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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) will announce its Q3 financial results on November 4, 2021, followed by a conference call at 4:30 p.m. ET. The company focuses on T cell-based cancer immunotherapies, with its lead candidate, lifileucel, aimed at treating metastatic melanoma. Iovance's TIL platform shows promise across various solid tumors, with ambitions to lead in tumor-infiltrating lymphocyte therapies.
Iovance Biotherapeutics will host a webcast on November 13, 2021 at 5:30 p.m. ET to present updates on its tumor-infiltrating lymphocyte (TIL) therapies in lung cancer and in combination with pembrolizumab. The conference will include insights from key leaders in the field. Additionally, posters will be presented at the SITC Annual Meeting from November 12-14, 2021, detailing phase 2 data for TIL therapy. Iovance aims to pioneer TIL cell therapies, with the potential first one-time cell therapy for solid tumors.
Iovance Biotherapeutics has announced key clinical data presentations at the SITC 36th Annual Meeting on TIL cell therapies for advanced cancers. An oral presentation on November 13 will focus on phase 2 results of TIL in combination with pembrolizumab for immune checkpoint inhibitor-naïve patients. Additionally, posters will cover TIL monotherapy efficacy in NSCLC and advancements in TIL manufacturing. These developments highlight Iovance's commitment to pioneering cancer immunotherapy.
Iovance Biotherapeutics has announced the successful infusion of the first patient with TIL cell therapy LN-145, produced at the Iovance Cell Therapy Center (iCTC). This milestone is part of the IOV-COM-202 study focusing on metastatic non-small cell lung cancer. The state-of-the-art iCTC facility in Philadelphia aims to meet the demand for TIL therapies, with capacity for thousands of patients. The company plans to balance internal and external TIL manufacturing, prioritizing accessibility and cost reduction for its therapies.
Iovance Biotherapeutics reported its second quarter 2021 financial results, highlighting advances in TIL therapy for cancer. The company has a cash position of $708.7 million as of June 30, sufficient to fund operations through 2023. Key clinical data was presented, showing an 86% overall response rate for lifileucel in combination with pembrolizumab for anti-PD-1 naïve melanoma. However, the net loss for Q2 was $81.4 million, an increase from $63 million in Q2 2020, with R&D expenses rising to $62.1 million.
Iovance Biotherapeutics (NASDAQ: IOVA) is set to release its second quarter financial results on August 5, 2021. The company, focused on T cell-based cancer therapies, will also provide a corporate update during a conference call at 4:30 p.m. ET. Iovance's innovative Tumor Infiltrating Lymphocyte (TIL) therapy targets solid tumors and blood cancers, with ongoing studies in metastatic melanoma and cervical cancer. Future clinical studies aim to evaluate TIL in earlier-stage cancers and blood cancers. Key details about the call are accessible on the Iovance website.
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.
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