Candidate: Placental eXpanded (PLX)-PAD Cells for COVID-19
Type: “Off the shelf,” placenta-based allogeneic mesenchymal-like cells with immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages. Pluristem reasons PLX cells may prevent or reverse dangerous overactivation of the immune system by reducing the incidence andor severity of COVID-19 pneumonia and pneumonitis.
Status: Pluristem said December 29 that it agreed to collaborate with Mexican pharmaceutical company Innovare R&D to expand its ongoing clinical program of PLX-PAD cells for treating Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 in Mexico. Innovare plans to open clinical sites and enroll patients for the proposed Mexican study, which it will fund, and will purchase PLX-PAD cells for the study from Pluristem. The agreement grants Innovare exclusive distribution rights in Mexico to supply PLX-PAD cells for treating severe COVID-19 cases complicated by ARDS, subject to positive clinical results and Mexican regulatory approval. However, all intellectual property and manufacturing rights remain with Pluristem.
Pluristem said it is conducting two Phase II studies in ARDS associated with COVID-19 in the U.S., Europe and Israel; an Expanded Access Program in the U.S.; and a per patient compassionate use program in Israel.
A Phase II study is planned in Mexico, subject to the approval of local authorities, with the goal of being conducted under a protocol cleared by the FDA in May for a Phase II up-to-140 patient study of PLX-PAD cells in severe COVID-19 cases complicated by ARDS. The trial is designed to evaluate the efficacy and safety of one or two intramuscular (IM) injections, in three different dosages, of PLX-PAD. Pluristem said.
On April 13, Pluristem treated its first patient suffering from COVID-19 complications in the U.S. under the FDA’s Single Patient Expanded Access Program, also called a compassionate use program, which is part of the U.S. Coronavirus TreatmentTreatment Acceleration Program (CTAP). The patient was treated with PLX cell therapy at Holy Name Medical Center in Teaneck, NJ. Before treatment, the patient was critically ill with respiratory failure due to acute respiratory distress syndrome (ARDS) and was under mechanical ventilation for three weeks, Pluristem said.
On April 7, Pluristem announced positive preliminary data from its compassionate use program treating seven patients suffering from acute respiratory failure and inflammatory complications associated with COVID-19 with PLX cells at three medical centers in Israel. Four of six patients who completed a one-week follow up showed improvement in respiratory parameters, of which three are in advanced stages of weaning from ventilators. One such patient showed no change, and one showed deterioration.
The company plans to apply to initiate a multinational regulated clinical trial program for the potential use of PLX cells in the treatment of patients suffering from complications associated with COVID-19.
In March, Pluristem said it had dosed three patients in two different Israeli hospitals under a compassionate use program for the treatment of COVID-19, as approved by the Israeli Ministry of Health. The company expects to enroll additional patients in Israel in coming days. Pluristem is studying the therapeutic effects of PLX cells through a collaboration with the BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies (BeCAT) at Charite’ University of Medicine Berlin.
The company added that it is in talks with U.S. and European regulators to define its clinical strategy for COVID-19.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: