BioCardia Follows up CardiAMP With CardiALLO Clearance for Heart Failure

The FDA has cleared BioCardia’ investigational new drug application (IND) to initiate a phase 1/2 trial of its CardiALLO neurokinin-1 receptor positive (NK1R+) allogeneic human mesenchymal stem cell (MSC) therapy for the treatment of patients with ischemic heart failure with reduced ejection fraction (ischemic HFrEF).¹

"We intend to provide a complete cell therapy solution for ischemic heart failure patients that encompasses both autologous and ‘off the shelf’ allogeneic cell therapies. Our therapies are synergistic in serving the full patient spectrum, as only about two-thirds of patients are expected to be responders to our autologous therapy," Peter Altman, PhD, president and chief executive officer, BioCardia, said in a statement.1 "We expect to see efficiencies in the upcoming CardiALLO trial for several reasons: we can leverage screening activity from the currently enrolling CardiAMP trial to direct ineligible patients into the CardiALLO trial; our allogeneic cell therapy is already manufactured and ready for use; and it will be delivered with our proprietary delivery system demonstrated in literature to be the safest and most efficient delivery method available today."

The trial will soon enroll patients with New York Heart Association Class 2 and 3 ischemic HFrEF who are ineligible for BioCardia’s autologous CardiAMP cell therapy and may benefit instead from an allogeneic therapy. The CardiALLO cells come younger, extensively prescreened donors and are expanded to yield multiple doses from a single donor. The therapy will be delivered using BioCardia’s Helix biotherapeutic delivery system.

"We are excited to study the role our allogeneic NK1R+ MSC therapy may play in helping hearts recover from injury as its mechanism of action involves Substance P. This binds to NK1R+ and has been shown to be an important factor in the development of inflammation, which plays a central role in both heart failure and regenerative processes following myocardial injury,” Altman added.¹

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CardiAMP is being evaluated in a phase 3 trial (NCT02438306), from which positive data were announced in October 2022 that showed improvements in 6-minute walk distance test (6MWT) scores at 6 months (6% improvement; 28.5 m; P = .01) and 24 months (8% improvement; 31.0 m; P > .05) compared to baseline.² Two-year survival was 100% and there were no serious adverse events observed.

“We have had our most recent safety data monitoring committee their recommendations were that the study should continue as designed and that no change or actions were required. They did ask that we provide an updated statistical analysis plan that would include an adaptive design,” co-principal investigator Carl Pepine, MD, professor, cardiovascular medicine, University of Florida, said in a conference call.³ “The remarkable thing is that in patients with very serious heart disease and very impaired cardiac function, there were no deaths in the first 1 years of follow up and there were only 2 hospitalizations out of the 10 patients in the 2 years."

REFERENCES

1. BioCardia announces FDA approval of IND application for allogeneic NK1R+ human mesenchymal stem cells for ischemic heart failure. News release. BioCardia. December 6, 2022. https://finance.yahoo.com/news/biocardia-announces-fda-approval-ind-120000674.html
2. BioCardia presents positive CardiAMP cell therapy heart failure trial two-year data at HFSA Annual Meeting. News release. BioCardia. October 3, 2022. https://finance.yahoo.com/news/biocardia-presents-positive-cardiamp-cell-110000572.html
3. CardiAMP Cell Therapy Trial for Heart Failure: Clinical Leadership and Management Call. Webcast. BioCardia. October 5, 2022. https://event.choruscall.com/mediaframe/webcast.html?webcastid=9NhAJ6lm