Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel cancer immunotherapies based
on tumor-infiltrating lymphocyte (TIL) technology, today announced
that it has entered into a lease agreement to build an
approximately 136,000 square foot commercial-scale production
facility in Philadelphia for commercial and clinical production of
autologous TIL products, including its candidate lifileucel. The
facility will allow production according to U.S. Food and Drug
Administration (FDA) guidelines and is designed to provide
scalability using modular processes. The facility will be designed
and built for an ultimate maximum capacity to manufacture TIL
products for several thousands of patients annually. The lease
agreement and construction of the new Iovance facility at the Navy
Yard is expected to ultimately create employment opportunities for
several hundred individuals in Philadelphia once at full capacity.
Iovance expects to invest approximately $75 million over three
years for equipment and construction of the manufacturing suites.
The facility is expected to be completed in approximately two
years.
“We are very excited to initiate building our commercial
manufacturing facility in Philadelphia. The 22-day Iovance Gen 2
TIL therapy process is robust and scalable, and has led to
impressive responses in melanoma, cervical and head and neck
indications,” commented Maria Fardis, Ph.D., M.B.A., president and
chief executive officer of Iovance. “Building our own internal
production capabilities will help us reduce the cost of operations
which is necessary for offering broad access to TIL therapy. We
look forward to beginning construction within the next few weeks.
Our intention is to continue collaborating with our existing
contract manufacturing organizations while we complete the facility
in 2021.”
“Today’s announcement is great news for the commonwealth as
hundreds of new, high-paying jobs will ultimately be created in the
biotechnology sector,” said Governor Tom Wolf. “I want to thank
Iovance for choosing Pennsylvania as the best place to do this
important and life changing work.”
“Iovance’s decision to expand to Philadelphia is further
evidence that our city’s reputation as a leading location for
technology, innovation, and life sciences is growing,” said City of
Philadelphia Mayor Jim Kenney. “Companies from around the country
and the world are seeing Philadelphia as the place they need to be
in order to attract talent and grow their business.”
“We are delighted that Iovance has selected Philadelphia for its
cutting-edge manufacturing facility,” said John Grady, President of
PIDC, Philadelphia’s public-private economic development
corporation. “At the Navy Yard, Iovance will build its custom
facility in an environment that will attract the talent to continue
the important work they do. We look forward to Iovance joining this
innovative and collaborative community.”
Iovance’s autologous TIL therapy involves collection of a tissue
sample from a patient, which is shipped to a facility where immune
cells can be isolated and amplified to populations numbering in the
billions of cells. This diverse, polyclonal population of active T
cells are then cryopreserved and shipped to sites across the U.S.
and Europe for infusion into the patient.
Following an extensive evaluation for a preferred location,
Iovance’s new facility will be located at 300 Rouse Boulevard at
the Navy Yard in Philadelphia. Philadelphia’s well-established and
growing life sciences sector has strong academic and research
institutions, a robust talent pipeline from recent college
graduates to senior executives and scientists, and a central
location on the East Coast. The Iovance facility is being developed
and built by Gattuso Development Partners, LLC and the design and
construction management firm CRB. Financial incentives have been
provided by the Commonwealth of Pennsylvania, the City of
Philadelphia, and PIDC, including the site’s designation as a
Keystone Opportunity Improvement Zone, which allows incentives for
business development. The real estate services firm JLL advised
Iovance on the facility lease transaction. Iovance also has
obtained a letter of intent from PIDC for a five-year option for
additional space to support further increases in maximum
capacity.
About the Philadelphia Navy Yard
The Navy Yard is home to one of the highest concentrations of
privately leased life science space in Philadelphia with more than
800,000 square feet and more than 2,500 employees in this sector
working at the campus. The diversity among these companies
encompasses large corporate offices, established and emerging
companies with R&D and manufacturing facilities, educational
institutions, and related capital ventures. Iovance has also leased
office space in the area to support the construction and build the
initial team on site. The Navy Yard is considered the most
successful redevelopment of a former military facility in the
country. A thriving riverfront neighborhood, the Navy Yard
currently features more than 7.5 million square feet of buildings
housing more than 13,500 employees working at over 150 companies.
Home to historic structures and new high-performance and LEED
certified development, the Navy Yard offers diverse, flexible
building choices with varying heights, vintages, and floorplates,
all powered by a nationally-recognized microgrid and oriented
around miles of riverfront access and world-class open space.
Future growth will support up to 10 million square feet of
commercial and residential development. PIDC, Philadelphia’s
public-private economic development corporation, is the master
developer of the Navy Yard. For more information, please visit
www.navyyard.org and follow us @NavyYardPhila on Twitter.
About PIDC
PIDC is Philadelphia’s public-private economic development
corporation. A non-profit founded in 1958 by the City of
Philadelphia and the Greater Philadelphia Chamber of Commerce,
PIDC’s mission is to spur investment, support business growth, and
foster developments that create jobs, revitalize neighborhoods, and
drive growth to every corner of Philadelphia. Over the last 60
years, PIDC has invested more than $14 billion of financing and
more than 3,000 acres of land sales – which has leveraged over $25
billion in total investment and assisted in retaining and creating
hundreds of thousands of jobs in Philadelphia. For more information
about PIDC, visit www.PIDCphila.com and follow us @PIDCphila on
Twitter.
About Gattuso Development Partners
Gattuso Development Partners is a developer of exceptional,
sustainable high performance workplaces. We recognize that the
right work environment is the most critical asset a business can
offer to attract, retain and inspire its employees and promote long
term success.
Gattuso professionals have played a key role in reshaping the
Philadelphia skyline and revitalizing its urban landscape through
their work with the urban development group at Liberty Property
Trust, including more than $3 billion of development on projects
like the Comcast Technology Center and the Comcast Center, in
Center City, Philadelphia. This work also includes the
redevelopment of the Philadelphia Navy Yard, considered the most
successful redevelopment of a former military facility anywhere in
the country; the Camden Waterfront; and more than 50 office/flex
buildings across the nation. Gattuso Development Partners is
committed to building upon this legacy to develop new and creative
work environments that reimagine the workplace for our clients,
starting with the construction of the Iovance manufacturing
facility at the Navy Yard. For more information, go to
www.gattusodevelopmentpartners.com.
About CRB
CRB is a leading provider of sustainable engineering,
architecture, construction management and consulting solutions to
the global life sciences and advanced technology industries. Our
more than 1,000 employees provide best-in-class solutions that
drive success and positive change for our clients, our people and
our communities. CRB is a privately held company with a rich
35-year history of serving clients throughout the world,
consistently striving for the highest standard of technical
knowledge, creativity and execution. For more information, go to
www.crbusa.com.
About JLL
JLL (NYSE: JLL) is a leading professional services firm that
specializes in real estate and investment management. Our vision is
to reimagine the world of real estate, creating rewarding
opportunities and amazing spaces where people can achieve their
ambitions. In doing so, we will build a better tomorrow for our
clients, our people and our communities. JLL is a Fortune 500
company with annual revenue of $16.3 billion, operations in over 80
countries and a global workforce of over 90,000 as of December 31,
2018. JLL is the brand name, and a registered trademark, of Jones
Lang LaSalle Incorporated. For further information, visit
jll.com.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics intends to commercialize lifileucel, an
autologous cell therapy product using TIL technology that amplifies
the body’s own immune response to eradicate solid tumors or attack
blood cancers. The company is currently conducting the pivotal
study innovaTIL-01 in patients with metastatic melanoma. In
addition, the company’s TIL therapies are being investigated for
the treatment of patients with locally advanced, recurrent or
metastatic cancers including cervical, head and neck, and non-small
cell lung cancer. 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 obtain and maintain
FDA or other regulatory authority approval of, or other action with
respect to, our product candidates; the strength of Company’s
product pipeline; the successful implementation of the Company’s
research and development programs and collaborations; our ability
to obtain tax incentives and credits; 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, including efficacy and safety results, from
ongoing Phase 2 studies may not be reflected in the final analyses
of these trials, including new cohorts within these trials, and may
not be supportive of product approval; the FDA or other regulatory
authorities may potentially delay the timing of their approval of,
or other action with respect to, the Company’s product candidates;
the Company’s ability to address FDA or other regulatory authority
requirements relating to its clinical programs and registrational
plans, such requirements including, but not limited to, clinical
and safety requirements as well as manufacturing and control
requirements; risks related to the Company’s accelerated FDA review
designations; and the ability of the Company to manufacture its
therapies using third party manufacturers. 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 Investor Relations Contacts:
Annie ChangSolebury Trout646-378-2972achang@troutgroup.com
Chad RubinSolebury Trout646-378-2947crubin@troutgroup.com
Iovance Media Relations Contact: Rich
AllanSolebury Trout646-378-2958rallan@troutgroup.com
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