Full Press Release Details
Iovance Biotherapeutics Announces Regulatory
and Clinical Updates for Lifileucel in Melanoma
Positive FDA Feedback on Potency Assay Matrix
to Support BLA Submission
Further Defines Frontline Melanoma Strategy
for Lifileucel in Combination with Pembrolizumab
CARLOS, Calif., April 5, 2022 -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company
developing novel T cell-based cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has provided feedback
on April 1, 2022 regarding Iovance's proposed matrix of potency assays for its upcoming Biologics License Application (BLA) for
lifileucel in metastatic melanoma. Iovance received positive feedback from the FDA on both its potency assay matrix and its proprietary
cell co-culture assay included in the potency assay matrix. Based on this response, Iovance expects to request a pre-BLA meeting in July
2022 and to complete a BLA submission for lifileucel by August 2022.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive
Officer of Iovance, stated, "The favorable feedback received from the FDA on our potency assays and assay matrix brings Iovance
a step closer to our submission of a BLA for lifileucel in metastatic melanoma. We look forward to bringing lifileucel to the market quickly
to offer melanoma patients a new option following anti-PD-1 therapy."
addition, Iovance today announced plans to open a Phase III study for lifileucel in combination with pembrolizumab for the treatment
of immune checkpoint inhibitor (ICI) na ve frontline metastatic melanoma in late 2022. Updated data from the combination
cohort of lifileucel and pembrolizumab in ICI na ve patients (Cohort 1A in the IOV-COM-202 study, n=12) demonstrated an overall
response rate (ORR) of 67%. Eight out of 12 patients had a confirmed objective response per RECIST 1.1, including three complete responses
and five partial responses. Six of the eight responders had ongoing response at the time of the last data cut, and five responders had
a duration of response of more than one year. The FDA previously granted Fast Track Designation for lifileucel in combination
with pembrolizumab for the treatment of ICI na ve metastatic melanoma based on the unmet medical need and potential advantages for
this combination over available care.
will host a conference call and live audio webcast to discuss these updates at 8:00 a.m. Eastern time on April 6, 2022. To participate
in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 3734669.
The live webcast can be accessed in the Investors section of the Company's website at www.iovance.com. The archived
webcast will also be available for one year in the Investors section at www.iovance.com.
About Iovance Biotherapeutics, Inc.
Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL)
therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system's
ability to recognize and destroy diverse cancer cells in each patient. Our lead late-stage TIL product candidate, lifileucel for metastatic
melanoma, has the potential to become the first approved one-time cell therapy for a solid tumor cancer. The Iovance TIL platform
has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy,
including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.
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; 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; 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.
Sara Pellegrino, IRC
Vice President, Investor Relations & Public Relations
650-260-7120 ext. 264
Director, Investor Relations & Public
650-260-7120 ext. 264