LAMP-pp65-DC is an investigational cancer vaccine being developed by Immunomic Therapeutics. It is currently being studied for the treatment of glioblastoma (also called glioblastoma multiforme) (GBM), an aggressive type of brain cancer.
How LAMP-pp65-DC vaccine works
LAMP-pp65-DC vaccine is based on the company’s LAMP-Vax platform combined with a patented CMV-based therapy. It consists of patient-derived immune cells called dendritic cells (DCs) that are engineered to produce pp65, a protein that is overproduced by the majority of glioblastoma cancer cells, along with another protein called lysosomal-associated membrane protein (LAMP).
LAMP is a naturally occurring protein normally found inside the lysosomes, or compartments within the cell where biomolecules are broken down. Due to the addition of LAMP, the proteins produced by the engineered DCs are directly diverted to the lysosome, where they are able to form complexes with a molecule called MHC-II. These complexes are then transported to the surface of the DCs in order to present the antigen fragment (pp65) to another type of immune cell called T-cells. Recognition by T-cells is thought to elicits an immune response that can promote immune attack against pp65-producing cancer cells.
The modified DCs are directly administered to the patient after priming the injection site with a tetanus-diphtheria (Td) toxin. Once administered under the skin, these DCs are intended to activate a immune response to selectively attack cancer cells in the brain without harming healthy cells.
LAMP-pp65-DC in clinical trials
An ongoing randomized Phase 1 study (NCT00639639), called ATTAC, is designed to evaluate the safety and feasibility of the LAMP-pp65 DC vaccine in newly diagnosed GBM patients. Eleven people received LAMP-pp65 DC together with the “helper drug” granulocyte macrophage colony stimulating factor (GM-CSF) following chemotherapy with temozolomide (TMZ). The single-site study is expected to finish in late 2019.
Results so far show that patients treated with LAMP-pp65 DC had an increased immune response against pp65 and prolonged survival, with a median overall survival (OS) of about 41 months and median progression-free survival (PFS) of about 25 months. These results confirm those of an earlier randomized and blinded pilot clinical trial, reporting that vaccination with LAMP-pp65-DC combined with Td toxin in newly diagnosed GBM patients was associated with prolonged survival.
A randomized, blinded, placebo-controlled Phase 2 study (NCT02465268), called ATTAC-II, study aims to enroll about 150 patients with newly diagnosed GBM to evaluate the efficacy of LAMP-pp65 DC given after strong doses of routine chemotherapy and radiation therapy. The study’s main objective is to evaluate overall survival (OS). It is currently recruiting participants at three sites in Florida and North Carolina, and expects to be completed in 2024. Eligible patients are being recruited — information is available by clicking on the trial’s identification number — and the company will help to pay travel costs for those who enroll in this trial.
Positive results were recently reported from an in vitro study that compared the efficacy of full-length LAMP with the shortened version of LAMP to stimulate T-cells obtained from healthy volunteers and patients with GBM. Results showed that treatment with full-length LAMP-pp65 DC vaccine was associated with enhanced T-cell activation and pp65-specific killing of brain cancer cells.
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