Iovance Biotherapeutics, Inc. - IOVA STOCK NEWS

Iovance Biotherapeutics (NASDAQ: IOVA) announced that its rolling Biologics License Application (BLA) for lifileucel is expected to conclude in Q1 2023. The FDA has provided crucial feedback on the investigational new drug application, which the company will address promptly. Lifileucel, aimed at treating advanced melanoma, currently has no FDA-approved therapy in its category. A successful pre-BLA meeting and ongoing clinical trials further support its potential approval, as Iovance strives to deliver the first individualized cell therapy for this patient group.

Iovance Biotherapeutics announced promising results from its C-144-01 trial for lifileucel, a TIL therapy for advanced melanoma. The trial, featuring 153 patients, reported a 31% objective response rate (ORR) with ongoing responses and a median duration of response not reached at 27.6 months. Median overall survival was 13.9 months. The company is on track to submit a rolling BLA to the FDA by year-end 2022. These results highlight the potential of lifileucel as a significant treatment option in a market currently lacking approved therapies for this patient group.

Iovance Biotherapeutics (NASDAQ: IOVA) initiated a rolling Biologics License Application (BLA) for lifileucel in advanced melanoma, expected to complete in Q4 2022. The company reported a net loss of $99.6 million for Q3 2022, up from $86.1 million in Q3 2021, with R&D expenses rising by 11% to $72.5 million. Their cash position stands at $366.6 million, enough to fund operations into 2024. Iovance aims for FDA approval and commercial launch in 2023, supported by advancements in clinical trials and manufacturing capabilities.

Iovance Biotherapeutics (NASDAQ: IOVA) will announce its Q3 financial results on November 3, 2022. A conference call and live audio webcast will be held at 4:30 p.m. ET for a detailed review and corporate update. Iovance is focused on pioneering T cell-based cancer immunotherapies, specifically targeting metastatic melanoma with its lead candidate, lifileucel, which aims to be the first approved one-time cell therapy for solid tumors. The archived webcast will be available for one year post-event.

Iovance Biotherapeutics has initiated the IOV-GM1-201 trial, marking a key step in developing its genetically modified TIL therapy, IOV-4001, targeting metastatic non-small cell lung cancer and advanced melanoma. The trial is a first-in-human study assessing the therapy's safety and efficacy. The innovative approach involves TALEN^® gene editing to inactivate PD-1, aiming to enhance anti-tumor activity. The trial is currently enrolling participants, indicating potential advancements in cancer treatment options.

Iovance Biotherapeutics announced oral and poster presentations for the C-144-01 trial at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting on November 10, 2022. The presentations cover the lifileucel TIL cell monotherapy for advanced melanoma and a Phase 1/2 study of TALEN-mediated PD-1–inactivated TILs in melanoma and NSCLC. A conference call will discuss the pooled analysis of the trial's cohorts. With a focus on advancing TIL therapies, Iovance aims to innovate cancer treatment.

Iovance Biotherapeutics, a late-stage biotechnology company focused on cancer immunotherapy, plans to present at several key conferences in September. These include the Wells Fargo Healthcare Conference on September 7, HC Wainwright Annual Global Investment Conference starting September 12, Baird Global Healthcare Conference on September 13, and the Cantor Oncology Conference on September 28. The events will feature discussions about their lead product candidate, lifileucel, which aims to be the first approved one-time cell therapy for solid tumors. Webcasts will be available online.

Iovance Biotherapeutics (NASDAQ: IOVA) announced the publication of clinical data and trial designs for its tumor infiltrating lymphocyte (TIL) therapies at the ESMO Congress 2022 in Paris, from September 9-13, 2022. Two key abstracts were presented: Abstract #844P on the efficacy of lifileucel in advanced melanoma and Abstract #883TiP detailing a study on PD-1 inactivated TIL. These advances are part of Iovance's commitment to developing TIL therapies aimed at transforming cancer treatment.

Iovance Biotherapeutics has initiated a rolling Biologics License Application (BLA) submission for lifileucel, a T cell-based therapy targeting advanced melanoma. This marks a significant step toward offering the first individualized, one-time cell treatment for patients with limited options. With no current FDA-approved therapies in this setting, Iovance's submission is anticipated to be completed by Q4 2022. The BLA is bolstered by positive clinical data from the C-144-01 trial, and the FDA has designated lifileucel as a regenerative medicine advanced therapy.