PHILADELPHIA, May 31, 2019 /PRNewswire/ -- Iovance Biotherapeutics, a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, has expanded its relationship with WuXi AppTec's Advanced Therapies Business Unit (WuXi ATU). WuXi will increase capacity for Iovance's innovaTIL-01 and innovaTIL-04 studies, which offer lifileucel and LN-145 for treatment of metastatic melanoma and recurrent, metastatic, or persistent cervical cancer, respectively.
"We are excited to continue our partnership with WuXi," said Maria Fardis, Ph.D., MBA, President and Chief Executive Officer of Iovance. "Being able to expand our relationship in order to broaden patient access to our treatments is very important to us. WuXi has been a strong partner in developing the Iovance TIL product and we look forward to further expansion of our ongoing relationship."
Felix Hsu, SVP and Global Head of WuXi Advanced Therapies, said, "We are pleased to expand our relationship and manufacturing partnership with Iovance, and look forward to helping to accelerate and expand their clinical trials where possible, so more patients get access to their treatments and the benefits they provide." WuXi manufactures TIL products for Iovance at its Commerce Center 3 facility, a 55,000-square-foot late phase and commercial manufacturing facility for cell therapies. It is one of three facilities in the Philadelphia Navy Yard supporting the development, manufacturing and quality control testing of cell and gene therapies.
About Iovance
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.
About WuXi AppTec
WuXi AppTec is a leading global pharmaceutical and medical device open-access capability and technology platform company with global operations. As an innovation-driven and customer-focused company, WuXi AppTec provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions. With its industry-leading capabilities such as small molecule R&D and manufacturing, cell therapy and gene therapy R&D and manufacturing, and medical device testing, WuXi platform is enabling more than 3,500 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi's dream that "every drug can be made and every disease can be treated." Please visit: http://www.wuxiapptec.com
About WuXi Advanced Therapies (WuXi ATU)
The Advanced Therapies Business Unit of WuXi AppTec is a Contract Development and Manufacturing Organization (CDMO) that is reducing the complexities of manufacturing by providing integrated platforms that enable cell and gene therapies to be developed, manufactured, and released faster and with greater predictability. Please visit www.advancedtherapies.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, including those product candidates that have been granted breakthrough therapy designation (BTD) by the FDA; 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 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 ability to maintain and benefit from accelerated FDA review designations, including BTD, which may not ultimately result in a faster development process or review of the Company's product candidates (and which may later be rescinded by the FDA if such product candidates no longer meet the conditions for qualification for the program), and does not in any way 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; 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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