Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies, and Cellectis (Euronext Growth: ALCLS - NASDAQ:
CLLS), a clinical-stage biopharmaceutical company focused on
developing immunotherapies based on gene-edited allogeneic CAR
T-Cells (UCART), announced today that the companies have entered
into a research collaboration and exclusive worldwide license
agreement whereby Iovance will license certain TALEN® technology
from Cellectis in order to develop tumor infiltrating lymphocytes
(TIL) that have been genetically edited to create more potent
cancer therapeutics.
The worldwide exclusive license enables Iovance
Biotherapeutics’ use of TALEN® technology addressing multiple gene
targets to modify TIL for therapeutic use in several cancer
indications. Financial terms of the license include development,
regulatory and sales milestone payments from Iovance
Biotherapeutics to Cellectis, as well as royalty payments based on
net sales of TALEN®-modified TIL products.
“We are very excited to be collaborating with
Cellectis in applying the TALEN® gene-editing technology to
Iovance’s TIL product. We believe that we can genetically modify
TIL to make a more tumor-reactive anti-cancer product,” said Maria
Fardis, Ph.D., MBA, President and Chief Executive Officer of
Iovance Biotherapeutics. She added: “We plan to move a
TALEN®-edited TIL therapy into a clinical trial as rapidly as
possible.”
“We are thrilled to be working with Iovance and
believe that applying our TALEN® technology to TIL-based products
will yield even better treatments for a variety of cancers,” added
André Choulika, Ph.D., Chairman and CEO, Cellectis. “Patients
remain at the heart of our company and it is our sincere hope that
this collaboration can help provide more efficacious options to
those in need.”
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 is currently
conducting pivotal studies in patients with metastatic melanoma and
advanced cervical cancer. In addition, the company’s TIL therapies
are 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’s T cell therapy for blood cancers called peripheral blood
lymphocyte (PBL) therapy is being initiated. For more information,
please visit www.iovance.com.
About Cellectis
Cellectis is developing the first of its kind
allogeneic approach for CAR-T therapies, pioneering the concept of
off-the-shelf and ready-to-use gene-edited CAR-T cells to treat
patients. As a clinical-stage biopharmaceutical company with over
20 years of expertise in gene editing, we are developing
game-changer product candidates in immune-oncology. Utilizing
TALEN®, our gene editing technology, and PulseAgile, our pioneering
electroporation system, we are harnessing the power of the immune
system to target and eradicate cancer cells.
As part of our commitment to a cure, Cellectis
remains dedicated to its goal of providing life-saving UCART
product candidates to address unmet need for multiple cancers
including B-cell acute lymphoblastic leukemia (B-ALL), non-Hodgkin
lymphoma (NHL) and multiple myeloma (MM). Cellectis is listed on
the Nasdaq (ticker: CLLS) and on Euronext Growth (ticker:
ALCLS).
Cellectis headquarters are in Paris, France,
with additional locations in New York, New York and Raleigh, North
Carolina. For more information, visit www.cellectis.com.
Follow Cellectis on social media: @Cellectis,
LinkedIn and YouTube.
TALEN® is a registered trademark owned by
Cellectis.
Iovance Biotherapeutics 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 equivalent,
and short term investment positions; 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.
Cellectis Forward-Looking Statements
This press release contains “forward-looking”
statements that are based on our management’s current expectations
and assumptions and on information currently available to
management. Forward-looking statements involve known and unknown
risks, uncertainties and other factors that may cause our actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements. Further information on
the risk factors that may affect company business and financial
performance is included in Cellectis’ Annual Report on Form 20-F
and the financial report (including the management report) for the
year ended December 31, 2018 and subsequent filings Cellectis makes
with the Securities Exchange Commission from time to time. Except
as required by law, we assume no obligation to update these
forward-looking statements publicly, or to update the reasons why
actual results could differ materially from those anticipated in
the forward-looking statements, even if new information becomes
available in the future.
Iovance Biotherapeutics Investor Relations
Contacts: Annie ChangSolebury
Trout646-378-2972achang@troutgroup.com
Chad RubinSolebury Trout646-378-2947crubin@troutgroup.com
Iovance Biotherapeutics Media Relations
Contact: Rich AllanSolebury
Trout646-378-2958rallan@troutgroup.com
Cellectis Media contacts:
Jennifer MooreVP of
Communications917-580-1088media@cellectis.com
Caitlin KasunichKCSA Strategic
Communications212-896-1241ckasunich@kcsa.com
Cellectis Investor Relations contact:
Simon HarnestVP of Corporate Strategy and
Finance646-385-9008simon.harnest@cellectis.com
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