Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies, today provided a regulatory update for its
tumor-infiltrating lymphocyte (TIL) therapy lifileucel in
metastatic melanoma. In preparation for the planned Biologics
License Application (BLA) submission for lifileucel, the Company
has been engaged in discussions with the U.S. Food and Drug
Administration (FDA), including a recent Type B meeting, regarding
the requirements and timing of certain information that would be
provided as part of its BLA submission.
The Company believes that clinical data from its
C-144-01 trial supports the potential for lifileucel as a treatment
for metastatic melanoma. Iovance and the FDA have reached agreement
on the duration of follow up for its pivotal Cohort 4 to support
the BLA submission. As part of the Type B meeting, the Company and
the FDA have not been able to agree on the required potency assays
to fully define its TIL therapy, which is required as part of a BLA
submission. The Company is continuing to refine the
information from its current potency assays and simultaneously
developing additional assays. As a result of these developments,
the BLA submission is not expected by the end of 2020. The Company
will continue to work closely with the FDA and now anticipates a
BLA submission to occur in 2021. Additional guidance on the BLA
submission timing will be provided when available.
“TIL is a first-in-class, one-time
administration cell therapy targeting solid tumors. As such,
definition of the product through a potency assay is an important
step toward submission of the BLA,” stated Maria Fardis, Ph.D.,
MBA, Iovance President and Chief Executive Officer. “We have
agreement with the FDA regarding the amount of clinical follow up
for the BLA, and we will work closely with the FDA to reach
alignment on our assays. Because Iovance recognizes the significant
unmet need in the melanoma patient population and believes the
compelling clinical data for lifileucel will offer a new therapy
for such patients, we are moving ahead with a great sense of
urgency. We look forward to further collaboration with the FDA and
will provide updates as they become available.”
As previously announced, updated Cohort 2 data
from the C-144-01 clinical trial presented at the 2020 American
Society of Clinical Oncology Annual Meeting showed an overall
response rate (ORR) of 36.4 percent with a median duration of
response not reached at 18.7 months of median study follow up
(n=66). Early Cohort 4 data previously reported by the Company
showed an ORR of 32.4 percent at 5.3 months of median study follow
up (n=68). Currently available treatment options for the patient
population in the C-144-01 study is limited to chemotherapy, with a
response rate of four to 10 percent and a very short duration of
response.
Webcast and Conference CallThe
Company will host a conference call today at 4:30 p.m. ET. The
conference call dial-in numbers are 1-844-646-4465 (domestic) or
1-615-247-0257 (international). The conference ID access number for
the call is 5866866. The live webcast can be accessed in the
Investors section of the Company’s website
at http://www.iovance.com. The archived webcast will be
available for a year in the Investors section
at www.iovance.com.
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
metastatic 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
StatementsCertain 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, restricted cash balances, and forecasted operating
expenses. 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, reaching
agreement with the FDA on the appropriate potency assay and the
timing to submit a biologics licensing application (“BLA”) to the
FDA), 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 that may have a
material adverse effect on the Company’s business and clinical
development, including general economic conditions, the Covid-19
pandemic and regulatory developments, not within the Company’s
control.
CONTACTSIovance
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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