Iovance Biotherapeutics (NASDAQ:IOVA) said it is expanding its tumor-infiltrating lymphocyte, or TIL, therapy platform across multiple solid-tumor indications after reporting a record second quarter marked by nearly $100 million in revenue and a 56% margin.
Speaking at the H.C. Wainwright 28th Annual Global Investment Conference, Brian Gastman, Iovance’s executive vice president of translational medicine and research, said the company has moved TIL therapy from academic research into commercial use. He said Iovance has treated more than 2,000 patients clinically and commercially and has two approved and commercialized therapies: Amtagvi, its flagship TIL therapy, and Proleukin, also known as interleukin-2.
TIL Manufacturing and Market Access
TIL therapy is a one-time, patient-specific treatment made from immune cells collected from a patient’s tumor. The cells are expanded into the billions and then returned to the same patient after preparatory treatment, Gastman said.
Iovance manufactures the therapy at its Iovance Cell Therapy Center in Philadelphia. The facility supports clinical and commercial supply and has modular capacity for more than 5,000 patients, according to Gastman. He said the facility is a strategic asset for controlling supply, expanding margins and creating operating leverage as treatment volumes increase.
The company has more than 95 authorized treatment centers, including roughly one-third in community settings, and expects to reach 110 centers by year-end. Gastman said more than 95% of U.S. patients are within 200 miles of a treatment center, while more than 80% are within 100 miles.
He also said Iovance has payer policies covering more than 250 million lives, including Medicare and commercial coverage, representing more than 75% of the U.S. population.
Melanoma Program and Frontline Trial
Gastman said the data supporting Amtagvi’s FDA approval, as well as approvals in Canada and Australia, showed durable responses in heavily pretreated melanoma patients. In an analysis of four experienced treatment centers, Iovance reported a 44% response rate, with response rates above 50% among patients treated in the second-line setting, he said.
The company is also studying TIL therapy earlier in advanced melanoma. In the IOV-COM-202 Cohort 1A trial, Amtagvi combined with pembrolizumab in immune checkpoint inhibitor-naïve patients produced response rates in the mid-60% range and a 30% complete-response rate at the time of analysis, according to Gastman.
Gastman said more mature data from the study are scheduled for an oral presentation at the European Society for Medical Oncology meeting. The regimen is also the experimental arm in Iovance’s international Phase III TILVANCE-301 confirmatory trial, which is intended to support confirmation of the company’s second-line accelerated approval and potentially support frontline approval.
Pipeline Targets Lung Cancer, Sarcoma and Endometrial Cancer
Iovance is advancing its standard TIL platform in non-small cell lung cancer, soft-tissue sarcoma and endometrial cancer. For non-squamous non-small cell lung cancer without EGFR, ROS or ALK alterations, Gastman said the company has previously reported a response rate of nearly 26%. With more than two years of follow-up, median duration of response had not been reached, he said.
The company expects to complete the lung cancer trial soon and present a larger data set by the end of the year, with a supplemental biologics license application planned for 2027. The program has received Fast Track designation from the FDA.
In soft-tissue sarcoma, Iovance is studying TIL therapy in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma. Gastman said an initial patient group showed a 50% response rate, with all responses ongoing and, in some cases, deepening. The program has progressed into a registrational trial called SARATOGA.
For advanced endometrial cancer, the company identified a signal in serous endometrial carcinoma. Gastman said TIL therapy produced a 40% response rate and 100% disease-control rate in the studied population. Iovance is engaging with the FDA and evaluating potential expedited development pathways, he said.
Next-Generation Programs
Iovance is also developing genetically modified TIL therapies and an engineered interleukin-2 program. IOV-4001 is a PD-1-inactivated TIL therapy that has been tested in melanoma and has moved into non-small cell lung cancer.
The company’s IOV-5001 program is designed to express IL-12 at the cell surface within the tumor microenvironment, an approach intended to limit broader systemic exposure. Gastman said Iovance plans to evaluate the therapy in tumors that have historically been more difficult for TIL therapy, including colorectal cancer, triple-negative breast cancer and head and neck cancer.
Its IOV-3001 engineered IL-2 program is currently in dose escalation, with additional information expected soon, Gastman said.
About Iovance Biotherapeutics (NASDAQ:IOVA)
Iovance Biotherapeutics, Inc is a biotechnology company focused on developing and commercializing individualized cell therapies for patients with cancer. Its platform uses tumor-infiltrating lymphocytes (TILs), immune cells collected from a patient’s tumor, expanded in a manufacturing facility and returned to the patient to help recognize and attack cancer cells.
The company’s lead product, Amtagvi (lifileucel), is an autologous TIL therapy approved by the U.S. Food and Drug Administration for certain adults with unresectable or metastatic melanoma that has progressed following prior treatment.
