Lite Strategy, Inc. · NASDAQ:LITS
Lite Strategy — MEI Pharma — Investor Day (June 2021)
41 slides from Lite Strategy's investor day presentation, Jun 14, 2021
Slide 1: Post-ASCO 2021 Investor & Analyst Event: Zandelisib in Focus
Post-ASCO 2021 Investor & Analyst Event: Zandelisib in Focus NASDAQ: MEIP June 10, 2021 Exhibit 99.1
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains, and our officers and representatives may from time to time make, statements that are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Examples of forward-
Slide 3: MEI Pharma: Who We Are
MEI Pharma: Who We Are Clinical Development Company Building a Leading Oncology Franchise with 4 Clinical-Stage Programs: Focus On HemOnc Zandelisib, Potential Best-in-Class PI3Kδ Inhibitor in Phase 2 Study Intended to Support Accelerated Approval Applications with U.S. FDA Well Capitalized with $16
Slide 4: Late-Stage Diversified Clinical Pipeline
PROGRAMS INDICATION COMBINATION PHASE 1/1B PHASE 2 PHASE 3 COMMERCIAL RIGHTS Zandelisib Oral PI3K Delta Inhibitor Follicular & Marginal Zone Lymphomas Relapsed/refractory (2L+) Rituximab U.S. co-promote; ex-U.S. Kyowa Kirin exclusive rights Zandelisib Oral P13K Delta Inhibitor Follicular & Marginal
Slide 5: Zandelisib Topline TIDAL Study Data on Track for Q4 CY2021
Zandelisib Topline TIDAL Study Data on Track to be Reported in the Fourth Quarter of CY2021 Enrollment Complete in Follicular Lymphoma Primary Efficacy Population The complete Phase 2 TIDAL study data are intended to be submitted to FDA to support accelerated approval applications
Slide 6: Zandelisib: Data Driven Advancement in the Treatment of B-cell Malignancies
Zandelisib: Data Driven Advancement in the Treatment of B-cell Malignancies
Slide 7: PI3Kδ – Key Therapeutic Target In B-cell Malignancies
PI3Kδ – Key Therapeutic Target In B-cell Malignancies PI3Kδ Is Involved in Multiple Critical Signaling Pathways Role of PI3Kδ Inhibitors Active in B-cell NHL and CLL As single agent In combination Potential for combination regimens that enable time-limited therapy Adhesion
Slide 8: Why Prior Approaches with Oral PI3Kδ Inhibitors Came Up Short
Options Tolerability Efficacy Comment: Realizing PI3Kδ Potential Lower potency ñ ò Improved tolerability, but at the cost of lower efficacy Reduced activity on B and T cells Lower daily dose Attempts to improve tolerability without cost to efficacy Implies different effects on B and T cells: not sup
Slide 9: Zandelisib Unique Properties Fulfill Potential of PI3Kδ Inhibition
Zandelisib Unique Properties Fulfill Potential of PI3Kδ Inhibition DEBULKING Cycles 1&2 Daily for 56 days LONG-TERM DISEASE CONTROL Starting Cycle 3 7 days on / 21 days off Unique Dosing Schedule Zandelisib clinical data to date validate optimized dosing schedule potential High response rates Durabl
Slide 10: Phase 1b Study Evaluating Zandelisib Single Agent or Combinations
Phase 1b multi-arm study with dose finding and expansion cohorts Various B-cell malignancies Main eligibility criteria: ECOG 0‒2, failure of ≥1 prior therapy, no prior PI3K or BTK therapy Disease assessment after 2, 4 and then every 6 cycles by Lugano and iwCLL criteria ~140 patients treated to date
Slide 11: Efficacy and Safety of Zandelisib on Intermittent Schedule in POD24 FL
Efficacy and Safety of the PI3Kδ Inhibitor Zandelisib (ME-401) on an Intermittent Schedule (IS) in Patients with Relapsed/Refractory Follicular Lymphoma (FL) with Progression of Disease within 24 Months of First-Line Chemoimmunotherapy (POD24) John M. Pagel1, Nishitha M. Reddy2, Deepa Jagadeesh3, An
Slide 12: Study Background
Study Background 37 patients with FL administered zandelisib on optimized schedule 18 with zandelisib alone 19 with zandelisib + rituximab Treatment regimen Zandelisib 60 mg daily x8 weeks then Days 1─7 of subsequent 28-day cycles Rituximab 375 mg/m2 weekly ×4 then on Day 1 of Cycles 3─6 POD24 in 22
Slide 13: Demographics and Baseline Characteristics
