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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 (ICT), a clinical stage biotechnology company developing a comprehensive platform of chimeric antigen receptor (CAR) T cell therapies with a focus on solid tumors, today announced the appointment of Robert Dallimore as SVP of Quality & Compliance.  

“I am very pleased to welcome Rob to ICT. This is a critical time for the Company,” said Larry (Lei) Xiao, Ph.D., ICT’s Founder and Chief Executive Officer. “His extensive experience in quality and compliance will be extremely beneficial to our efforts in advancing our GCC19CART through the regulatory process and preparation for commercial launch in the United States.” 

“I’m thrilled to bring my expertise to ICT,” said Robert Dallimore. “The ICT team has made excellent progress in advancing GCC19CART program. I look forward to contributing to the next stages of this progress by leveraging my expertise and experience to ensure successful BLA applications and commercial launches.”  

Mr. Dallimore joins us from MacroGenics, Inc., where he was the Vice President of Quality from May 2013 to March 2022. From January 2012 to May 2013, he was the Director of Quality at Teva Pharmaceuticals, from January 2008 to December 2011, a Vice President of Quality at Intercell USA, and was in Quality Assurance roles at MedImmune, Aviron, and Evans Vaccines. He brings over 20 years of Quality experience in Biologics Development.  

Mr. Dallimore has an Honors Degree in Chemistry from the University of Wales, Bangor, U.K. 

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 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 (ICT), a clinical stage biotechnology company developing a comprehensive platform of chimeric antigen receptor (CAR) T cell therapies with a focus on solid tumors, today announced the appointment of Lucy Lu, M.D. as Chief Operations Officer.  

“We are excited to welcome Lucy to the team during this critical time for the company,” said Larry (Lei) Xiao, Ph.D., ICT’s Founder and Chief Executive Officer. “Her extensive experience across multiple business functions will contribute to our efforts in advancing our multiple programs into the clinic in the United States.” 

“I am thrilled to be joining ICT,” said Lucy Lu, “ICT has achieved compelling clinical response data in its IRB trials, with a 50% Overall Response Rate (ORR) in the treatment of 3^rd plus line colorectal cancer patients. I am enthusiastic to join ICT and help advance our clinical programs in the U.S.”  

Dr. Lu joins us from Avenue Therapeutics, Inc., where she was the President and Chief Executive Officer from its inception until March 2022. During her tenure at Avenue, Dr. Lu co-invented the foundational patents for intravenous tramadol, led a Nasdaq IPO for Avenue, directed a successful Phase 3 development program, and signed a two-stage Stock Purchase and Mergers and Acquisition agreement with InvaGen Pharmaceuticals Inc., a subsidiary of Cipla Limited. From February 2012 to June 2017, Dr. Lu was the Executive Vice President and Chief Financial Officer of Fortress Biotech, Inc. Prior to working in the biotech industry, Dr. Lu had 10 years of experience in healthcare-related equity research and investment banking. From February 2007 through January 2012, Dr. Lu was a senior biotechnology equity analyst with Citigroup Investment Research.  

Dr. Lu holds an M.D. degree from the New York University School of Medicine and an M.B.A. from the Leonard N. Stern School of Business at New York University. Dr. Lu obtained a B.A. from the University of Tennessee’s College of Arts and Science. 

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 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

ROCKVILLE, Md., March 16, 2021 — Innovative Cellular Therapeutics (ICT), a clinical stage biotechnology company developing a comprehensive platform of chimeric antigen receptor (CAR) T cell therapies with a focus on solid tumors, today announced the appointment of Eugene (Gene) Kennedy, M.D. as Chief Medical Officer. Dr. Kennedy is an experienced biopharma executive with a track record of leadership in both industry and academia, and expertise in oncology, immuno-oncology, and clinical development.

“We are thrilled to announce the addition of Gene to the ICT team during this critical time for the company,” said Larry (Lei) Xiao, Ph.D., ICT’s Founder and Chief Executive Officer. “His extensive experience in overseeing clinical strategy and execution will be extremely beneficial as we advance our programs into the clinic in the United States.”

