Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Lion Biotechnologies — Investor Presentation (June 2017)

41 slides from Iovance Biotherapeutics's investor presentation, Jun 5, 2017

  1. Slide 1: Corporate Presentation June 2017

    Corporate Presentation June 2017 © 2017, Lion Biotechnologies

  2. Slide 2: Forward-looking statements

    This presentation contains forward - looking statements reflecting management’s current beliefs and expectations . These forward looking statements can be identified with words such as “expects”, “plans”, “projects”, “potential”, “suggests”, “may”, or similar expressions . Such forward - looking sta

  3. Slide 3: Corporate Highlights

    • Clinical - stage biotechnology company focused on the development and commercialization of tumor infiltrating lymphocyte (TIL) therapy for cancer patients • Leveraging and enhancing the utility of TIL therapy as demonstrated by Dr. Steven Rosenberg at the NCI ̶ 56% ORR and a 24% CR rate in 101 met

  4. Slide 4: TIL Therapy Process

    TIL Therapy Process EXTRACTION: Patient’s TIL are removed from suppressive tumor microenvironment (via surgical resection of a lesion) EXPANSION: TIL expanded exponentially ex vivo to yield 10 9 – 10 11 TIL PREPARATION: Patient receives non - myeloablative lymphodepletion, to eliminate potentially s

  5. Slide 5: Lion Biotechnologies Pipeline

    Lion Biotechnologies Pipeline © 2017, Lion Biotechnologies 5 INDICATION REGIMEN N PARTNER PRECLINICAL PHASE 1 PHASE 2 Melanoma Combination TIL ± TBI 101 Melanoma Combination TIL + ipi Melanoma Combination TIL + Keytruda 170 Melanoma Combination TIL + Opdivo 12 Ocular (Uveal) Melanoma TIL 23 Melanoma

  6. Slide 6: Key Collaborations and Partnerships

    National Cancer Institute/NIH • Cooperative Research And Development Agreement (CRADA) with Dr. Steve Rosenberg 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 MedImm

  7. Slide 7: TIL Therapy

    TIL Therapy 7 © 2017, Lion Biotechnologies

  8. Slide 8: TIL Therapy: Highly Individualized, Specific, and Potent Attack Against Solid Tumors

    • Leverages and enhances 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 mainte

  9. Slide 9: Lion Manufacturing Process & Logistics

    Lion Manufacturing Process & Logistics Gen 1 Duration: ~5 - 6 Weeks Gen 2 Duration: ~3.5 Weeks Cryopreserved Product 9 Excise 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

  10. Slide 10: Manufacturing Capacity

    Manufacturing Capacity Adequate Capacity to Support a Broad Clinical Plan 10 © 2017, Lion Biotechnologies • Lion’s Manufacturing process is centralized at the following CMO sites: ̶ Lonza, Walkersville ̶ Wuxi AppTech ̶ Moffitt as CMO ̶ PharmaCell (EU) • Lion developed the Gen 1 process through modif

  11. Slide 11: Melanoma

    Melanoma 11 © 2017, Lion Biotechnologies

  12. Slide 12: NCI Study with TIL Therapy in Melanoma

    12 NCI Study with TIL Therapy in Melanoma (1) Goff, S.L. et al. Randomized, Prospective Evaluation Comparing Intensity of Lymphodepletion Before Adoptive Transfer of Tumor - In filtrating Lymphocytes for Patients With Metastatic Melanoma. Journal of Clinical Oncology, 34(20), 2389 - 2397. © 2017, Li

  13. Slide 13: NCI Study Treatment-Related Toxicities

    The toxicities of treatment were largely associated with the known side effects of nonmyeloablative chemotherapy (NMA) or total body irradiation (TBI) and administration of high dose IL - 2 (1) 13 NCI Study Treatment - Related Toxicities (1) Goff, S.L. et al. Randomized, Prospective Evaluation Compa

