wedbush pacgrow healthcare conference august 11, … presentation...acute myeloid leukemia front...
TRANSCRIPT
[ NASDAQ: MEIP ]
Wedbush PacGrow Healthcare Conference
August 11, 2015
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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.
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MEI Pharma (Nasdaq: MEIP)
• San Diego-based oncology company with three wholly owned drug
candidates
• All three drug candidates in the clinic with data expected by year end
• Strong intellectual property protection for all drug candidates
• Strong cash position: $70.5 million as of March 31, 2015
• Experienced management team with proven oncology drug
development experience
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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
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Pracinostat in MDS: What We Learned
• Evidence of activity in combination with azacitidine in pilot study1
89% (8/9) overall response rate; combination “very well tolerated”
• Top-line data from randomized Phase II study released in March 2015
Addition of Pracinostat to azacitidine did not improve rate of complete
remission compared to azacitidine alone
Combination of Pracinostat plus azacitidine resulted in high rate of early
drug discontinuations, primarily due to tolerability
Patients receiving Pracinostat plus azacitidine for > 4 cycles achieve
prolonged progression-free & overall survival compared to
azacitidine alone (HRs < 0.6); data still maturing
o Data submitted for presentation at ASH in December 2015
1 Quintás-Cardama et al. ASH 2012: Abstract 3821
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Azacitidine Azacitidine + Vorinostat
CR rate 24% (22/92) 15% (14/91)
Off Tx due to toxicity / side
effect / complication9% (8/92) 24% (22/91)
Relapse-free survival, on
Tx > 6 months (median)7 months 13 months (P = .11)
North American Intergroup Randomized
Phase II MDS Study (SWOG S1117)1
1 Sekeres et al. ASH 2014: LBA - 5
Conclusions / Opinion:
• “Are combination regimens in MDS too toxic? Or do we need to manage
toxicities better?”
• “ORR is not the right endpoint for large MDS trials. We need to focus on
durable responses, and on OS.”
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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)
Phase II Study of Pracinostat in AMLDuration on Study and Best Response1
1 Garcia-Manero et al. EHA 2015: Abstract P568
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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%)
Phase II Study of Pracinostat in AML vs. MDSDiscontinuations in First Two Cycles Due to Tolerability*
* Includes adverse events, patient decisions/informed consent withdrawals and “other”
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Phase II Study of Pracinostat in AMLOverall Survival by Risk Group1
Patients are censored as of the date of last contact to determine survival status on or after May 15, 2015. CNSR, censored.
1 Garcia-Manero et al. EHA 2015: Abstract P568
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AZA-AML-0011 MEI-0042
Conventional
Care Regimens(n=247)
Azacitidine(n=241)
Pracinostat +
Azacitidine(n=50)
CR rate 21.9% 19.5% 42%
60-day mortality rate 18.2% 16.2% 10%
One-yearsurvival rate 34.2% 46.5% 60%
Overall survival 6.5 months10.4 months
(P = .1009)?
International Phase III Study of Azacitidine in
Newly Diagnosed AML (AZA-AML-001)
1 Dombret et al. Blood. 2015 Jul 16;126(3):291-92 As of ASH abstract submission on August 4, 2015
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• Novel mechanism of action directly targets mitochondrial OXPHOS
complex I1, resulting in rapid loss of cellular energy (ATP)
• Evidence of single agent activity in Phase I dose-escalation study in
refractory solid tumors2
• Phase 1b combination study with topotecan in relapsed/refractory
ovarian and small cell lung cancers closed to enrollment
Initial survival estimates expected in Q4 2015
• New pre-clinical data shows significantly enhanced anti-tumor
activity when combined with VEGFR tyrosine-kinase inhibitor (TKI)3
ME-344: Novel Mitochondrial Inhibitor
1 Lim et al. Am J Cancer Res. 2015;5(2):689-7012 Bendell et al. Cancer. 2015 Apr 1;121(7):1056-633 Manevich et al. AACR 2015: Abstract 5409
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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
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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
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PWT143: Highly Selective PI3K Delta Inhibitor
• First PI3K delta inhibitor (Idelalisib) approved in July 2014
Recommended starting dose: 150 mg orally, twice daily
• PWT143 has shown superior pre-clinical activity compared to other
PI3K delta inhibitors, including Idelalisib
• First-in-human study initiated in June 2015
Measurable plasma levels as well as significant on target activity
observed at 10 mg starting dose level; PK results suggest daily dosing
• PK/PD data submitted for presentation at ASH in December 2015
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Upcoming Clinical Milestones
Pracinostat
Overall survival estimate from Phase II study in AML (Q4 2015)
ME-344
Initial survival estimates from Phase Ib study + topotecan (Q4 2015)
Initiation of Phase II study + TKI (Q1 2016)
PWT143
PK data from first-in-human study (Q4 2015)
Initiation of Phase I study in hematologic cancer (Q1 2016)
[ NASDAQ: MEIP ]
Wedbush PacGrow Healthcare Conference
August 11, 2015