Innovative Cellular Therapeutics' Solid Tumor CAR-T Therapy LYL273 (GCC19CART) Secures Global Licensing Deal with Lyell Immunopharma

Nov 11, 2025 12:15 CST Updated 12:16

ICT

Oncology Drug Developer

Lyell Immunopharma

Cell Therapy New Drug Developer

With the development of CAR-T for solid tumors in China, there have been breakthrough advancements in various major solid tumor indications. The editor knows that this will definitely attract the attention of overseas pharmaceutical companies.

Recently, a well-known solid tumor CAR-T development company abroadLyell Immunopharma, Inc., Announces Acquisition ofICT's Solid Tumor CAR-T Candidate DrugLYL273(GCC19CART) Rights outside Greater ChinaRights.

It is worth noting that this isLyell Immunopharma, a company initially focused on the development of solid tumor CAR-T (primarily ROR1 CAR-T), has introduced its first solid tumor CAR-T product after discontinuing the ROR1 CAR-T project for solid tumors. This product is also the only publicly disclosed solid tumor pipeline in the company’s current portfolio.

In additionLyell Immunopharma's nearly 70 millionThe cash and equity acquisition price in US dollars, along with subsequent milestone payments totaling up to 820 million US dollars.According to the agreement, Lyell will provideICTPayment of $40 million upfront and 1.9 million shares of Lyell common stock;ICT is also eligible for additional cash and equity consideration, as well as royalties on future net sales. The additional cash consideration includes potential clinical milestones of $30 million, late-stage regulatory milestones of up to $115 million, and commercial sales milestones of up to $675 million. The additional equity consideration includes up to 1.85 million shares upon the achievement of certain clinical or late-stage regulatory milestones.Lyell Common Stock.

——There is no doubt thatLyell Immunopharma, Inc. for this product fromICT's Focus on Solid Tumor CAR-T.

LYL273(GCC19CART)

GCC19CART is the first clinical candidate pipeline developed by ICT based on its solid tumor universal CoupledCAR® platform technology.

GCC19CART is a targetedGCC（GCC in Primary Colorectal Cancer (CRC) cells with stable expression, in metastaticElevated expression in CRC cells isSpecific Marker of CRCMolecule）CAR-T cells, and according to Lyell Immunopharma, Inc.Disclosure,GCC19CART also improves CAR-T cell performance in harsh conditions by enhancing CD19 CAR expression and controlling cytokine release.Solid TumorAmplification in the microenvironment, immune cell infiltration, and tumor-killing capability. Currently,GCC19CART is currently undergoing clinical research in China and the United States.

GCC19CART is mainly developed for the treatment of metastaticColorectal cancer (mCRC), and other cancers expressing GCC. GCC19CART has been granted Fast Track designation by the U.S. FDA for the treatment of mRCR.

According to the report,CRC is the second leading cause of cancer-related deaths globally, and the incidence of CRC in people under 55 is on the rise; however, only 6% of approved therapies are for third-line or later treatment.mCRC partially or completely responds to subsequent treatments, with a median overall survival usually less than 12 months. ——There is a significant unmet clinical need.

ORR 50%,DCR 83%

August 13, 2025ICT AnnouncesSuccessfully completed the key dose escalation trial of GCC19CART for third-line or higher relapsed/refractory metastatic colorectal cancer (R/R mCRC) patients in the U.S. Phase I clinical trial (NCT05319314).

A total of 12 patients received GCC19CART treatment, 6 of whom received a dose of1×10^6 CAR-T cell/kg (Dose Level 1)) ofGCC19CART, the dose for the other 6 patients is2×10^6 CAR-T cell/kg(Dose Level 2). All patients received one cycle of lymphodepleting chemotherapy on day -3, includingCyclophosphamide (300 mg/㎡) andFludarabine (30mg/㎡).

As of the data cutoff date on October 28, 2025, dose-dependent clinical activity was reported in 12 patients. Across two dose levels,The overall response rate was 50% (6/12).，The disease control rate was 83%.。At dose level 2, the overall response rate was 67% (4/6)., including one patient with complete pathological remission, one patient with complete reduction (100% partial remission) in target lesion tumor volume, and two additional patients confirmed to have partial remission; at dose level 2, the disease control rate was 83%, with a median progression-free survival of 7.8 months.

GCC19CART has controllable safety.，The incidence and severity of treatment-related adverse events at dose level 2 were higher than those at dose level 1.No Grade 3 or higher cytokine release syndrome (CRS) was observed in the trial.; 1 subject experienced transient Grade 3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS);Two subjects experienced Grade 3 diarrhea. Since the establishment of an optimized diarrhea management protocol (including preventive measures), the most recent three treated patients have not experienced Grade 3 or higher diarrhea. Additionally, one case occurred at dose level 2.Dose-limiting toxicity, including grade 3 diarrhea, grade 4 enterocolitis, died of fungal sepsis 48 days after infusion, but not related toGCC19CART has no direct association.

Senior Physician at the Dana-Farber Cancer Institute's Gastrointestinal Cancer Center, Assistant Professor of Medicine at Harvard Medical School, Boston, Massachusetts,The Principal Investigator of this Phase 1 clinical trialDr. Benjamin L. Schlechter stated, "We rarely see such deep and durable responses in colorectal cancer patients who have undergone multiple prior chemotherapies. The results from this initial cohort of heavily pretreated patients are encouraging."

Notably, at this year's ASCO conference,ICT reported in the abstract that, compared with previous trials in China, U.S. research showsThere is a potential trend for the safety and efficacy of GCC19CART to improve.

Summary

Looking at the global development of CAR-T for solid tumors, Chinese companies are the main research and development force, among which CARsgen Therapeutics is a notable player.CT041 is the fastest in progress and has already submitted an application for market approval to the China National Medical Products Administration. In the future, we will see more breakthroughs in China's solid tumor CAR-T pipelines.