2023

Innovative Cellular Therapeutics (ICT) Presented Updated Data of the China-IRB Study of GCC19CART in Metastatic Colorectal Cancer at European Society for Medical Oncology (ESMO) Congress 2023

Innovative Cellular Therapeutics (ICT) Presented Updated Data of the China-IRB Study of GCC19CART in Metastatic Colorectal Cancer at European Society for Medical Oncology (ESMO) Congress 2023 700 900 Innovative Cellular Therapeutics

ROCKVILLE, MARYLAND, October 31st, 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 Cancer

Abstract: 4936
Session Title: Colorectal cancer
Date and Time: Sunday, October 22nd, 2023 at 12:00 to 13:00 CEST
Presenter: 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 (1×106 cells/kg) and 8 subjects have been enrolled to dose level 2 (2×106 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

Innovative Cellular Therapeutics (ICT) Presented Data at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting

Innovative Cellular Therapeutics (ICT) Presented Data at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting 1600 1868 Innovative Cellular Therapeutics

ROCKVILLE, MARYLAND, May 24th, 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 cancer

Session Type: Oral Abstract

Session Title: Gene and Cell Therapy Trials in Progress

Presenter: Victor Lu, Ph.D, Chief Technology Officer, ICT

Date 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 (1×106 cells/kg) and 8 patients were enrolled in dose level 2 (2×106 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

Innovative Cellular Therapeutics (ICT) Presented Updated Data at the American Association for Cancer Research (AACR) Annual Meeting

Innovative Cellular Therapeutics (ICT) Presented Updated Data at the American Association for Cancer Research (AACR) Annual Meeting 1000 1500 Innovative Cellular Therapeutics

ROCKVILLE, MARYLAND, May 2nd, 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 Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida April 14-19, 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 cancer

Session Type: Minisymposium
Session Title: Immunotherapy
Presenter: Victor Lu, Ph.D, Chief Technology Officer, ICT
Date and Time: April 16th, 2023 at 3:00 pm – 5:00 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 (1×106 cells/kg) and 8 patients were enrolled in dose level 2 (2×106 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 thyroid 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