Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies (tumor-infiltrating lymphocyte, TIL and
peripheral-blood lymphocyte, PBL), today presented new interim
clinical data for the tumor infiltrating lymphocyte (TIL) therapy
LN-145 in combination with pembrolizumab in advanced, recurrent, or
metastatic head and neck squamous cell carcinoma (HNSCC) who are
immune checkpoint inhibitor (ICI) naive at the
35th Anniversary Annual Meeting of the Society
for Immunotherapy of Cancer (SITC).
“We are very pleased to present initial safety and
efficacy data for our tumor infiltrating lymphocyte (TIL) cell
therapy LN-145 in combination with pembrolizumab as a potential new
therapeutic approach in ICI naive head and neck cancer,” said Maria
Fardis, Ph.D., President and Chief Executive Officer of Iovance
Biotherapeutics. “Following one-time TIL administration and
pembrolizumab as per the approved label, the overall response rate
was 44.4 percent and median duration of response has not been
reached at 8.6 months of study follow up in patients with advanced,
recurrent, or metastatic HNSCC. This is the first time that
combination of Iovance TIL with anti-PD-1 antibody data is being
presented in ICI naive patients. We continue evaluating the
combination of TIL with pembrolizumab in additional solid tumor
indications and look forward to presenting our findings as our
program progresses.”
New interim results from the ongoing IOV-COM-202 study of LN-145
in various settings and indications are now available from Cohort
2A in a poster titled, “Safety and efficacy of tumor infiltrating
lymphocytes (TIL; LN-145) in combination with pembrolizumab for
advanced, recurrent or metastatic HNSCC.” As of the October 16,
2020 data extract date for the poster, LN-145 in combination with
pembrolizumab shows a 44.4% overall response rate (ORR) (one
complete response and three partial responses) and a disease
control rate of 88.9% (n=9). Median DOR was not reached at 8.6
months of median study follow up (1.0+ to 10.9+ months).
The HNSCC patients in Cohort 2A were PD-1 blockade naive and 89
percent had progressed on prior chemotherapy (1.0 mean prior line
of therapy). The adverse event profile of the combination therapy
was consistent with those of pembrolizumab and TIL therapy,
lymphodepletion and IL-2, as well as the underlying disease. HPV
status was positive in four patients, negative in three patients
and unknown in two patients. CPS scores were greater than or equal
to 20 in five patients, below 20 in two patients and missing in two
patients. The poster is available in the “Publications and
Scientific Presentations” section of the Iovance corporate
website.
Poster in Head and Neck Cancer at SITC
Annual Meeting (November 9-14, 2020):
- Abstract #353: Safety and efficacy of tumor
infiltrating lymphocytes (TIL; LN-145) in combination with
pembrolizumab for advanced, recurrent or metastatic HNSCC
- Authors: A Jimeno, et al.
- Presentation Times: Wednesday, Nov. 11, from
5:15-5:45 p.m. EST and Friday, Nov. 13, from 4:40-5:10 p.m.
EST.
- Location: Virtual Poster Hall at
www.sitcancer.org
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 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 investments, restricted cash balances and forecasted
operating expenses, including our statements regarding the
sufficiency of our cash reserves to execute commercial launch and
pipeline programs, which assumes no material change in liabilities.
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 currently expect
to submit a biologics licensing application (“BLA”) to the FDA
during 2021), 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 unanticipated
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.
CONTACTS
Iovance Biotherapeutics, Inc:Sara Pellegrino,
IRCVice President, Investor Relations & Public
Relations650-260-7120 ext. 264Sara.Pellegrino@iovance.com
Solebury Trout:Chad Rubin
(investors)646-378-2947crubin@troutgroup.com
Rich Allan (media)646-378-2958rallan@troutgroup.com
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