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Innovative Cellular Therapeutics to Present CoupledCAR® Solid Tumor CAR-T Clinical Data at Upcoming Scientific Meetings

Innovative Cellular Therapeutics to Present CoupledCAR® Solid Tumor CAR-T Clinical Data at Upcoming Scientific Meetings 671 768 Innovative Cellular Therapeutics

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 CoupledCARTM 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: CoupledCARTM 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 CoupledCARTM 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: CoupledCARTM 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

Innovative Cellular Therapeutics to Present New Clinical Data with CoupledCAR® CAR-T in Colon Cancer at the LifeSci Partners Private Company Virtual Summer Symposium on August 5, 2020

Innovative Cellular Therapeutics to Present New Clinical Data with CoupledCAR® CAR-T in Colon Cancer at the LifeSci Partners Private Company Virtual Summer Symposium on August 5, 2020 470 631 Innovative Cellular Therapeutics

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

Bob Yedid
LifeSci Advisors
646-597-6989
bob@lifesciadvisors.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

Innovative Cellular Therapeutics Announces Details of Two Abstracts on its Novel CoupledCAR® Solid Tumor CAR-T Technology to be Presented Orally at the 23rd American Society of Gene & Cell Therapy Meeting

Innovative Cellular Therapeutics Announces Details of Two Abstracts on its Novel CoupledCAR® Solid Tumor CAR-T Technology to be Presented Orally at the 23rd American Society of Gene & Cell Therapy Meeting 1719 1732 Innovative Cellular Therapeutics

ROCKVILLE, Md., April 29, 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 details of two abstracts on its novel CoupledCAR® solid tumor CAR-T technology for treating colorectal and thyroid cancers. The abstracts have been selected for oral presentation on May 15, 2020, at the 23rd American Society of Gene & Cell Therapy (ASGCT) Annual Meeting, which will be conducted virtually.

“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® in China 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.”

ICT will present the two abstracts back-to-back in a virtual presentation on Friday, May 15, 2020, at 9:30 AM EDT, during the Clinical Trials Spotlight Symposium. The abstracts describe two heavily pre-treated patient cohorts with colorectal cancer and thyroid cancer, respectively, that achieved near Complete Remission (nCR) or Partial Remission (PR) after treatment with CoupledCAR®, and may be found here.

Novel CoupledCAR® Technology for Treating Colorectal Cancer

Session Date/Time: Friday May 15, 2020 8:00 AM – 9:45 AM EDT
Session Title/Location: Clinical Trials Spotlight Symposium, Room 310
Presentation Time: 9:30 AM – 9:45 AM EDT
Presenter:  Larry (Lei) Xiao, PhD, Innovative Cellular Therapeutics 
Abstract Number: 1304

CoupledCAR® Technology for Treating Thyroid Cancer

Session Date/Time: Friday May 15, 2020 8:00 AM – 9:45 AM EDT
Session Title/Location: Clinical Trials Spotlight Symposium, Room 310
Presentation Time: 9:30 AM – 9:45 AM EDT
Presenter: Larry (Lei) Xiao, PhD, Innovative Cellular Therapeutics
Abstract Number: 1303

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 thyroid, colon, and prostate 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

Bob Yedid
LifeSci Advisors
646-597-6989
bob@lifesciadvisors.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

Innovative Cellular Therapeutics Announces Acceptance of Abstract on its Novel CoupledCAR® Technology for Treating Colorectal Cancer for Oral Presentation at the 23rd American Society of Gene & Cell Therapy (ASGCT) Annual Meeting

Innovative Cellular Therapeutics Announces Acceptance of Abstract on its Novel CoupledCAR® Technology for Treating Colorectal Cancer for Oral Presentation at the 23rd American Society of Gene & Cell Therapy (ASGCT) Annual Meeting 1300 1625 Innovative Cellular Therapeutics

ROCKVILLE, Md., April 14, 2020 — 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 acceptance of its abstract titled Novel CoupledCAR® Technology for Treating Colorectal Cancer. The abstract will be presented orally at the 23rd American Society of Gene & Cell Therapy (ASGCT) Annual Meeting, which will be conducted virtually, May 12-15, 2020.

“CoupledCAR® is ICT’s novel, in-house developed, proprietary CAR-T platform technology for the treatment of solid tumors. We have already achieved promising responses in several indications with CoupledCAR® in human proof-of-concept trials in China. We have also initiated pre-IND discussions with the FDA on taking several of our CoupledCAR® therapies into clinical trials in the United States,” said Larry (Lei) Xiao, Ph.D., ICT’s Founder and Chief Executive Officer. “We are excited for the opportunity to share our human data and strong efficacy results from our CoupledCAR® colorectal tumor program with the scientific community at ASGCT in May.”

The oral presentation of ICT’s abstract will be conducted virtually on Friday, May 15, 2020, at 9:30 AM EDT during the Clinical Trials Spotlight Symposium. Additional details are provided below.

Novel CoupledCAR® Technology for Treating Colorectal Cancer

Session Date/Time: Friday May 15, 2020, 8:00 AM – 9:45 AM EDT
Session Title: Clinical Trials Spotlight Symposium
Presentation Time: 9:30 AM – 9:45 AM EDT

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 thyroid, colon, and prostate 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

Bob Yedid
LifeSci Advisors
646-597-6989
bob@lifesciadvisors.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

Maryland Tech Council Announces Nomination of Innovative Cellular Therapeutics as “Emerging Life Sciences Company of the Year” Finalist

Maryland Tech Council Announces Nomination of Innovative Cellular Therapeutics as “Emerging Life Sciences Company of the Year” Finalist 1745 1664 Innovative Cellular Therapeutics

ROCKVILLE, Md., March 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, announced today that it has been nominated as a finalist for “Emerging Life Sciences Company of the Year,” by Maryland Tech Council (MTC). The winner of the award will be revealed at MTC’s annual Industry Awards Celebration on May 13, 2020.

MTC is the largest technology trade group serving the advanced technology and biotechnology communities of Maryland. Its mission is to advocate for the interests of the technology community, further the role of technology in the Maryland economy, and nurture an environment where technology companies can collaborate, grow and succeed.

“We are honored to be nominated for the Emerging Life Sciences Company of the Year award by Maryland Tech Council,” said Larry (Lei) Xiao, Ph.D., ICT’s Founder and Chief Executive Officer. “After establishing our U.S. business in 2018, we moved our global headquarters to Rockville in early 2019 to further concentrate our focus on the U.S. market and to leverage the strong life sciences talent pool in Maryland as we expand our operations and hiring in the area.”

Dr. Xiao noted that ICT has already made significant progress since moving to Maryland, including hiring most of ICT’s senior executives and obtaining FDA IND clearance for the Company’s ArmoredCAR® ICTCAR014 CAR-T program, which is now moving into a U.S. Phase 1 clinical trial in relapsed or refractory NHL, including for PD-L1 positive patients. ICT has also initiated pre-IND discussions with the FDA for its first CoupledCARTM based solid tumor CAR-T programs.

“We appreciate the support and recognition from Maryland Tech Council and the local life sciences community during this exciting time for our company,” Dr. Xiao added.

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-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 CoupledCARTM solid tumor platform technology. ICT has already achieved promising responses with CoupledCARTM in thyroid, colon, and prostate 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 U.S. FDA Investigational New Drug (IND) application 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 Contacts:

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

Innovative Cellular Therapeutics Appoints Cell and Gene Therapy Manufacturing Expert Christopher Ballas, Ph.D., as SVP of Manufacturing

Innovative Cellular Therapeutics Appoints Cell and Gene Therapy Manufacturing Expert Christopher Ballas, Ph.D., as SVP of Manufacturing 1366 911 Innovative Cellular Therapeutics

ROCKVILLE, Md., January 07, 2020 — 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 the appointment of Christopher Ballas, Ph.D., as Senior Vice President of Manufacturing. Dr. Ballas previously served in senior manufacturing roles at Rocket Pharmaceuticals and WuXi AppTec, with a focus on gene and cell-based therapies. 

“Our need for quality vector and cell production is growing as we advance our liquid and solid tumor CAR-T programs into the clinic in the United States. We intend to assume full control of our key manufacturing processes,” said Larry (Lei) Xiao, Ph.D., ICT’s Founder and Chief Executive Officer. “Chris is a valued addition to the ICT management team, as he will lead our manufacturing efforts and the expansion of our related infrastructure,” Dr. Xiao added.

Dr. Ballas brings more than 20 years’ experience of working on cell and gene therapies. Most recently, he served as Vice President of Manufacturing for Rocket Pharmaceuticals, a leading publicly traded U.S. gene therapy company. Previously, he served as Senior Director of Process Development and Commercialization for WuXi AppTec, where he was responsible for manufacturing operations and program management for gene therapy clients. Dr. Ballas oversaw key programs including CAR-T, TIL, and classic CD34+ stem cell gene therapy. 

Prior to WuXi AppTec, Dr. Ballas ran autologous cell therapy clinical trials for Cook Medical. Dr. Ballas also held several roles at the Indiana University School of Medicine, where he developed the initial, scalable, clinical production capabilities for lentiviral vectors at the IU Vector Production Facility. As a faculty member, Dr. Ballas developed his own research programs targeting stem cells for gene therapy, which resulted in the collaborative development of an ultra-high throughput microinjection device with colleagues at the University of California Riverside (US9885059). In the past, Dr. Ballas served as an expert consultant to numerous companies on gene therapy and the production and use of viral vectors for gene therapies with contributions to Chemistry, Manufacturing, and Control (CMC), regulatory filings, and regulatory meetings.

