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

1153 Days ago

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 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.

Investor Relations Contacts:    Media Relations Contact:
Brad Fackler   Kate L. Barrette
Innovative Cellular Therapeutics   RooneyPartners LLC
240-297-4120    212.223.0561
bradfackler@ictbio.com    kbarrette@rooneyco.com
Kerry Conlin    
Stern Investor Relations    

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