Tumor Infiltrating Lymphocyte Cell Therapy for Treatment of Solid Tumors
August 2021
© 2021, Iovance Biotherapeutics, Inc | 1 |
Forward Looking Statements
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 | 2 |
NASDAQ: IOVA
Iovance: Developing to commercialize TIL Cell Therapy
~500 Patients Treated with Iovance TIL Using Proprietary Process
Platform
- 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
Pipeline
- Pivotal programs in metastatic melanoma and advanced cervical cancers
- Registration-supportingstudy in non-small cell lung carcinoma (NSCLC)
- Combinations with immune-checkpoint inhibitors in earlier lines
- Academic collaborations in new indications
Assets Partners
- ~$709M cash (6/30/21)
- Global rights to all programs, IP and technology
- Iovance manufacturing
facility (iCTC)
© 2021, Iovance Biotherapeutics, Inc | 3 |
Corporate Goals and Updates
2020 Accomplishments; Anticipated 2021 Milestones
2020
Agreement with FDA on melanoma Cohort 4 | BLA: FDA feedback received for potency assays; | |||||
Regulatory | clinical follow up; Cohort 2 supportive | additional assay data submission and interactions | ||||
planned in 2H21 | ||||||
| Melanoma: early pivotal Cohort 4 data and | Melanoma: TIL + pembrolizumab data at ASCO | ||||
updated Cohort 2 data | Cervical: last patient dosed in Cohort 2, potential to | |||||
| Cervical: last patient dosed in cervical | include in BLA | ||||
Clinical | pivotal cohort | | NSCLC: initial LN-145 clinical data (Cohort 3B); patient | |||
| NSCLC: Moffitt TIL data; registration directed | dosing in IOV-LUN-202 | ||||
| ||||||
study initiated | HNSCC: expanding TIL + pembrolizumab in basket | |||||
| HNSCC: initial data for | study | ||||
TIL + pembrolizumab | NSCLC: LN-145 clinical data at medical meeting (Cohort | |||||
3B) | ||||||
Manufacturing | Gen 3 process in clinic | | Melanoma and NSCLC: 16-day Gen 3 process in | |||
clinic | ||||||
>90% success rate in >400 patients | Completion of Navy Yard GMP facility (iCTC); start | |||||
clinical manufacturing at iCTC | ||||||
© 2021, Iovance Biotherapeutics, Inc | 4 |
Iovance Immuno-Oncology Pipeline
Product Candidate | Indication(s) | IND-Enabling | Phase 1 | Phase 2 | Pivotal | ||
Lifileucel/LN-144 | Melanoma (post-anti-PD-1) | C-144-01 Study, Cohorts 2 & 4 | FDA RMAT designation | ||||
Lifileucel | Cervical cancer (post-chemo;post-chemo & post-anti-PD-1) | C-145-04 Study, Cohorts 1 & 2 | FDA BTD | ||||
TIL | |||||||
LN-145 | NSCLC (2L post-chemo & post-anti-PD-1) | IOV-LUN-202 Study, Cohorts | 1 & 2 | ||||
LN-145 | NSCLC (2-4L incl. post-anti-PD-1) | IOV-COM-202 Study, Cohort | 3B | ||||
LN-145 | HNSCC (post-anti-PD-1) | C-145-03 Study, Cohort 2 | |||||
Lifileucel + pembro | Melanoma (anti-PD-1 naïve) | IOV-COM-202 Study, Cohort | 1A | ||||
Lifileucel + pembro | Cervical cancer (1L, chemo & anti-PD-1 naïve) | C-145-04 Study, Cohort 3 | |||||
TIL | LN-145 + pembro | NSCLC (anti-PD-1 naïve) | IOV-COM-202 Study, Cohort | 3A | |||
Combinations | |||||||
LN-145 + ipi/nivo | NSCLC (post-anti-PD-1) | IOV-COM-202 Study, Cohort | 3C | ||||
LN-145 + pembro | HNSCC (anti-PD-1 naive) | IOV-COM-202 Study, Cohort | 2A | ||||
PD-1 Selected TIL | LN-145-S1 | Melanoma (post-anti-PD-1) | IOV-COM-202 Study, Cohort | 1B | |||
LN-145-S1 | HNSCC (post-anti-PD-1) | C-145-03 Study, Cohort 4 | |||||
Third Generation | LN-145 Gen 3 + core biopsy | NSCLC (2L post-chemo & post-anti-PD-1) | IOV-LUN-202 Study, Cohort | 3 | |||
(Gen 3) TIL | LN-144 Gen 3 | Melanoma (post-anti-PD-1) | IOV-COM-202 Study, Cohort | 1C | |||
16-day manufacturing | C-145-03 Study, Cohort 3 | ||||||
LN-145 Gen 3 | HNSCC (post-anti-PD-1) | ||||||
PBL Therapy | IOV-2001 | CLL/SLL (post-BTKi) | IOV-CLL-01 Study | ||||
PD-1 Inactivated TIL | IOV-4001 | Multiple | |||||
IL-2 Analog | IOV-3001 | Multiple | |||||
Abbreviations: BTD=breakthrough therapy designation; BTKi=Bruton's tyrosine kinase inhibitor; CLL/SLL=chronic lymphocytic leukemia and small lymphocytic lymphoma; HNSCC=head and neck squamous cell carcinoma; IL- 2=interleukin 2; ipi/nivo=ipiliumumabn/nivolumab; NSCLC=non-small cell lung cancer; PBL=peripheral blood lymphocytes; RMAT=Regenerative Medicines Advanced Therapy; TIL=tumor infiltrating lymphocytes
© 2021, Iovance Biotherapeutics, Inc.
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Iovance Biotherapeutics Inc. published this content on 19 August 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 19 August 2021 20:13:13 UTC.