Iovance Biotherapeutics, Inc. · NASDAQ:IOVA
Iovance Biotherapeutics — Investor Presentation (January 2019)
34 slides from Iovance Biotherapeutics's investor presentation, Jan 7, 2019
Slide 1: Corporate Presentation January 2019
Corporate Presentation January 2019
Slide 2: Forward-looking statements
This presentation contains “forward - looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Compan y,” “we,” “us,” or “our”). We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “int
Slide 3: Leveraging Tumor Infiltrating Lymphocyte (TIL) to Address Unmet Need
Manufacturing Development, Clinical Program Establishment 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 2015 Fi
Slide 4: Leveraging TIL to Address Unmet Need
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 2015 First patient dosed for Gen 1 l ifileucel in melanoma/ Gen 2
Slide 5: Investment Highlights
© 2019, Iovance Biotherapeutics, Inc. Leading cell therapy company focused on treatment of solid tumors Investment Highlights 5 Large market opportunity starting in solid tumors Accelerated path to approval in melanoma confirmed with FDA Efficient and scalable proprietary manufacturing • Initial foc
Slide 6: TIL Therapy Elicits a Highly Individualized, Specific and Potent Attack Against Solid Tumors
© 2019, Iovance Biotherapeutics, Inc. TIL Therapy Elicits a Highly Individualized, Specific and Potent Attack Against Solid Tumors 6 • 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 het
Slide 7: Competitive Advantages of TIL in Solid Tumors
© 2019, Iovance Biotherapeutics , Inc. Competitive Advantages of TIL in Solid Tumors 7 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 maint
Slide 8: Developed Centralized, Scalable and Efficient GMP Manufacturing
EXCISE: Patient’s TIL are removed via surgical resection of a lesion EXTRACT: Tumor is fragmented and placed in media for TIL to leave the tumor and enter media EXPAND: TIL expanded via IL - 2 + OKT3 exponentially ex vivo to yield 10 9 – 10 11 TIL PREPARE & INFUSE : Patient receives non - myeloablat
Slide 9: Broad, Iovance-Owned IP Around TIL Therapy
Manufacturing Multiple layers of patent applications filed for Gen 2 TIL products • Iovance is pursuing claims covering cryopreserved TIL products, manufacturing processes and methods of treatment • Includes two recently granted U.S. patents for methods of treatment in a broad range of cancers • U.S
Slide 10: Significant Market Potential in Solid Tumors
(1) https://seer.cancer.gov Solid Tumor Indication Deaths (1) New Cases (1) Melanoma 9,320 91,270 Cervix Uteri 4,170 13,240 Oral Cavity, Pharynx & Larynx 13,740 64,690 Lung & Bronchus 154,050 234,030 Bladder 17,240 81,190 Breast 41,400 268,670 Pancreatic 44,330 55,440 Brain & Other Nervous System 16
Slide 11: Current Clinical Pipeline and Select Collaboration Studies
Company sponsored studies Select investigator sponsored proof - of - concept studies Lifileucel C - 144 - 01 Melanoma 164 — LN - 145 C - 145 - 04 Cervical cancer 47 — LN - 145 C - 145 - 03 Head & neck cancer 47 — Lifileucel + pembrolizumab LN - 145 + pembrolizumab LN - 145 IOV - COM - 202 Melanoma H
Slide 12: Metastatic Melanoma
TOVANCE BIOTHERAPEUTICS ADVANCING IMMUNO-ONCOLOGY Metastatic Melanoma
Slide 13: Potential Market for Metastatic Melanoma
• Estimated 9,320 U.S. patients deaths due to melanoma in 2018 (1) • Limited options after progression on checkpoint and BRAF/MEK inhibitors • 4,950 U.S. patients are on 3 rd and 4 th line of therapy (2) • 6,282 U.S. patients are on 2 nd line therapy (2) • TIL is available as a 2 nd line for those w
Slide 14: Cohort 2, Phase 2 Trial in Metastatic Melanoma
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 or a BRAF or BRAF/MEK • Age ≥ 18 • ECOG PS 0 - 1 Endpoints • Primary: efficacy defined as ORR by inv
Slide 15: Adverse Events Tend to be Early and Transient
© 2019, Iovance Biotherapeutics , Inc. 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 15 COHORT 2 (1) Treatment - Emergent Adverse Events refer to all AEs starting on or after the first dose date
Slide 16: Lifileucel is Potentially an Efficacious Treatment for Patients with Limited Options
• In heavily pretreated metastatic melanoma patients, preliminary efficacy is notable for: • ORR 38% (3.3 prior lines of therapy) vs. standard of care chemotherapy has ~10% ORR (in 2 nd line) • Median DOR is 6.4 months , range 1.3+ to 14+ • Single treatment of TIL led to DCR of 77% in late stage met
Slide 17: Responders from TIL Therapy had Progressed on Checkpoint Inhibitors
© 2019, Iovance Biotherapeutics , Inc. Lifileucel time to response and current duration of for evaluable patients (partial response or better) Responders from TIL Therapy had Progressed on Checkpoint Inhibitors 17 COHORT 2 (1) BOR is best overall response on prior anti - PD - 1 immunotherapy (2) U:
Slide 18: TIL Therapy Provides Deep Responses
© 2019, Iovance Biotherapeutics , Inc. Lifileucel best overall response rate (1) TIL Therapy Provides Deep Responses 18 COHORT 2 (1) Per RECIST 1.1, two patients (31,33) had BOR of SD: met PR criteria at Day 42 and PD at Day 84 due to new lesions • 72% of patients had a reduction in tumor burden • M
Slide 19: Lifileucel in Metastatic Melanoma Single-Arm Registrational Cohort 4
Cohort 2: Cryopreserved TIL product (Gen 2) N=60 Enrollment Closed Cohort 4: Cryopreserved TIL product (Gen2) N=75 Cohort 1: Non - cryopreserved TIL product N=30 Enrollment Closed COHORT 4 Key inclusion criteria • Measurable metastatic melanoma and ≥ 1 lesion resectable for TIL generation • Progress
Slide 20: Development Efforts in Late Stage (2L/3L) Melanoma Treatment
© 2019, Iovance Biotherapeutics , Inc. 2L/3L melanoma treatment has no current standard of care Development Efforts in Late Stage (2L/3L) Melanoma Treatment 20 Combination with anti - PD - 1 Single agent (1) Idera Pharmaceuticals Results Dec 14, 2018 (2) Milhem M et al., AACR 2018 (3) Ribas A et al.
