Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology
company focused on innovating, developing, and delivering novel
polyclonal tumor infiltrating lymphocyte (TIL) therapies for
patients with cancer, today announced the U.S. Food and Drug
Administration (FDA), because of resource constraints, requires
additional time to complete the Priority Review of Iovance’s
Biologics License Application (BLA) for lifileucel. The BLA is
seeking accelerated approval of lifileucel for patients with
advanced melanoma. The FDA extended the new target action date for
a decision under the Prescription Drug User Fee Act (PDUFA) to
February 24, 2024, but agreed to work with Iovance to expedite the
remaining review for a potentially earlier approval date.
The FDA recently notified Iovance that they had insufficient
resources to review a recent response to an information request for
the ongoing BLA review prior to the planned late-cycle review
meeting scheduled for September 11, 2023. In a meeting with the FDA
held on September 14, 2023, the FDA acknowledged the resource
constraints and agreed to work closely with Iovance to expedite the
remaining review.
The overall BLA process continues under Priority Review with
several recent positive status updates. The FDA reiterated there
are no major review issues, and there are no plans to hold an
advisory committee meeting. In addition, all pre-approval
inspections of clinical sites. internal and external manufacturing
and testing facilities have been successfully completed. The FDA is
also engaged and has expressed no concerns on the status of the
TILVANCE-301 confirmatory trial in frontline advanced melanoma,
which remains on track to be well underway by the PDUFA date.
Frederick Vogt, Ph.D., J.D., Interim President and Chief
Executive Officer of Iovance, stated, “While the resource
constraints at FDA have extended our PDUFA date, Iovance and FDA
remain engaged to complete the review process as quickly as
possible. We appreciate FDA management’s efforts to expedite the
remaining review so that we can bring lifileucel to critically ill
patients with no other FDA approved options after current standard
of care. We are confident in the potential for lifileucel to
redefine the treatment paradigm for these patients. With the
strength of our clinical data, manufacturing capabilities, and
commercial readiness efforts, Iovance is well positioned to rapidly
serve the U.S. melanoma community immediately following an
approval.”
Lifileucel, if approved, will be the first and only TIL therapy
for patients with advanced melanoma, as well as the first one-time
cell therapy for a solid tumor cancer. Lifileucel is an
individualized therapy intended for patients with advanced melanoma
who progressed on or after prior anti-PD-1/L1 therapy and targeted
therapy, where applicable. There are no FDA approved therapies in
this treatment setting.
The FDA accepted the BLA for lifileucel in May 2023 under
Priority Review and previously granted a Regenerative Medicine
Advanced Therapy (RMAT) designation for lifileucel in advanced
melanoma. The extension of the PDUFA date does not impact the
Priority Review status or RMAT designation.
The BLA submission for lifileucel is supported by positive data
from the C-144-01 clinical trial in patients with advanced melanoma
who progressed on or after prior anti-PD-1/L1 therapy and targeted
therapy, where applicable. If lifileucel receives accelerated
approval, the randomized Phase 3 TILVANCE-301 trial in frontline
advanced melanoma can serve as the confirmatory study to support
full approval. TILVANCE-301 is expected to be well underway at the
time of approval.
About Iovance Biotherapeutics, Inc.
Iovance 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; whether clinical trial results from our pivotal studies
and cohorts, and meetings with the FDA, may support registrational
studies and subsequent approvals 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 prior
pre-BLA meeting with the FDA); the risk that the FDA may not
approve or may delay approval for our BLA submission for lifileucel
in metastatic melanoma; 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.
CONTACTS
Iovance Biotherapeutics, Inc:
Sara Pellegrino, IRCSenior Vice President, Investor Relations
& Corporate Communications650-260-7120 ext.
264Sara.Pellegrino@iovance.com
Jen SaundersDirector, Investor Relations & Public
Relations267-485-3119Jen.Saunders@iovance.com
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