Iovance Biotherp Stock Price, News & Analysis

Iovance Biotherapeutics (NASDAQ: IOVA) announced promising clinical data for its T cell-based therapy, lifileucel, in combination with pembrolizumab for advanced melanoma patients naïve to immune checkpoint inhibitors. In the IOV-COM-202 study, the initial cohort of 7 patients exhibited an overall response rate (ORR) of 86%, with 43% achieving complete responses. Early responses were durable, and safety profiles were consistent with known therapies. Iovance will host a call on June 6 to discuss the data further, demonstrating its commitment to advancing immunotherapy for cancer treatment.

Iovance Biotherapeutics is set to present at three virtual healthcare conferences in June 2021, highlighting its innovative T cell-based cancer immunotherapies.

• Jefferies Virtual Healthcare Conference: June 1 at 3:30 p.m. ET.
• Goldman Sachs 42nd Annual Global Healthcare Conference: June 9 at 5:30 p.m. ET.
• JMP Securities Life Sciences Conference: June 17 at 2:00 p.m. ET.

Live and archived webcasts will be accessible on the Iovance website.

Iovance Biotherapeutics reported promising results for lifileucel in advanced melanoma. The IOV-COM-202 study showed an impressive 86% overall response rate (ORR) when combined with pembrolizumab in ICI-naïve patients, compared to 33% with pembrolizumab alone. Additionally, follow-up data from the C-144-01 study revealed that the median duration of response (DOR) was not reached after 28 months. These findings suggest that lifileucel may provide significant benefits when used early in treatment, particularly for patients who previously progressed on anti-PD-1 therapy.

Iovance Biotherapeutics (NASDAQ: IOVA) announced FDA feedback on its potency assays for lifileucel, a T cell-based cancer immunotherapy. The company plans to continue developing and validating these assays, aiming for a biologics license application (BLA) submission in the first half of 2022. The FDA recognized the unmet need for metastatic melanoma patients through a regenerative medicines advanced therapy (RMAT) designation for lifileucel. This therapy utilizes a patient's own immune cells to target cancer, with pivotal studies already completed for metastatic melanoma and cervical cancer.

Iovance Biotherapeutics announced positive data from the C-144-01 study published in the Journal of Clinical Oncology, showcasing lifileucel TIL therapy for metastatic melanoma. With a median follow-up of 18.7 months, the overall response rate (ORR) was 36%, and the median overall survival (OS) was 17.4 months. Notably, 69% of patients experienced durable responses lasting over a year. Lifileucel's efficacy showed consistency across various patient subgroups, providing a promising treatment avenue for those resistant to existing therapies. The study highlights advancements in TIL therapy manufacturing for broader patient access.

On May 6, 2021, Iovance Biotherapeutics (NASDAQ: IOVA) released its Q1 2021 financial results, highlighting significant progress in its TIL therapies for various cancers. The company reported a net loss of $75.4 million or $0.51 per share, with cash reserves of $610.2 million as of March 31, 2021, sufficient to fund operations into 2023. The ongoing clinical trials for lifileucel in melanoma and cervical cancer show promising response rates, including a 36.4% overall response rate in advanced melanoma. Iovance also announced an updated license agreement with NIH, enhancing its patent portfolio.

Iovance Biotherapeutics (NASDAQ: IOVA) announced participation in several virtual conferences in May 2021, focusing on their T cell-based cancer immunotherapies. Key presentations include a fireside chat at the Truist Securities Life Sciences Summit on May 5, a talk on tumor infiltrating lymphocytes (TILs) at the Multi-Functional Cell Therapies Summit on May 6, a presentation at the PEGS Boston Virtual Conference on May 13, and a keynote at the Sachs Associates Immuno-Oncology Forum on May 19. Iovance aims to enhance treatment for solid tumors and blood cancers using TIL therapy.

Iovance Biotherapeutics has announced key findings from clinical trials for its T cell-based therapy lifileucel at the ASCO 2021 Annual Meeting. The presentations will focus on lifileucel's efficacy for advanced melanoma, both as a standalone treatment and in combination with pembrolizumab. Two abstracts have been accepted: one evaluating the impact of prior anti-PD-1 therapy and the other assessing the safety and efficacy of the combination therapy for patients who have not previously received immune checkpoint inhibitors. The meeting is scheduled for June 4-8, 2021.

Iovance Biotherapeutics will report its first quarter financial results on May 6, 2021, at 4:30 PM ET, followed by a conference call. The company specializes in T cell-based cancer immunotherapies, particularly tumor infiltrating lymphocyte (TIL) therapy, targeting solid tumors and blood cancers. Iovance has completed dosing in pivotal programs for metastatic melanoma and cervical cancer, and is conducting studies for non-small cell lung cancer and earlier stage cancers. Details of the conference call can be found on their website.