Iovance Biotherapeutics (NASDAQ:IOVA)
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1 Year : From Apr 2019 to Apr 2020
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.
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.
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.
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.
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.
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