Iovance Biotherapeutics to Present Updated Data from Clinical Study in Advanced Melanoma at ASCO 2020 Virtual Scientific Prog...
April 29 2020 - 12:01PM
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies, today announced that new interim data from Cohort
2 in the C-144-01 study of lifileucel in advanced melanoma will be
provided as an oral presentation at the American Society of
Clinical Oncology’s (ASCO) upcoming ASCO20 Virtual Scientific
Program, to be held May 29-31, 2020. 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 therapies |
Authors: |
Amod Sarnaik, et al. |
Session Title: |
Melanoma/Skin Cancers |
Session Type: |
Oral Abstract Session |
Abstract Number: |
10006 |
Location: |
ASCO20 Virtual Scientific Program at
https://meetings.asco.org/am/virtual-program |
Date/Time: |
available for on-demand viewing starting at 8:00am ET on May
29, 2020 |
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. We may, in some cases, use terms such as “predicts,”
“believes,” “potential,” “continue,” “estimates,” “anticipates,”
“expects,” “plans,” “intends,” “may,” “could,” “might,” “will,”
“should” or other words that convey uncertainty of future events or
outcomes to identify these forward-looking statements. The
forward-looking statements include, but are not limited to, risks
and uncertainties relating to 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 timing of and our ability to successfully submit,
obtain and maintain FDA or other regulatory authority approval of,
or other action with respect to, our product candidates, including
those product candidates that have been granted breakthrough
therapy designation (“BTD”) or regenerative medicine advanced
therapy designation (“RMAT”) by the FDA and new product candidates
in both solid tumor and blood cancers; the strength of the
Company’s product pipeline; the successful implementation of the
Company’s research and development programs and collaborations; the
Company’s ability to obtain tax incentives and credits; the
guidance provided for the Company’s future cash, cash equivalents,
short term investment and restricted cash balances; the success of
the Company’s manufacturing, license or development agreements; the
acceptance by the market of the Company’s product candidates, if
approved; and other factors, including general economic conditions
and regulatory developments, not within the Company’s control. The
factors discussed herein could cause actual results and
developments to be materially different from those expressed in or
implied by such statements. Actual results may differ from those
set forth in this press release due to the risks and uncertainties
inherent in the Company’s business, including, without limitation:
the preliminary clinical results, which may include efficacy and
safety results, from ongoing Phase 2 studies may not be reflected
in the final analyses of these trials or subgroups within these
trials; a slower rate of enrollment may impact the Company’s
clinical trial timelines; 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 data within
these trials may not be supportive of product approval; 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 Company’s interpretation of communications with
the FDA may differ from the interpretation of such communications
by the FDA; risks related to the Company’s ability to maintain and
benefit from accelerated FDA review designations, including BTD and
RMAT, 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 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;
and additional expenses may decrease our estimated cash balances
and increase our estimated capital requirements. 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 filings with the Securities and
Exchange Commission. Copies of these filings are available online
at www.sec.gov or www.iovance.com. The forward-looking statements
are made only as of the date of this press release and the Company
undertakes no obligation to publicly update such forward-looking
statements to reflect subsequent events or circumstances.
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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