  14. Slide 14: NCI Study Survival in Melanoma

    14 Goff, S.L. et al. Randomized, Prospective Evaluation Comparing Intensity of Lymphodepletion Before Adoptive Transfer of Tumor - In filtrating Lymphocytes for Patients With Metastatic Melanoma. Journal of Clinical Oncology, 34(20), 2389 - 2397. NCI Study Survival in Melanoma Overall Survival of pa

  15. Slide 15: NCI Study Melanoma Patient

    NCI Study Melanoma Patient 15 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 © 2017, Lion Biotechnologies

  16. Slide 16: NCI Study Survival Benefit in Second and Third Line Patients

    16 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. NCI Study Survival Benefit in Second and Third Line Patients Durable remissions in melanoma regardless

  17. Slide 17: Lion C-144-01 Study Design

    Phase 2, Multicenter, 3 - Cohort Study to Assess the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes (LN - 144) for Treatment of Patients with Metastatic Melanoma Key Inclusion Criteria: • Measurable metastatic melanoma and ≥ 1 lesion resectable for TIL generation • At least one pri

  18. Slide 18: Lion C-144-01 Patient Characteristics

    CHARACTERISTIC N=16, % Gender, n (%) Male 7 (43.8) Female 9 (56.3) Age, n (%) Mean (SD) 54.8 (8.44) Median 54.5 Min, Max 41, 72 Prior therapies, n (%) IL - 2 2 (12.5) anti - CTLA - 4 14 (87.5) anti - PD - 1 16 (100.0) CHARACTERISTIC N=16, % Baseline ECOG score, n (%) 0 9 (56.3) 1 7 (43.8) BRAF Statu

  19. Slide 19: Lion C-144-01 Safety: Treatment Emergent Serious Adverse Events

    Lion C - 144 - 01 Safety: Treatment Emergent Serious Adverse Events 19 Treatment Emergent SAEs by PT; * not related to therapy event occurred 6 months after treatment PREFERRED TERM 144 - 01 (N=16) ANY GRADE n (%) GRADE ≥3 n (%) GRADE 5 n (%) Number of subjects reporting at least one Treatment - Eme

  20. Slide 20: Lion C-144-01 Efficacy

    20 * In Efficacy Set 1 of 14 patients was not evaluable due to melanoma - related death prior to first tumor assessment. Lion C - 144 - 01 Efficacy • All patients entering the study had received an anti - PD - 1 checkpoint inhibitor • Median number of IL - 2 administrations was 6 RESPONSE PATIENTS,

  21. Slide 21: Lion C-144-01 Efficacy

    • ORR is 29% • Tumor reduction was seen in 77% of patients representing those who had tumor reduction in the target lesions • Responses were noted regardless of BRAF mutational status including one long lasting CR (15+ months) 21 Lion C - 144 - 01 Efficacy * BRAF mutants - Of 14 patients in Efficacy

  22. Slide 22: Lion C-144-01 Time to Best Response and Duration

    22 Lion C - 144 - 01 Time to Best Response and Duration • Mean time to first response: 1.6 months • Median follow up for this data: 4.1 months © 2017, Lion Biotechnologies

  23. Slide 23: Lion C-144-01 Percent Change in Sum of Diameters

    23 Lion C - 144 - 01 Percent Change in Sum of Diameters © 2017, Lion Biotechnologies

  24. Slide 24: Lion C-144-01 Patient Scan

    14 months Post Treatment Pre - Treatment 6 weeks Post - Treatment Lion C - 144 - 01 Patient Scan Patient is in CR Lion C - 144 - 01 © 2017, Lion Biotechnologies 24

  25. Slide 25: Lion C-144-01 Phase 2 Trial in Metastatic Melanoma (Upcoming Protocol Amendment)

    A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN - 144) for Treatment of Patients with Malignant Melanoma Key Inclusion Criteria: • Measurable metastatic melanoma and ≥ 1 lesion resectable for TIL generation • At least one prior systemic

