In Vivo CAR-T Technology and Community Delivery Expand Cancer Treatment Access
Next-generation in vivo CAR-T therapy enables cancer treatment with a single injection, while new Texas legislation and community-based delivery models expand patient access to this advanced cellular therapy.
A method called "in vivo CAR-T" that directly alters immune cells within the body with a single injection is recently changing the landscape of the cancer treatment market. The technology omits the complex process of extracting a patient's cells, manipulating them outside the body, and reinjecting them to activate immune cells that attack cancer cells.
In vivo CAR-T involves placing a "blueprint (mRNA)" containing genetic information into a special carrier (such as lipid nanoparticles) and administering it to the patient with a single injection. The immune cells in the body accept this blueprint and generate CAR-T cells on their own, enabling them to attack cancer cells. The technology is gaining attention as a "game changer" that could resolve the high costs and long manufacturing times that were cited as drawbacks of existing CAR-T therapies.
Traditional "first-generation CAR-T therapy" was created by extracting the patient's cells and manufacturing them "outside the body (ex vivo)." While effective, the manufacturing process was overly complex, taking at least several weeks to produce and costing hundreds of millions of Korean won. It also had limitations, being available only at large hospitals with specialized facilities.
Global pharmaceutical companies have entered the race to secure in vivo CAR-T technology. Eli Lilly recently acquired the biotech company Orna Therapeutics for $2.4 billion (approximately 3 trillion Korean won). Bristol-Myers Squibb acquired Orbital Therapeutics, a biotech company developing in vivo CAR-T treatments, for $1.5 billion (approximately 2.17 trillion Korean won) in October last year.
Domestic biotech companies have also joined the race to develop related technologies. QurCell is developing its own CAR-T therapy, "Anvalcell," and is preparing to file for a patent. Another biotech company, AbClon, has partnered with a Swedish company to begin developing an "in vivo CAR-T" platform. They are currently conducting phase 2 clinical trials for the in vivo CAR-T treatment candidate "AT101."
The Center for Cancer and Blood Disorders, an independent oncology practice with 46 physicians treating patients at 22 clinics across the Dallas-Fort Worth Metroplex, has launched a new program to deliver Chimeric Antigen Receptor T-Cell (CAR-T) within its community-based practices. As one of the first independent practices to deliver this innovative therapy outside of a hospital in Texas, the Center's program marks a milestone in expanding patient access to cutting-edge care in cancer centers close to where patients live.
The oncologist-led program will significantly expand patient access to CAR-T, an advanced cellular therapy which harnesses the body's immune system to fight cancer. CAR-T therapy modifies a patient's T-cells to target and destroy cancer cells, offering a cutting-edge approach to personalized cancer care.
In collaboration with Medical City Fort Worth Hospital, the Center is treating its first patient with CAR-T, a 62-year-old Bowie man with B-Cell Lymphoma. The Center's CAR-T care delivery model allows for seamless monitoring and care coordination between the Center's physician-based clinic and local hospitals, ensuring patient safety and improving treatment outcomes.
The opening of the program comes on the heels of critical changes in Texas insurance law. A recently enacted Texas law, House Bill 3057, aims to increase access to potentially curative treatments for more patients battling cancer across Texas by obligating most fully-insured and commercial plans delivered, issued or renewed on or after January 1, 2026 in Texas to provide coverage for medically necessary CAR-T therapy that is administered by an FDA-certified provider within the plan's network. The bill was co-authored by Rep. Brooks Landgraf and Sen. Kevin Sparks. Sen. Adam Hinojosa co-sponsored the bill in the state Senate.
Before HB 3057 went into effect, cancer centers were required to hold a costly and complex accreditation from the Foundation for the Accreditation of Cellular Therapy (FACT) in order for insurance providers to cover the treatment — even though FACT is not required by the U.S. Food and Drug Administration. By removing the requirement of FACT accreditation, the law opens up increasing opportunity for community centers to bring CAR-T therapy closer to home.