Iovance Biotherapeutics, Inc. is a biopharmaceutical company, which engages in the development and commercialization of cell therapies as novel cancer immunotherapy products. Its lead product candidate, LN-144 for metastatic melanoma, is an autologous adoptive cell therapy utilizing tumor-infiltrating lymphocytes (TIL), which are T cells derived from patients' tumors. The company was founded by Robert T. Brooke on September 17, 2007, and is headquartered in San Carlos, CA.
相关临床试验
40
20 进行中
药物批准
2
批准总数
监管机构
2
监管机构数
成立时间
2007
进行中（未招募）
18
45.0%
Available
1
2.5%
已完成
4
10.0%
尚未招募
2
5.0%
招募中
12
30.0%
终止
2
5.0%
撤回
1
2.5%
- Cellectis' board approved a strategic transformation on September 11, 2026, ending internal development of CAR-T candidates lasme-cel and eti-cel and refocusing on in vivo gene editing. - The company will advance two preclinical programs, .HEAL-101 targeting APOC3 for severe hypertriglyceridemia and .HEAL-201 targeting PCSK9 for severe hypercholesterolemia, both LNP-delivered. - Cellectis attributed the CAR-T exit to improved frontline regimens, bispecific antibody competition and slower enrollment, and will seek partners for the discontinued assets. - The operational realignment is designed to extend the cash runway into H2 2028, with preliminary Phase 1 data from .HEAL-101 expected in H2 2027 and .HEAL-201 in H1 2028.
- Health Canada approved lifileucel (Amtagvi), a tumor-infiltrating lymphocyte therapy for metastatic melanoma, in August 2025, but no province has yet agreed to publicly fund it. - Ontario patients seeking out-of-country coverage for TIL therapy at U.S. centers have been uniformly rejected, with the province citing the ongoing pan-Canadian Pharmaceutical Alliance review process. - The average time from Health Canada approval to provincial funding in Canada is approximately 730 days, longer than in any other G7 country. - Patients and advocates argue the funding gap creates a "catch-22" where terminally ill individuals cannot access an approved therapy before they become medically ineligible or die.
- Iovance Biotherapeutics received FDA clearance to initiate a Phase 1/2 basket trial for IOV-5001, a next-generation IL-12 tethered tumor infiltrating lymphocyte therapy targeting solid tumors. - The trial will enroll patients with advanced colorectal, triple-negative breast, and estrogen receptor-low breast cancers, representing over 100,000 U.S. deaths annually. - IOV-5001 is engineered to express IL-12 only within tumors and tether it to cell surfaces to enhance efficacy while preventing systemic toxicity. - The therapy aims to improve upon earlier IL-12 TIL treatments that demonstrated a 63% confirmed objective response rate in previous studies.
- The FDA's Center for Biologics Evaluation and Research issued untitled letters to four pharmaceutical companies on March 9, 2026, citing false or misleading promotional claims for cancer biologics including Bristol Myers Squibb's Breyanzi, Novartis' Kymriah, Gilead's Tecartus, and Iovance Biotherapeutics' Amtagvi. - The enforcement action specifically targeted promotional materials that referenced exploratory survival data such as overall survival and progression-free survival that went beyond the outcomes supporting regulatory approval for these CAR-T cell therapies. - This represents a significant expansion of the FDA's pharmaceutical marketing crackdown from direct-to-consumer advertising to direct-to-physician scientific marketing, with the agency warning that misleading claims could affect clinical decision-making and patient safety. - The letters signal increased CBER enforcement activity following a historically quiet period, with only one biologic drugmaker receiving a warning letter since 2019 before this recent action.
- Real-world data from 41 patients treated with commercial Amtagvi demonstrated a 44% objective response rate in advanced melanoma, surpassing the 31% rate from the pivotal clinical trial. - Earlier treatment with Amtagvi showed superior outcomes, with a 52% response rate in patients receiving two or fewer prior therapies compared to 33% after three or more lines. - The study reinforces Amtagvi's position as the first FDA-approved T cell therapy for solid tumors and the only approved treatment for advanced melanoma patients previously treated with anti-PD-1 and targeted therapy. - Results were presented at the 2026 ASTCT and CIBMTR Tandem Meetings, supporting consideration of TIL therapy as soon as possible after immune checkpoint inhibitor treatment.
- A systematic review of seven studies demonstrates that tumor-infiltrating lymphocyte (TIL) therapy achieves objective response rates of 14-49% and overall survival ranging from 8-48 months in patients with advanced melanoma. - The FDA-approved lifileucel therapy showed a 31.4% objective response rate with median overall survival of 13.9 months and 5-year survival of 19.7% in heavily pretreated patients. - A case study reports successful TIL therapy in a patient with concurrent advanced melanoma and chronic lymphocytic leukemia, achieving durable response with complete molecular clearance of circulating tumor DNA. - TIL therapy demonstrates superior progression-free survival compared to ipilimumab (7.2 vs 3.1 months) and shows potential as an effective second-line treatment for checkpoint inhibitor-resistant melanoma.
- Iovance Biotherapeutics announced interim data from its Phase 2 IOV-LUN-202 trial showing lifileucel achieved a 25.6% objective response rate in previously treated advanced nonsquamous NSCLC patients. - The median duration of response was not reached after 25.4 months of follow-up, demonstrating unprecedented durability compared to standard-of-care docetaxel which shows 12.8% response rate and 5.6 months duration. - The FDA has provided positive regulatory feedback on the trial design, with lifileucel expected to launch in the second half of 2027 following supplemental BLA submission. - The one-time TIL cell therapy showed improved safety profile with reduced hospitalization days and lower cytopenia incidence following regimen optimization.
- A phase II trial of lifileucel autologous tumor-infiltrating lymphocyte therapy demonstrated feasibility and disease stability in 53 patients with recurrent and/or metastatic head and neck squamous cell carcinoma. - The treatment achieved a 76% disease control rate with 64% of patients experiencing stable disease, and median overall survival reached 9.5 months in heavily pretreated patients. - Results support further development of lifileucel for head and neck cancer, particularly as combination therapy, with manageable side effects primarily related to the preparatory regimen.
- Health Canada granted conditional marketing authorization for AMTAGVI, marking the first T-cell therapy approved for solid tumors in Canada, specifically for advanced melanoma treatment. - The approval is based on safety and efficacy data from the mid-stage C-144-01 trial, with conditional status pending confirmatory trials to demonstrate clinical benefit. - AMTAGVI is indicated for adult patients with unresectable or metastatic melanoma who have progressed after at least one prior systemic therapy and lack satisfactory treatment alternatives. - Iovance plans to authorize its first Canadian treatment center within months and continues pursuing approvals in additional international markets including the U.K., Australia, and Switzerland.
- The tumor-infiltrating lymphocyte (TIL) therapy market is transitioning from experimental to commercial use following the FDA approval of Iovance Biotherapeutics' AMTAGVI for advanced melanoma in 2024. - Multiple companies including Obsidian Therapeutics, KSQ Therapeutics, and Biosyngen are advancing novel TIL therapies through early-stage trials targeting diverse solid tumor indications beyond melanoma. - The market is expected to surge significantly by 2034, driven by expanding applications to cervical cancer, non-small cell lung cancer, endometrial cancer, and other solid tumors. - Key technological advances including CRISPR gene editing, automated manufacturing platforms, and reduced production times are addressing traditional scalability and cost challenges.
