Candidate: Cell therapy targeting COVID-19
Type: Mesenchymal stem cell (MSC) based treatments
Status: Cynata said May 8 that it received approval from an ethics committee in Australia to begin a clinical trial assessing early efficacy of its Cymerus™ mesenchymal stem cells (MSCs) in adults admitted to intensive care with COVID-19. The MEND (MEseNchymal coviD-19) Trial will be an open-label, randomised controlled clinical trial to investigate early efficacy of Cymerus MSCs in 24 adult patients admitted to intensive care with COVID-19 and respiratory distress.
In the MEND trial, 12 patients will be randomized to receive Cymerus MSC infusions, in addition to standard of care, while the other 12 patients will be randomized to the control group receiving standard of care. The primary efficacy endpoint will be improvement in PaO2/FiO2 ratio (a measure of hypoxemia, a low level of oxygen in the blood caused by compromised lung function) by Day 7. Safety and tolerability up to Day 28 will also be a primary endpoint.
Cynata added that it was evaluating clinical development opportunities to expand the MEND trial beyond Australia. Cynata cited promising preclinical trial results shown by its Cymerus MSCs in several conditions that can arise from a severe COVID-19 infection, notably in ARDS, as well as in other inflammatory conditions including sepsis and cytokine release syndrome.
In March, Cynata tweeted that it was “engaging in explorative talks with international pharma companies and other collaborators” about potential applications of Cymerus MSCs in treating severe complications arising in patients infected with COVID-19. Cymerus is the company’s patented process of generating cell-based products from intermediate cells, known as mesenchymoangioblasts (MCAs), which in turn are derived from induced pluripotent stem cells (iPSCs).
Cynata has said it has achieved positive preclinical data for MSC therapies in sepsis and lung disease, and is collaborating with the Critical Care Research Group at Prince Charles Hospital in Brisbane, Australia, to investigate in an animal model the utility of Cymerus MSCs as a treatment for ARDS.
Cynata says the potential of MSCs in treating the consequences of COVID-19 is underpinned by a study published March 13 in Aging and Disease, concluding that the intravenous transplantation of MSCs was “safe and effective for treatment” in seven enrolled patients with COVID-19 pneumonia in Beijing. Pulmonary function and symptoms of all seven patients significantly improved in two days after MSC transplantation, while two patients with common pneumonia and one severe pneumonia patient recovered and were discharged 10 days after treatment.
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: