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

ICT's lead "armored" CAR-T program, ICTCAR014, demonstrated responses in two patients treated forrefractory 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.

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