Iovance Biotherapeutics, Inc. · NASDAQ:IOVA
Iovance Biotherapeutics — Lion Biotechnologies — Investor Presentation (November 2016)
34 slides from Iovance Biotherapeutics's investor presentation, Nov 3, 2016
Slide 1: Corporate Presentation October 2016
Corporate Presentation October 2016 © 2016, Lion Biotechnologies
Slide 2: Forward-Looking Statements
This presentation contains forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that can be identified with words such as “expects”, “plans”, “projects”, “potential”, “suggests”, “may”, or similar expressions . Such forward - looking statements invo
Slide 3: Establishing leadership in immuno-oncology with TIL technology
Driven by scientific vision and grounded in collaboration, Lion Biotechnologies is establishing leadership in immuno - oncology by developing Tumor - Infiltrating Lymphocyte (TIL) technology to deliver personalized oncology therapies to patients with unmet medical needs © 2016, Lion Biotechnologies
Slide 4: Tumor-Infiltrating Lymphocyte (TIL) Therapy
Tumor - Infiltrating Lymphocyte (TIL) Therapy • Autologous adoptive cell therapy ̶ Resect tumor ̶ Isolate and expand TIL ex vivo ̶ Lymphodeplete patients 7 days prior to TIL infusion ̶ Infuse TIL followed by IL - 2 © 2016, Lion Biotechnologies 4 Excise tumor Expan d TIL Infuse patient with TIL 1 2 3
Slide 5: Clinical-stage cancer immunotherapy company highlights
• Clinical - stage biotechnology company focused on the development and commercialization of novel cancer immunotherapy products • Leveraging and enhancing the power of tumor infiltrating lymphocytes (TILs) to treat solid tumors • Broad pipeline of programs using TILs ̶ Durable responses in metastat
Slide 6: Company Snapshot
Top 10 Shareholders Stock Price Performance Financial Snapshot 6 Company Snapshot News Highlights 0 2,000 4,000 6,000 8,000 10,000 12,000 $4 $5 $6 $7 $8 $9 $10 6-Oct-15 6-Dec-15 6-Feb-16 6-Apr-16 6-Jun-16 6-Aug-16 6-Oct-16 Price ($) Volume (000s) © 2016, Lion Biotechnologies 6 Investor Name Shares (
Slide 7: Lion Biotechnologies Pipeline and Partners
7 Lion Biotechnologies Pipeline and Partners Indication Regimen Partner Preclinical Phase 1 Phase 2 Melanoma TIL LN - 144 (n=20) — Melanoma Combination TIL ± TBI (n=101) NCI Melanoma Combination TIL + Keytruda (n=170) NCI Melanoma Combination TIL + ipi Moffitt Cervical Cancer TIL LN - 145 — Head & N
Slide 8: Leveraging the power of each patient's own immune cells through TIL
Leveraging and enhancing the power of each patient’s own immune cells through TIL © 2016, Lion Biotechnologies 8
Slide 9: TIL Therapy: Highly Individualized, Specific and Potent Attack
• Leverages the body’s natural defense against cancer using a patient’s own TIL • Polyclonal and can recognize multiple neoantigens ̶ Solid tumors are heterogeneous • Durable response with one - time treatment • Potential to establish immunological memory, requiring no additional maintenance therapy
Slide 10: Adoptive Cell Transfer: Maximizes Potency of TILs
EXTRACTION: Patient’s TILs removed from suppressive tumor microenvironment (via surgical resection of lesions or biopsies) EXPANSION: TILs expanded from small tumor fragments using T - cell growth factor interleukin 2 (IL - 2) – TILs allowed to multiply to large numbers before re - infusing them int
Slide 11: Manufacturing Process & Logistics
Manufacturing Process & Logistics 11 Excis e tumor Shipment IV infusion Post - Lymphodepletion + IL - 2 Dissect tumor into fragments Expansion with IL - 2 Co - culture TIL with feeder cells and OKT3 Expand TILs with IL - 2 Prepare infusion bag Shipment © 2016, Lion Biotechnologies
Slide 12: Melanoma
Melanoma © 2016, Lion Biotechnologies 12
Slide 13: TIL Therapy in Melanoma is Very Promising
• Recent data from a randomized Phase 2 trial at NCI in 101 patients with metastatic melanoma at NCI confirmed TIL treatment was associated with high, durable objective response rates, including for patients that were refractory to checkpoint inhibitors 1 ̶ Complete responses have been observed in 2
Slide 14: Treatment-Related Toxicities
14 Treatment - Related Toxicities Adverse Event NMA (n=51) TBI (n=50) Grade 3 and 4 toxicities Febrile neutropenia Bacteremia Urinary tract infection Atrial fibrillation Thrombotic microangiopathy 25 13 0 2 0 36 5 2 3 13 ICU transfer on index admission Planned observation Cytokine - related symptoms
Slide 15: Excellent Survival in Melanoma
15 Goff, S.L. et al. Randomized, Prospective Evaluation Comparing Intensity of Lymphodepletion Before Adoptive Transfer of Tumo r - Infiltrating Lymphocytes for Patients With Metastatic Melanoma. Journal of Clinical Oncology, 34(20), 2389 - 2397. Excellent Survival in Melanoma Overall Survival of pa
Slide 16: Melanoma Patient Response
