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This article is reprinted from OncLive. The original link is https://www.onclive.com/view/gcc19cart-demonstrates-preliminary-antitumor-activity-in-refractory-mcrc.

Key Takeaways

• GCC19CART showed significant antitumor activity in refractory mCRC, with a 56% overall response rate across two dose levels.
• Dose level 2 demonstrated higher efficacy, achieving an 80% ORR and a median PFS of 7.8 months.
• Adverse effects included cytokine release syndrome and neurotoxicity, consistent with other CAR T-cell therapies.
• Strategies are being implemented to manage treatment-related diarrhea and colitis, with ongoing trials to provide further insights.

GCC19CART generated responses in refractory metastatic colorectal cancer.

The median progression-free survival (PFS) was 5.0 months in dose level 1 and 7.8 months in dose level 2 at median follow-ups of 16.6 months and 7.4 months, respectively.

“Preliminary results indicate that GCC19CART exhibits significant clinical antitumor activity in patients with refractory mCRC. The trial is ongoing, and updated data will be presented,” lead study author Bridget Keenan, MD, PhD, of UCSF Helen Diller Family Comprehensive Cancer Center in San Francisco, California, and colleagues wrote in a poster presentation.

Cytokine release syndrome (CRS) was observed in 100% of patients; CRS occurred at grade 1 (66.7%) and grade 2 (33.3%). Immune effector cell–associated neurotoxicity syndrome (ICANS) occurred in 2 patients at grade 2 (11.1%) and grade 3 (11.1%). Diarrhea was reported in 8 of 9 patients at grade 1 (33.3%), grade 2 (33.3%), and grade 3 (22.2%).

One patient treated at dose level 2 experienced a dose-limiting toxicity. This patient had grade 3 diarrhea, grade 4 enterocolitis, and grade 5 sepsis; the cause of death was fungal sepsis 48 days following the infusion of GCC19CART.

“Adverse [effects (AEs)] were related to the GCC19CART mechanism and were consistent with what has been observed with other CAR T-cell products. Strategies to further optimize the management of treatment-related diarrhea and colitis are currently being implemented,” Keenen noted.

Design of the Study

Study investigators noted that, “GCC19CART [is] the first clinical candidate from the CoupledCAR solid tumor platform, [which] pairs solid tumor CAR T cells with CD19-targeting CAR T cells to enhance proliferation, activation, and persistence against solid tumors.” GCC19CART is designed to target GCC, a known mucosal marker.

Investigators initially screened patients for GCC expression prior to enrollment, but this practice was discontinued after 95% of screened patients (n = 95/98) with mCRC were GCC positive by immunohistochemistry.

Eligible patients with mCRC that was refractory to standard chemotherapy underwent leukapheresis followed by a lymphodepleting chemotherapy regimen consisting of fludarabine at 30 mg/m² and cyclophosphamide at 300 mg/m² administered on day –3. On day 0, patients received a single infusion of GCC19CART at their assigned dose level.

The primary end point of the trial was safety; secondary end points included ORR, duration of response, PFS, overall survival, and pharmacokinetics. Responses were assessed locally using RECIST 1.1 criteria.

The median age of the 9 patients treated across the 2 dose levels was 48 years (range, 39-57). The majority of patients were male (56%), and patients received a median of 3 prior lines of therapy (range, 2-5). The origin of the disease was primarily from the left colon (44%) and rectum (44%), with a smaller proportion originating from the rectosigmoid (11%). Patients had a median of 2 disease sites (range, 1-4).

Results also revealed reductions in tumor size in 3 of 4 patients treated at dose level 1 and 4 of 5 patients treated at dose level 2. However, 1 patient treated at dose level 1 who had a best response of SD and experienced a reduction in tumor size experienced disease progression due to the appearance of a new lesion at month 2.

Reference

Keenan BP, Lieu CH, Fakih M, et al. A phase 1 dose-escalation study of GCC19CART: A novel CAR T-cell therapy for metastatic colorectal cancer in the United States. J Clin Oncol. 2025;43(suppl 4):175. doi:10.1200/JCO.2025.43.4_suppl.175

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:

ir@ictbioinc.com

ROCKVILLE, MARYLAND, October 31^st, 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 20^th to 24^th.

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 22^nd, 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

ROCKVILLE, MARYLAND, May 24^th, 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 20^th, 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

ROCKVILLE, MARYLAND, May 2^nd, 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

ROCKVILLE, MARYLAND, August 18, 2022 (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 the first patient has been enrolled in its Phase I trial of GCC19CART for Relapsed/Refractory Metastatic Colorectal Cancer (R/R mCRC). The study (NCT05319314) is an open-label, single arm, multicenter Phase 1 dose-escalation clinical trial evaluating the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of GCC19CART in patients with relapsed or refractory metastatic colorectal cancer (R/R mCRC) in the U.S. 

“This is an important and exciting milestone for ICT,” said Dr. Larry Lei Xiao, Chief Executive Officer of ICT. “There is a significant unmet medical need for R/R mCRC patients. We believe that GCC19CART has the potential to provide significant clinical benefit to these patients.” 

GCC19CART is ICT’s lead product candidate from the Company’s CoupledCAR^® technology. It has been tested in 35 patients in an IRB-approved trial in China. The data from the trial has been presented at ASCO, ASGCT, and AACR meetings in 2022. 

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 U.S. Food and Drug Administration (FDA) has provided a Study-May-Proceed letter for the Company’s Investigational New Drug (IND) application for a Phase 1 clinical trial of GCC19CART targeting relapsed or refractory metastatic colorectal cancer. ICT expects to initiate this U.S. focused clinical trial, referred to as CARAPIA-1, in the summer of 2022. 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, Inc 

ir@ictbioinc.com 

ROCKVILLE, MARYLAND, May 26^th, 2022 (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 acceptance of an abstract for poster presentation at the upcoming 2022 ASCO Annual meeting in Chicago, IL from June 3-7, 2022.

ICT will provide updated data on 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 are as follows:

A Phase 1 Dose Escalation Study of GCC19CART a Novel CoupledCAR® Therapy for Subjects with Metastatic Colorectal Cancer

Abstract: 3582

Session Title: Gastrointestinal Cancer —Colorectal and Anal Date and Time: Saturday, June 4^th, 2022 at 8:00 – 11:00 am CDT

This presentation highlights data from the 21 subjects who were enrolled in two dose escalation groups in IRB-approved studies in China, based on a data cutoff of May 3^rd, 2022. Of the 21 subjects, 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.

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 U.S. Food and Drug Administration (FDA) has provided a Study-May-Proceed letter for the Company’s Investigational New Drug (IND) application for a Phase 1 clinical trial of GCC19CART targeting relapsed or refractory metastatic colorectal cancer. ICT expects to initiate this U.S. focused clinical trial, referred to as CARAPIA-1, in the summer of 2022. 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

Kevin Gardner 
LifeSci Advisors 
617-283-2856 
kgardner@lifesciadvisors.com

Chris Calabrese 
LifeSci Advisors
917-680-5608
ccalabrese@lifesciadvisors.com

• Clinical Data from one research site for GCC19CART, ICT’s lead solid tumor program, for 3^rd line plus relapsed/refractory metastatic colorectal cancer (R/R mCRC) shows patients receiving a dose of 2×10^6 CAR T cells / kg demonstrating a 57% (4/7) objective response rate.  
• Pre-Clinical Data demonstrates CoupledCAR® technology promotes efficient in vivo expansion and superior functionality of CAR-T cells in a mouse model for prostate cancer. 

ROCKVILLE, MARYLAND, April 21, 2022 (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 data at the 2022 Annual Meeting of the American Association for Cancer Research (AACR), held at the Ernest N. Morial Convention Center in New Orleans, Louisiana through April 8-13, 2022.  

The two poster presentations highlight the Company’s CoupledCAR® technology, focusing on clinical data from the GCC19CART program in relapsed / refractory metastatic colorectal cancer (R/R mCRC) in one poster and the identification of a tumor target and preclinical data elucidating the mechanism of action in the Company’s prostate cancer program in the second. 

“We are very excited to share these data at AACR 2022, as we are now focusing on developing GCC19CART and other solid tumor programs in the U.S,” said Larry (Lei) Xiao, Ph.D., ICT’s Founder and Chief Executive Officer. “Our two poster presentations demonstrate our CoupledCAR® technology’s promise of overcoming the typical challenges in treating solid tumors with cellular therapies.” 

