Iovance Biotherapeutics, Inc. · NASDAQ:IOVA
Iovance Biotherapeutics — Investor Presentation (April 2021)
50 slides from Iovance Biotherapeutics's investor presentation, Apr 12, 2021
Slide 1: Tumor Infiltrating Lymphocyte Cell Therapy for Treatment of Solid Tumors
Tumor Infiltrating Lymphocyte Cell Therapy for Treatment of Solid Tumors April 2021 © 2021, Iovance Biotherapeutics, Inc 1
Slide 2: Forward Looking Statements
Forward Looking Statements 2 Certain matters discussed in this presentation are “forward - looking statements” of Iovance Biotherapeutics, Inc, Inc . (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLR
Slide 3: Iovance: Developing to commercialize TIL Cell Therapy
Iovance: Developing to commercialize TIL Cell Therapy 400+ Patients Treated with Iovance TIL Using Proprietary Process 3 NASDAQ: IOVA © 2021, Iovance Biotherapeutics, Inc Partners Assets • ~$635M cash (12/31/20) • Global rights to all programs, IP and technology • Iovance manufacturing facility ( i
Slide 4: Investment Highlights
Leading cell therapy company focused on treatment of solid tumors Investment Highlights • Initial focus in post - checkpoint solid tumors • Expansion into combinations and earlier lines of therapy • Five company - sponsored programs in melanoma, cervical, head & neck, NSCLC, and chronic lymphocytic
Slide 5: 2020 Accomplishments; Anticipated 2021 Milestones
2020 Accomplishments; Anticipated 2021 Milestones 5 Corporate Goals and Updates Clinical Melanoma : early pivotal Cohort 4 data and updated Cohort 2 data Cervical : last patient dosed in cervical pivotal cohort NSCLC : Moffitt TIL data; registration directed study initiated HNSCC : initial data for
Slide 6: Key Highlights for Melanoma Cohort Data
Key Highlights for Melanoma Cohort 2 Data © 2021, Iovance Biotherapeutics, Inc 6 2019: Melanoma Data update at SITC (1) 36.4% ORR 34.8% ORR as read by independent review committee (IRC) (N=66) by investigator and Melanoma Cohort 2 showed 36.4% ORR Median DOR still not reached at 28.1 months of media
Slide 7: Tumor Infiltrating Lymphocytes (TIL): Leading Platform for Treatment of Solid Tumors
Tumor Infiltrating Lymphocytes (TIL): Leading Platform for Treatment of Solid Tumors 7 Remove Tumor Sample Expand & Rejuvenate Patient - specific T Cells Lymphodepletion & Infusion (1) Simpson - Abelson et al. , ESMO 2020 • Highly personalized • One - time therapy • Patient’s own immune system ampli
Slide 8: TIL Mechanism of Action
TIL Mechanism of Action Circulation Migration Peptide Antigen Recognition Lysis (Tumor Killing ) 8 Infusion of tumor - infiltrating lymphocytes (TIL) Tumor Peripheral blood Blood vessel Tumor cell TIL TIL Tumor bed TIL Lysing tumor cell T - cell receptor Tumor antigen peptide MHC - I Chemokine recep
Slide 9: Competitive Advantages of TIL in Solid Tumors
Competitive Advantages of TIL in Solid Tumors Checkpoints TCR CAR - T (Liquid tumors) TIL (Solid tumors) Target multiple tumor antigens Target only single tumor antigen Mainly target only single/ surface tumor antigen Target multiple tumor antigens Long maintenance period One - time treatment One -
Slide 10: Manufacturing Process
Manufacturing Process © 2021, Iovance Biotherapeutics, Inc 10
Slide 11: Iovance Streamlined GMP Manufacturing Process
11 Iovance Streamlined 22 - Day GMP Manufacturing Process Gen 2 Process: 22 Days 1 2 Patient Intake Tumor Sample Procurement 3 4 NMA - LD TIL Infusion 5 6 IL - 2 Infusions Recovery/Discharge 4 2 TIL were generated from skin, lymph nodes, liver, lung, peritoneal, musculo - skeletal, breast, and other
Slide 12: Iovance Cell Therapy Center: iCTC
Iovance Cell Therapy Center: i CTC © 2021, Iovance Biotherapeutics, Inc. 12 • Build - to - suit custom facility in Philadelphia • ~136,000 ft 2 , $85M investment • First set of clean rooms occupied • Clinical supply planned in 2021 • Commercial GMP planned in 2022 • Significant reduction in COGS exp
