Innovative Cellular Therapeutics Co., Ltd.

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 2X10 6 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, 1X10 6 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, 2X10 6 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 2X10 6 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 . Investor Relations Contacts: Innovative Cellular Therapeutics: ir@ictbioinc.com

ROCKVILLE, Md., Oct. 31, 2023 (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 the Company presented at European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain from October 20th to 24th. ICT presented updated data from its China-IRB study of GCC19CART, its lead product candidate from the Company’s CoupledCAR® technology, being developed to treat patients with relapsed/refractory metastatic colorectal cancer (R/R mCRC) in a poster presentation. Presentation details were as follows: A Phase 1 Dose Escalation Study of GCC19CART a Novel CoupledCAR® Therapy for Subjects with Metastatic Colorectal CancerAbstract: 4936Session Title: Colorectal cancer Date and Time: Sunday, October 22nd, 2023 at 12:00 to 13:00 CESTPresenter: Lucy Lu, MD, Chief Operations Officer of ICT This presentation highlights updated survival data from the 21 subjects who were enrolled in two dose escalation groups in IRB-approved studies in China. Of the 21 subjects who were enrolled on or before Dec 13, 2021, 13 subjects have been enrolled to dose level 1 (1x106 cells/kg) and 8 subjects have been enrolled to dose level 2 (2x106 cells/kg). The combined objective response rate (ORR) per RECIST 1.1 for both dose levels was 28.6% (6/21). For dose level 1, the ORR was 15.4% (2/13). For dose level 2, the ORR was 50% (4/8) and the rest of the 4 subjects had a best overall response of SD for a disease control rate (DCR) of 100% out to three months. The most common adverse events were cytokine release syndrome (CRS) in 20/21 subjects (Grade 1 19/21 (90.4%) or Grade 3 1/21 (4.8%)) and diarrhea in 20/21 subjects (Grade 1 6/21 (28.6%) Grade 2 5/21 (23.8%) Grade 3 9/21 (42.9%)). Neurotoxicity was observed in 2/21 (9.5%) subjects with one Grade 3 and one Grade 4 and resolved with corticosteroids. The median overall survival (OS) is approximately 13 months for patients in dose level 1. The median OS is approximately 24 months in dose level 2 with 4 of the 8 patients still alive. The Company’s Phase 1 study of GCC19CART is enrolling patients with R/R mCRC at multiple sites in the U.S. About Innovative Cellular Therapeutics Innovative Cellular Therapeutics (ICT) is a private clinical stage biotechnology company headquartered in Rockville, MD. ICT is focused on the development of cellular immunotherapies for the treatment of solid tumors. ICT’s unique CoupledCAR® technology platform is designed to overcome the common challenges of treating solid tumors. ICT has achieved promising preclinical and proof-of-concept clinical results in late-stage solid tumors, such as colorectal cancer and prostate cancer. The Company has a broad pipeline of CAR-T candidates targeting additional solid tumors. For more information, please visit www.ictbio.com. Investor Relations Contacts: Innovative Cellular Therapeutics:ir@ictbioinc.com

ROCKVILLE, Md., May 24, 2023 (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 the Company presented at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual meeting in Los Angeles, California. May 16-20, 2023. ICT presented GCC19CART, its lead product candidate from the Company’s CoupledCAR® technology, being developed to treat patients with relapsed/refractory metastatic colorectal cancer (R/R mCRC) in an oral presentation. Details for the oral presentation are as follows: A phase 1 dose escalation study of GCC19CART - a novel CoupledCAR therapy for subjects with metastatic colorectal cancerSession Type: Oral AbstractSession Title: Gene and Cell Therapy Trials in ProgressPresenter: Victor Lu, Ph.D, Chief Technology Officer, ICTDate and Time: May 20th, 2023, at 2:45 pm – 3:00 pm ET This presentation highlights data from the 21 patients who were enrolled in two dose escalation groups at 5 hospitals in China. Patients were followed for safety and preliminary evidence of efficacy. Thirteen patients were enrolled in dose level 1 (1x106 cells/kg) and 8 patients were enrolled in dose level 2 (2x106 cells/kg). For dose level 1, the objective response rate (ORR) per RECIST 1.1 was 15% (2/13). For dose level 2, The ORR per RECIST 1.1 was 50% (4/8). Median follow-up has exceeded 20 months. The most common adverse events were cytokine release syndrome (CRS) and diarrhea. Neurotoxicity was observed in 2 patients that was resolved with corticosteroids. Overall, GCC19CART demonstrated meaningful dose dependent clinical activity and an acceptable safety profile in patients with R/R mCRC. GCC19CART is now in clinical development in the U.S. and is on track to complete Phase 1 dose escalation clinical trial this year. About Innovative Cellular Therapeutics Innovative Cellular Therapeutics (ICT) is a private clinical stage biotechnology company headquartered in Rockville, MD. ICT is focused on the development of cellular immunotherapies for the treatment of solid tumors. ICT’s unique CoupledCAR® technology platform is designed to overcome the common challenges of treating solid tumors. ICT has achieved promising preclinical and proof-of-concept clinical results in late-stage solid tumors, such as colorectal cancer and prostate cancer. The Company has a broad pipeline of CAR-T candidates targeting additional solid tumors. For more information, please visit www.ictbio.com. Investor Relations Contacts:Innovative Cellular Therapeutics:ir@ictbioinc.com