Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor-infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), is celebrating the official opening of the Iovance Cell Therapy Center (iCTC). The iCTC, located at the Philadelphia Navy Yard, is the first centralized, scalable, state-of-the-art manufacturing facility dedicated to producing TIL cell therapies for patients with solid tumor cancers. The current capacity is expected to meet potential demand for thousands of patients per year with multiple types of cancers, including clinical trial patients and future commercial patients.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “Since Iovance was founded, we have been dedicated to advancing novel cell therapies for patients with solid tumor cancers. As the hub of cell and gene therapy and the home of leading hospitals and academic centers, Philadelphia became the city of choice for our internal manufacturing. A little over two years after breaking ground, iCTC is now one of the largest cell therapy manufacturing facilities in the world and may ultimately house hundreds of employees. We now have the capacity to supply broad access to TIL therapies for patients. I believe that the important ecosystem within Cellicon Valley will continue to contribute to our advancements to pioneer a new class of treatment for cancer.”
A ribbon cutting event celebrates the opening with special guests including Pennsylvania Governor Tom Wolf, Philadelphia Mayor Jim Kenney, and other government officials and collaborators within Cellicon Valley. Patients, caregivers, and patient advocacy organizations, including Melanoma Research Foundation (MRF), Melanoma Research Alliance (MRA) and the Society for Gynecological Oncology’s Foundation for Women’s Cancer cut the ribbon on behalf of everyone who is currently fighting cancer, and in memory of those who lost their battles with cancer.
“The iCTC is a symbol of significant innovation and opportunity for the commonwealth as hundreds of new, high-paying jobs will ultimately be created at this facility,” said Governor Tom Wolf. “Iovance has already made a positive impact on the region and worked with a great sense of urgency to complete construction and begin initial manufacturing for patients with cancer.”
“The iCTC represents a new model in cell therapy manufacturing and bolsters Philadelphia’s reputation as a leading location for technology, innovation, and life sciences,” said City of Philadelphia Mayor Jim Kenney. “Iovance is a great example of what companies from around the country and the world may accomplish in establishing Philadelphia as the place to attract talent and grow their business.”
Located at 300 Rouse Boulevard and with approximately 136,000 square feet of space, the iCTC is among the largest cell therapy manufacturing facilities today. The iCTC is currently supplying Iovance clinical studies, and commercial manufacturing is expected to begin after initial product approval. The iCTC was developed and built by Gattuso Development Partners, LLC and the design and construction management firm CRB. Financial incentives were 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.
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.
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 or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; 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 forecasts and increase our estimated capital requirements; and other factors, including general economic conditions and regulatory developments, not within our control.
Iovance Biotherapeutics, Inc:
Sara Pellegrino, IRC
Vice President, Investor Relations & Public Relations
650-260-7120 ext. 264