Iovance Biotherapeutics, Inc. · NASDAQ:IOVA
Iovance Biotherapeutics — Investor Presentation (May 2020)
52 slides from Iovance Biotherapeutics's investor presentation, May 22, 2020
Slide 1: Investigating the Power of Tumor Infiltrating Lymphocytes for Treatment of Cancer
Investigating the Power of Tumor Infiltrating Lymphocytes for Treatment of Cancer May 2020
Slide 2: Forward-looking statements
Certain matters discussed in this presentation are “forward - looking statements” of Iovance Biotherapeutics, Inc. (hereinafter re ferred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “p
Slide 3: 2020 Recent Updates
2020 Recent Updates © 2020, Iovance Biotherapeutics 3 2020 Updates Last patient dosed in Cohort 4 pivotal melanoma program: supporting a BLA in melanoma in 2020 90%+ manufacturing success rate in > 300 patients Oral presentation from Cohort 2 melanoma program at ASCO20 Data showing effect of Moffitt
Slide 4: Tumor-Infiltrating Lymphocytes (TIL) – Unique Mechanism in Immuno-oncology
• Highly personalized therapy • Our own immune system amplified and rejuvenated Tumor - Infiltrating Lymphocytes (TIL) – Unique Mechanism in Immuno - oncology © 2020, Iovance Biotherapeutics 4 Excise Tumor Culture & Expand with IL - 2 Reinfuse Post - Lymphodepletion
Slide 5: Proprietary Centralized, Scalable, and Efficient GMP Manufacturing
© 2020, Iovance Biotherapeutics 5 Iovance Proprietary Centralized, Scalable, and Efficient GMP Manufacturing Gen 2 Process Time: 22 Days 1 2 Patient Intake Surgical Resection 3 4 NMA - LD TIL Infusion 5 6 IL - 2 Infusions Recovery/Discharge 4 2
Slide 6: TIL Mechanism of Action
TIL Mechanism of Action Circulation Migration Recognition Lysis © 2020, Iovance Biotherapeutics 6 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 recept
Slide 7: Development milestones
Manufacturing Development, Clinical Program Establishment Pre - Commercialization (1) Rosenberg, S. A., et al. Clinical Cancer Research , 2011, 17, 4550 (2) Goff, S. L. et al. Journal of Clinical Oncology , 2016, 34(20), 2389 - 2397 FDA Orphan Drug Designation for l ifileucel in malignant melanoma 2
Slide 8: Key Highlights
Key Highlights © 2020, Iovance Biotherapeutics 8 2019: Melanoma Data update at SITC (8 Nov 2019) (1) 36.4% ORR 34.8% ORR as read by independent review committee (IRC) (N=66) by investigator and Melanoma Cohort 2 showed Median DOR not reached at 17.0 months of median study follow up (investigator ass
Slide 9: 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, non - small cell lung cancer (N
Slide 10: Highly Individualized, Specific, and Potent Attack Against Cancer
Leverages and enhances the body’s natural defense against cancer using a patient’s own TIL • Polyclonal: Can recognize multiple neoantigens: • Effective in solid tumors which are heterogeneous • Individualized: TIL of each patient is specific and private with almost no overlap of uCDR3 between patie
Slide 11: 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 12: Broad, Iovance-Owned IP Around TIL Therapy
Manufacturing Twelve granted or allowed U.S. patents for compositions and methods of treatment in a broad range of cancers relating to Gen 2 manufacturing process including combinations with PD - 1 antibodies Advanced Technologies Patent applications filed for a wide range of TIL technologies includ
Slide 13: Iovance Commercial Manufacturing Facility
© 2020, Iovance Biotherapeutics 13 Iovance Commercial Manufacturing Facility • Build - to - suit custom facility located in the Navy Yard, Philadelphia, PA • ~136,000 sq. feet, $85 mil investment • Clean room build initiated April 2020 • Commercial GMP production is expected to commence in 2022 • Si
Slide 14: Significant Market Potential in Solid Tumors
(1) https://seer.cancer.gov Solid Tumor Indication Deaths (1) New Cases (1) Melanoma 7,230 96,480 Cervix Uteri 4,250 13,170 Lung & Bronchus 142,670 228,150 Oral Cavity, Pharynx & Larynx 10,860 53,000 Breast 41,760 268,600 Pancreatic 45,750 56,770 Brain & Other Nervous System 17,760 23,820 90% of all
