On April 27, 2021 Instil Bio, Inc. ("Instil") (Nasdaq: TIL) reported that it received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of melanoma stages IIB to IV with its ITIL-168 TIL therapy (Press release, Instil Bio, APR 27, 2021, View Source [SID1234583993]).
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"The Orphan Drug Designation incentivizes biotech companies to develop new therapies that are important for patients. We are pleased to advance development of ITIL-168 for the treatment of melanoma stages IIB to IV with this designation," said Bronson Crouch, Chief Executive Officer of Instil.
Orphan Drug Designation confers potential benefits to sponsors, including tax credits for qualified clinical testing, waiver of BLA user fees, and eligibility of market exclusivity for 7 years upon marketing approval.
About ITIL-168
ITIL-168 is an investigational, autologous cell therapy made from tumor infiltrating lymphocytes, or TILs. ITIL-168 is manufactured with Instil’s proprietary, optimized, and scalable manufacturing process, which has been designed to capture and preserve the maximum diversity of each patient’s TILs; the manufacturing process also offers significant scheduling flexibility for patients and physicians at the time of both tumor resection and TIL treatment. Instil plans to investigate ITIL-168 in a global phase 2 trial in advanced melanoma in 2021 and additional solid tumor indications in Phase 1 clinical trials beginning in 2022.