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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 announced successful manufacturing of tumor-infiltrating lymphocyte (TIL) therapy from cryopreserved tumor samples shipped from Australia. This innovation may address shipment challenges and enhance global access to TIL therapy. The company will present findings at the upcoming Tandem Meetings from February 2-6, 2022, in Salt Lake City, Utah. Two key abstracts will be presented, including results on ex vivo expansion of TILs and their treatment with decitabine. Iovance aims to lead in developing TIL therapies for cancer, particularly lifileucel for metastatic melanoma.
Iovance Biotherapeutics (NASDAQ: IOVA) announced that Fred Vogt, Interim CEO, will present at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 7:30 a.m. ET. The event will feature a live and archived webcast available on their website. Iovance is focused on developing T cell-based immunotherapies, with a lead candidate, lifileucel, showing promise for treating metastatic melanoma. The company emphasizes innovation in cell therapy aimed at improving cancer care.
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) granted inducement stock options for 107,900 shares to eleven new non-executive employees on December 16, 2021. This grant is part of Iovance's 2021 Inducement Plan and complies with Nasdaq Listing Rule 5635(c)(4). The stock options have an exercise price of $17.80, equivalent to the closing price on the grant date. Each option vests over three years, with one-third vesting after one year and the rest quarterly thereafter, contingent on continued employment.
Iovance Biotherapeutics (NASDAQ: IOVA) recently announced its participation in key December conferences focused on cancer immunotherapy. The company will engage in a fireside chat at the JMP Securities Hematology and Oncology Summit on December 7 at 1:40 p.m. ET. Additionally, Iovance will present an on-demand poster at the ESMO Immuno-Oncology Annual Meeting from December 8-11, highlighting AKT inhibition's impact on TIL expansion. At the American Society of Hematology Annual Meeting from December 11-14, a poster will detail the Phase 1/2 study of IOV-2001 for chronic lymphocytic leukemia.
Iovance Biotherapeutics (NASDAQ: IOVA) announced the grant of inducement stock options for 168,575 shares to seven new non-executive employees on November 18, 2021. The options, part of the 2021 Inducement Plan, have an exercise price of $19.05, equal to the closing stock price on the grant date. Each option vests over three years, with one-third vesting on the first anniversary and the remainder in quarterly installments. This move is aligned with Iovance's focus on developing T cell-based cancer immunotherapies, notably its lead candidate lifileucel for metastatic melanoma.
Iovance Biotherapeutics (NASDAQ: IOVA) reported promising clinical data on its lifileucel TIL cell therapy combined with pembrolizumab, presented at the SITC Annual Meeting. The overall response rates were 57.1% in cervical cancer, 60.0% in melanoma, and 38.9% in head and neck cancer. Notably, a 30% complete response rate was observed in melanoma patients. The findings support continued investigation of TIL therapy as a treatment option. A conference call is scheduled for November 13, 2021, to discuss these results further.
Iovance Biotherapeutics has announced new clinical data for its TIL therapy, LN-145, showcasing a 21.4% overall response rate in heavily pre-treated patients with metastatic non-small cell lung cancer (mNSCLC). The therapy demonstrated effectiveness even in patients resistant to previous treatments. The clinical trial results were presented during the SITC Annual Meeting in Washington, D.C. and suggest continued investigation of LN-145 in upcoming studies. The company emphasizes the significance of these findings in addressing unmet needs in second-line mNSCLC treatment.
Iovance Biotherapeutics (NASDAQ: IOVA) has announced promising clinical data for its tumor-infiltrating lymphocyte (TIL) therapy, showcasing an overall response rate (ORR) of 50% in cervical cancer patients and 87.5% in metastatic melanoma when combined with pembrolizumab. For relapsed non-small cell lung cancer (NSCLC), the TIL therapy demonstrated an ORR of 21.4%. Iovance will present updated results at the upcoming SITC Annual Meeting, signaling a potentially significant step forward in immunotherapy for various cancers.
Iovance Biotherapeutics (NASDAQ: IOVA), a leader in T cell-based cancer therapies, announced its participation in several major conferences in November 2021. Key presentations include:
- Festival of Biologics, Basel: November 9 at 11:10 a.m. ET
- Cowen 5th Annual IO Next Summit: November 15 at 3:45 p.m. ET
- Stifel 2021 Virtual Healthcare Conference: November 17 at 11:20 a.m. ET
- Cell Immunotherapies for Solid Tumors Summit: November 18 at 10:30 a.m. ET
- Piper Sandler 33rd Annual Virtual Healthcare Conference: November 22 at 10:00 a.m. ET
The company focuses on pioneering tumor infiltrating lymphocyte therapies for cancer treatment.
Iovance Biotherapeutics (NASDAQ: IOVA) reported its third quarter 2021 results, showcasing ongoing advancements in T cell-based cancer immunotherapies. The company continues to develop lifileucel, with an expected FDA BLA submission in H1 2022. Iovance received FDA Fast Track designation for lifileucel in combination with pembrolizumab for metastatic melanoma. The cash position stood at $660.8 million, adequate to fund operations into 2023. However, net loss for Q3 was $86.1 million, up from $58.6 million in Q3 2020, raising concerns about increasing R&D and administrative expenses.