Upload
hoangdiep
View
216
Download
1
Embed Size (px)
Citation preview
[ NASDAQ: MEIP ]
Cantor Fitzgerald Healthcare Conference
July 8, 2015
2
Forward-Looking Statements
These slides and the accompanying oral presentation contain
forward-looking statements. Actual events or results may differ
materially from those projected in any of such statements. Additional
information concerning factors that may cause actual events or
results to differ from those projected is contained in MEI Pharma’s
most recent annual report on Form 10-K and quarterly reports on
Form 10-Q, as well as other subsequent filings with the SEC.
3
MEI Pharma (Nasdaq: MEIP)
• San Diego-based oncology drug development company with three
wholly owned drug candidates in the clinic
Pracinostat: Oral HDAC inhibitor with evidence of clinical activity
o Improving response rates in ongoing Phase II elderly AML study
ME-344: Novel mitochondrial inhibitor with single-agent activity
o Phase Ib study + topotecan enrollment closed; initial survival
estimates expected in Q4 2015
o Compelling pre-clinical combination data with VEGFR TK inhibition
PWT143: PI3K delta inhibitor with promising pre-clinical activity
o First-in-human study initiated in June 2015
• Intellectual property protection extending past 2028 in US
• Strong cash position
• Management team with proven drug development experience
4
Management Team
EXECUTIVE MANAGEMENT
Daniel Gold, PhD
President & Chief Executive OfficerFormer Chief Scientific Officer & Founder, Favrille
Robert Mass, MD
Chief Medical OfficerFormer Head of Medical Affairs, BioOncology, Genentech
Thomas Zech
Chief Financial OfficerFormer Chief Financial Officer, Pacira Pharmaceuticals
David Urso, JD
SVP, Corporate Development & General CounselFormer Principal, Forward Ventures / COO, Tioga Pharmaceuticals
Karen Potts, PhD
SVP, Regulatory AffairsFormer SVP of Regulatory Affairs, Trius Therapeutics
BOARD OF DIRECTORS
Christine White, MD (Lead Director)Former Head of Global Medical Affairs, Biogen Idec
Charles Baltic, JDCo-Head of Healthcare, Needham & Co.
Leah Cann, MBATwo-time Wall Street Journal All-Star Analyst
Kevan Clemens, PhDFormer Head of Global Oncology, Roche
Nick Glover, PhDFormer President & CEO, YM BioSciences
Daniel Gold, PhDPresident & CEO, MEI Pharma
Thomas Reynolds, MD, PhDFormer Chief Medical Officer, Seattle Genetics
William RueckertFormer Chairman, Novogen Limited
5
DRUG CANDIDATE INDICATION / COMBINATION PRE-CLINICAL PHASE I PHASE II PHASE III
EP
IGE
NE
TIC
SP
RO
GR
AM
PracinostatHDAC Inhibitor
Acute Myeloid LeukemiaFront Line, ElderlyAzacitidine (Vidaza®)
Myelodysplastic SyndromeFront Line, Int-2 & High-RiskAzacitidine (Vidaza®)
Myelodysplastic SyndromeRefractory to HMAAzacitidine (Vidaza®) or
Decitabine (Dacogen®)
MyelofibrosisFront Line & Relapsed/RefractoryRuxolitinib (Jakafi®)
CA
NC
ER
ME
TA
BO
LIS
M
PR
OG
RA
M
ME-344Mitochondrial Inhibitor
Small Cell Lung CancerAdvanced or MetastaticTopotecan (Hycamtin®)
Ovarian CancerAdvanced or MetastaticTopotecan (Hycamtin®)
SIG
NA
LIN
G
PR
OG
RA
M
PWT143PI3K Delta Inhibitor
Hematologic Cancers
Clinical Development Pipeline
6
Pracinostat: Evidence of Clinical Activity in
Hematologic Diseases
• As a single agent in elderly acute myeloid leukemia (AML)
14% (2/14) CR rate in Phase I dose-escalation study1
• As a single-agent in myelofibrosis
36% (8/22) clinical improvement rate in Phase II study2
• Combined with azacitidine in myelodysplastic syndrome (MDS)
89% (8/9) ORR rate in pilot study3
• Combined with azacitidine in newly diagnosed elderly AML
54% (27/50) CR/CRi/MLFS rate in Phase II study4
1 Garcia‐Manero et al. 2010 ASH Annual Meeting, Abstract 32922 Quintás-Cardama et al. Leukemia Research, 2012 Sep;36(9):1124-73 Quintás-Cardama et al. 2012 ASH Annual Meeting, Abstract 38214 Garcia-Manero et al. 2015 EHA Annual Congress, Abstract P568
7
Intermediate Risk-2 or High Risk MDS Patients
Previously Untreated with HMA
Pracinostat
+
Azacitidine
Placebo
+
Azacitidine
Pracinostat: Phase II Study in Front Line MDS
• 102 evaluable patients at 19 sites in the U.S.
