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
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.
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