Plasmid DNA Vaccine Candidate for Skin Cancer Granted FDA Fast Track

Immunomic Therapeutics, Inc., a clinical-stage biotechnology company pioneering the development of LAMP-mediated nucleic acid-based immunotherapy, today announced that the U.S. FDA granted Fast Track Designation to the ITI-3000 program for treating patients with Merkel cell carcinoma.

The company is currently enrolling a phase 1 study evaluating ITI-3000, a plasmid DNA vaccine targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer typically caused by the Merkel cell polyomavirus.

Dr. William Hearl, Chief Executive Officer of ITI, stated in a press 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."