First Participant Dosed in ITI-3000 Study for Merkel Cell Carcinoma


Could a vaccine help treat cancer such as Merkel cell carcinoma (MCC)? Immunomic Therapeutics believes so. Its therapeutic plasmid DNA (pDNA) vaccine, ITI-3000, is designed for those with MCC, a rare and highly aggressive skin cancer. According to Clinical Trials Arena, the first participant was recently dosed in a Phase 1 clinical study evaluating the safety, immunogenicity, and tolerability of ITI-3000.

The clinical trial page explains that ITI-3000 is: 

a DNA vaccine which contains sequences for both LAMP1 and LTS220A, the truncated form of the LT antigen of MCPyV with a detoxifying serine to alanine mutation at position 220.

Altogether, eight patients will enroll within this study. These are all participants who have polyomavirus-positive Merkel cell carcinoma and have undergone surgical treatment at least one year prior to study participation. At the time of participants, participants show no evidence of disease activity. 

During the trial, participants will receive 4mg ITI-3000. Researchers will evaluate dose-limiting toxicities, adverse reactions, and other elements. Data from the study should be available in the middle to latter part of 2023. 

About Merkel Cell Carcinoma (MCC

Merkel cell carcinoma (MCC), or neuroendocrine carcinoma of the skin, is a form of rare and aggressive skin cancer. It develops in Merkel cells, which are found in your skin’s outer layer. MCC typically manifests as a painless red, bluish-red, or flesh-colored nodule. This cancer often presents on the face, neck, or head. The lump may be the size of a dime or rapidly growing, firm, raised or dome-shaped, or – in some cases – tender or sore. 

Scientists and researchers hypothesize that the Merkel cell polyomavirus plays a role in MCC development, though they believe there are also other causes. Risk factors include being over 50 years old, having a history of skin cancer, excessive (real or fake) sun exposure, having lighter skin, or being immunocompromised. Unfortunately, Merkel cell carcinoma has both a high rate of recurrence and a high rate of metastasis.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

Share this post

Share on facebook
Share on twitter
Share on linkedin
Share on pinterest
Share on print
Share on email