Slide 13: First Set of Cleanrooms (Flex Suite) Complete
First Set of Cleanrooms (Flex Suite) Complete 13 © 2021, Iovance Biotherapeutics, Inc
Slide 14: Clinical, Manufacturing, and Regulatory Registration & Commercialization
Clinical, Manufacturing, and Regulatory Registration & Commercialization (1) Rosenberg et al., Clin Cancer Res 2011 (2) Goff et al., J Clin Oncol 2016 Melanoma: First patient dosed for Gen 1 l ifileucel Gen 2 manufacturing developed and transferred to CMOs 2016 Melanoma: FDA Fast Track designation f
Slide 15: Broad, Iovance-Owned IP Around TIL Therapy
Broad, Iovance - Owned IP Around TIL Therapy 15 © 2021, Iovance Biotherapeutics, Inc TIL products and compositions: Gen 2, Gen 3, use of co - stimulants, selection of TIL, stable and transient genetic modifications 2 Tumor Sample Procurement 3 4 NMA - LD TIL Infusion 5 IL - 2 Infusions 4 2 TIL from:
Slide 16: Significant Market Potential in Solid Tumors
(1) https://seer.cancer.gov accessed March 2021 Solid Tumor Indication Deaths (1) New Cases (1) Melanoma 6,850 100,350 Cervix Uteri 4,290 13,800 Lung & Bronchus 135,720 228,820 Oral Cavity, Pharynx & Larynx 14,500 65,630 Breast 42,170 276,480 Pancreatic 47,050 57,600 Brain & Other Nervous System 18,
Slide 17: Current Clinical Pipeline and Select Collaboration Studies
Select investigator sponsored proof - of - concept studies MDA TIL NCT03610490 Ovarian, colorectal, pancreatic ~54 LN - 145 NCT03449108 Ovarian, sarcomas, thyroid ~54 Moffitt TIL + nivolumab NCT03215810 Non - small cell lung 20 Regimen Trial Indication N Partner Phase 1 Phase 2 Pivotal Company spons
Slide 18: Metastatic Melanoma
Metastatic Melanoma © 2021, Iovance Biotherapeutics, Inc 18
Slide 19: Potential Market for Metastatic Melanoma
(1) https://seer.cancer.gov accessed March 2021 (2) Keytruda USPI accessed Mar 2021 (4%) and Weber et al., Lancet Oncol 2015 (ICC 10%) (3) Global Burden of Disease Cancer Collaboration, JAMA Oncol 2019 (4) Kirchburger et al., Eur J Cancer 2016 and Goldinger et al., J Clin Oncol 2018 • Estimated 7,00
Slide 20: C-144-01: Phase 2 Study Design
Endpoints • Primary: Efficacy defined as IRC ORR Study Updates • Mar 2019: Cohort 4 (pivotal trial) FPI • Jan 2020: last patient dosed • Dec 2020: Cohort 2 median DOR not reached at 28.1 months of median study follow up • April 2021: updated cohort 2 data at AACR • Data Extract: 14 Dec 2020 for Coho
Slide 21: C-144-01 Cohort 2 Patient Characteristics
C - 144 - 01 Cohort 2 Patient Characteristics C - 144 - 01 Cohort 2 by Investigator (AACR 2021) (1) % is calculated based on number of patients who received prior anti - CTLA - 4 Characteristics Cohort 2, N= 66 Gender, n (%) Female 27 (41) Male 39 (59) Age, years Median 55 Min, Max 20, 79 Prior ther
Slide 22: C-144-01 Cohort 2 Safety: Treatment Emergent Adverse Events
• The adverse event profile was consistent with the underlying advanced disease and the safety profile of the NMA - LD and IL - 2 regimens • Median number of IL - 2 doses administered was 6 • Decreasing frequency of AEs over time is reflective of potential benefit of one - time treatment with lifile
Slide 23: C-144-01 Cohort 2 Efficacy
• After a median study follow - up of 28.1 months, median DOR was still not reached (range 2.2, 35.2+) • Mean number of TIL cells infused: 27.3 x 10 9 • Responses were demonstrated: • In patients who received prior anti - CTLA - 4 or BRAF/MEK inhibitors • Regardless of BRAF mutational status • Regar
Slide 24: C-144-01 Cohort 2 Efficacy: Tumor Burden Reduction
C - 144 - 01 Cohort 2 Efficacy 81% (50/62) of patients had a reduction in tumor burden 11 patients (17.7%) had further SOD reduction since previous data cut (23 April 2020) Best Overall Response *Patients with BRAF V600 mutation Three subjects had no post TIL disease assessment due to early death, a
Slide 25: C-144-01 Cohort 2 Efficacy: Time to Response
