BioCardia, a clinical-stage regenerative medicine company headquartered in San Carlos, CA, develops novel therapies to improve the lives of patients suffering from cardiovascular diseases with large unmet medical needs. BioCardia is exploring NK1R+ allogenic mesenchymal stem cells in COVID-19 induced Acute Respiratory Distress and is in the throes of its CardiAMP Cell Therapy Heart Failure Trial. To learn more about BioCardia’s on-going work, I caught up with CEO Peter Altman. Here’s what he had to say.
How is BioCardia exploring NK1R+ allogenic mesenchymal stem cells in COVID-19 induced Acute Respiratory Distress?
Altman: ARDS is a type of respiratory failure characterized by the rapid onset of widespread inflammation in the lungs and is a factor in the leading cause of death for COVID-19 patients. Our allogenic mesenchymal stem cell therapy has potential to address inflammation as these cells are viewed as having broad anti-inflammatory properties. Our NK1R+ subset of these cells also is selected for the receptor, which binds to substance P, an important neuropeptide associated with inflammation throughout the body and a primary mediator of inflammation in the airways.
We believe we are the only company utilizing NK1R+ cells whose anti-inflammatory effects may be enhanced by substance P, and because of that, we feel our approach may have more potential than others being explored for ARDS. We are in the early stages of developing an IND for submission to the FDA for this allogenic NK1R+ cell therapy delivered via IV for ARDS caused by COVID-19. This cell therapy is also being advanced for the treatment of heart failure under the name of CardiALLO. We expect to submit our responses on the heart failure IND to the FDA shortly and may receive IND acceptance by the end of June. A recent animal study completed for CardiALLO showed that cardiac ejection fraction, fractional shortening and cardiac outflow as measured by echocardiography were statistically significantly improved in treated animals. We are very excited about the potential of these allogenic NK1R+ MSC to counter inflammation in the heart and lungs, and in the positive impact that could have for patients suffering from COVID-19 and heart failure.
What is CardiAMP Cell Therapy Heart Failure Trial? How will it impact patients?
Altman: The CardiAMP Heart Failure Trial is studying CardiAMP cell therapy, an autologous, minimally processed bone marrow-derived mononuclear cell formulation designed to stimulate the body’s natural healing response in treating heart failure which develops after a heart attack. The cells have been shown to release important cytokines to promote cell-to-cell signaling and have demonstrated salutatory benefits in chronic HF. The trial is evaluating the cell therapy’s ability to improve patient survival, exercise capacity and quality of life, as well as its safety. The CardiAMP Heart Failure Trial is the first multicenter clinical trial of an autologous cell therapy to prospectively select patients based on the phenotypes of the source cells to maximize the probability of patient benefit. The therapy also uses our proprietary delivery system — the Helix Biotherapeutic Delivery System — that published literature has shown to present the lowest risk to patients for biotherapeutic delivery compared to other delivery methods evaluated, and is three to six times more efficient at delivering cells to the heart muscle than other methods.
Twelve-month results for the initial 10-patient roll-in cohort for the CardiAMP Heart Failure Trial have shown average improvements that are greater than those in the randomized, placebo-controlled Phase II trial which proceeded this study. Eight of the 10 patients experienced clinically meaningful improvement in exercise capacity, seven patients enjoyed clinically meaningful improvement in quality of life, statistically significant improvement in a measure of heart function (wall motion score) was seen, and all patients were alive and out of the hospital. We are encouraged that these positive results may translate into improvements for the broader treated patient population in the study.
The ongoing multi-center, double-blinded, randomized (3:2), controlled pivotal CardiAMP Heart Failure Trial is expected to enroll 260 patients at up to 40 centers nationwide. The national co-principal investigators are Amish Raval, MD, of the University of Wisconsin and Carl Pepine, MD, of the University of Florida, Gainesville. In March 2020, the Data Safety Monitoring Board indicated there were no safety concerns with the CardiAMP study results and recommended that the trial continue, as planned. To date, 74 patients have been enrolled at 25 active centers. The trial is sponsored, in part, by the Maryland Stem Cell Research Foundation and has reimbursement from the Centers for Medicare and Medicaid Services (CMS).