TIL therapy is considered one of the most competitive and commercially promising technological directions in the field of immunotherapy for solid tumors. From 2011 to 2020, a total of 79 clinical trials related to TIL therapy were conducted worldwide, involving 22 TIL candidate products. The types of tumors treated with TIL in clinical trials are no longer limited to melanoma but have expanded to various types of cancers such as lung cancer, ovarian cancer, liver cancer, and breast cancer.
As a pioneer in TIL cell therapy, Iovance Biotherapeutics submitted a rolling Biologics License Application (BLA) to the U.S. FDA in March this year for its independently developed lifileucel (LN-144), which was granted priority review. If successfully approved, lifileucel is expected to become the world's first cell therapy for the treatment of solid tumors.
Image source: Cell & Gene Therapy Insights 2020; 6(6), 855-863 DOI: 10.18609/cgti.2020.088
Chinese pharmaceutical companies are also actively deploying TIL therapy and have developed multiple products under development. Currently, a total of five TIL cell products (from GRIT Biotechnology, Juncell Therapeutics, ZhiLing Bio, TCRCure) have received approval from the CDE in China, entering the registration clinical phase. R&G registration department provided Pre-IND communication and IND application services for two of these products, deeply participating in discussions on non-clinical and CMC materials, drafting of clinical protocols, and discussions on responding to regulatory feedback, among other work, assisting the sponsors in successfully obtaining IND clinical trial approvals for their drugs, playing an important role in accelerating the two products into the registration clinical phase.
In the past five years, the registration team of R&G has successfully completed registration application services for over 200 pharmaceuticals and medical devices, assisting nearly 20 cell and gene therapies to receive CDE approval for registrational clinical trials, providing end-to-end guidance and application services from manufacturing, quality control, non-clinical to clinical processes for multiple cell therapy companies with zero application experience.
R&G registration department can provide a complete registration service system, including strategy consulting and registration applications, for pharmaceuticals and medical devices in China, the United States, Europe, and some Asia-Pacific regions. The registration team in China consists of numerous senior registration directors (over 10 years of experience) and registration experts specializing in chemical drugs, biological drugs, pharmacology, toxicology, clinical medicine, and QC, forming a meticulously and professionally managed, stable, and highly service-oriented registration team.