Slide 15: Current Clinical Pipeline and Select Collaboration Studies
Regimen Trial Indication N Partner Phase 1 Phase 2 Pivotal Company sponsored studies Lifileucel C - 144 - 01 Melanoma 178 — LN - 145 C - 145 - 04 Cervical cancer 138 — LN - 145/ LN - 145 - S1 C - 145 - 03 Head & neck cancer 55 — Lifileucel + pembrolizumab LN - 145 - S1 LN - 145 + pembrolizumab LN -
Slide 16: Metastatic Melanoma
Metastatic Melanoma © 2020, Iovance Biotherapeutics 16
Slide 17: Potential Market for Metastatic Melanoma
(1) in 2019, https://seer.cancer.gov ; (2) CheckMate - 37 Trial Results (ICC 10%), Keytruda label (4%); (3) JAMA Oncol . 2019; 5(12):1749 - 1768. doi:10.1001/jamaoncol.2019.2996; (4) Eur J Cancer . 2016; 65:182 - 184. J Clin Oncol . 2018; 36 (suppl: abstr e21588) • Estimated 7,230 (1) U.S. patient d
Slide 18: C-144-01: Phase 2 Study Design
Endpoints • Primary: Efficacy defined as IRC ORR Study Updates • March 2019: Cohort 4 (pivotal trial) FPI June 2019: Full Cohort 2 data on 66 patients presented at ASCO • November 2019: IRC Cohort 2 data presented at SITC • November 2019: Investigator read of Cohort 2 sub - analysis for primary refr
Slide 19: C-144-01: Cohort 2 Update at ASCO 2019
Baseline Demographics N= 66 (%) Prior therapies Mean # prior therapies 3.3 Anti - PD - 1 66 (100) Anti - CTLA - 4 53 (80) BRAF/MEK 15 (23) Progressive Disease (PD) for at least 1 prior therapy Anti - CTLA - 4 41 (77) Anti - PD - 1 65 (99) Target lesions sum of diameter (mm) Mean (SD) 106 (71) Min, M
Slide 20: Adverse Events Tend to be Expected, Early and Transient
Adverse Events Tend to be Expected, Early and Transient **Treatment - Emergent Adverse Events refer to all AEs starting on or after the first dose date of TIL up to 30 days. Patients wit h multiple events for a given preferred term are counted only once using the maximum grade under each preferred t
Slide 21: Potentially Efficacious Treatment for Patients with Limited Options
Responses N=66 (%) Objective Response Rate 24 (36.4%) Complete Response 2 (3%) Partial Response 22 (33.3%) Stable Disease 29 (43.9%) Progressive Disease 9 (13.6%) Non - Evaluable 4 (6.1%) Disease Control Rate 53 ( 80.3%) In heavily pretreated metastatic melanoma patients (3.3 mean prior therapies) •
Slide 22: Responders Previously Progressed on Checkpoint Inhibitors
Lifileucel time to response and current duration of response for evaluable patients (partial response or better) Responders Previously Progressed on Checkpoint Inhibitors © 2020, Iovance Biotherapeutics 22 BOR is best overall response on prior anti - PD - 1 immunotherapy ASCO 2019: One patient subse
Slide 23: TIL Therapy Provides Deep Responses
• 81% of evaluable patients had a reduction in tumor burden • Mean Time to response 1.9 months (range 1.3 - 5.6) • All assessments are by RECIST 1.1 • Responses are deep – nearly all responders are >30% BRAF mutant patients TIL Therapy Provides Deep Responses © 2020, Iovance Biotherapeutics | Strict
Slide 24: Lifileucel for Primary Refractory Metastatic Melanoma
Lifileucel, a Potential Therapy for Metastatic Melanoma Patients who are Primary Refractory to Prior Anti - PD1 Therapy © 2020, Iovance Biotherapeutics ClinicalTrials.gov identifier: NCT02360579 SMR Annual Meeting | November 20 - 23, 2019 | Salt Lake City, UT, USA 24
Slide 25: Metastatic Melanoma Patients Primary Refractory to Anti-PD1/L1
• High unmet medical need for patients with advanced melanoma who have a BOR of PD to checkpoint therapy, known as primary refractory or primary resistance • 40 - 65% of all metastatic melanoma patients are primary refractory to initial immune Anti - PD1/L1 therapy (1) • TIL therapy offers a potenti
Slide 26: Subset Analysis of Cohort 2 Primary Refractory Patients
