Welcome to our dedicated page for Iovance Biotherapeutics news (Ticker: IOVA), a resource for investors and traders seeking the latest updates and insights on Iovance Biotherapeutics stock.
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) is a clinical-stage biopharmaceutical company dedicated to advancing and commercializing innovative cancer immunotherapies. The company specializes in tumor-infiltrating lymphocyte (TIL) therapies, which harness the body's immune system to target and eliminate cancer cells.
Core Business: Iovance’s primary focus is on developing autologous T-cell therapies designed to treat various solid tumors. Their lead candidate, lifileucel (marketed as AMTAGVI™), has recently gained FDA approval for treating advanced melanoma. This milestone marks it as the first T-cell therapy approved for a solid tumor cancer.
Clinical Trials and Achievements: Lifileucel has shown promise in clinical trials, producing durable responses in patients with metastatic melanoma. Iovance continues to explore its efficacy in other cancers including head and neck carcinoma, cervical cancer, and non-small cell lung cancer through trials like IOV-LUN-202. Preliminary data suggests significant potential benefits, with ongoing responses and durations extending over six months.
Regulatory and Market Footprint: Iovance is preparing for further U.S. regulatory approvals and is working towards global commercialization. The FDA’s recent hold on IOV-LUN-202 due to safety concerns has not affected other trials or the priority review of lifileucel in advanced melanoma.
Manufacturing and Partnerships: With manufacturing facilities like the Iovance Cell Therapy Center (iCTC) and partnerships with entities such as WuXi Advanced Therapies, Iovance is well-equipped to scale production to meet clinical and commercial demands.
Financial Overview: The company reported a net loss of $113.0 million for Q1 2024, reflecting heavy investment in R&D and commercialization efforts. Revenue from Proleukin® sales outside the U.S. contributed $0.7 million, demonstrating ongoing diversification.
Commitment to Innovation: Iovance remains committed to pioneering advancements in cell therapy, including gene-edited approaches, to extend and improve the lives of cancer patients. For more information, please visit www.iovance.com.
Iovance Biotherapeutics (NASDAQ: IOVA) announced a conference call on June 29, 2021, to discuss recent clinical data for its LN-145 TIL therapy targeting non-small cell lung cancer (NSCLC). The company aims to enhance patient care through T cell-based immunotherapies that utilize tumor-infiltrating lymphocytes (TILs) from patients' own tumors. Iovance is also engaged in pivotal programs for metastatic melanoma and cervical cancer, with ongoing studies for other cancers, demonstrating a strong commitment to advancing cancer treatment.
Iovance Biotherapeutics (NASDAQ: IOVA) announced promising clinical results for its TIL therapy LN-145 in relapsed/refractory metastatic non-small cell lung cancer (mNSCLC). The ongoing study showed a 21.4% overall response rate and a 64.3% disease control rate among patients previously treated with immunotherapies. Notably, the median duration of response was not reached within an 8.2-month follow-up. The company also initiated a registration-supporting trial, IOV-LUN-202, for LN-145 in second-line mNSCLC, aiming to address significant unmet medical needs.
Iovance Biotherapeutics (NASDAQ: IOVA) has announced updated clinical data for lifileucel in advanced melanoma at the ASCO 2021 Annual Meeting. The median duration of response (DOR) for Cohort 2 is not yet reached at 33.1 months, with an overall response rate of 36.4%. Early intervention with lifileucel after anti-PD-1 therapy shows promise for better treatment outcomes. A study indicates that shorter prior anti-PD-1 therapy duration correlates with nearly doubled DOR. Safety profiles remain consistent with previous data, showing no new risks.
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.
FAQ
What is the current stock price of Iovance Biotherapeutics (IOVA)?
What is the market cap of Iovance Biotherapeutics (IOVA)?
What does Iovance Biotherapeutics specialize in?
What is lifileucel, marketed as AMTAGVI™?
What recent regulatory challenges has Iovance faced?
Who are Iovance's key manufacturing partners?
What are the financial highlights for Iovance in Q1 2024?
Which cancers are Iovance's TIL therapies being tested for?
How does Iovance's TIL therapy work?
What is the significance of the FDA approval of AMTAGVI™?
What future plans does Iovance have for lifileucel?
Where can I find more information about Iovance Biotherapeutics?