Dr. Ballas has a Ph.D. in Cellular and Molecular Pathology from the Vanderbilt University School of Medicine and was a Children’s Brittle Bone Foundation fellow during his post-doctoral fellowship at Case Western Reserve University School of Medicine.

Dr. Ballas said, “I have a passion for solving the practical challenges associated with producing and using viral vectors to deliver genes and create differentiated therapies. ICT’s CAR-T platform is unique and compelling, and I look forward to leveraging my experience to optimize and expand our manufacturing capability to produce world-class products with the potential to transform cancer immunotherapy.”

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

Innovative Cellular Therapeutics Secures Equity Financing to Advance its Next Generation Liquid and Solid Tumor CAR-T Programs

Innovative Cellular Therapeutics Secures Equity Financing to Advance its Next Generation Liquid and Solid Tumor CAR-T Programs 1366 907 Innovative Cellular Therapeutics

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

Innovative Cellular Therapeutics Announces FDA Clearance of IND for its Dominant Negative PD-1 “Armored” Next Generation CAR-T Cell Therapy

Innovative Cellular Therapeutics Announces FDA Clearance of IND for its Dominant Negative PD-1 “Armored” Next Generation CAR-T Cell Therapy 3000 2250 Innovative Cellular Therapeutics

ROCKVILLE, Md., December 4, 2019 — Innovative Cellular Therapeutics (ICT), a biotechnology company developing a comprehensive platform of chimeric antigen receptor (CAR) T cell therapies for blood cancers and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’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 expects to initiate a U.S. clinical trial evaluating ICTCAR014 in patients with relapsed or refractory non-Hodgkin lymphoma (NHL), including patients whose tumors are PD-L1 positive, in the first part of 2020. Dr. David L. Porter of the Abramson Cancer Center of the University of Pennsylvania will be the Lead Principal Investigator for the clinical trial.

“The clearance of our first U.S. IND is a significant step as we expand our U.S. activities,” said Larry (Lei) Xiao, Ph.D., Chairman and Chief Executive Officer of ICT. “Building upon the encouraging data presented in November at the Society for Immunotherapy of Cancer (SITC), which showed objective response rate of over 92%, the ICTCAR014 program highlights our accelerated and de-risked approach for developing novel immunotherapies. Our development strategy translates rapid clinical proof-of-concept trials in China into U.S. and global development programs with the goal of regulatory approval through expedited review pathways. We look forward to advancing ICTCAR014 into our first U.S. clinical trial.”

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 demonstrated 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 cancer. 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 U.S., ICTCAR014, is a next generation CD19-targeting 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. ICT’s lead candidate in China, ICTCAR003, is a CD19-targeting CAR-T cell therapy for the treatment of B-cell acute lymphoblastic leukemia. The Company also has a broad pipeline of CAR-T candidates targeting solid tumors. For more information, please visit www.ictbio.com.


Investor Relations Contacts:

Bob Yedid
LifeSci Advisors
646-597-6989
Bob@lifesciadvisors.com

Media Relations Contacts:

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

Innovative Cellular Therapeutics Announces Data at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting

Innovative Cellular Therapeutics Announces Data at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting 805 612 Innovative Cellular Therapeutics

ICT’s lead “armored” CAR-T program, ICTCAR014, demonstrated responses in two patients treated for refractory diffuse large B-cell lymphoma (DLBCL) in an investigator-sponsored clinical trial in China; safe and well-tolerated

Currently in preclinical development in the U.S. for the treatment of Non-Hodgkin Lymphoma

ROCKVILLE, Md., May 08, 2019 (GLOBE NEWSWIRE) — Innovative Cellular Therapeutics (ICT), a biotechnology company developing cellular immunotherapies for the treatment of cancer, announced the presentation of data from its ongoing investigator-sponsored clinical trial and preclinical studies of lead candidate ICTCAR014 in a poster presentation titled “Dominant negative PD1 Armored CART Cells Induce Remission in Refractory Diffuse Large B Cell Lymphoma (DLBCL) Patients” at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting held from April 28 – May 2, 2019 in Washington, D.C.

Additionally, Victor Lu, Ph.D., ICT’s Head of Regulatory Affairs, presented a talk titled “Manufacturing challenges during late phase development of gene therapy products – from a biotech company’s perspective” during a pre-Approval Commercialization Workshop at the meeting. The talk covered the challenges of manufacturing cell therapies for use in patients and methods to approach these challenges, including thorough product characterization, implementation of consistent manufacturing controls, and robust process validation and comparability studies.

