Innovative Cellular Therapeutics Announces the Publication of Groundbreaking GCC19CART™ Study to Treat mCRC in JAMA Oncology

ROCKVILLE, Md., Sept. 19, 2024 (GLOBE NEWSWIRE) — Innovative Cellular Therapeutics, Inc. (ICT), a clinical-stage biotechnology company developing a comprehensive portfolio of chimeric antigen receptor (CAR) T cell therapies for solid tumors, today announced that its groundbreaking study on GCC19CART^TM therapy has been published in JAMA Oncology on September 19, 2024. The study represents a significant milestone in the field of CAR-T cell therapy for solid tumors, with particular focus on metastatic colorectal cancer (mCRC).

The published results highlight the successful use of GCC19CART^TM therapy in heavily pretreated patients with mCRC, achieving an objective response rate (ORR) of 57% at 2X10⁶ CAR-T cells/kg and median overall survival (mOS) of 22.8 months.

“To our best knowledge, this is the first report to show that CAR-T therapy can be effective in treating solid cancers as a single agent in adult solid tumor setting,” said Dr. Larry (Lei) Xiao, Co-founder and CEO of ICT. “This product is based on the CoupledCAR platform technology, which integrates multiple genes and sequentially activating their spatiotemporal expression. In contrast to other attempts of administering CAR-T cells directed against solid cancers, it enables CAR-T cells targeting solid cancers to expand and activate within the immune system without binding to antigens. These CAR-T cells are then efficiently traffic from the immune system to the solid tumor microenvironment outside the blood, achieving effective tumor cell killing. The expansion and activation of these solid cancer targeting CAR-T cells are independent of solid tumor antigens, demonstrating efficacy not only in metastatic colorectal cancer but also with potential for application in other types of tumors.”

U.S. Data Adds Further Validation

In parallel with these results, data from ICT’s ongoing phase 1 clinical trials in the U.S. also show encouraging progress. At the first dose, 1X10⁶ CAR-T cells/kg dose level, 2 out of 4 patients achieved Partial Response (PR), resulting in an ORR of 50%. At the second dose, 2X10⁶ CAR-T cells/kg dose level, 4 out of 5 patients achieved Partial Response (PR), resulting in an ORR of 80%. These findings, though preliminary, indicate that the treatment may exceed expectations in efficacy. Dr. Eric Rowinsky, ICT’s Chief Medical Officer, commented on the U.S. results: “Putting the ICT technology into prospective, the last three therapies approved in this setting has demonstrated ORRs ranging from 1-6%, indicating the potential of this treat to palliate patients with advanced disease and potentially make major impacts on the natural history of disease in early disease settings.”

For more information, please refer to the full article in JAMA Oncology.

About Innovative Cellular Therapeutics

Innovative Cellular Therapeutics (ICT) is a private clinical-stage biotechnology company headquartered in Rockville, MD. ICT is focused on developing cellular immunotherapies for the treatment of solid tumors. The Company’s proprietary CoupledCAR^® technology platform is designed to overcome the unique challenges of treating solid tumors by enabling the expansion and activation of CAR-T cells independent of tumor antigens. ICT has achieved promising proof-of-concept clinical results in metastasis solid cancers, such as colorectal cancer and prostate cancer. In its ongoing phase 1 U.S. clinical trials, ICT has achieved an ORR of 80% in patients with metastatic colorectal cancer at the 2X10⁶ CAR-T cells/kg dose level. These promising preliminary results highlight the potential of ICT’s technology to significantly impact the treatment of advanced disease. The Company is advancing a broad pipeline of CAR-T candidates targeting other solid tumors. For more information, please visit www.ictbio.com.

Investor Relations Contacts:

Innovative Cellular Therapeutics:

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