C - 144 - 01 Cohort 2 Efficacy 79% of responders had received prior ipilimumab One PR converted to CR after 24 months post - lifileucel Time to Response for Evaluable Patients (PR or Better) (1) BOR is best overall response on prior anti - PD - 1 immunotherapy (2) U: unknown (3) Patient 22 BOR is PR
Slide 26: C-144-01 Cohort 2 Biomarkers
C - 144 - 01 Cohort 2 Biomarkers Site of Tumor Resection Appropriate amount of TIL was manufactured from tumors regardless of location of resection Total Cell Dose Site of Tumor Resection Target lesion SOD reductions were seen across the range of TIL total cell dose © 2021, Iovance Biotherapeutics,
Slide 27: C-144-01 Cohort 2: Conclusions
• In heavily pretreated metastatic melanoma patients who progressed on multiple prior therapies, including anti - PD - 1 and BRAFi/MEKi, if BRAFV600 mutant, lifileucel treatment resulted in: • 36.4% ORR • Median DOR not reached at 28.1 months of median study follow up • Responses deepened over time:
Slide 28: Melanoma Post-Checkpoint Treatment Landscape
Agent ORR % ( N) Current Development Status Prior Lines of Tx Patient Characteristics Combination with Anti - PD - 1 Checkpoints LAG - 3 + nivo (BMS) 12% (N=61) (1) Multiple 1L studies 1+ All comers, ECOG ≤2 • LAG - 3 expression ≥1% (N=33) ORR=18%; • LAG - 3 expression <1% (N=22) ORR=5% TLR9 agonist
Slide 29: Cervical Cancer
Cervical Cancer © 2021, Iovance Biotherapeutics, Inc 29
Slide 30: Potential Market for Cervical Cancer
For PD - L1+ patients, post - chemo receiving Keytruda (3) ORR 14.3% Third line patients: ORR 3.4% ( 6) Available Care for chemotherapy in 2L or 3L metastatic cervical patients 3.4 - 13% (4 - 6) New Cases WW each year (1) 601k 14k Diagnoses in U.S. each year (2) 260k 4k Deaths WW each year (1) Death
Slide 31: Pivotal Phase 2 Study of Lifileucel in Cervical Carcinoma
Pivotal Phase 2 Study of TIL Therapy Lifileucel (Formerly LN - 145) in Recurrent, Metastatic or Persistent Cervical Carcinoma (NCT03108495) © 2021, Iovance Biotherapeutics, Inc 31 Endpoints • Primary: ORR as determined by IRC • Secondary: safety and efficacy Study Updates • 3Q 2020: Last patient dos
Slide 32: Adverse Events Tend to be Early and Transient
Frequency of AEs over time is reflective of potential benefit of one - time treatment with TIL (lifileucel) Adverse Events Tend to be Early and Transient 32 © 2021, Iovance Biotherapeutics, Inc *The number of AEs is cumulative and represent the total number of patients dosed. Treatment - Emergent Ad
Slide 33: Significant Response Observed in Heavily Pretreated Patients
Baseline Demographics N= 27 (%) Prior therapies Mean # prior therapies 2.4 Platinum - based 27 (100) Taxane 26 (96) Anti - VEGF 22 (82) PD - 1/PD - L - 1 4 (15%) Target lesions sum of diameter (mm) Mean (SD) 61 (38) Min, Max 10, 165 Histologic Cell Type, n (%) Squamous Cell Carcinoma 12 (44) Adenoca
Slide 34: Responses Observed Early On and Consistent with Melanoma
Lifileucel time to response and current duration for evaluable patients (partial response or better) Responses Observed Early On and Consistent with Melanoma • Mean time to first response 1.9 months • Mean time to best response 2.4 months © 2021, Iovance Biotherapeutics, Inc 34 C - 145 - 04 (ASCO 20
Slide 35: Three Complete Responses Observed with Lifileucel
Lifileucel best overall response rate Three Complete Responses Observed with Lifileucel • 78% of patients had a reduction in tumor burden • Mean time to response 1.9 months • All assessments are by RECIST 1.1 • Responses are deep 35 © 2021, Iovance Biotherapeutics, Inc C - 145 - 04 (ASCO 2019)
Slide 36: Cervical Cancer Treatment Landscape
Agent ORR % ( N) Current Dev Status Prior Line of Tx Patient Characteristics Antibody - drug conjugate tisotumab vedotin (TV) (Genmab/ Seagen ) 24% (N=101) (1) Phase 2 1+ Recurrent or metastatic cervical cancer that progressed on standard therapy ≤2 prior systemic regimens mDOR = 8.3 mons, mOS = 12.
