Immunomic Therapeutics Receives FDA Fast-Track Designation 

On December 13, 2022, Pharmjet announced that its partner, Immunomic Therapeutics, received fast-track designation (FTD) from the U.S. Food and Drug Administration (FDA) for the clinical study of their plasmid DNA vaccine ITI-3000 in patients with Merkel cell carcinoma (MCC).

The PharmaJet Stratis Needle-free Injection System (NFIS) has been specifically chosen due to its ability to precisely deliver the vaccine to the intramuscular tissue layer. According to Chris Cappello, President, and CEO of PharmaJet, NFIS has previously been used successfully in the administration of therapeutics for the prevention or treatment of lymphoma, advanced solid tumors, HPV, and other oncology applications.

Enrollment for this phase one study is currently ongoing.

Dr. William Hearl, Chief Executive Officer of ITI, states, “The FDA’s decision to grant FTD underscores the potential for the ITI-3000 program to address a serious unmet need and serve as a meaningful therapeutic option for patients with Merkel cell carcinoma.” Dr. Hearl expects to report on the phase one trial data next year and is looking forward to working closely with the FDA for a potential next-phase clinical trial.


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