Melanoma Patient 16 Rosenberg et al. Adoptive cell therapy for the treatment of patients with metastatic melanoma Curr Opin Immunol , 21(2), 233 - 240. Pre - Treatment 12+ Days © 2016, Lion Biotechnologies
Slide 17: Survival Benefit in Second and Third Line Patients
17 Rosenberg, S.A. et al. Durable Complete Responses in Heavily Pretreated Patients with Metastatic Melanoma Using T - Cell Transfer Immunotherapy. Clinical Cancer Research , 17(13), 4550 - 4557. Survival Benefit in Second and Third Line Patients Durable remissions in melanoma regardless of prior th
Slide 18: LN-144: Phase 2 Trial in Refractory Metastatic Melanoma
A Phase 2, Multicenter, Single - arm Study to Assess the Safety and Efficacy of Cell Transfer Therapy Using Autologous Tumor Infiltrating Lymphocytes (LN - 144) Followed by IL - 2 for Treatment of Patients with Metastatic Melanoma • Key Inclusion Criteria: ̶ Measurable metastatic melanoma and ≥ 1 le
Slide 19: Cervical Cancer
Cervical Cancer © 2016, Lion Biotechnologies 19
Slide 20: Cervical Cancer and TIL Treatment Data
Cervical Cancer and TIL Treatment Data 20 Stevanovic , et al. Complete Regression of Metastatic Cervical Cancer After Treatment with Human Papillomavirus - Targeted Tumor - Infiltrating T Cells, J Clin Oncol 2015, 33 (15) Hinrichs et al., HPV - targeted Tumor - Infiltrating Lymphocytes for Cervical
Slide 21: TIL Market Opportunity
TIL Market Opportunity © 2016, Lion Biotechnologies 21
Slide 22: Market Opportunity for TIL Therapy
• 64% percent of new cases per year for patients 20 - 70 years old • Metastatic (regional and distant) melanoma patients compose 13% of all new cases at ~10,000 cases • Prevalence of melanoma in US (2013): >1 million © 2016, Lion Biotechnologies 22 Market Opportunity for TIL Therapy (1) Source: http
Slide 23: Competitive Advantages of TILs in Solid Tumors
© 2016, Lion Biotechnologies 23 Competitive Advantages of TILs in Solid Tumors Checkpoints TCR CAR TIL Utility in several solid tumors Few solid tumors treated so far No examples of utility in solid tumors Utility in melanoma and HPV cancers Long maintenance period One - time treatment One - time tr
Slide 24: Future Directions: Next Generation TILs
• Pre - sorted TILs offer many benefits ̶ Select high potency TIL (Select for PD - 1, 4 - 1BB Expression) ̶ Need lower cell numbers ̶ Duration of manufacturing ̶ COGS ̶ IP generation • Genetic engineering of TIL ̶ Expression of cytokines to increase potency ̶ Modulation of PD - 1/CTLA - 4/LAG - 3 on
Slide 25: Key Collaborations and Partnerships
• National Cancer Institute/NIH ̶ Cooperative Research And Development Agreement with Dr. Steve Rosenberg (CRADA) ̶ Development of TIL for metastatic melanoma, bladder, lung, breast, and HPV - associated cancers and combination therapies ̶ TIL + PD - 1 combination clinical trial to treat melanoma •
Slide 26: Leadership and Organization Overview
Leadership and Organization Overview © 2016, Lion Biotechnologies 26
Slide 27: Management Team
Management Team © 2016, Lion Biotechnologies 27 Maria Fardis , Ph.D., MBA President and CEO Gregory Schiffman , MBA CFO Michael Lotze , M.D. CSO Steven Fischkoff , M.D. CMO
Slide 28: Management Biographies
Maria Fardis , Ph.D. – President & CEO ̶ Most recently, Maria was COO at Acerta, served as a key component to the Company’s rapid growth • Responsible for increasing the number of patients enrolled in studies from less than 100 to 1,300+ • AstraZeneca acquired Acerta in early 2016, as Acerta was pre
Slide 29: Board of Directors
Iain Dukes, Ph.D. – Chairman ̶ Partner of OrbiMed ; formerly SVP, Bus. Dev. and Licensing at Merck ̶ 20+ years in pharma research, drug discovery, scientific and technology licensing, start - up company leadership, and valuing comm ercial stage assets Wayne Rothbaum – Director ̶ President and Managi
Slide 30: Scientific Advisory Board
Scientific Advisory Board © 2016, Lion Biotechnologies 30 Mario Sznol , M.D. Jeffrey Weber, M.D. James Mulé, PhD. Patrick Hwu , M.D. Cassian Yee, M.D. Daniel Powell, PhD.
Slide 31: Financial Summary
Financial Summary 31 As of June 30, 2016 (in millions) Common shares outstanding 58.4 Preferred shares 12.2 Warrants/options 6.95 Cash $191.6 Debt $0 © 2016, Lion Biotechnologies
Slide 32: Thank you
Thank you © 2016, Lion Biotechnologies 32
Slide 33: Clinical Regressions in Late-Stage Disease
33 Clinical Regressions in Late - Stage Disease Rosenberg, S.A. et al. (2009, April). Adoptive Cell Therapy for the Treatment of Patients with Metastatic Melanoma. Current Opinion in Immunology, 21(2), 233 - 240. © 2016, Lion Biotechnologies
Slide 34: Compelling Results in Late-Stage Disease
34 Dudley, M. E. et al. (2010, December). CD8 Enriched “Young” Tumor Infiltrating Lymphocytes Can Mediate Regression of Metastatic Melanoma. Clinical Cancer Research, 16(24), 6122 - 6131. Compelling Results in Late - Stage Disease © 2016, Lion Biotechnologies
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