A subset analysis of data from Cohort 2 of C - 144 - 01 study focused on primary refractory patients was presented at SMR 2019 conference Subset Analysis of Metastatic Melanoma Cohort 2 C - 144 - 01 Patients Primary Refractory to Anti - PD1/L1 26 (1) Gide T.N., et al. Primary and Acquired Resistance
Slide 27: C-144-01: Cohort 2 Update at SMR 2019
In n=42 patients primary refractory to anti - PD - 1/L1, defined as BOR of PD to the earliest anti - PD - 1/L1 treatment: • Mean duration on first anti - PD - 1/L1 was 3.1 months • 57% PD - L1 High/Positive (TPS ≥ 1%) C - 144 - 01: Cohort 2 Update at SMR 2019 © 2020, Iovance Biotherapeutics 27 COHOR
Slide 28: Treatment Emergent Adverse Events in Primary Refractory Patients
• Patients with multiple events for a given preferred term are counted only once using the maximum grade under each preferred t erm • Treatment - Emergent Adverse Events refer to all AEs starting on or after the first dose date of TIL up to 30 days Patients Primary Refractory to Anti - PD1/L1 Treatm
Slide 29: Potentially Efficacious Treatment for Metastatic Melanoma
In 42 patients primary refractory to anti - PD1/L1: • Median DOR has not been reached at median 12.0 months study follow up • ORR was notable in this sub - group at 40.5% Patients Primary Refractory to Anti - PD1/L1 Potentially Efficacious Treatment for Metastatic Melanoma (1) © 2020, Iovance Biothe
Slide 30: Time to Response for Primary Refractory Patients
Patients Primary Refractory to Anti - PD1/L1 Time to Response for Evaluable Patients with PR or Better (1) 71% of the responders are ongoing on study COHORT 2 – PRIMARY REFRACTORY SUBGROUP © 2020, Iovance Biotherapeutics 30
Slide 31: Lifileucel in Metastatic Melanoma Primary Refractory to Anti-PD1/L1
40 - 65% of all metastatic melanoma patients are primary refractory to initial ICI therapy (1) Lifileucel offers a highly efficacious therapy in patients who were primary refractory to prior anti - PD1/L1 ICI therapy (2) • 40.5% ORR in patients who were primary refractory to anti - PD1/L1, which is
Slide 32: Cohort 4 is a Pivotal Single-Arm Registrational Trial
Key Inclusion Criteria • Measurable metastatic melanoma and ≥ 1 lesion resectable for TIL generation • Progression on at least one prior line of systemic therapy including immune checkpoint inhibitor and if BRAF V600 mutation positive, BRAF or BRAF/MEK targeted therapy Endpoints • Primary: efficacy
Slide 33: Late Stage (2L/3L) Melanoma Treatment Development Efforts
2L/3L melanoma treatment has no current standard of care Late Stage (2L/3L) Melanoma Treatment Development Efforts (1) Ascierto P et al., ESMO 2017; (2) Idera Pharmaceuticals Press Release April 21, 2020; (3) Milhem M et al., SITC 2019; (4) Amin et al., ASCO 2019, Abstract 9555; (5) Ramalingam et al
Slide 34: Cervical Cancer
Cervical Cancer © 2020, Iovance Biotherapeutics 34
Slide 35: Potential Market for Cervical Cancer
For PD - L1 + patients, post - chemo receiving Keytruda (3) ORR 14.3% Available Care for chemotherapy in 2L metastatic cervical patients 4.5 - 13% (4)(5) New Cases WW each year (1) 601k 13k Diagnoses in U.S. each year (2) 260k 4k Deaths WW each year (1) Deaths in U.S. each year (2) Available care: C
Slide 36: C-145-04: Pivotal Phase 2 Trial in Cervical Cancer
Phase 2, multicenter study to evaluate the efficacy and safety of autologous Tumor Infiltrating Lymphocytes (LN - 145) in patients with recurrent, metastatic or persistent cervical carcinoma (NCT03108495) C - 145 - 04: Pivotal Phase 2 Trial in Cervical Cancer © 2020, Iovance Biotherapeutics 36 Endpo
Slide 37: LN-145 in Cervical Cancer Interim Update at ASCO 2019
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 38: Adverse Events Tend to be Early and Transient
Frequency of AEs over time is reflective of potential benefit of one - time treatment with TIL (LN - 145) Adverse Events Tend to be Early and Transient © 2020, Iovance Biotherapeutics 38 **Treatment - Emergent Adverse Events refer to all AEs starting on or after the first dose date of TIL up to 30 d
