Full Press Release Details
Tumor Infiltrating Lymphocyte Cell Therapy for Treatment of
Solid Tumors April 2021 2021, Iovance Biotherapeutics, Inc 1
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 "PSLRA") . All such written or oral statements made in this presentation, other than statements of historical fact,
are forward - looking statements and are intended to be covered by the safe harbor for forward - looking statements provided by the PSLRA
. Without limiting the foregoing, we may, in some cases, use terms such as "predicts," "believes," "potential,"
"continue," "estimates," "anticipates," "expects," "plans," "intends,"
"forecast," "guidance," "outlook," "may," "could," "might," "will,"
"should" or other words that convey uncertainty of future events or outcomes and are intended to identify forward - looking
statements . Forward - looking statements are based on assumptions and assessments made in light of management's experience and
perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate . Forward
- looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise
any such statements, whether as a result of new information, future events or otherwise . Forward - looking statements are not guarantees
of future performance and are subject to risks, uncertainties and other factors, many of which are outside of our control, that may cause
actual results, levels of activity, performance, achievements and developments to be materially different from those expressed in or
implied by these forward - looking statements . Important factors that could cause actual results, developments and business decisions
to differ materially from forward - looking statements are described in the sections titled "Risk Factors" in our filings
with the Securities and Exchange Commission, including our most recent Annual Report on Form 10 - K and Quarterly Reports on Form 10
- Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business
: the effects of the COVID - 19 pandemic ; risks related to the timing of and our ability to successfully develop, submit, obtain and
maintain U . S . Food and Drug Administration ("FDA") or other regulatory authority approval of, or other action with respect
to, our product candidates, and our ability to successfully commercialize any product candidates for which we obtain FDA approval ; preliminary
and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials may not be reflected in the
final analyses of our ongoing clinical trials or subgroups within these trials ; the risk that enrollment may need to be adjusted for
our trials and cohorts within those trials based on FDA and other regulatory agency input ; the new version of the protocol which further
defines the patient population to include more advanced patients in our cervical cancer trial may have an adverse effect on the results
reported to date ; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials
based on feedback from the FDA or other regulatory authorities ; the risk that our interpretation of the results of our clinical trials
or communications with the FDA may differ from the interpretation of such results or communications by the FDA ; the acceptance by the
market of our product candidates and their potential reimbursement by payors, if approved ; our ability or inability to manufacture our
therapies using third party manufacturers or our own facility may adversely affect our potential commercial launch ; the results of clinical
trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials ; the risk that unanticipated
expenses may decrease our estimated cash balances and increase our estimated capital requirements ; and other factors, including general
economic conditions and regulatory developments, not within our control . 2021, Iovance Biotherapeutics, Inc
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 CTC ) Pivotal
programs in metastatic melanoma and advanced cervical cancers Registration - supporting study in non - small cell lung carcinoma
(NSCLC) Combinations with immune - checkpoint inhibitors in earlier lines Academic collaborations in new indications
Pipeline Leading cell therapy platform in solid tumors Clinical data in multiple indications Consistent GMP manufacturing
process across solid tumors Next gen research in selected and genetically modified TIL Platform
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 leukemia (CLL)
indications Accelerated path to approval in melanoma and cervical cancer BLA submission expected 2021 Melanoma:
RMAT, Orphan Drug, and Fast Track Cervical: BTD, Orphan Drug, and Fast Track US and EU capacity with contract manufacturers
Iovance Cell Therapy Center ( i CTC ) under construction in Philadelphia Rapid 22 - day Gen 2 manufacturing with 90%+
success rate 400+ patients treated with Iovance proprietary process 2021, Iovance Biotherapeutics, Inc 4 Large market
opportunity & strong unmet need Potential to be the first cell therapy approved for solid tumors in melanoma and cervical Efficient
& scalable proprietary manufacturing
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 TIL + pembrolizumab Cervical
: Complete enrollment into Cohort 2, under consideration for inclusion in the BLA NSCLC: Add a new cohort in the basket study; combine
TIL + ipilimumab/nivolumab NSCLC : Start patient dosing in IOV - LUN - 202 HNSCC: Expanding the HNSCC TIL + pembrolizumab in basket study
(as part of moving TIL in earlier lines); Close C - 145 - 03 HNSCC single therapy Manufacturing Gen 3 process in clinic >90% success
rate in >400 patients Melanoma : Initiate administration of 16 - day Gen 3 process in clinic in the basket study Completion of Navy
Yard GMP facility ( i CTC ); start clinical manufacturing at i CTC 2021, Iovance Biotherapeutics, Inc x 2020 2021 x x x x x x
Regulatory Agreement with FDA on melanoma Cohort 4 clinical follow up; Cohort 2 supportive Additional work on potency assays BLA : Continue
work on potency assays to support submission of a BLA to FDA for lifileucel; additional assay data submitted to FDA x x x x x
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 median study follow up Responses
deepened over time (1) Sarnaik et al., SITC 2019 (2) Chesney, et. al. AACR 2021. Abstract #5329. Presentation #CT008 April 2021: Updated
Cohort 2 Data at AACR Plenary Session (2) by investigator
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 amplified
and rejuvenated (1) TIL - Unique Mechanism of Action 2021, Iovance Biotherapeutics, Inc
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 receptor Chemokine TIL IFN
Granzyme Perforin TIL Lysing tumor cell 2021, Iovance Biotherapeutics, Inc
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 - time treatment One - time treatment
Utility in several solid tumors Few solid tumors treated so far No examples of successful utility in solid tumors Available data in:
melanoma, cervical, head & neck, and lung cancers Potential l ong - term irreversible toxicities Potential o n - target, off - tissue
effects Potentially immunogenic: cytokine release syndrome No unexpected off tumor tissue effects found to date Off - the - shelf Autologous
Autologous Autologous TIL target a diverse array of cancer antigens; we believe this approach represents a highly differentiated, personalized,
and targeted immunotherapy 9 2021, Iovance Biotherapeutics, Inc
Manufacturing Process 2021, Iovance Biotherapeutics,
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 organs. 2021, Iovance
Biotherapeutics, Inc
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 expected
First Set of Cleanrooms (Flex Suite) Complete 13 2021,
Iovance Biotherapeutics, Inc
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 for l ifileucel received Cervical and head
and neck studies began 2017 Melanoma : L ifileucel Cohort 2 clinical data (N=47, 38% ORR by investigator) Melanoma: FDA RMAT designation
for l ifileucel in advanced melanoma received Melanoma: FDA EOP2 meeting for l ifileucel held 2018 Melanoma: Last patient dosed in pivotal
cohort 4 Cervical: Last patient dosed in the pivotal Cohort 1 NSCLC : Moffitt TIL shows durable CRs in post - PD1 NSCLC HNSCC: First
TIL + pembro data at SITC 2021 2019 Melanoma: First patient dosed in registrational cohort Melanoma: IRC data from Cohort 2 presented