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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) has appointed Jean-Marc Bellemin as Chief Financial Officer, a move aimed at enhancing the company's strategic financial oversight. Bellemin brings 27 years of experience, including significant roles in public biopharma companies. His previous positions include CFO at Gritstone Oncology and Actelion Pharmaceuticals, where he contributed to substantial revenue growth and multiple product launches. The appointment is timely as Iovance transitions toward commercializing TIL cell therapy for cancer treatment, with ongoing clinical studies in advanced stages.
Iovance Biotherapeutics, a late-stage biotechnology firm focused on T cell-based cancer immunotherapies, announced presentations at key conferences from December 1-3, 2020. Events include the Piper Sandler 32nd Annual Virtual Healthcare Conference, and the Cellular Immunotherapies for Solid Tumors Summit, where they will discuss the clinical success of their TIL technology. The company is advancing TIL therapy for various cancers, including metastatic melanoma and cervical cancer. Webcasts of the presentations will be available on their website.
Iovance Biotherapeutics (NASDAQ: IOVA) presented interim data for its tumor infiltrating lymphocyte (TIL) therapy, LN-145, combined with pembrolizumab for advanced head and neck squamous cell carcinoma (HNSCC). The study showed a 44.4% overall response rate (ORR) and a disease control rate of 88.9%, with a median duration of response not yet reached at 8.6 months. The trial participants were PD-1 blockade naive, and 89% had progressed on prior chemotherapy. Iovance continues to explore additional solid tumor indications for this combination therapy.
Iovance Biotherapeutics (NASDAQ: IOVA) reported its third quarter 2020 results alongside a corporate update, highlighting an agreement with the FDA to move the BLA submission for lifileucel to 2021. The company initiated a registration-directed study for lung cancer and reported strong financials with $719.7 million in cash. However, net losses increased to $58.6 million in Q3 2020. R&D expenses grew due to clinical trials and internal team expansion. Iovance aims to lead in TIL therapy development and is set to present data at the SITC Annual Meeting.
Iovance Biotherapeutics (NASDAQ: IOVA) will release its Q3 2020 financial results on November 5, 2020, followed by a conference call at 4:30 p.m. EST for a corporate update. The company focuses on T cell-based cancer immunotherapies, and its pivotal studies include treatments for metastatic melanoma and advanced cervical cancer. Iovance aims to enhance patient care by making immunotherapies accessible for various cancers. Key challenges may impact clinical trial timelines and regulatory approvals, particularly due to COVID-19 and potential FDA feedback.
Iovance Biotherapeutics, a late-stage biotechnology company focused on T cell-based cancer immunotherapies, announced its participation in several upcoming conferences in November 2020. Key events include the Next Generation CAR and T Cell Therapies Conference on Nov. 2, the Credit Suisse 29th Annual Virtual Healthcare Conference on Nov. 9, and the SITC Annual Meeting from Nov. 9-14, featuring a presentation on tumor infiltrating lymphocytes for advanced cancers. Archived webcasts will be available on the Iovance website.
Iovance Biotherapeutics announced new interim data for its tumor infiltrating lymphocyte therapy, LN-145, combined with pembrolizumab for treating head and neck squamous cell carcinoma (HNSCC). This data will be presented at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) from November 9-14, 2020. The therapy employs a patient's own immune cells to combat cancer, with ongoing studies in metastatic melanoma and advanced cervical cancer, showcasing the company's commitment to enhancing patient care with innovative T cell-based immunotherapies.
Iovance Biotherapeutics, a biotechnology firm focused on cancer immunotherapies, announced participation in two upcoming virtual conferences. On October 6, 2020, the company will present at the Jefferies Cell Therapy Summit at 3:00 p.m. EDT, with a webcast available on their website. Following this, from October 12-16, 2020, they will present at the Alliance for Regenerative Medicine Meeting on the Mesa, with presentations available on demand starting October 12. Iovance specializes in TIL therapy for solid tumors and blood cancers.
Iovance Biotherapeutics (NASDAQ: IOVA) has announced a regulatory update regarding its TIL therapy, lifileucel, for metastatic melanoma. Following discussions with the FDA, the company is refining potency assays required for its Biologics License Application (BLA) submission, which is now expected in 2021 instead of 2020. Clinical trial data shows lifileucel has an overall response rate of 36.4% in Cohort 2, compared to 4-10% for current chemotherapy options. The company emphasizes urgency in addressing unmet patient needs while working closely with the FDA to finalize regulatory requirements.
Iovance Biotherapeutics, a late-stage biotechnology firm, will present at the BTIG Biotechnology Conference 2020 on August 11 at 2:30 PM ET. The event will focus on their T cell-based cancer immunotherapies, particularly Tumor Infiltrating Lymphocyte (TIL) therapy for solid tumors and blood cancers. The company is conducting pivotal studies in metastatic melanoma and advanced cervical cancer, and its TIL therapies are being explored for various cancers. A live webcast will be available on their investor website.
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