Immunomic Therapeutics Receives FDA Fast Track Designation for pDNA Vaccine for Skin Cancer

December 13, 2022

The vaccine is exclusively delivered with the PharmaJet Stratis Needle-free Injection System.

Vaccine exclusively delivered with the PharmaJet Stratis® Needle-free Injection System

Immunomic Therapeutics received FDA fast track designation for the clinical study of their plasmid DNA vaccine ITI-3000 in patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer. 

Enrollment is in progress for the phase 1 study that exclusively uses the PharmaJet Stratis Needle-free Injection System (NFIS). The PharmaJet Stratis NFIS was chosen due to its ability to precisely deliver the vaccine to the intramuscular tissue layer.

“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,” says Dr. William Hearl, Chief Executive Officer of ITI, in a news release. “We are committed to unlocking the full potential of ITI-3000 in patients with this aggressive form of skin cancer. We expect to report top-line data from our ongoing phase 1 trial of ITI-3000 in MCC patients next year and look forward to working closely with the FDA on a potential next phase clinical study design, while simultaneously continuing dialogue with possible partners.” 

Fast Track Designation is designed to facilitate the development and expedite the FDA review of drugs to treat serious conditions and fulfill unmet medical needs, enabling drugs to reach patients earlier

“We are pleased that our partner Immunomic Therapeutics has received fast track designation for this important DNA therapeutic for aggressive skin cancer,” says Chris Cappello, President and CEO, PharmaJet. “The PharmaJet NFIS have been used successfully in administration of therapeutics for the prevention or treatment of lymphoma, advanced solid tumors, HPV and other oncology applications.”

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