Iovance Biotherapeutics to Present Clinical and Pre-Clinical Data for Tumor Infiltrating Lymphocyte (TIL) Therapies at Society for Tumor Immunotherapy of Cancer’s (SITC) 38th Annual Meeting
2023年10月31日 - 10:05PM
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 publication of abstracts
for poster presentations reporting clinical data and trial design
for tumor infiltrating lymphocyte (TIL) therapies at the Society
for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting in San
Diego, CA, November 1-5, 2023.
An abstract on the four-year analysis of pooled Cohorts 2 and 4
of the C-144-01 trial reports the longest follow-up data on
lifileucel treatment outcomes in the largest population of patients
with anti–PD-1–refractory advanced melanoma treated with TIL
therapy. As of the data cutoff date of June 16, 2023, median
C-144-01 trial follow-up was 48.1 months in heavily pretreated
patients with advanced melanoma. One-time lifileucel TIL therapy
demonstrated durable efficacy with a four-year OS rate of 22.2%.
The longest response was ongoing at 59.9 months. Treatment-emergent
adverse events were consistent with known safety profiles of
lymphodepletion and IL-2, and their incidence decreased over time.
The four-year analysis further supports the use of lifileucel as a
potential treatment option in these patients that is differentiated
from other immunotherapies.
Iovance Posters at SITC Annual Meeting
- Long-term efficacy and safety of lifileucel tumor infiltrating
lymphocyte (TIL) cell therapy in patients with advanced melanoma: A
4-year analysis of the C-144-01 study
- Poster: Saturday, Nov. 4, 2023, 9:00 a.m.–8:30 p.m. PT
- Tumor infiltrating lymphocytes (TIL) with inducible and
membrane-bound IL-12 exhibit superior antitumor activity in vitro
- Poster: Friday, Nov. 3, 2023, 9:00 a.m.–7:00 p.m. PT
- Trial-in-Progress: TILVANCE-301, a phase 3 study of lifileucel
tumor infiltrating lymphocyte (TIL) cell therapy combined with
pembrolizumab (pembro) vs pembro alone in treatment-naïve
unresectable or metastatic melanoma
- Poster: Saturday, Nov. 4, 2023, 9:00 a.m.–8:30 p.m. PT
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 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, 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.
CONTACTSIovance 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
Iovance Biotherapeutics (NASDAQ:IOVA)
過去 株価チャート
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Iovance Biotherapeutics (NASDAQ:IOVA)
過去 株価チャート
から 6 2023 まで 6 2024