Immunomic Therapeutics Receives Fast Track Designation for Rare Skin Cancer Vaccine

Pharmajet partner, Immunomic Therapeutics, received Fast Track Designation from the US Food and Drug Administration (FDA) for a clinical study investigating its plasmid DNA vaccine, ITI-3000, in patients with Merkel cell carcinoma (MCC).¹

The PharmaJet Stratis Needle-free Injection System (NFIS) vaccine was selected because it can deliver the vaccine precisely into the intramuscular tissue layer. Enrollment is currently in progress for the phase 1 study. PharmaJet executives said the company expects to report top-line data from the ongoing trial next year and will work with the FDA on a potential next phase clinical trial.

The PharmaJet NFIS was previously used successfully in administration of therapeutics for the prevention or treatment of lymphoma, advanced solid tumors, human papillomavirus, and other oncology applications.

Immunomic Therapies is a privately held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms.

MCC, also known as neuroendocrine carcinoma, usually appears as a flesh-colored nodule that presents on the face, head, or neck.² Approximately 3000 cases of MCC are diagnosed in the United States every year, although recent statistics indicate the number is growing.2 MCC is a rare, aggressive form of skin cancer with a risk of returning and metastasizing within several years of the initial diagnosis. More than 4 out of 5 Americans diagnosed with MCC are older than 70, and men are nearly 2 times as likely to have it, compared to women. Risk factors for MCC include sun exposure, fair skin, and a weakened immune system.

Reference

1. 1. PharmaJet Partner Immunomic Therapeutics receives FDA fast track designation for pDNA vaccine for skin cancer. News release. Immunomic Therapeutics. December 13, 202. Accessed December 14, 2022. https://www.immunomix.com/pharmajet-partner-immunomic-therapeutics-receives-fda-fast-track-designation-for-pdna-vaccine-for-skin-cancer/
2. Skin Cancer Foundation. Merkel Cell Carcinoma Overview. Accessed December 14, 2022. https://www.skincancer.org/skin-cancer-information/merkel-cell-carcinoma/