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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

ROCKVILLE, Md., Nov. 10, 2020 (GLOBE NEWSWIRE) — Innovative Cellular Therapeutics (ICT), a clinical stage biotechnology company developing a comprehensive platform of chimeric antigen receptor (CAR) T cell therapies for solid and liquid tumors, today announced its plans to participate in and host one-on-one meetings at three investor conferences this month.

“We appreciate the opportunity to present and discuss the recent clinical data achieved with our in-house developed, proprietary CoupledCAR® solid tumor CAR-T platform technology. We achieved a 60% Overall Response Rate (ORR) and a 20% Complete Remission (CR) rate in seven colorectal and three thyroid cancer patients. CR was achieved in both indications in ongoing human proof-of-concept trials being conducted across multiple hospital sites in China, coordinated through our R&D engine in Shanghai,” said Larry (Lei) Xiao, Ph.D., ICT’s Founder and Chief Executive Officer. “We are already in pre-IND discussions with the FDA to advance our CoupledCAR® solid tumor CAR-T therapies into the clinic in the United States in the near future.”

Investor Conference Details:

Conference: Investival Showcase Virtual 2020, partnered with Jefferies
Dates: November 11-16, 2020
Presentation Time: Presentation is pre-recorded and accessible through the conference website below
Presenter: Morten Marott, CFO
Website Link: here

Conference: Stifel 2020 Virtual Healthcare Conference
Dates: November 16, 2020
Presentation Time: 1:20 PM – 1:50 PM EST
Presenter: Morten Marott, CFO
Webcast Link: here

Conference: Jefferies Virtual London Healthcare Conference 2020
Dates: November 17-19, 2020

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 and liquid 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 platform technology. ICT has already achieved promising responses with CoupledCAR® in colorectal and thyroid cancer patients in ongoing human proof-of-concept trials being conducted across multiple hospital sites in China, coordinated through its Shanghai-based R&D engine. ICT is initiating its first U.S. clinical trial with its most advanced program, ICTCAR014, after having received FDA IND clearance in late 2019. ICTCAR014 is based on ICT’s proprietary ArmoredCAR® liquid tumor 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

ROCKVILLE, Md., Nov. 10, 2020 (GLOBE NEWSWIRE) — Innovative Cellular Therapeutics (ICT), a clinical stage biotechnology company developing a comprehensive platform of chimeric antigen receptor (CAR) T cell therapies for solid and liquid tumors, today announced its plans to present CoupledCAR® solid tumor CAR-T clinical data at two key oncology conferences.

ICT will make data presentations at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020) and at the American Society of Hematology (ASH) 62nd ASH Annual Meeting and Exposition (ASH 2020) conferences. The data describe two heavily pre-treated patient groups with colorectal cancer and thyroid cancer, respectively. The group of seven colorectal cancer patients was treated with anti-GCC (guanylate cyclase 2C) CoupledCAR® CAR-T cells, while the group of three thyroid cancer patients was treated with anti-TSHR (thyroid stimulating hormone receptor) CoupledCAR® CAR-T cells. In both groups, the CoupledCAR® CAR-T cells showed rapid and significant expansion in vivo as well as infiltration into the tumor tissue sites, demonstrating enhanced tumor killing and shrinkage. 71.4% (5/7) Overall Response Rate (ORR) and 14.3% (1/7) Complete Remission (CR) rate was achieved in the colorectal cancer group. 66.7% (2/3) ORR and 33.3% (1/3) CR was achieved in the thyroid cancer group.

“CoupledCAR® is ICT’s novel, in-house developed, proprietary CAR-T platform technology designed to overcome the challenges observed with conventional CAR-T therapies in treating solid tumors. CoupledCAR® significantly improves the expansion of CAR-T cells in vivo and enhances the CAR-T cells’ migration ability and resistance to immunosuppression in the tumor microenvironment. This allows the CoupledCAR® CAR-T cells to infiltrate tumor tissue sites and increase anti-tumor activities,” said Larry (Lei) Xiao, Ph.D., ICT’s Founder and Chief Executive Officer. “We are excited to share the strong human proof-of-concept efficacy results achieved with CoupledCAR® across multiple hospital sites in China, coordinated through our R&D engine in Shanghai, and have initiated pre-IND discussions with the FDA to advance our CoupledCAR® solid tumor CAR-T therapies into the clinic in the United States in the near future.”

SITC 2020 Presentations:

Session Date/Time: November 11-14, 2020, 9:00 AM – 5:00 PM EST
Session Title/Location: Virtual Poster Hall
Abstract Title: Novel CoupledCAR^TM Technology for Treating Colorectal Cancer
Abstract Number: 701

Session Date/Time: November 11-14, 2020, 9:00 AM – 5:00 PM EST
Session Title/Location: Virtual Poster Hall
Abstract Title: CoupledCAR^TM Technology for Treating Thyroid Cancer
Abstract Number: 700

ASH 2020 Presentations: 

Session Date/Time: Sunday, December 6, 2020, 2:00 PM – 3:30 PM PST 
Session Title/Location: 801. Gene Editing, Therapy and Transfer I
Abstract Title: Novel CoupledCAR^TM Technology for Treating Colorectal Cancer
Oral Presentation Time: 3:00 PM PST
Publication Number: 501 – link here

Session Date/Time: Saturday, December 5, 2020, 7:00 AM – 3:30 PM PST
Session Title/Location: 801. Gene Editing, Therapy and Transfer: Poster I
Abstract Title: CoupledCAR^TM Technology for Treating Thyroid Cancer
Publication Number: 1541 – link here

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 and liquid 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 platform technology. ICT has already achieved promising responses with CoupledCAR® in colorectal and thyroid cancer patients in ongoing human proof-of-concept trials being conducted across multiple hospital sites in China, coordinated through its Shanghai-based R&D engine. ICT is initiating its first U.S. clinical trial with its most advanced program, ICTCAR014, after having received FDA IND clearance in late 2019. ICTCAR014 is based on ICT’s proprietary ArmoredCAR® liquid tumor 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

ROCKVILLE, Md., July 28, 2020 (GLOBE NEWSWIRE) — Innovative Cellular Therapeutics (ICT), a clinical stage biotechnology company developing a comprehensive platform of chimeric antigen receptor (CAR) T cell therapies for solid and liquid tumors, today announced that it will present new clinical data at the LifeSci Partners Private Company Virtual Summer Symposium on August 5, 2020.

