver • Orphan Drug Designation has been granted in HCC by the FDA and EMA TRX-TP Rapid conversion in liver to active me
Slide 15: MIV-818 – Study design phase 1 monotherapy
MIV-818 – Study design phase 1 monotherapy Population studied • advanced inoperable HCC, intrahepatic bile duct cancer and liver metastatic disease from solid tumors • 9 patients (Phase 1a) doses of 3-70 mg for 3-5 days in 21-day cycles, 10 patients (Phase 1b) dose escalation starting at 40 mg for 5
Slide 16: MIV-818 - Safety summary
MIV-818 - Safety summary • Overall safety and tolerability profile in line with expectations for this type of advanced cancer patients o Decreases in blood counts were seen frequently with MIV-818 but resolved rapidly and are easily monitored • Supports evaluating MIV-818 in combination with other d
Slide 17: Summary of efficacy phase 1b
Summary of efficacy phase 1b Phase 1b change in liver target lesions* LM • Four HCC patients showed stable disease in the liver over an extended period of time LM = Liver Metastatic Disease iCCA = Intrahepatic Bile Duct Cancer HCC = HepatoCellular Carcinoma • Based on objective response (RECIST v1.1
Slide 18: MIV-818 POC demonstrated by liver biopsies
MIV-818 POC demonstrated by liver biopsies Biopsies from two MIV-818 treated patients • Evidence of MIV-818 delivery to the tumor (measured MIV-818 metabolites) (n m o l/g ) 5 0 0 R e c t o s ig m o id c a r c in o m a 4 0 0 Normal liver Tumor • Clear signs of MIV-818 induced DNA-damage L iv e r c o
Slide 19: Conclusions MIV-818 phase 1 monotherapy
Conclusions MIV-818 phase 1 monotherapy • Safety profile to date supports moving forward with development. Decreases in blood cell counts were the most common side effects, these resolved quickly • In Phase 1b four patients out of seven with primary liver cancer (e.g. HCC, iCCA) had stable disease a
Slide 20: The treatment landscape of advanced HCC
The treatment landscape of advanced HCC Slide 20
Slide 21: HCC Epidemiology and current treatments
HCC Epidemiology and current treatments Primary liver cancers: 850,000 cases worldwide annually • 90% are hepatocellular carcinoma (HCC) • 3rd leading cause of cancer-related death, with 600,000 deaths wordwide Llovet et al Hepatology vol 73, 2021 Slide 21
Slide 22: MIV-818 – A new unique tool in HCC
MIV-818 – A new unique tool in HCC Current development pipeline of new HCC-therapies consists of a variation of combination trials with two main mechanisms of actions Stimulation of Blocking blood immune system supply to tumor* Marketed drugs (anti-PD1): Marketed drugs: Keytruda® Lenvima® (Tyrosine
Slide 23: MIV-818 – to be explored in combinations in HCC
MIV-818 – to be explored in combinations in HCC • represents a unique mechanism to treat HCC selectively Inhibition of DNA targeting tumor cells in the liver replication • adds a novel tool that may be combined with or added to any of the two main mechanisms Our upcoming trial will study MIV-818 wit
Slide 24: MIV-818 - aiming to be the new improved second line treatment
MIV-818 - aiming to be the new improved second line treatment Stimulation of Blocking blood immune system supply to tumor 1st line treatment Tecentriq® + Avastin ® MIV-818 Inhibition of DNA MIV-818 + MIV-818 + replication Keytruda® Lenvima® 2nd line treatment Keytruda ® * Lenvima ® Nexavar ® * Keytr
Slide 25: Next step in our development of MIV-818
Next step in our development of MIV-818 Slide 25
Slide 26: MIV-818 combinations enhances efficacy in tumor models
MIV-818 combinations enhances efficacy in tumor models Keytruda® Lenvima® • Combination of MIV-818 and Keytruda® results in stronger • Addition of MIV-818 to Lenvima® in a preclinical inhibition of tumor growth than either drug alone model significantly enhances efficacy • Signs of enhanced immune a
Slide 27: Phase 1b and phase 2a combination study
Phase 1b and phase 2a combination study Patient population to be studied • advanced inoperable HCC • must have progressed on or are intolerant of first line standard therapy for HCC and are candidates for Keytruda ® or Lenvima® treatment Primary objective • to assess safety and tolerability of MIV-8
Slide 28: Upcoming combination study in 2nd line HCC
Upcoming combination study in 2nd line HCC Phase 1a Phase 1b Mono Phase 1b Combo Phase 2a Combo MIV-818 + Lenvima® MIV-818 + Lenvima® dose escalation in HCC dose expansion in HCC Single patient Intrapatient dose 3+3 dose escalation escalation MIV-818 + Keytruda® MIV-818 + Keytruda® dose escalation i
Slide 29: MIV-818 – Key advantages
MIV-818 – Key advantages Once daily oral dosing Patient convenience Targeting the liver Tumor selective for liver cancer Bypasses resistance through the pro-drug Increased efficacy approach Unique Mechanism of Attractive for Action combinations Slide 29
Slide 30: On track to initiate the combination study in 2021 as planned
On track to initiate the combination study in 2021 as planned • The clinical combination study with MIV-818 has been approved in UK, where additional sites will be opened • We also plan to open sites in Spain and South Korea • The sites in South Korea will be beneficial from patient recruitment pers
Slide 31: Upcoming milestones 2021
Upcoming milestones 2021 Slide 31
Slide 32: Upcoming milestones 2021
Upcoming milestones 2021 MIV-818: First patient in combination study expected to be enrolled Q4 2021 Birinapant: IGM plan to start a combination study with birinapant (IGM-9427) Q4 2021 and IGM-8444 Slide 32
Slide 33: Thank you!
Thank you! Slide 33