EQS-News

First Patients Dosed in Phase I/II Trial of Enlivex’s Off-the-Shelf Cell Therapy Candidate, AllocetraTM

EQS-News: Enlivex Therapeutics, Ltd. First Patients Dosed in Phase I/II Trial of Enlivex’s Off-the-Shelf Cell Therapy Candidate, AllocetraTM 02.12.2022 / 14:00 CET/CEST The issuer is solely responsible for the content of this announcement. On November 13, Enlivex (NASDAQ: ENLV) announced that the first patient has been dosed in its Phase I/II clinical trial of Allocetra. The novel off-the-shelf cell therapy is designed to help break through the immune-suppressing tumor microenvironment – a key roadblock rendering potent immunotherapies less effective against solid cancers – to render those tough-to-treat cancers more responsive to these treatments.

After a growing body of preclinical data demonstrated Allocetra’s potential to prolong survival duration and increase survival probability in mice, the Phase I/II studies are an important next step in evaluating their efficacy in humans.

Immunotherapies Tap the Body’s Own Cancer-Fighting Capabilities – But Solid Cancers Remain Resistant

As the field of immunotherapy makes strides, solid tumors continue to elude these novel treatments largely due to their complex and ever-adapting “tumor microenvironments.” These microenvironments leverage a range of immune-suppressing mechanisms that counteract the potent effects immunotherapies have had on skin and blood cancers.

Chimeric Antigen Receptor (CAR)-T therapies, for example, have demonstrated a success rate as high as 90% for refractory B lymphocytic leukemia but as low as 17% for solid cancers. Novartis AG’s (NYSE: NVS) Kymriah, the first CAR-T therapy to receive approval from the Food and Drug Administration, has since shown a durable remission and long-term survival rate, with as many as 55% of treated patients still alive more than five years later compared to the standard disease prognosis of 10% to 25%.

The reason for this difference is largely due to the range of mechanisms tumors use to resist or evade the immune system including disguising themselves as healthy cells, releasing immune suppressing signals, and blocking immune cells from getting into the core of the tumor. The more the tumor grows, the stronger these immunosuppressive mechanisms get – making it harder for the immune system to detect it.