Poster Presentation Details: 

Title: “Novel CoupledCAR^® technology for treating colorectal cancer” 

Poster Session:  Adoptive Cell Therapy 

Abstract Number: 2747 / 3  

Poster Section: 30 

This presentation highlights data from one institution participating in ICT’s IRB approved trial with GCC19CART for patients with R/R mCRC conducted at multiple institutions in China. In these patients, the study therapy was well tolerated. Clinical activity was seen in a dose dependent fashion with patients receiving a dose of 2×10⁶ CAR T cells / kg demonstrating a 57% (4/7) objective response rate per RECIST 1.1 criteria. 

Title: “Antigen-independent expansion enhances efficacy of CAR-T cells against solid tumor” 

Poster Session:  Adoptive Cell Therapy 

Abstract Number: 2838 / 4 

Poster Section: 36 

This presentation characterizes prostatic acid phosphatase (PAP) as the tumor target selected by ICT for its prostate cancer program and demonstrates how CoupledCAR expands solid tumor-targeting CAR-T cells in vivo. The pre-clinical data demonstrated that CoupledCAR can significantly enhance the expansion and anti-tumor efficacy of PAP CAR-T cells both in vitro and in vivo in a mouse model. 

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 U.S. Food and Drug Administration (FDA) has provided a Study-May-Proceed letter for the Company’s Investigational New Drug (IND) application for a Phase 1 clinical trial of GCC19CART targeting relapsed or refractory metastatic colorectal cancer. ICT expects to initiate this U.S. focused clinical trial, referred to as CARAPIA-1, in the summer of 2022. 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

Kevin Gardner 
LifeSci Advisors 
617-283-2856 
kgardner@lifesciadvisors.com

Chris Calabrese 
LifeSci Advisors
917-680-5608
ccalabrese@lifesciadvisors.com

• GCC19CART is an autologous CAR T therapy candidate that has shown promising results in over 30 R/R mCRC patients in China 
• ICT plans to initiate a Phase 1 Trial of GCC19CART in the U.S. for the Treatment of R/R mCRC in mid-2022 

ROCKVILLE, MARYLAND, April 19, 2022 (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 the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to GCC19CART, the Company’s lead solid tumor therapy candidate in treating patients with relapsed and refractory metastatic colorectal cancer R/R mCRC. 

“We are pleased that GCC19CART has received FDA Fast Track Designation highlighting the large unmet need in patients with relapsed or refractory colorectal cancer,” said Larry (Lei) Xiao, Ph.D., ICT’s founder and Chief Executive Officer. “GCC19CART is our lead solid tumor product candidate from our CoupledCAR^® platform technology that has shown early promising clinical results in China. We are now focusing our efforts on its development in the U.S.” 

The FDA’s Fast Track Designation aims to facilitate development and expedite the review of new therapeutics to treat serious or life-threatening conditions in order to fill an unmet medical need. Once a drug candidate receives Fast Track Designation, early and frequent communication between the FDA and the sponsor is encouraged throughout the entire drug development and review process. A drug candidate that receives Fast Track Designation is eligible for Accelerated Approval and Priority Review, if relevant criteria are met. It is also eligible for Rolling Review which means that the sponsor can submit completed sections of its Biologic License Application (BLA) for review by FDA, rather than waiting until every section of the BLA is completed before the entire application can be reviewed. 

GCC19CART for R/R mCRC 

GCC19CART is the lead solid tumor candidate from ICT’s proprietary CoupledCAR^® technology platform, which has been specifically designed to target and eliminate cancer cells expressing guanylyl cyclase C (“GCC”), a marker for colorectal cancer. The FDA has granted Fast Track Designation to GCC19CART based on its potential to address the unmet need for patients with R/R mCRC who have failed standard therapies.  

R/R mCRC is a disease with a large unmet medical need. Once a patient fails multiple lines of standard of care (SOC) treatments as defined by the National Comprehensive Cancer Network (NCCN), there are very few effective options. The currently approved third line treatments in the U.S. provide an overall response rate (ORR) of 1 to 1.6% and overall median survival of 6.4 to 7.1 months. 

