Enlivex Therapeutics Initiates First Clinical Trial of Allocetra in Patients with Cancer

Enlivex Therapeutics, a clinical-stage macrophage reprogramming immunotherapy company, has initiated the first clinical trial of Allocetra in patients with cancer. The trial is a Phase I/II study evaluating the safety and potential efficacy of Allocetra combined with standard-of-care chemotherapy in patients with peritoneal metastases arising from solid cancer. Peritoneal cancer is a terminal disease with a poor prognosis, and patients with peritoneal metastases are in urgent need of novel treatment options.

The trial will enroll approximately 12 patients across four cohorts and will evaluate the safety and potential preliminary efficacy of Allocetra combined with SOC chemotherapy. The study will begin with two cohorts of intra-patient and intra-cohort dose escalation to determine the maximum feasible dose (MFD) of Allocetra in this population, followed by two additional cohorts comparing administration of Allocetra at the selected dose either before or after administration of SOC via a pressurized intraperitoneal aerosol chemotherapy procedure (PIPAC).

Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Macrophages play a critical role in the immune system, and diseases such as solid cancers, sepsis, and others reprogram macrophages out of their homeostatic state, contributing to the severity of these diseases.

Sheba Medical Center, one of the top ten hospitals in the world, has been selected as a clinical site for the trial. Prof. Aviram Nissan, M.D., Head of the Department of General and Oncological Surgery at Sheba Medical Center, and Principal Investigator of the trial, commented, "We hope that the combination of chemotherapy and Allocetra will generate a breakthrough in the treatment of peritoneal metastases, which are not treatable in most patients with anti-cancer drugs available today."

Key Takeaways:

• Enlivex Therapeutics has initiated the first clinical trial of Allocetra in patients with cancer.
• The trial is a Phase I/II study evaluating the safety and potential efficacy of Allocetra combined with standard-of-care chemotherapy in patients with peritoneal metastases arising from solid cancer.
• Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state.
• Peritoneal cancer is a terminal disease with a poor prognosis, and patients with peritoneal metastases are in urgent need of novel treatment options.
• Sheba Medical Center has been selected as a clinical site for the trial.
• The trial will enroll approximately 12 patients across four cohorts.

Statistics:

• Peritoneal cancer is a terminal disease with a poor prognosis.
• Patients with peritoneal metastases are in urgent need of novel treatment options.
• The trial will enroll approximately 12 patients across four cohorts.
• The study will begin with two cohorts of intra-patient and intra-cohort dose escalation to determine the maximum feasible dose (MFD) of Allocetra in this population.
• The trial will evaluate the safety and potential preliminary efficacy of Allocetra combined with SOC chemotherapy.

Sources:

• GlobeNewswire. "Enlivex Therapeutics Initiates First Clinical Trial of Allocetra in Patients with Cancer"
• Enlivex Therapeutics website
• Sheba Medical Center website