Corporate Overview
January 2023
© 2023, Iovance Biotherapeutics, Inc. | 1 |
Forward-Looking Statements
Certain matters discussed in this press release are "forward-looking statements" of Iovance Biotherapeutics, 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 press release, 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; whether clinical trial results from our pivotal studies and cohorts may support registration and approval by the FDA; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; 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 changing landscape of care for cervical cancer patients may impact our clinical trials in this indication; 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 (including from the recent pre-BLA meeting with the FDA); the risk that the rolling BLA submission for lifileucel
in metastatic melanoma may take longer than expected; 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 forecasts and increase our estimated capital requirements; and other factors, including general economic conditions and regulatory developments, not within our control.
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© 2023, Iovance Biotherapeutics, Inc.
Global Leadership in Innovating, Developing and Delivering TIL Therapy for Patients with Cancer
Platform
500+
Patients Treated with Iovance TIL
90%+
Manufacturing Success Rate
22-day
Proprietary Manufacturing Process
Pipeline
1 Rolling BLA Submission in Progress
6 Active
Clinical Trials
5 Tumor Types in Clinic
3Fast 1BTD 1RMAT Track
Designations
People & Assets
~$367M*
Cash as of 9/30/22
60+
US and International Patents
500+
Employees
Partners &
Collaborators
The University of Texas
MD Anderson Cancer Center
Abbreviations: BLA=Biologics License Application; BTD=Breakthrough Therapy Designation; RMAT=Regenerative Medicine Advanced Therapy Designation *Anticipated cash runway, inclusive of proceeds from equity sold through at-the-market (ATM) facility in 4Q22, is sufficient well into 2024
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© 2023, Iovance Biotherapeutics, Inc.
2022 Accomplishments
REGULATORY | BLA: Commenced rolling BLA submission in August 2022 | |||||
PIPELINE | Advanced melanoma (post-anti-PD-1): Cohort 4 data at SITC 2022 and in JITC | |||||
Frontline advanced melanoma: began Phase 3 trial | ||||||
NSCLC: enrolled additional patients in IOV-LUN-202 and IOV-COM-202 trials | ||||||
Cervical: expanded Cohort 2 to support regulatory submissions | ||||||
TIL combinations: continued ongoing solid tumor cohorts of TIL + pembrolizumab | ||||||
Genetically-modified TIL: initiated IOV-GM1-201first-in-human trial of IOV-4001 | ||||||
Research: advanced new products toward clinic | ||||||
MANUFACTURING | ||||||
Executed GMP commercial readiness activities, scaled up production at iCTC | ||||||
COMMERCIAL | Executed ATC onboarding activities and payer engagement | |||||
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© 2023, Iovance Biotherapeutics, Inc.
Iovance Solid Tumor Pipeline Highlights
PRODUCT CANDIDATE | INDICATION(S) | PHASE 1 | PHASE 2 | PIVOTAL |
Advanced
Melanoma (Metastatic or Unresectable)
Next Generation
Metastatic
NSCLC
Next Generation
Cervical
Lifileucel + pembro | Frontline | TILVANCE-301 Phase 3 | Confirmatory, FTD |
TIL (Lifileucel/LN-144) | Post-anti-PD-1 | C-144-01, Cohorts 2 & 4 | Rolling BLA In Progress, RMAT |
Lifileucel + pembro | Anti-PD-1 naïve | IOV-COM-202, Cohort 1A | |
PD-1 Inactivated TIL (IOV-4001) | Post-anti-PD-1 | IOV-GM1-201, Cohort 1 | |
LN-145 | 2L post-chemo & post-anti-PD-1 | IOV-LUN-202, Cohorts 1 & 2 | |
LN-145 + pembro | Anti-PD-1 naïve | IOV-COM-202, Cohort 3A | |
LN-145 | 2-4L incl. post-anti-PD-1 | IOV-COM-202, Cohort 3B* | |
LN-145 + ipi/nivo | Post-anti-PD-1 | IOV-COM-202, Cohort 3C | |
LN-145 Gen 3 + core biopsy | 2L post-chemo & post-anti-PD-1 | IOV-LUN-202 Cohort 3 | |
PD-1 Inactivated TIL (IOV-4001) | 2-4L incl. post-anti-PD-1 | IOV-GM1-201, Cohort 2 | |
Lifileucel | Post-chemo & post-anti-PD-1 | C-145-04, Cohort 2 | BTD, ODD |
LN-145 + pembro | 1L - chemo and anti-PD-1 naïve | C-145-04, Cohort 3* |
*Enrollment complete
Abbreviations: 1L=first line; 2L=second line; 4L=fourth line; BTD=breakthrough therapy designation; FTD=fast track designation; ipi/nivo=ipilimumab/nivolumab; NSCLC=non-small cell lung cancer; ODD=orphan drug designation; PD-1=programmed cell death protein-1; RMAT=Regenerative Medicines Advanced Therapy; TIL=tumor infiltrating lymphocytes
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© 2023, Iovance Biotherapeutics, Inc.
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Iovance Biotherapeutics Inc. published this content on 10 January 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 January 2023 21:16:36 UTC.