On September 23, 2021 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), reported that the Iovance Cell Therapy Center (iCTC) successfully manufactured and delivered the first clinical batch of TIL cell therapy LN-145 (Press release, Iovance Biotherapeutics, SEP 23, 2021, View Source [SID1234590219]). The first Iovance clinical study participant infused with LN-145 manufactured at iCTC is enrolled in a metastatic non-small cell lung cancer (mNSCLC) cohort in the IOV-COM-202 basket study in solid tumors.
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Igor Bilinsky, Ph.D., Chief Operating Officer of Iovance, stated, "We are thrilled to announce that one of our clinical study participants has received the first infusion of our internally manufactured Iovance TIL cell therapy. I applaud the efforts of our Iovance team at iCTC in achieving the important construction and manufacturing milestones that led to this moment. Moving forward, we are diversifying between internal and external TIL manufacturing for clinical studies, and iCTC remains on track to provide commercial supply upon potential product approval. Establishing our internal manufacturing capabilities is a top priority at Iovance to ensure broad access to and reduce the costs of Iovance TIL cell therapy."
The iCTC, located at the Philadelphia Navy Yard, is the first centralized, scalable, state-of-the-art manufacturing facility dedicated to producing potentially life-saving TIL cell therapies for patients with solid tumor cancers. 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 current capacity is expected to meet the demand for thousands of patients per year with multiple types of cancers.
Sumit Verma, Senior Vice President of Commercial Manufacturing at Iovance, added, "Since breaking ground two years ago, we completed construction of the iCTC and built our organization to lead the next chapter in manufacturing and delivering novel cell therapies for patients with cancer. Philadelphia and the Cellicon Valley ecosystem have been instrumental in our progress. At iCTC we have recruited an extraordinary and diverse internal team, and we continue to recruit new highly skilled employees to further support our growth and success."