• One-to-one randomization, double-blind
• Primary endpoint: CR
Secondary endpoints: overall response rate, hematologic improvement,
clinical benefit rate, duration of response, progression-free survival, rate
of leukemic transformation, overall survival, safety and tolerability
8
Pracinostat: Phase II Study in Front Line MDSTop-Line Data
• No difference in CR rate compared to azacitidine alone
• Data from event-driven endpoints (duration of response, event and
progression free survival and overall survival) immature
Longer follow-up required to achieve meaningful conclusions
• Fatigue, gastrointestinal toxicities and myelosuppresion occurred
more frequently in combination group
Resulted in higher rate of drug discontinuations compared to
azacitidine alone
o Discontinuation difference most evident during first 2 cycles
9
Elderly (Age ≥ 65 years) Patients with Newly Diagnosed AML
Pracinostat: Phase II Study in Front Line AML
Pracinostat
+
Azacitidine
• 50 patients enrolled at 15 sites in the U.S.
Last patient in on November 24, 2014
• Primary endpoint: CR + CRi + MLFS*
Secondary endpoints: overall response rate, complete cytogenetic
response, duration of response, event-free survival, overall survival,
safety and tolerability
• Response assessments end of cycle 1 or 2, then every other cycle
until CR is achieved or as clinically indicated
* Morphologic leukemia-free state (i.e., marrow CR)
10
MDS (MEI-003) MDS (MEI-003) AML (MEI-004)
Azacitidine
(n=51)
Pracinostat +
Azacitidine
(n=51)
Pracinostat +
Azacitidine
(n=50)
Cycle 1 4 5 3
Cycle 2 0 8 4
Total 4 (8%) 13 (25%) 7 (14%)
Pracinostat: Phase II Study in Front Line AML vs. MDS
Cycle 1 and 2 Discontinuations Due to Tolerability*
* Includes adverse events, patient decisions/informed consent withdrawals and “other”
11
Pracinostat: Phase II Study in Front Line AMLData from European Hematology Association (EHA)
• 54% (27/50) achieved primary endpoint
CR rate = 32% (16/50)
• Most responses occur within first two cycles and continue to
improve with ongoing therapy
• The most common treatment-emergent AEs included febrile
neutropenia, thrombocytopenia, nausea and fatigue
• 60-day mortality rate = 10% (5/50)
• Median overall survival not yet reached
32 patients (64%) still living
While these data are encouraging, longer follow-up is necessary
to get an accurate overall survival estimate of the combination
12
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Response Based on Clinical
Review of Efficacy Data
CR
CRi
MLFS
PR/Pri
Stable Disease
Progressive Disease
No On-Study Assessment
Time to 1st Bone Marrow
Assessment for Responders
Ongoing
Months on Study
1stLin
e E
lderly A
ML P
atients
(N
=50)
Pracinostat: Phase II Study in Front Line AMLDuration on Study and Best Response
13
Pracinostat: Phase II Study in Front Line AMLOverall Survival (OS) by Risk Group*
* Patients still living are censored as of the date of last contact to determine survival status
on or after May 15, 2015 (CNSR = censored)
14
Pracinostat: Phase II Study in Front Line AMLClinical Update since EHA
• Patients continue to improve with ongoing therapy
CR rate now 42% (21/50)
• Median overall survival not yet reached
32 patients (64%) still living (range, 8-17 months)
15
Conventional Care
