Type: Cell-based immunotherapy designed to rebalance a life-threatening unbalanced immune system, using the immune system’s own natural regulation mechanisms.
2021 Status: Enlivex Therapeutics on February 3 reported positive top-line results from a multi-center, investigator-initiated Phase II trial (NCT04590053) evaluating Allocetra in 16 severe and critical COVID-19 patients. Fourteen of 16 (87.5%) patients recovered and were discharged from the hospital after an average of 5.3 days following Allocetra administration (an average of 4.2 days for severe patients and 7.2 days for critical patients). Of the 16 patients, nine (9/16, 56%) were in severe condition and seven (7/16, 44%) were critical.
When results were added to those of a five-patient Phase Ib study, Enlivex said, 19 of the 21 (90.5%) patients recovered and were discharged from the hospital after an average of 5.6 days following Allocetra administration (an average of 4.1 days for severe patients and 7.7 days for critical patients).
None of the Phase II patients died in the Phase Ib and Phase II trials. Most patients in both studies had pre-existing risk factors such as male gender, obesity, and hypertension.
2020 Status: Enlivex on December 3 reported positive interim results of an investigator-initiated Phase II trial (NCT04590053) evaluating Allocetra in six severe and two critical COVID-19 patients. All seven patients treated through November 26 showed complete recovery and were discharged from the hospital after an average of 4.7 days following Allocetra administration. Combined with previously-treated patients in a since-concluded Phase Ib study, all 12 patients treated through November 26 showed complete recovery and were discharged from the hospital, after an average of 5.5 days following Allocetra administration.
The eighth treated patient in the Phase II study (and 13th treated patient overall), a critical patient, showed clinical improvement following treatment with Allocetra and was classified as of December 3 as being in moderate/severe condition, remaining hospitalized. Thirteen COVID-19 patients have been treated to date with Allocetra, with the Phase II trial set to recruit up to 24 patients.
In October, Enlivex announced positive topline results of an investigator-initiated multi-center Phase II clinical trial of its lead product candidate Allocetra in five COVID-19 patients—three in severe condition and two in critical condition. All five showed complete recovery and were released from the hospital after averages of 5.5 days (severe patients) and 8.5 days (critical patients) following administration of Allocetra, at which time they were all COVID-19 PCR negative.
Based on the positive results, plus positive safety and efficacy results of Allocetra in 10 sepsis patients in an earlier study, Enlivex said it shifted recruitment of additional patients from the investigator-initiated clinical trial into a larger Phase II clinical trial of COVID-19 patients in severe or critical condition “as soon as reasonably practicable,” subject to regulatory approval.
None of the patients reported severe adverse events relating to the administration of Allocetra. The first patient was dosed in August. The trial, which began in May, was designed to assess Allocetra plus standard of care therapy in patients with COVID-19 associated lung dysfunction. The change in PaO2/FiO2 ratio number and severity of adverse events and serious adverse events will be the co-primary study endpoints, while safety, tolerability, cytokine profile, and efficacy parameters will also be evaluated. Lead investigator for the trial is Prof. Vernon van Heerden, Head of the Critical Care Medicine Unit at Hadassah Hospital in Israel.
The trial ran independently of Enlivex’s planned Phase IIb clinical trial of Allocetra for the treatment of organ failures associated with sepsis. The Phase IIb trial will be a controlled, randomized study that is expected to begin in the fourth quarter.
Enlivex reasons that Allocetra may potentially be beneficial for COVID-19 patients with moderate to severe symptoms, based on “compelling” preliminary results from a Phase Ib trial that showed safety and an indication of efficacy of Allocetra in patients with severe sepsis who were admitted to the ICU.
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: