Lifileucel is a Cell Therapy owned by Iovance Biotherapeutics, and is involved in 14 clinical trials, of which 5 were completed, 7 are ongoing, and 2 are planned.

Lifileucel (LN-144) comprises of patient’s tumor infiltrating lymphocytes (TILs). TILs exhibit strong anti-tumor effector functions. When antigen-specific CD8+ T cells are exposed to processed antigens presented in association with human leukocyte antigen (HLA) class I proteins, they are activated. They expand clonally and differentiate. Differentiation process induces the formation of a large number of modified lysosomes loaded with lytic components such as perforin and several types of granzymes. In case of direct cell-cell interaction, activated CTLs release lytic components leading to specific destruction of tumor cells expressing specific antigens. These components cause cell death by disruption of cell membrane and activation of the apoptotic pathway. CD4+ T cells respond to antigens presented by the HLA class II proteins expressed by antigen-presenting cells also mediate antitumor immunity. Natural killer cells express several ligands of the tumor necrosis factor family and can induce apoptosis of malignant cell targets.

The revenue for Lifileucel is expected to reach a total of $2.2bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Lifileucel NPV Report.

Lifileucel was originated by National Cancer Institute US and is currently owned by Iovance Biotherapeutics.

Lifileucel Overview

Lifileucel (LN-144) is under development for the treatment of relapsed/refractory metastatic melanoma, recurrent head and neck cancer squamous cell carcinoma and non-small cell lung cancer. The therapeutic candidate is administered through intravenous route. It is developed as a ready to infuse autologous cellular immunotherapy product and contains adoptive cellular immunotherapy regimen. The therapeutic candidate consists of autologous tumor infiltrating lymphocytes (TILs) isolated from the patient’s tumor further expanded and then infused back to the patient enabling the patient robust immune response.

Iovance Biotherapeutics Overview

Iovance Biotherapeutics (Iovance) is a biotechnology company that focuses on the development and commercialization of novel immunotherapy products for treating various cancers. It develops products based on its tumor-infiltrating lymphocyte (TIL) technology. The company’s lead product candidates include lifileucel is an autologous, ready-to-infuse cell therapy indicated for the treatment of melanoma and metastatic cervical cancer; and LN-145 for the treatment of head and neck cancer. The company also focuses on investigating TIL therapy for treatment of a range of cancer. The company operates a research facility in Tampa, Florida. Iovance is headquartered in San Carlos, California, the US.

The operating loss of the company was US$342.7 million in FY2021, compared to an operating loss of US$261.9 million in FY2020. The net loss of the company was US$342.3 million in FY2021, compared to a net loss of US$259.6 million in FY2020.

Quick View – Lifileucel

Report Segments
  • Innovator
Drug Name
  • Lifileucel
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Companies
Highest Development Stage
  • Phase II

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.