ICT plans to initiate a Phase 1 study designed to evaluate the safety, tolerability, and activity of GCC19CART in patients with R/R mCRC in the U.S. in mid-2022. 

IRB-approved clinical study of GCC19CART 

In an IRB-approved clinical study that enrolled 35 patients in China, a 50% Overall Response Rate (ORR) in the treatment of 3^rd plus line colorectal cancer patients was seen in the 8 patients who are treated with 2X10^6 GCC19CART cells/kg.  

About Innovative Cellular Therapeutics 

Innovative Cellular Therapeutics (ICT) is a private clinical stage biotechnology company with a global headquarter in Rockville, MD, and a research and development office in Shanghai, China. 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 U.S. Food and Drug Administration (FDA) has provided a Study-May-Proceed letter for the Company’s Investigational New Drug (IND) application for a Phase 1 clinical trial of GCC19CART targeting relapsed and refractory metastatic colorectal cancer. ICT expects to initiate this U.S. focused clinical trial, referred to as CARAPIA-1, in the summer of 2022. 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

Kevin Gardner 
LifeSci Advisors 
617-283-2856 
kgardner@lifesciadvisors.com

Chris Calabrese 
LifeSci Advisors
917-680-5608
ccalabrese@lifesciadvisors.com

Innovative Cellular Therapeutics Receives FDA Clearance of IND Application to Initiate a Phase 1 Clinical Trial for GCC19CART, a CoupledCAR® Platform Product Candidate for Relapsed or Refractory Metastatic Colorectal Cancer

ROCKVILLE, Md., Sept. 01, 2021 (GLOBE NEWSWIRE) — Innovative Cellular Therapeutics (ICT), a Maryland based clinical stage biotechnology company developing the CoupledCAR® platform of chimeric antigen receptor (CAR) T-cell therapies for solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has provided a Study-May-Proceed letter for the Company’s Investigational New Drug (IND) application for a Phase 1 clinical trial of GCC19CART targeting relapsed and refractory metastatic colorectal cancer. ICT expects to initiate this U.S. focused clinical trial, referred to as CARAPIA-1, in the first half of 2022.

“We believe that the Study-May-Proceed letter from FDA for our IND represents a critical step forward and clearance of the last significant regulatory barrier before we can start working toward generating potentially compelling clinical data for patients with solid tumors with our CoupledCAR T-cell therapies in the U.S.,” said Victor Lu, Ph.D., Senior Vice President of Regulatory Affairs of ICT.

“This IND clearance builds upon the promising clinical data generated by our team in Shanghai demonstrating objective responses with manageable expected toxicity when administered to heavily pretreated colorectal cancer patients as single-agent experimental therapy,” said Eugene Kennedy, M.D., Chief Medical Officer of ICT. “I look forward to advancing this program in the U.S. while we continue to develop proof-of-concept data for additional solid tumor indications.”

“Because GCC19CART and all future product candidates from our CoupledCAR platform share key aspects of technology and manufacturing, we believe the IND clearance is a first step towards validation of not only GCC19CART, but the potential of the entire platform,” said Larry (Lei) Xiao, Ph.D., Chairman and Chief Executive Officer of ICT. “Indeed, we are advancing an extensive product candidate pipeline individually targeting multiple solid tumor indications. We are excited by the potential of our CoupledCAR platform based therapeutic candidates to address the significant unmet need of patients with advanced colorectal cancer and other solid tumors.”

About GCC19CART
Based on ICT’s proprietary solid tumor CoupledCAR^® technology platform, GCC19CART is a CAR T-cell therapy intended to treat refractory or relapsed metastatic colorectal cancer that expresses the target antigen guanylate cyclase 2C (GCC or GUCY2C). GCC-CART has already demonstrated encouraging results in proof-of-concept human trials in China. ICT is moving GCC19CART into a U.S. clinical trial.

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:
Julie Savage
Innovative Cellular Therapeutics
ir@ictbioinc.com

Irina Koffler
LifeSci Advisors
646-970-4681
ikoffler@lifesciadvisors.com

Media Relations Contact:
Kate L. Barrette
RooneyPartners LLC
212-223-0561
kbarrette@rooneyco.com