Dosing of TI-3000 pDNA Vaccine Begins in Phase 1 Merkel Cell Carcinoma Trial

The first patient with Merkel cell carcinoma in a phase 1 study has been dosed with the plasmid DNA (pDNA) vaccine, ITI-3000, according to an announcement by Immunomic Therapeutics, Inc.¹

ITI-3000 utilizes the Universal Intracellular Targeted Expression (UNITE) platform, powered by LAMP, to boost the presentation of antigens and level the immune response. In in vivo models, the agent demonstrated the ability to activate antigen-specific CD4-positive T cells.

The phase 1, open-label, first-in-human, study (NCT05422781) will be conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center in Seattle, Washington. Eight patients with Merkel cell carcinoma who have undergone surgery will be administered 4 mg of ITI-3000 in the study.²

The goal of the study is to investigate the safety, tolerability, and efficacy of the agent. The coprimary end points of the study include the number of patients with dose-limiting toxicities, adverse events (AEs), and serious AEs. The study is also assessing the number patients with changes from baseline in physical exam findings, hematology lab results, chemistry lab results, urinalysis lab results, and vital signs as coprimary end points. The exploratory end points of the study include immune assessments for anti-Merkel cell polyomavirus (MCPyV) T-cell response, immune assessment for anti-MCPyV LT antibodies, and immune assessments for anti-MCPyV oncoprotein antibodies.

"Despite recent advances in cancer immunotherapy, there remains a need for therapies to treat this rather rare, but aggressive form of skin cancer, and we believe that our proprietary approach, utilizing nucleic acid vaccines with the power to leverage the body’s natural biochemistry to develop a broad immune response, holds tremendous potential in this indication," said William Hearl, PhD, chief executive officer of Immunomic Therapeutics, in a press release

To be eligible for inclusion in the study, patients aged 18 years or older must have evidence of Merkel cell carcinoma and have complete surgery. All patients are required to have a Karnofsky performance score of ≥ 70 or an ECOG performance score of 0-1, a life expectancy of ≥ 3 months, and adequate renal, hepatic, and bone marrow function. In addition, patients must agree to use contraception during the study.

Patients will be excluded if they are participating in another therapeutic clinical trial or have received prior systemic treatment. Patients who are pregnant/breast feeding, or who have certain comorbidities are ineligible for inclusion in the study.

"We look forward to reporting top-line results from the phase 1 trial in the second quarter of next year,” said Hearl, in the press release.

_REFERENCES:

_{1. Immunomic Therapeutics announces first patient dosed in phase I clinical trial of ITI-3000 pDNA vaccine for the treatment of merkel cell carcinoma. New release. Immunomic Therapeutics. July 20, 2022. Accessed July 22, 2022. https://bit.ly/3cETj5z}

_{2. Study to evaluate the safety, tolerability and immunogenicity of 4 mg Of ITI-3000 in patients with polyomavirus-positive merkel cell carcinoma (MCC). ClinicalTrials.gov. Updated June 16, 2022. Accessed July 22, 2022. https://clinicaltrials.gov/ct2/show/NCT05422781}