“We are excited to announce the presentation of first-in-human clinical data from our lead therapeutic candidate, ICTCAR014, at ASGCT. Our investigator-sponsored clinical trial is a valuable source of human clinical proof-of-concept data for ICTCAR014, for which we intend to submit a U.S. IND for the treatment of Non-Hodgkin Lymphoma this year,” commented Lei Xiao, Ph.D., ICT’s Chief Executive Officer. “We are pursuing the opportunity to make a substantial difference for patients worldwide through our development of improved next-generation CAR-T therapies.”

ICT’s lead candidate, ICTCAR014, consists of anti-CD19 CAR-T cells with a dominant negative PD1 molecule. Preclinically, these “armored” CAR-T cells show enhanced capability of tumor killing after multiple-round tumor challenging and more “memory-like” phenotypes compared with conventional CAR-T cells. These results suggest dominant negative PD1 molecules may protect CAR-T cells from exhaustion in the tumor microenvironment and enhance anti-tumor efficacy by blocking the PD1-PDL1/2 interaction.

In an investigator-sponsored trial in China, two patients treated with ICTCAR014 for refractory diffuse large B-cell lymphoma (DLBCL) demonstrated significant tumor mass decrease as shown in PET/CT results and ongoing responses.

About Innovative Cellular Therapeutics

Innovative Cellular Therapeutics (ICT) is a biotechnology company focused on the development of cellular immunotherapies for the treatment of cancer. ICT is a clinical stage biotechnology company and has achieved promising preclinical and clinical results in late-stage leukemia and lymphoma with novel CAR-T constructs. ICT’s lead CAR-T candidate in the U.S., ICTCAR014, targets CD19 and PD1 for the treatment of Non-Hodgkin Lymphoma. ICT’s lead CAR-T candidate in China, ICTCAR003, targets CD19 for the treatment of B-cell acute lymphoblastic leukemia. The Company also has a broad pipeline of CAR-T candidates targeting other blood and liquid cancers and solid tumors. For more information, please visit www.ictbio.com.

Innovative Cellular Therapeutics Announces Successful Completion of Pre-IND Meeting With FDA

Innovative Cellular Therapeutics Announces Successful Completion of Pre-IND Meeting With FDA 1366 911 Innovative Cellular Therapeutics

ROCKVILLE, Md., March 19, 2019 (GLOBE NEWSWIRE) — Innovative Cellular Therapeutics (ICT), a biotechnology company developing cellular immunotherapies for the treatment of cancer, today announced it has successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA). At the meeting, the FDA provided feedback regarding ICT’s planned initiation of clinical trials under a U.S. IND for its lead CAR-T candidate, ICTCAR014, for the treatment of Non-Hodgkin Lymphoma (NHL).

“The positive feedback we received from the FDA during the pre-IND meeting was encouraging and aligns clearly with our plan to submit an IND for ICTCAR014 to the FDA in the second quarter of 2019,” said Lei Xiao, Ph.D., ICT’s Chief Executive Officer. “We appreciate the FDA’s support and guidance as we pursue our mission of bringing novel, targeted immunotherapies to the cancer patients that need them most.”

“The FDA was supportive of our detailed plan for U.S. clinical studies and provided helpful feedback on our proposed quality assurance and comparability experiments,” said Victor Lu, Senior Vice President and Head of Regulatory Affairs. “In following these recommendations, we are ensuring our compliance with the FDA’s established regulatory standards for gene modified cellular products. We have built a plan to address the FDA’s comments and are moving forward with the IND application process on our original timeline.”

To facilitate the clinical development of ICTCAR014 in the U.S., ICT recently established a new headquarters in Rockville, Maryland. It is also working with an American Contract Development and Manufacturing Organization to manufacture CAR-T cell product for clinical trials that will occur in different locations across the country. In anticipation of the phase 3 pivotal clinical trials and the BLA submission to the FDA, ICT is also laying the groundwork for commercial manufacturing capabilities of CAR-T technology in the U.S.

The Company’s lead program, ICTCAR014, is a novel “armored CAR” therapeutic candidate that targets CD19 and PD1. It is currently in preclinical development for the treatment of Non-Hodgkin Lymphoma in the U.S. Research has shown that the inhibition of PD1 may enhance CAR-T cell function.

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 cancer. ICT has achieved promising preclinical and clinical results in late-stage leukemia and lymphoma with its next generation CAR-T constructs. ICT’s lead CAR-T candidate in the U.S., ICTCAR014, targets CD19 and PD-1 for the treatment of non-Hodgkin lymphoma. ICT’s lead CAR-T candidate in China, ICTCAR003, targets CD19 for the treatment of B-cell acute lymphoblastic leukemia. The Company also has a broad pipeline of CAR-T candidates targeting solid cancer tumors.