“We have seen a 71% Overall Response Rate with 14% Complete Response in seven metastatic colon cancer patients treated in proof-of-concept trials in China with CoupledCAR^®, ICT’s novel, in-house developed, proprietary CAR-T platform technology for solid tumors,” said Larry (Lei) Xiao, Ph.D., ICT’s Founder and Chief Executive Officer. “We are excited to present details on our recent advancements, as we move towards U.S. IND filings for our CoupledCAR^® solid tumor CAR-T therapies,” he added.

LifeSci Partners Summer Symposium Presentation Details

Session Date: Wednesday August 5, 2020 
Presentation Time: 7:30 AM – 7:55 AM EDT
Presenter:  Victor Lu, PhD, SVP, Head of Regulatory Affairs, Innovative Cellular Therapeutics 
Webcast Registration Information: https://lifesci.events/SummerSymposium 

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 and liquid 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 platform technology. ICT has already achieved promising responses with CoupledCAR^® in colon and thyroid cancer patients in human proof-of-concept trials through its Shanghai-based R&D platform. ICT is initiating its first U.S. clinical trial with its most advanced program, ICTCAR014, after having received FDA IND clearance in late 2019. ICTCAR014 is based on ICT’s proprietary ArmoredCAR^® liquid tumor 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

ROCKVILLE, Md., Dec. 17, 2019 (GLOBE NEWSWIRE) — Innovative Cellular Therapeutics (ICT), a clinical stage biotechnology company developing a comprehensive platform of chimeric antigen receptor (CAR) T cell therapies for liquid and solid tumors, today announced that it has closed a U.S. dollar Series B+ equity financing for an undisclosed amount. The lead investor, LH Ventures, is a prominent venture capital firm targeting disruptive technologies in the healthcare sector and other innovations. Proceeds from the capital raise will be used to advance ICTCAR014 – ICT’s next generation CD19-targeting armored CAR-T cell therapy that expresses a dominant negative PD-1 protein to block immunosuppression by cancer cells – into a U.S. clinical trial in the first part of 2020, and to further develop ICT’s “CoupledCAR” CAR-T cell therapy platform in solid tumors.

“We are deeply impressed by the ICT team, their innovation capabilities and the response of the initial patients to the Company’s next generation armored dominant negative PD-1 CAR-T cell therapy and CoupledCAR technologies,” said Xin Xie, Ph.D., Partner at LH Ventures. “We believe ICT’s platform technologies will create significant breakthroughs in the fight against both liquid and solid tumors.”

“We are excited to have LH Ventures support the expansion of our global activities and help us advance the clinical development of our next generation CAR-T technologies for liquid and solid tumors in the United States,” said Larry (Lei) Xiao, Ph.D., ICT’s Founder and Chief Executive Officer. “They are joined by a group of other renowned, international investors who also believe in the viability of our platform technologies.”

About LH Ventures
LH Ventures is a prominent venture capital firm targeting early stage opportunities of innovation and disruptive technologies. It boasts an investment team consisting of entrepreneurs, scientists, doctors, and capital market experts. LH Ventures identifies teams and companies which have significant value potential and helps them grow into industry leaders.

About ICTCAR014
The U.S. Food and Drug Administration (FDA) has cleared ICT’s Investigational New Drug (IND) application for ICTCAR014, a next generation CD19-targeting CAR-T cell therapy that expresses a dominant negative PD-1 protein to block immunosuppression by cancer cells. ICT is moving ICTCAR014 into a U.S. clinical trial. ICTCAR014, referred to as an “armored” CAR-T cell therapy, has already shown encouraging results in proof-of-concept human trials in China. As highlighted in ICT’s presentation at the November 2019 Society for the Immunotherapy of Cancer (SITC) meeting, ICTCAR014 demonstrated a 92.3% objective response rate (53.8% complete remission; 38.5% partial remission) in 13 initial patients with relapsed or refractory non-Hodgkin lymphoma. Significant tumor shrinkage and limited toxicity were observed.

About Innovative Cellular Therapeutics
Innovative Cellular Therapeutics (ICT) is a clinical stage biotechnology company focused on the development of cellular immunotherapies for the treatment of liquid and solid tumors. ICT has achieved promising preclinical and clinical results in late-stage leukemia and lymphoma with its next generation CAR-T constructs. ICT’s lead candidate in the United States, ICTCAR014, is a next generation CD19-targeting armored CAR-T cell 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. In solid tumor, ICT has compelling human data from IRB-approved proof-of-concept trials in China demonstrating the viability of its proprietary “CoupledCAR” technology platform. For more information, please visit www.ictbio.com.

Investor Relations Contacts:

Innovative Cellular Therapeutics
ir@ictbioinc.com

Bob Yedid
LifeSci Advisors
646-597-6989
ir@ictbioinc.com

Media Relations Contacts:

Kate L. Barrette
RooneyPartners LLC
212-223-0561
kbarrette@rooneyco.com