Slide 39: Significant Response Observed in Patients with Limited Options
Responses N=27 (%) Objective Response Rate 12 (44%) Complete Response 3 (11%) Partial Response 9 (33%) Stable Disease 11 (41%) Progressive Disease 4 (15%) Non - Evaluable 0 Disease Control Rate 23 ( 85%) In heavily pretreated cervical cancer patients (2.4 mean prior therapies) • CR 11% • ORR 44% • D
Slide 40: Responses Observed Early On and Consistent with Melanoma
LN - 145 time to response and current duration of 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 © 2020, Iovance Biotherapeutics 40
Slide 41: Three Complete Responses Observed with LN-145
LN - 145 best overall response rate Three Complete Responses Observed with LN - 145 • 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 with majority of responders are over 30% 41 © 2020, Iovance Biotherapeutic
Slide 42: Development Efforts in Recurrent, Metastatic or Persistent Cervical Carcinoma
Recurrent, metastatic, or persistent cervical carcinoma has no current standard of care Development Efforts in Recurrent, Metastatic or Persistent Cervical Carcinoma Agent ORR % ( N) Current Dev Status Prior Line of Tx Patient Characteristics Antibody - drug conjugate tisotumab vedotin (TV) ( Genmab
Slide 43: Additional Solid Tumor Studies
Additional Solid Tumor Studies © 2020, Iovance Biotherapeutics 43
Slide 44: Non-Small Cell Lung Cancer (NSCLC)
Non - Small Cell Lung Cancer (NSCLC) © 2020, Iovance Biotherapeutics 44
Slide 45: Moffitt NSCLC TIL plus Nivo Study in Patients Who Have Received Prior Nivolumab
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 46: Moffitt TIL in Post-Nivolumab NSCLC
Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non - Small Cell Lung Cancer (NCT03215810) Moffitt TIL in Post - Nivolumab NSCLC © 2020, Iovance Biotherapeutics 46 (1) Creelan, et. al., Durable complete responses to adoptive cell transfer using tumor infiltrating lymphocytes (TIL) in
Slide 47: TIL in Earlier Lines of Therapy in Combination with SOC
A prospective, open - label, multi - cohort, non - randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN - 144 (Lifileucel)/LN - 145 in combination with pembrolizumab or TIL LN - 145/LN - 145 - S1 as a single therapy (NCT03645928) TIL in Earlier Lines of Therapy in
Slide 48: Research Focus into Next Generation TIL
Select more potent TIL • PD - 1 positive selected TIL by Iovance • PD - 1 positive selected TIL also through collaboration with CHUM Expand the TIL platform into new indications/regimens • Triple Negative Breast Cancer (Yale) • First patient dosed in Phase 1/2 study for PBL in CLL • IOV - 3001 IL -
Slide 49: Iovance Biotherapeutics Global Reach and Scale
Iovance Biotherapeutics Global Reach and Scale © 2020, Iovance Biotherapeutics 49 Iovance Biotherapeutics has ~190 employees • Headquartered in San Carlos, CA • 3 additional offices • Iovance commercial manufacturing facility in Philadelphia, PA (under construction) San Carlos, CA New York City, NY
Slide 50: Well Capitalized in Pursuit of TIL Commercialization
March 31, 2020 In millions (unaudited) Common shares outstanding 127 Preferred shares 4 (1) Options 12 Cash, cash equivalents, short - term investments, restricted cash $251 (2) Debt 0 (1) Preferred shares are shown on an as - converted basis (2) Includes Restricted Cash of $5.5 million Well Capital
Slide 51: Upcoming Milestones 2020
Last patient dosed in Cohort 4 for lifileucel in support of registration in melanoma Top line data from melanoma Top line data from cervical Last patient dosed in pivotal program of LN - 145 for cervical cancer Hold a pre - BLA meeting with FDA Upcoming Milestones 2020 File BLA © 2020, Iovance Bioth
Slide 52: Thank You
TOVANCE BIOTHERAPEUTICS ADVANCING IMMUNO-ONCOLOGY Thank You NX
Iovance Biotherapeutics — Investor Presentation (May 2020) on 6ix