  26. Slide 26: Cervical Cancer

    Cervical Cancer 26 © 2017, Lion Biotechnologies

  27. Slide 27: NCI Cervical Cancer and TIL Treatment Data

    NCI Cervical Cancer and TIL Treatment Data 27 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 Cervi

  28. Slide 28: Lion C-145-04 Phase 2 Trial in Cervical Carcinoma

    A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of Adoptive Cell Therapy Using Autologous Tumor Infiltrating Lymphocytes (LN - 145) in Patients with Recurrent, Metastatic or Persistent Cervical Carcinoma N=47; Simon’s two - stage design LN - 145 , non - cryopreserved product will be

  29. Slide 29: Head and Neck Cancer

    Head and Neck Cancer 29 © 2017, Lion Biotechnologies

  30. Slide 30: Lion C-145-03 Phase 2 Trial in Head and Neck SCC

    A Phase 2 Study to Evaluate the Safety, Tolerability and Efficacy of Cell Transfer Therapy Using Autologous Tumor Infiltrating Lymphocytes (LN - 145) followed by IL - 2 in Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck N=47; Simon’s two - stage design Key Incl

  31. Slide 31: TIL Market Opportunity

    TIL Market Opportunity 31 © 2017, Lion Biotechnologies

  32. Slide 32: Market Opportunity for TIL Therapy in US

    • Lion’s lead indication for TIL is metastatic melanoma: ̶ Prevalence of melanoma in US (2014) is greater than 1.17 million cases ̶ 74% percent of new cases each year occur in patients 20 - 74 years old (1) ̶ Metastatic (regional and distant) melanoma patients compose 13% of all new cases ~10,000 ca

  33. Slide 33: Competitive Advantages of TILs in Solid Tumors

    33 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 treatment One - time treatment

  34. Slide 34: Ongoing and Future Directions

    • Continuous improvement in process development ̶ Shortening of the process further ̶ Automation • Evaluation of biomarkers for response • Selected TILs, modifying the properties may offer benefits ̶ Selection of more specific TIL (Select for PD - 1, 4 - 1BB Expression) 34 Ongoing and Future Directi

  35. Slide 35: Financials

    Financials 35 © 2017, Lion Biotechnologies

  36. Slide 36: Financial Summary

    Financial Summary 36 As of March 31, 2017 (IN MILLIONS) Common shares outstanding 62.4 Preferred shares 8.8 Warrants/options/RSU’s 13.8 Cash $147.2 Debt $0 © 2017, Lion Biotechnologies

  37. Slide 37: Anticipated 2017 Key Milestones

    Anticipated 2017 Key Milestones 37 © 2017, Lion Biotechnologies • Evaluate potential opportunistic partnerships in alignment with our core competencies x MDA • Define the regulatory pathway for LN - 144 melanoma drug candidate in U.S. • Initiate regulatory interactions with ex - U.S. health authorit

  38. Slide 38: Thank you

    Thank you © 2017, Lion Biotechnologies

  39. Slide 39: MDACC TIL Manufacturing Process

    MDACC TIL Manufacturing Process Total Processing Time approx. 5 - 6 weeks 39 Excise tumor IV infusion Post - Lymphodepletion + IL - 2 4 - 1BB antibody Expansion with IL - 2 Co - culture TIL with feeder cells and OKT3 Expand TILs with IL - 2 Prepare infusion bag © 2017, Lion Biotechnologies Dissect t

  40. Slide 40: Clinical Regressions in Late-Stage Disease

    40 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. © 2017, Lion Biotechnologies

  41. Slide 41: Compelling Results in Late-Stage Disease

    41 Dudley, M. E., et al. (2010, December). CD8 Enriched “Young” Tumor Infiltrating Lymphocytes Can Mediate Regression of Metasta tic Melanoma. Clinical Cancer Research, 16(24), 6122 - 6131. Compelling Results in Late - Stage Disease © 2017, Lion Biotechnologies

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