Iovance Biotherapeutics Inc. (NASDAQ:IOVA) has announced its Q3 2020 financial results and provided corporate updates.
Iovance moves lifileucel BLA submission to 2021
Maria Fardis, the company’s CEO and President, said that the company has moved the lifileucel BLA submission date to 2021 following a meeting with the FDA. The change is to offer time to reach an agreement on required potency assays for TIL’s full definition. She said that the company is looking forward to commencement a registration study in NSCLC and present preliminary TIL in combination with Anti-PD1 therapy data in the neck and head cancer.
The company is currently in a strong financial position, which will allow it to advance its clinical programs and continue operating plans. The company had cash of $719.7 million at the end of the quarter, which is enough to execute the commercial launch of programs that include IOV-LUN-202 in NSCLC. Fardis confirmed that she believes that the company is better positioned to lead in the developing, manufacturing, and commercializing TIL cell therapy for cancer treatment.
Iovance and the FDA agreed on the duration of follow up for the vital data for lifileucel BLA in metastatic melanoma during the quarter. There is currently more work underway on potency assays supporting the BLA with discussions with the FDA regarding the assays expected to continue. Iovance expects to submit the BLA early next year.
Iovance dosed last cervical cancer patient in C-145-04 study
In the study of the TIL cell therapy in cervical cancer, the company dosed the last patient in the pivotal Cohort 1 lifileucel C-145-04 study. In NSCLC, the company finalized the protocol for a potential registration study investigating LN-145 in patients having recurrent/metastatic NSCLC. The focus will be on patients who do not show driver mutations and those that previously received a single approved line systemic therapy.
Iovance will present TIL therapy’s updated data in head and neck squamous cell carcinoma in an abstract at the upcoming annual Society for Immunotherapy of Cancer Meeting. HNSCC patients that received a combination of LN-145 and pembrolizumab showed a 44% overall response rate.