Slide 21: Cervical Cancer
TOVANCE BIOTHERAPEUTICS ADVANCING IMMUNO-ONCOLOGY Cervical Cancer
Slide 22: Cervical Cancer Market and Physician Quote
“TIL immunotherapy with LN - 145 is literally redefining what is treatable and potentially curable in advanced metastatic chemo - refractory cervical cancer. Patients who only two years ago would be facing hospice as their only alternative now have access to this potentially life extending new treat
Slide 23: Phase 2 Trial in Cervical Cancer (C-145-04)
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) Recurrent, metastatic or persistent cervical carcinoma with 1 prior therapy Simon’s two - stage
Slide 24: TIL Offers a Favorable Treatment for Cervical Cancer Patients
(1) The patients reported are a combination of Gen 1 and Gen 2 manufacturing process (2) The composition of the relevant patient population may differ between Iovance trials and published data for CPIs (USPI used) but serves as a point of reference for assessing the overall efficacy landscap e for r
Slide 25: Head & Neck Cancer
TOVANCE BIOTHERAPEUTICS ADVANCING IMMUNO-ONCOLOGY Head & Neck Cancer
Slide 26: Head & Neck Cancer Facts
(1) Global Burden of Disease Cancer Collaboration, Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost , Y ears Lived With Disability, and Disability - Adjusted Life - years for 29 Cancer Groups, 1990 to 2016: A Systematic Analysis for the Global Burden of Disease Study. J
Slide 27: Phase 2 Trial in Head & Neck Cancer (C-145-03)
BASELINE DEMOGRAPHICS N= 13 (%) Prior therapies Median prior therapies (min, max) 3 (1, 5) Anti - PD - 1 11 (85) Anti - CTLA - 4 3 (23) Number of target & non - target lesions (at baseline) >3 10 (77) Phase 2 study to evaluate the efficacy and safety of autologous Tumor Infiltrating Lymphocytes (LN
Slide 28: TIL Offers a Favorable Treatment Option for Head & Neck Cancer in Post-CPI Patients
© 2019, Iovance Biotherapeutics , Inc. TIL Offers a Favorable Treatment Option for Head & Neck Cancer in post - CPI Patients 28 • N=13 • 31% ORR • 4 PRs • DOR (min, max): 2.8, 7.6 months Head & Neck Cancer TEAE (≥40%), any grade N=13 (%) Chills 10 (77) Hypotension 8 (62) Hyponatremia 7 (54) Pyrexia
Slide 29: Investigation of TIL in Earlier Lines of Therapy in Combination with SOC
A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN - 144 or LN - 145) in Patients with Solid Tumors (NCT03645928) Melanoma PD - 1/PDL - 1 Naïve Melanoma Head & Neck Cohort 1: TIL+ Pembro N=12 Cohort 2: TIL+ Pembro N=12 RR NSCLC NSCLC Cohort 3: TIL N=12 PD - 1/PDL - 1 Naïve
Slide 30: Research Focus into Next Generation TIL
© 2019, Iovance Biotherapeutics , Inc. Research Focus into Next Generation TIL 30 Prepare or select more potent TIL • Use anti - 4 - 1BB, anti - OX40, or other co - stimulants in cocktails in ex vivo growth of TIL • License to uses of 4 - 1BB agonists obtained from Moffitt Cancer Center • Select mor
Slide 31: Value Drivers for 2019
• Single arm registrational trial beginning in early 2019 aiming towards BLA in 2020 • Manufacturing optimization has demonstrated scalability and is moving towards commercialization • Strong balance sheet providing three years of cash runway • Multiple shots on goal for proof - of - concept studies
Slide 32: Achieved and Upcoming Milestones
Demonstrate consistent, scalable, rapid proprietary manufacturing method x x Demonstrate activity in melanoma post - checkpoint inhibitor (difficult to treat patients) x Align on registration pathway with FDA x Demonstrate activity in post - CPI cervical, head & neck tumors x Secure new IP around TI
Slide 33: Well Capitalized in Pursuit of TIL Commercialization
In millions - unaudited (2) Common shares outstanding 123 Preferred shares 6 (1) Warrants/options/RSU’s 7 Cash, cash equivalents, short - term investments $469 (3) Debt 0 (1) Preferred shares are shown on an as - converted basis (2 ) As of December 31, 2018. Financial numbers presented herein are un
Slide 34: Thank you
TOVANCE BIOTHERAPEUTICS ADVANCING IMMUNO-ONCOLOGY Thank you
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