We are Developing a Pipeline of Secretome Products
We are developing multiple, novel secretomes to address the spectrum of diseases that are driven by the most common pathological processes – inflammation, mitochondrial dysfunction, fibrosis, and apoptosis..
Our secretome products are collected from the media in which we grow our nMSCs. We filter and then concentrate this media several-fold to produce a cell-free and highly potent form of the solution that the human body uses to heal itself.
Cells grown in different conditions produce different secretomes, enabling Secretome Therapeutics to produce a pipeline of novel, patented secretomes that have the potential to address the many diseases that are driven by pathological inflammation, fibrosis, and apoptosis.
STM-21 For the Prevention of Cisplatin-Induced Acute Kidney Injury (C-AKI)
We are initially developing STM-21 for the prevention of the serious toxicities that arise from cancer treatments, beginning with cisplatin-induced acute kidney injury (C-AKI). We expect to begin a Phase 1 clinical study for this indication in the first quarter of 2023.
Cisplatin treatment remains part a key component of 1st, 2nd, and 3rd-line chemotherapy in numerous other cancer types, but the regimen is often associated with kidney toxicity. Approximately 30% of cancer patients treated with cisplatin develop C-AKI1, and occurrence of AKI can lead to prolonged hospitalization, result in chronic kidney disease or kidney failure, and reduce survival. In hospitalized patients with cancer, AKI is associated with a 4.7-fold increase in the risk of death and a substantial increase in cost-of-care2.
In addition to increased morbidity and mortality, C-AKI significantly complicates the care of cancer patients. Impairments in kidney function lead to unpredictable fluctuations in the concentrations of medications patients are taking. Patients with kidney dysfunction are also excluded from most clinical studies which are an important alternative particularly for patients with the greatest need, those with relapsed or refractory tumors.
With no treatments approved to treat or prevent C-AKI, the only option is to discontinue or reduce cisplatin treatment, which risks progression of the underlying cancer. A prophylactic intervention for C-AKI could improve survival, reduce costs, and ease the management of these patients.
STM-01 For the Treatment of Dilated Cardiomyopathy
STM-01 is a cellular therapy comprised of the neonatal MSCs that produce our secretomes.
STM-01 has proven superior to all other stem cell therapeutics in restoring cardiac function in animals following an induced heart attack, reflecting an ability to halt or reverse the inflammation, apoptosis, and other processes that compromise heart function in this model. The results below compare STM-01 to vehicle (IMDM), cardiosphere-derived cells (CDC), adult MSCs, adult cardiac progenitor cells (BM-MSC), and umbilical cord blood derived MSCs (UCBC).
In multiple animal models, STM-01 has significantly reduced markers of inflammation and fibrosis, and produced functional improvement on validated endpoints of disease. The U.S. FDA has cleared our Investigational New Drug application to study STM-01 in patients progressing towards heart failure.
We are initially developing STM-01 for the treatment of dilated cardiomyopathy (DCM), a chronic cardiac disease that effects roughly 1.2 million Americans. In DCM, the left ventricle dilates and loses contractile strength, leading to a reduced ejection fraction, i.e. the ability to pump sufficient blood supply to the body. Despite the availability of several effective medications, many patients progress to heart failure and will die prematurely.
In a swine model of myocardial infarction, treatment with STM-01 reduced infarct size and improved ejection fraction.
Collectively, our preclinical results indicate that STM-01 may improve ejection fraction and slow progression to heart failure in patients with DCM and other progressive forms of heart failure.