Demographics and Baseline Characteristics POD24 N = 22 Non-POD24 N = 15 Total N = 37 Age, median (range) 61.5 (38─82) 63 (47─87) 62 (38–87) Prior therapies, median (range) 2 (1─4) 1 (1─5) 2 (1–5) Prior lines of therapy 1 ≥ 2 7 (32%) 15 (68%) 9 (60%) 6 (40%) 16 (43%) 21 (57%) Refractory to prior ritu
Slide 14: High Response Rate in All FL Patients
High Response Rate in All FL Patients Including Both POD24 and Non-POD24 Groups POD24 N = 22 Non-POD24 N = 15 Total N = 37 Overall response rate (ORR) 18 (82%) 14 (93%) 32 (87%) Regimen Monotherapy Combination with rituximab 8/11 (73%) 10/11 (91%) 6/7 (86%) 8/8 (100%) 14/18 (78%) 18/19 (95%) Prior l
Slide 15: Prolonged Duration of Response in POD24
DOR POD24 Non-POD24 (n = 18) (n = 14) All (n = 32) Months since first response Prolonged Duration of Response in POD24
Slide 16: No Cumulative Toxicity Over Time
No Cumulative Toxicity Over Time Grade ≥3 Adverse Events (AEs) in ≥ 2 Patients, n (%) N = 37 Neutropenia 6 (16) ALT/AST increased 3 (8) Rash 3 (8) Diarrhea 2 (5) Colitis 2 (5) Hypokalemia 2 (5) Hyponatremia 2 (5) COVID-19 infection* 2 (5) Discontinuation due to AEs in 3 patients (8%) Gr 3 skin rash
Slide 17: Prolonged DOR and PFS with Zandelisib ± Rituximab
Z-R Mono (n = 18) (n = 14) Z-R Mono (n = 19) (n = 18) Prolonged DOR and PFS with Zandelisib ± Rituximab Duration of Response Progression Free Survival
Slide 18: Maturing Data Support Registrational Studies in iNHL
Maturing Data Support Registrational Studies in iNHL – Phase 2 TIDAL and Phase 3 COASTAL Zandelisib Alone N = 18 Zandelisib-R N = 19 Overall response rate 78% (n=14) 95% (n=18) Median DOR NR NR Median PFS 15.7 mo NR Phase 2 TIDAL Phase 3 COASTAL NR=“not reached”
Slide 19: Phase 2 TIDAL Trial Intended to Support Accelerated Approval
Zandelisib at 60 mg daily x2 cycles (56 days) N = 120 Zandelisib at 60 mg 7 days on / 21 days off starting at Cycle 3 until toxicity or PD If toxicity: Re-challenge at resolution Histologically confirmed diagnosis of FL, Grade 1, 2, or 3a Relapsed or refractory to 2 prior systemic therapies includin
Slide 20: Phase 3 COASTAL Trial Intended to Support Full Approval
Phase 3 COASTAL Trial Intended to Support Full Approval Globally – Confirmatory Study for US Accelerated Approval SCREENING EOT FOLLOW-UP PERIOD TARGET POPULATION Patients with R/R FL or MZL who received ≥ 1 line of prior systemic therapy Enrollment N=534 Randomized 1:1 ARM 1 Zandelisib + R for 6 cy
Slide 21: Zandelisib Properties Enable Flexible Combination Usage
Moreno et al, Target Oncol 2019 Zandelisib Properties Enable Flexible Combination Usage DEBULKING + LONG-TERM DISEASE CONTROL 7 days on / 21 days off Starting Cycle 3 Unique Dosing Schedule Zandelisib clinical data to date validate optimized dosing schedule potential High response rates Durable resp
Slide 22: Initial Results of Zandelisib and Zanubrutinib Combination
Initial Results of the Combination of PI3Kδ Inhibitor Zandelisib (ME-401) and the BTK Inhibitor Zanubrutinib in Patients with Relapsed or Refractory (R/R) B-cell Malignancies Jacob D. Soumerai1, Deepa Jagadeesh2, Huda S. Salman3, Izidore S. Lossos4, Nishitha M. Reddy5, Adam S. Asch6, Vaishalee P. Ke
Slide 23: Potential of Dual Targeted Therapy with Zandelisib
Dual inhibition of PI3Kδ and BTK pathways displays synergistic activity* Full dose not needed to show synergy Combination therapy may overcome resistance to either agent *De Rooij, Blood 2015 Objective: Leverage zandelisib dose schedule in combination with zanubrutinib to provide deeper and prolonge
Slide 24: Study Conduct Groups A and B
Treatment in 28-day cycles Zandelisib 60 mg daily x2 cycles then Days 1─7 in Cycles ≥3 Zanubrutinib 160 mg twice daily No DLT in the 28-day period In Cycle 2 1 MZL patient had Gr 3 AST/ALT with Gr 3 rash and discontinued due to recurrent rash 1 MCL patient had Gr 3 AST/ALT, recovered and referred to
Slide 25: Demographics and Baseline Characteristics
All N = 20 Group A N = 7 Group B N = 13 Age, median (range) 70 (44–85) 74 (44–85) 69 (55–83) Prior therapies, median (min–max) 2 (1–8) 2 (1–3) 2 (1–8) Diagnosis FL CLL/SLL MZL MCL DLBCL/HGBCL 8 (40%) 5 (25%) 2 (10%) 1 (5%) 4 (20%) 1 (14%) 3 (43%) 1 (14%) 1 (14%) 1 (14%) 7 (54%) 2 (15%) 1 (8%) 0 3 (2
