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FDA Grants Approval to Iovance's AMTAGVI for Advanced Melanoma In a significant stride towards revolutionizing cancer treatment, Iovance Biotherapeutics, Inc. (NASDAQ: NASDAQ:IOVA ) has achieved a monumental milestone. The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Iovance's AMTAGVI™ (lifileucel) suspension for intravenous infusion, marking a groundbreaking advancement in the fight against advanced melanoma. Unveiling a Paradigm Shift in Cancer Therapy: AMTAGVI™ represents a paradigm shift in cancer therapy, offering a novel approach to treating solid tumor cancers. Unlike conventional treatments, AMTAGVI™ harnesses the power of the body's own immune system by deploying patient-specific T cells known as Tumor-Infiltrating Lymphocytes (TILs). This innovative therapy targets adult patients with unresectable or metastatic melanoma who have previously undergone treatment with a PD-1 blocking antibody and, if applicable, a BRAF inhibitor. Personalized Precision Medicine: At the core of AMTAGVI™ lies a personalized precision medicine approach. Through a proprietary process, the therapy collects and expands a patient's unique T cells derived from their own tumor tissue. By returning billions of activated T cells to the body, AMTAGVI™ empowers the immune system to recognize and destroy cancer cells with unprecedented specificity. Accelerated Approval and Clinical Efficacy: The FDA's accelerated approval of AMTAGVI™ underscores its remarkable clinical efficacy and potential to address unmet medical needs. Clinical trials, including the pivotal C-144-01 study, demonstrated deep and durable responses in patients with advanced melanoma. Notably, a substantial percentage of patients achieved objective responses, with a median duration of response surpassing 12 months. Transformative Impact on Patient Care: For patients grappling with advanced melanoma, AMTAGVI™ offers a ray of hope where conventional treatments have fallen short. With an estimated 8,000 melanoma-related deaths annually in the U.S. alone, the approval of AMTAGVI™ signifies a critical breakthrough in transforming the treatment landscape and improving patient outcomes. Commitment to Accessibility and Support: Recognizing the importance of accessibility, Iovance is dedicated to ensuring the widespread availability of AMTAGVI™ through its comprehensive support program, IovanceCares™. This initiative provides patients and Authorized Treatment Centers (ATCs) with invaluable resources, including copay support, financial assistance, and travel accommodations, to facilitate seamless access to therapy. Conclusion: In the realm of cancer therapeutics, the approval of AMTAGVI™ marks a historic milestone, heralding a new era of personalized and precision medicine. As Iovance ( NASDAQ:IOVA ) continues its pursuit of addressing unmet medical needs across various solid tumor types, the groundbreaking success of AMTAGVI™ serves as a beacon of hope for patients, clinicians, and researchers alike in the relentless fight against cancer.
NASDAQ:IOVA
by DEXWireNews
Iovance BioTherapeutics (NASDAQ: $IOVA) Popping Pre-market! 🎉Iovance Biotherapeutics, Inc., a clinical-stage biotechnology company, focuses on developing and commercializing cancer immunotherapy products to harness the power of a patient's immune system to eradicate cancer cells. It has six ongoing phase 2 clinical studies, including C-144-01, of its lead product candidate, lifileucel, for the treatment of metastatic melanoma; C-145-04, of its product candidate lifileucel for recurrent, metastatic, or persistent cervical cancer; and C-145-03, of its product candidate LN-145, for recurrent and/or metastatic head and neck squamous cell carcinoma. Iovance Biotherapeutics, Inc. has collaborations and licensing agreements with H. Lee Moffitt Cancer Center; M.D. Anderson Cancer Center; Ohio State University; Centre hospitalier de l'Université de Montreal; Cellectis S.A.; and Novartis Pharma AG. The company was formerly known as Lion Biotechnologies, Inc. and changed its name to Iovance Biotherapeutics, Inc. in June 2017. Iovance Biotherapeutics, Inc. was incorporated in 2007 and is headquartered in San Carlos, California.
NASDAQ:IOVALong
by Bullishcharts
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IOVA - IOVANCE FINISHED FUELING UP AND ABOUT TO TURN ON ENGINEIovance Biotherapeutics aims to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patient's own immune cells to attack cancer. TIL cells are extracted from a patient's own tumor tissue, expanded through a proprietary process, and infused back into the patient. Upon infusion, TIL reach tumor tissue, where they attack cancer cells. The company has completed dosing in the pivotal study in patients with metastatic melanoma and cervical cancer. In addition, the company's TIL therapy is being investigated for the treatment of patients with locally advanced, recurrent or metastatic cancers including head and neck and non-small cell lung cancer. A clinical study to investigate Iovance T cell therapy for blood cancers called peripheral blood lymphocyte (PBL) therapy is open to enrollment. What an amazing opportunity. RISK 5% REWARD 22% 4.44 RISK TO REWARD RATIO Enough cash on hand ~$720M cash (9/30/20) to last 3 years of R&D 2021 - Year to get some FDA News - HUGE POTENTIAL MARKET FOR CANCER TREATMENT Research/ Study showing promise. Developing Iovance manufacturing facility plans for commercialization 75 Million$ Investment scheduled for completion this year.
NASDAQ:IOVALong
by Edrisahmadyar
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