Slide 37: HNSCC & NSCLC
HNSCC & NSCLC © 2021, Iovance Biotherapeutics, Inc 37
Slide 38: IOV-COM-202: Global Phase 2 Study of TIL Therapy in Solid Tumors
© 2021, Iovance Biotherapeutics, Inc 38 1A: Melanoma PD - 1/ PD - L1 Naïve LN - 144 + Pembrolizumab N=12 2A:Head and Neck PD - 1/ PD - L1 Naïve LN - 145 + Pembrolizumab N=19 IOV - COM - 202: Global Phase 2 Study of TIL Therapy in Solid Tumors (NCT03645928) 1B: Melanoma ≥ 1 prior systemic therapies L
Slide 39: Head and Neck Squamous Cell Carcinoma (HNSCC)
Head and Neck Squamous Cell Carcinoma (HNSCC) © 2021, Iovance Biotherapeutics, Inc 39
Slide 40: Potential Market for Head and Neck Squamous Cell Carcinoma
HNSCC Facts Potential Market for Head and Neck Squamous Cell Carcinoma (HNSCC) 40 Abbreviations: ORR, objective response rate; TIL, tumor infiltrating lymphocytes. (1) Global Burden of Disease Cancer Collaboration, JAMA Oncol 2019 (2) https://seer.cancer.gov accessed Mar 2021 (3) Keytruda USPI acces
Slide 41: LN-145 in Anti-PD-1 Naive HNSCC: Cohort 2A
LN - 145 in Anti - PD - 1 Naive HNSCC: Cohort 2A © 2021, Iovance Biotherapeutics, Inc 41 TEAE consistent with other indications Efficacy (N=9) ORR=44% (11% CR and 33% PR) DCR=89% IOV - COM - 202 (SITC 2020) PD - L1 Status CPS ≥ 20 CPS ≥ 20 CPS < 20* CPS ≥ 20 * CPS > 1
Slide 42: Non-Small Cell Lung Cancer (NSCLC)
Non - Small Cell Lung Cancer (NSCLC) © 2021, Iovance Biotherapeutics, Inc 42
Slide 43: Potential Market for Non-Small Cell Lung Cancer
9% ORR for docetaxel in 2L NSCLC following progression on chemo (3) New Cases WW each year (1) 2.1M 229k Diagnoses in U.S. each year (2) 1.8M 136k Deaths WW each year (1) Deaths in U.S. each year (2) Available NSCLC care: Checkpoint Inhibitor + Chemo as first line option (1) Global Burden of Disease
Slide 44: Efficacy Data Post Moffitt TIL Infusion
Responses N=12 (%) Objective Response Rate 3 (25%) Complete Response 2 (17%) Partial Response 1 (8%) • ORR 25%; • 1 CR is noted in EGFR Δ Ex19 post afatinib , osimertinib , nivolumab • Median DOR not reached; • All 3 responders on TIL were relapsed or refractory to monotherapy Nivo • The TIL CR resp
Slide 45: Moffitt TIL in Post-Nivolumab NSCLC
In 12 evaluable patients with advanced NSCLC who received nivolumab and TIL: • Two CRs out to one year • (PD - L1 low=1, EGFR mutation=1) • ORR 25% Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non - Small Cell Lung Cancer (NCT03215810) Moffitt TIL in Post - Nivolumab NSCLC © 2021,
Slide 46: IOV-LUN-202: Phase 2 Study of LN-145 in NSCLC
Phase 2, multicenter study of LN - 145 in Patients with Metastatic Non - Small - Cell Lung Cancer, IOV - LUN - 202 (NCT04614103) IOV - LUN - 202 46 Endpoints: • Primary: Efficacy defined as ORR by IRC • Secondary: Safety and efficacy Study Updates • Ten sites are active Cohort 1: NSCLC Patient with
Slide 47: Research Focus into Next Generation TIL
Select more potent TIL • Iovance PD - 1 positive selected TIL • PD - 1 positive selected TIL also through collaboration with CHUM Expand the TIL platform into new indications/regimens • IOV - 3001 IL - 2 analog licensed from Novartis: IND enabling studies in 2021 Genetically modify to make a more tu
Slide 48: Iovance Global Reach and Scale
Iovance Global Reach and Scale © 2021, Iovance Biotherapeutics, Inc 48 Iovance Biotherapeutics has >250 employees • >76% of employees have over 1 year of cell therapy experience • Headquartered in San Carlos, CA • 4 additional offices • Iovance commercial manufacturing facility in Philadelphia, PA S
Slide 49: Well Capitalized in Pursuit of TIL Commercialization
December 31, 2020 In millions (unaudited) Common shares outstanding 146.9 Preferred shares outstanding 3.6 (1) Options 12.6 Cash, cash equivalents, short - term investments, restricted cash $635.0 (2) Anticipated cash runway sufficient into 2023 Debt $0 ( 1 ) Preferred shares are shown on an as - co
Slide 50: Thank You
Thank You © 2021, Iovance Biotherapeutics, Inc 50
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