Slide 26: Disease Response in 100% of Patients with iNHL and CLL
CR/CRi in 2/8 FL (25%) and 2/5 CLL (40%) Longer follow-up needed to assess deepening response Evaluable n = 18 FL n = 8 CLL/SLL n = 5 MZL n = 2 MCL n = 1 DLBCL/HGBCL n = 2 ORR, n (%) 8 (100) 5 (100) 2 (100) 1 (100) 0 Group A 1 (100) 3 (100) 1 (100) 1 (100) 0 Group B 7 (100) 2 (100) 1 (100) 0 0 Disea
Slide 27: Maximum Percent Change in SPD from Baseline
Median follow-up 3.6 months for Group A (range 0.6─21.3) 6.6 months for Group B (range 1.9─14.1) DIAGNOSIS DLBCL/HGBCL MZL CLL FL MCL 80 70 60 50 40 30 20 10 0 -10 -20 -30 -40 -50 60 -70 -80 -90 -100 SPD change from baseline (%) a = Group A a a a a a a Maximum Percent Change in SPD from Baseline
Slide 28: Treatment-Emergent Adverse Events of Special Interest
* 1 DLBCL patient had several Grade 3 AEs on Day 1 attributed to prior therapy and discontinued treatment on Day 17 Grade 3-4 AESI, n (%) Group A (n = 7) Group B (n = 13) ALT / ALT increased 2 (29) 2 (15) Rash 1 (14) 0 CMV colitis 1 (14) 0 Pneumonia *1 (14) 0 Diarrhea 0 0 Atrial fibrillation 0 0 Tre
Slide 29: Expanding Zandelisib Development Activities to Explore Full Potential
Expanding Zandelisib Development Activities to Explore Full Potential Zandelisib Single Agent Ph 2 Study TIDAL in 3L+ FL and MZL Ph 2 study K02 in 3L+ in iNHL (Japan) Zandelisib + Rituximab Ph 3 Study COATSAL in 2L+ FL and MZL Other Zandelisib Combinations + Zanubrutinib in FL and MCL in 2L+ + R-CHO
Slide 30: Key Upcoming 12 Month Milestones Across Portfolio
Key Upcoming 12 Month Milestones Across Portfolio Zandelisib TIDAL: announce top-line FL data in Q4 2021 Initial results of phase 1b evaluating zandelisib with zanubrutinib in FL and MCL under clinical collaboration with BeiGene New clinical studies to expand development, including: COASTAL, intende
Slide 31: PI3Ki in Lymphoma
PI3Ki in Lymphoma Deepa Jagadeesh, MD, MPH Cleveland Clinic June 10, 2021
Slide 32: Indolent NHL
Indolent NHL Indolent Non-Hodgkin lymphoma (iNHL) remains incurable and the most common subtype is follicular lymphoma (FL) Treatment goal in iNHL is to improve outcomes, with regimens that are highly effective and better toxicity profile Continued efforts have led to recent approvals of novel thera
Slide 33: Current Treatments
Current Treatments Treatment regimens used in FL includes Chemoimmunotherapy Single agent rituximab BR – bendamustine+ rituximab RR – rituximab + Revlimid PI3K inihibitors FDA approved – Idelalisib, Duvelisib, copanlisib, and umbralisib In clinical trials – Zandelisib (ME-401) EZH2 inhibitor Tazemet
Slide 34: BCR Pathway
BCR Pathway Chauhan et al Cancer Manag Res. 2021; 13: 677–692
Slide 35: PI3K Inhibitors in FL
PI3K Inhibitors in FL Pagel et al ASCO 2021;Salles et al Heamatologica 2017 ; Flinn et al JCO 2021; Flinn et al JCO 2019; Dreyling et al JCO 2017 Idelalisib Duvelisib Copanlisib Umbralisib Zandelisib Targets PI3Kδ PI3Kδ Pan Pi3K PI3Kδ, CK1ε PI3Kδ Half life 8.2 hrs 5.2-10.9 hrs 39.1 hrs 91 hrs ~28 hr
Slide 36: Zandelisib
Zandelisib Potent, highly selective oral PI3Kδ inhibitor Long half life and sustained high tumor concentration of the drug permits intermittent schedule (IS) administration IS decreased the incidence of AE without compromising efficacy Preliminary data shows promising clinical activity with single a
Slide 37: R-CHOP + Zandelisib in DLBCL
R-CHOP + Zandelisib in DLBCL Study Schema E'} Cleveland Clinic
Slide 38: Conclusions
Conclusions Treatment landscape of FL and other iNHL is rapidly evolving with addition of newer treatment modalities Unanswered questions remain as to the optimal sequencing of current treatments Future research – integrate novel agents in the upfront setting, combination of novel agents, feasibilit
Slide 39: Thank you
Thank you £3 Cleveland Clinic
Slide 40: Q&A
Q&A
Slide 41: Post-ASCO 2021 Investor & Analyst Event: Zandelisib in Focus
Post-ASCO 2021 Investor & Analyst Event: Zandelisib in Focus NASDAQ: MEIP June 10, 2021