Regimens
(n=247)
Azacitidine
(n=241)
CR 54 (22%) 47 (20%)
Overall Survival6.5 months
(95%CI: 5.0-8.6)
10.4 months
(95%CI: 8.0-12.7)
Phase III Study of Azacitidine Alone in Elderly AML*
* Global, multi-center, randomized, open-label pivotal study, patients at least 65 years old
with newly diagnosed or secondary AML with > 30% bone marrow blasts
16
• Evidence of single agent activity in Phase I dose-escalation study in
refractory solid tumors1
Generally well tolerated at 10 mg/kg weekly
o Dose limiting toxicity of Grade 3 neuropathy at 15 and 20 mg/kg
• Phase 1b combination study with topotecan in relapsed/refractory
ovarian and small cell lung cancers closed to enrollment
Initial survival estimates expected by Q4 2015
• Novel mechanism of action directly targeting mitochondrial OXPHOS
complex I2, resulting in rapid loss of cellular energy (ATP)
• New pre-clinical data shows significantly enhanced anti-tumor
activity when combined with VEGFR tyrosine-kinase inhibitor (TKI)
ME-344: Lead Mitochondrial Inhibitor
1 Cancer 2015 Apr 1;121(7):1056-632 Am J Cancer Res 2015;5(2):689-701
17
Spontaneous Breast Tumor ModelNintedanib (VEGFR/PDGFR/FGFR TKI) + ME-344*
0
200
400
600
800
1000
1200
0 1 2 3 4 5 6 7 8 9 10
Weeks
Vehicle BIBF ME BIBF+MENint
Tumor Growth Inhibition
ME-344 Nint + ME-344
* Collaboration with Miguel Quintela-Fandino, MD, PhD, Spanish National Cancer
Research Centre, Madrid
18
0
200
400
600
800
1000
1200
1400
T0 T1 T2 T3 T4 T5 T6 T7 T8 T9 T10 T11 T12 T13 T14 T15
Vehicle ME344 BIBF BIBF+ME344Nint Nint + ME-344
Weeks
Human KRas Mutated Lung XenograftNintedanib (VEGFR/PDGFR/FGFR TKI) + ME-344*
Tumor Growth Inhibition
* Collaboration with Miguel Quintela-Fandino, MD, PhD, Spanish National Cancer
Research Centre, Madrid
19
PWT143: Highly Selective PI3K Delta Inhibitor
• Acquired from Pathway Therapeutics in September 2013
• Expands drug development pipeline
Clinically validated target in hematologic diseases
• Distinct chemical structure and evidence of improved pre-clinical
activity compared to other PI3K delta inhibitors in development
• First-in-human study initiated in June 2015
• PK data anticipated by Q4 2015
20
Intellectual Property
Pracinostat
• 3 issued US and 77 issued foreign patents
2 US and 8 foreign applications pending
• Composition of matter to May 2028 in US, Aug 2026 in EP
May 2033 with up to 5 years patent term restoration in US
Aug 2031 with up to 5 years Supplementary Protection Certificate in EP
ME-344
• 2 issued US and 18 issued foreign patents
3 US and 7 foreign applications pending
• Composition of matter to Sep 2025 in US and EP
Sep 2029 with up to 4 years of patent term restoration in US
Sep 2030 with up to 5 years Supplementary Protection Certificate in EP
PWT143
• 1 issued US patent
3 US and 29 foreign applications pending
• Composition of matter to Jan 2031 in US, pending in EP
21
Financial Highlights
• Cash: $70.5 million as of March 31, 2015
• Debt: None
• Shares outstanding: 33.3 million
22
Upcoming Clinical Milestones
Pracinostat
Overall survival estimate from Phase II study in elderly AML (Q4)
ME-344
Survival estimate from Phase Ib + topotecan study (Q4)
PWT143
Data from first-in-human study (Q4)
[ NASDAQ: MEIP ]
Cantor Fitzgerald Healthcare Conference
July 8, 2015