Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies, today presented long-term interim data from Cohort
2 in the C-144-01 study of lifileucel in advanced melanoma during
an oral session at the American Society of Clinical Oncology’s
(ASCO) ASCO20 Virtual Scientific Program.
“We are very pleased to present the long term follow up data for
lifileucel in melanoma at the ASCO Scientific Program,” said Maria
Fardis, Ph.D., President and Chief Executive Officer of Iovance
Biotherapeutics. “The median duration of response has not been
reached at 18.7 months of study follow up supporting potential
benefit of the one-time treatment of lifileucel TIL therapy in
advanced melanoma patients. The latest data at ASCO also
demonstrate durable responses with lifileucel across the broad
spectrum of our study population, including a wide age range of
metastatic melanoma patients who have received prior anti-CTLA-4
and BRAF targeted treatments, and equally in patients with PD-L1
high and low status.”
Jason Chesney, MD PhD, Director, James Graham Brown Cancer
Center, University of Louisville and C-144-01 study investigator
stated, “One of the greatest challenges oncologists face today is
the treatment of melanoma patients who have progressed on immune
checkpoint and BRAF/MEK inhibitors. The preliminary results
of the C-144-01 study demonstrate that autologous tumor
infiltrating lymphocytes (TILs; lifileucel) induce durable clinical
responses in a significant percentage of this moribund
population. Importantly, this new study opens the door for
trials of TILs in many other cancer types and in combination with
our growing repertoire of immunomodulatory agents.”
Updated interim results from Cohort 2 are now available from an
oral abstract session titled, “Long-term follow up of lifileucel
(LN-144) cryopreserved autologous tumor infiltrating lymphocyte
therapy in patients with advanced melanoma progressed on multiple
prior therapies.” As of the April 23, 2020 data extract for the
oral presentation, lifileucel shows a 36.4% overall response rate
(2 complete responses and 22 partial responses) and a disease
control rate of 80% (n=66). Median duration of response (DOR) was
not reached at 18.7 months of median study follow up (2.2 to 26.9+
months).
The Cohort 2 patients had heavily pretreated metastatic melanoma
with high baseline disease burden. They have progressed on multiple
prior therapies (3.3 mean prior therapies), including anti-PD-1 and
BRAF/MEK inhibitors. The adverse event profile was consistent with
the underlying advanced disease, lymphodepletion and IL-2
regimens.
Michael Kaplan, President and CEO of the Melanoma Research
Alliance, stated, “While the last decade has brought incredible
progress in delivering new treatments for melanoma, we know that
more than half of patients with advanced melanoma are still in need
of additional options. It is particularly exciting to see a new
treatment approach, like lifileucel, that can offer hope and real
results for some for whom checkpoint immunotherapy alone has yet to
prove successful. The Melanoma Research Alliance is excited that
Iovance has taken a significant step forward in ensuring more
treatment options for patients who once had very few.”
The oral abstract session is available on demand in the ASCO
Meeting Library at https://meetinglibrary.asco.org/. Details of the
presentation are as follows:
Title:
Long-term follow up of lifileucel (LN-144) cryopreserved autologous
tumor infiltrating lymphocyte therapy in patients with advanced
melanoma progressed on multiple prior
therapiesAuthors: Amod Sarnaik, et
al.Session Title: Melanoma/Skin
CancersSession Type: Oral Abstract
SessionAbstract Number:
10006Location: ASCO20 Virtual Scientific Program
at https://meetings.asco.org/am/virtual-program
About Iovance Biotherapeutics,
Inc. Iovance Biotherapeutics aims to improve patient care
by making T cell-based immunotherapies broadly accessible for the
treatment of patients with solid tumors and blood cancers. Tumor
infiltrating lymphocyte (TIL) therapy uses a patient’s own immune
cells to attack cancer. TIL cells are extracted from a patient’s
own tumor tissue, expanded through a proprietary process, and
infused back into the patient. After infusion, TIL reach tumor
tissue, where they attack tumor cells. The company has completed
dosing in the pivotal study in patients with metastatic melanoma
and is currently conducting a pivotal study in patients with
advanced cervical cancer. In addition, the company’s TIL therapy is
being investigated for the treatment of patients with locally
advanced, recurrent or metastatic cancers including head and neck
and non-small cell lung cancer. A clinical study to investigate
Iovance T cell therapy for blood cancers called peripheral blood
lymphocyte (PBL) therapy is open to enrollment. 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, filings with the Securities and Exchange
Commission (“SEC”), reports to stockholders and in meetings with
investors and analysts, 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.
These forward-looking statements include, but are not limited to,
statements regarding the success, timing, projected enrollment,
manufacturing and production capabilities, and cost of our ongoing
clinical trials and anticipated clinical trials for our current
product candidates (including both Company-sponsored and
collaborator-sponsored trials in both the U.S. and Europe), such as
statements regarding the timing of initiation and completion of
these trials; the strength of the Company’s product pipeline; and
the guidance provided for the Company’s future cash, cash
equivalents, short term investment and restricted cash balances.
