Iovance Biotherapeutics to Present Updated Clinical Data for Tumor Infiltrating Lymphocyte (TIL) Therapy Lifileucel in Advanc...
March 10 2021 - 5:28PM
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies, today announced that long-term interim data from
Cohort 2 in the C-144-01 clinical study (NCT02360579) in advanced
melanoma has been accepted as an oral presentation in a Clinical
Trials Plenary Session at the upcoming American Association for
Cancer Research (AACR) 2021 Annual Meeting.
Abstract Title: Lifileucel
(LN-144), a cryopreserved autologous tumor infiltrating lymphocyte
(TIL) therapy in patients with advanced (unresectable or
metastatic) melanoma: durable duration of response at 28-month
follow up Authors: Jason Alan Chesney, MD, PhD, et
al.Abstract Number: 5329Presentation
Number: CT008Session Title:
Immunooncology and Cell Therapy Trials Session Date and
Time: Saturday, April 10, 2021, 3:30 PM - 5:50 PM
ETLocation: AACR Virtual Annual Meeting 2021 at
www.aacr.org
In addition to the oral presentation, three Iovance
poster presentations at AACR will highlight the design of clinical
trials in progress in solid tumors and chronic lymphocytic leukemia
or small lymphocytic lymphoma (CLL/SLL). These posters are intended
to educate physicians about study design and will not include
clinical data. Posters will be available from 8:30 a.m. ET on
Saturday, April 10 through Monday, June 21, 2021 in the Virtual
ePoster Hall at www.aacr.org.
- Abstract Title: A
Phase 2, multicenter study of autologous tumor infiltrating
lymphocytes (TIL) (LN 144/LN-145/LN-145-S1) in patients with solid
tumorsAuthors: Scott Gettinger, MD, et
al.Abstract Number: CT235
- Abstract Title: A
Phase 1/2 study evaluating the safety and efficacy of IOV-2001 in
patients with relapsed or refractory chronic lymphocytic leukemia
(CLL) or small lymphocytic lymphoma (SLL)Authors:
Meixiao Long, MD, PhD, et al.Abstract Number:
CT244
- Abstract Title: A
phase 2 multicenter study of autologous tumor infiltrating
lymphocytes (TIL; LN-145) cell therapy in patients with metastatic
non-small cell lung cancer (mNSCLC)Authors:
Erminia Massarelli, MD, PhD, et al.Abstract
Number: CT246
The AACR Annual Meeting program covers the latest
discoveries across the spectrum of cancer research—from population
science and prevention; to cancer biology, translational, and
clinical studies; to survivorship and advocacy—and highlights the
work of the best minds in research and medicine from institutions
all over the world. For more information, please visit the AACR
Annual Meeting page at
www.aacr.org/meeting/aacr-annual-meeting-2021.
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. Upon infusion, TIL reach tumor
tissue, where they attack cancer cells. The company has completed
dosing in pivotal programs in patients with metastatic melanoma and
cervical cancer. In addition, the company’s TIL therapy is being
investigated in a registration-supporting study for the treatment
of patients with locally advanced, recurrent or metastatic
non-small cell lung cancer. Clinical studies are also underway to
evaluate TIL in earlier stage cancers in combination with currently
approved treatments, and to investigate Iovance peripheral blood
lymphocyte (PBL) T cell therapy for blood cancers. 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, 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; preliminary and interim clinical results, which may
include efficacy and safety results, from ongoing clinical trials
may not be reflected in the final analyses of our ongoing clinical
trials or subgroups within these trials; 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 new
version of the protocol which further defines the patient
population to include more advanced patients in our cervical cancer
trial may have an adverse effect on the results reported to date;
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; 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 increase our estimated capital requirements; and other
factors, including general economic conditions and regulatory
developments, not within our 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
Zara Lockshin
(media)646.378.2960zlockshin@troutgroup.com
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