Immunomic Recruits Experts for FDA Approval, 'Full-Scale Preparation for New Drug Authorization'

[Asia Economy Reporter Hyungsoo Park] HLB's U.S. subsidiary Immunomic Therapeutics announced on the 15th that it has appointed FDA regulatory expert Frances Harrison as Vice President.

Earlier, Immunomic completed the U.S. Phase 2 clinical trial (ATTAC-II) for glioblastoma (GBM) on the 7th and began data analysis. Considering that data analysis typically takes about a month, the company recruited an expert. Immunomic plans to initiate the regulatory approval process as soon as the data analysis is completed.

It is expected that as early as the beginning of next month, the company will announce the primary endpoint, the median overall survival (mOS) of patients, along with key top-line results.

Immunomic completed the Phase 2 clinical trial of the dendritic cell therapy ‘ITI-1000’, an antigen-presenting cell treatment, six years after the clinical trial began. Glioblastoma has not seen any new drugs since the approval of temozolomide (brand name Temodal) about 20 years ago. It is one of the representative intractable diseases urgently requiring the development of new treatments.

In the Phase 1 trial, Immunomic’s new drug candidate showed a median overall survival (mOS) of 38.3 months, significantly longer than the 14 months observed in the control group treated with existing therapies. If the Phase 2 results are also positive, the company plans to apply for Breakthrough Therapy Designation and submit a Biologics License Application (BLA) to the U.S. FDA.

Frances Harrison, appointed as Vice President in charge of regulatory affairs, is an expert who has been responsible for regulatory strategy development, submissions, and negotiations with the FDA for 30 years at multinational companies such as Boston Scientific and Allergan. She has conducted regulatory procedures over 75 times in 125 countries. After the data analysis is completed, she will be responsible for the ITI-1000 new drug approval process and communication with the FDA.

William Hull, CEO of Immunomic, said, "Recruiting a professional with many years of FDA regulatory experience at the time of completing the Phase 2 key data aggregation is a tremendous opportunity," and added, "We will proceed with the new drug approval process through close communication with the FDA."

‘ITI-1000’ is a therapeutic agent developed using Immunomic’s cell therapy vaccine platform ‘UNITE’. It is an immune cell therapy that activates the pp65 protein of cytomegalovirus, which is highly expressed in glioblastoma, in dendritic cells. Treatments using antibodies or synthetic drugs have difficulty crossing the blood-brain barrier (BBB) to reach the tumor site. Since this therapy uses autologous cells, it can easily reach the cancer lesions. Clinical trials were conducted at Duke University and the University of Florida in the U.S.

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