Iovance Biotherapeutics Completes Patient Dosing in Registration-Enabling Cohort 4 of the C-144-01 Melanoma Study with Lifile...
January 15 2020 - 8:00AM
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies, today announced that the company has completed
dosing the last patient in the registration-enabling Cohort 4 of
the C-144-01 study of lifileucel in the treatment of patients with
advanced melanoma. Cohort 4 has the primary endpoint of objective
response rate (ORR) to be read out by an Independent Review
Committee.
“We are quite pleased to complete patient dosing
of this pivotal cohort in our study of lifileucel ahead of schedule
due to increased demand, bringing this potential therapy one step
closer to patients,” said Maria Fardis, Ph.D., MBA, Iovance
President and Chief Executive Officer. “We remain on track to
submit a Biologics License Application (BLA) subsequent to
discussions with FDA, for regulatory approval of lifileucel in late
2020. Lifileucel could be the first approved cell therapy product
for solid tumors.”
Iovance Tumor Infiltrating Lymphocytes (TIL) for
melanoma, lifileucel, is an investigational, patient-derived cell
therapy that involves a 22-day manufacturing process at a
centralized facility. Cohort 4 in the C-144-01 study includes
post-PD-1 patients with Stage IIIC/IV unresectable melanoma who
also have received BRAF/MEK therapy if clinically indicated.
Lifileucel has been granted Regenerative Medicine Advanced Therapy
(RMAT), Fast Track and Orphan Drug designations in advanced
melanoma.
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”).
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,
and short term investment 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; 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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