Tumor-infiltrating lymphocyte therapy to file for listing, Iovance share price halved

On May 26, Iovance Biotherapeutics reported positive results from the study, codenamed C-144-01, evaluating the company's lead candidate, lifileucel, a tumor-infiltrating lymphocyte (TIL) therapy, in advanced (unresectable or metastatic) disea.

In registry cohort 4 (n=87), the independent review committee (IRC) objective response rate (ORR) using RECIST 1 criteria was 29% (95% confidence interval (CI): 15%, 34%), 3 Cases were CR (complete remission), and 22 were PR (partial remissio.

The findings of cohort 4 were supported by cohort 2 (n=66), with an IRC-assessed ORR of 35% (95% CI: 25%, 46%), 5 CRs and 18 P.

Treatment-emergent adverse event profiles in both cohorts were consistent with those of underlying disease and known non-myeloablative lymphoid failure and interleukin-2 (IL-2), and between cohorts 2 and

In terms of patient enrollment, patients in cohort 4 had a higher baseline disease burden than patients in cohort 2, including a significantly higher proportion (64%) of patients with elevated baseline lactate dehydrogenase (LDH) levels, a well-known poor prognostic fact.

Iovance said it will submit a Biologics License Application (BLA) for the product in Augu.

Iovance is a pioneer in TIL technology, which is based on the human body's own T.

Compared with existing therapies, the advantages of TIL technology include: ① It can target a variety of tumor antigens; ② It can achieve one-time treatment; ③ Since TIL is autologous, it has fewer adverse reactio.

However, Iovance's development of lifileucel has not progressed smooth.

In May 2021, Iovance again received a response letter from the FDA requesting additional data on the efficacy of lifileucel to ensure that each batch of TIL products met the standar.

However, less than 20 hours after the news was released that day, the company's five-year Chief Executive Officer (CEO) .

The clinical results disclosed two days ago did not seem to satisfy investo.