These statements involve risks, uncertainties and other factors
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,
including, without limitation, the following substantial known and
unknown risks and uncertainties inherent in the Company’s business:
the COVID-19 pandemic may have an adverse effect on the Company and
its clinical trials, including potential slower patient
recruitment, inability of clinical trial sites to collect data,
inability of the Company or its contract research organizations to
monitor patients, as well as U.S. Food and Drug Administration
(“FDA”) availability due to competing priorities; our ability to
achieve long-term profitability and successfully commercialize our
products alone or with third parties, as well as our history of
operating losses and our expectations that we will continue to
incur significant operating losses; our limited operating history
in our current line of business, which makes it difficult to
evaluate our prospects, our business plan or the likelihood of our
successfully implementing such business plan; risks related to the
timing of and our ability to successfully develop, submit, obtain
and maintain FDA or other regulatory authority approval of, or
other action with respect to, our product candidates (including
with respect to lifileucel for the treatment of metastatic
melanoma, for which we expect to submit a biologics licensing
application (“BLA”) to the FDA during 2020), and our ability to
successfully commercialize any product candidates for which we
obtain FDA approval; our limited history in conducting clinical
trials, on which our future profitability is substantially
dependent, and our need to rely on third parties, including
contract research organizations, contract manufacturing
organizations and consultants, in connection with the conduct,
supervision and monitoring of our clinical trials for our product
candidates; preliminary and interim clinical results, which may
include efficacy and safety results, from ongoing Phase 2 studies
may not be reflected in the final analyses of our ongoing clinical
trials or subgroups within these trials; the risk that a slower
rate of enrollment may delay the Company’s clinical trial timelines
or otherwise adversely impact our clinical development activities;
the risk that enrollment may need to be adjusted for the Company’s
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 the Company’s cervical cancer trial may have an adverse
effect on the results reported to date; the risk that the results
obtained in our ongoing clinical trials may not be indicative of
results obtained in future clinical trials or that data within
these trials may not be supportive of product approval, including
that later developments with the FDA may be inconsistent with
already completed FDA meetings; the risk that the FDA may not
agree with our approach to expand our cervical cancer trial to
include Cohort 2 of the C-145-04 trial; the risk that changes in
patient populations may result in changes in preliminary clinical
results; the Company’s ability or inability to address FDA or other
regulatory authority requirements relating to its clinical programs
and registrational plans, such requirements including, but not
limited to, clinical, safety, manufacturing and control
requirements; the risk that regulatory authorities may potentially
delay the timing of FDA or other regulatory approval of, or other
action with respect to, our product candidates, or 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 the Company’s interpretation
of the results of its clinical trials or communications with the
FDA may differ from the interpretation of such results or
communications by the FDA; our ability to obtain and maintain
intellectual property rights related to our product pipeline; our
ability to successfully implement our research and development
programs and collaborations; the acceptance by the market of our
product candidates and their potential reimbursement by payors, if
approved; our ability to obtain tax incentives and credits and the
risk that our existing net operating loss carryforwards and
research tax credits may expire or otherwise be limited in use; the
success of our manufacturing, license or development agreements;
risks related to the Company’s ability to maintain and benefit from
accelerated FDA review designations, including breakthrough therapy
designation or regenerative medicine advanced therapy designation,
which may not result in a faster development process or review of
the Company’s product candidates (and which may later be rescinded
by the FDA), and which does not assure approval of such product
candidates by the FDA or the ability of the Company to obtain FDA
approval in time to benefit from commercial opportunities; the
ability or inability of the Company to manufacture its therapies
using third party manufacturers or its own facility may adversely
affect the Company’s potential commercial launch; the results of
clinical trials with collaborators using different manufacturing
processes may not be reflected in the Company’s sponsored trials;
our dependence on additional financing to fund our operations and
complete the development and commercialization of our product
candidates, and the risks that raising such additional capital may
restrict our operations or require us to relinquish rights to our
technologies or product candidates; the risk that additional
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
the Company’s control.
A further list and description of the Company’s risks,
uncertainties and other factors can be found in the Company’s most
recent Annual Report on Form 10-K and the Company’s subsequent
reports that we file or furnish with the SEC from time to time.
Copies of these reports are available online at www.sec.gov or
www.iovance.com. The forward-looking statements in this press
release should be considered in light of these risks and
uncertainties. All forward-looking statements made in this press
release are based solely on information available to us as of the
date of this press release and the Company undertakes no obligation
to publicly update or revise such forward-looking statements,
whether as a result of subsequent events, changed circumstances,
new information or otherwise.
CONTACTS:Iovance Biotherapeutics,
Inc:Sara Pellegrino, IRCVice President, Investor Relations
& Public Relations650-260-7120 ext.
264Sara.Pellegrino@iovance.com
Solebury Trout:Annie Chang
(investors)646-378-2972achang@troutgroup.com
Chad Rubin (investors)646-378-2947crubin@troutgroup.com
Rich Allan (media)646-378-2958rallan@troutgroup.com
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