ICT has achieved compelling clinical response data in China, with an aggregate 60% Overall Response Rate (ORR) and 20% Complete Remission (CR) rate in 10 third-line patients. The seven colorectal cancer patients (57% ORR / 14% CR), and the three thyroid cancer patients (67% ORR / 33% CR), were treated with the Company’s in-house developed proprietary CoupledCAR® solid tumor CAR-T platform technology. ICT remains on track to submit U.S. Investigational New Drug (IND) applications in these two indications in 2021. 

“We are confident that our colorectal and thyroid cancer programs have been significantly de-risked. This confidence is based on the outcomes of our recent clinical proof-of-concept trials, which were conducted in patients who had exhausted all available treatment options, across four hospital sites through our Shanghai-based R&D center,” said Dr. Xiao.

Dr. Kennedy is a surgical oncologist who most recently served as Chief Medical Officer of Lumos Pharma (Lumos) and, prior to its merger with Lumos, of NewLink Genetics (NewLink). Before that, he served as NewLink’s Vice President for Clinical and Medical Affairs. In these roles, Dr. Kennedy was responsible for design, implementation, and execution of all Phase 1-3 clinical trials and for overseeing medical affairs and regulatory strategy. Dr. Kennedy has filed multiple INDs for both small molecule and biologic drug candidates.

Prior to joining NewLink, Dr. Kennedy had an academic career as Associate Professor of Surgery at Thomas Jefferson University in Philadelphia, Assistant Professor of Surgery at Louisiana State University in New Orleans, and Instructor of Surgery at the Johns Hopkins School of Medicine in Baltimore.

Dr. Kennedy received a B.A. from the University of Virginia in Charlottesville and his M.D. from the Medical College of Virginia in Richmond. He obtained his General Surgical residency and Surgical Oncology fellowship training, along with a post-doctoral fellowship in immuno-oncology, at Johns Hopkins. He also completed additional surgical training at the Royal College of Surgeons in Ireland School of Medicine Beaumont Hospital in Dublin, Ireland.

“I am extremely excited about the progress of Innovative Cellular Therapeutics’ colorectal and thyroid cancer programs towards U.S. clinical trials, and about the potential of the company’s CoupledCAR® solid tumor CAR-T platform technology in additional future indications,” said Dr. Kennedy. “The responses achieved in the company’s proof-of-concept trials in third-line colorectal and third-line thyroid cancer patients in China, and the extent to which these responses have already been confirmed in evaluations by top U.S. and Chinese independent third-party reviewing institutions, are remarkable and unprecedented. I am focused on bringing these revolutionary new therapies to cancer patients around the globe.”

About Innovative Cellular Therapeutics

Innovative Cellular Therapeutics (ICT) is a Rockville, Maryland-based clinical stage biotechnology company focused on the development of cellular immunotherapies for the treatment of solid tumors. ICT is in pre-Investigational New Drug (IND) discussions with the U.S. Food and Drug Administration (FDA) for its first solid tumor CAR-T programs, based on the Company’s proprietary CoupledCAR® solid tumor CAR-T platform technology. ICT has already achieved promising responses with CoupledCAR® in third-line colorectal and third-line thyroid cancer patients in ongoing clinical proof-of-concept trials being conducted across multiple hospital sites in China, coordinated through the Company’s Shanghai-based R&D center. ICT received its first U.S. Investigational New Drug (IND) application clearance for its ICTCAR014 program in late 2019. ICTCAR014 is based on ICT’s in-house developed proprietary ArmoredCAR® liquid tumor CAR-T platform technology and is a next generation CD19-targeting CAR-T therapy that expresses a dominant negative PD-1 (dnPD-1) protein to block immunosuppression by cancer cells. ICTCAR014 is being developed for patients with relapsed or refractory non-Hodgkin lymphoma (NHL), including PD-L1 positive patients. For more information, please visit www.ictbio.com.  

Investor Relations Contacts:

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