First Patient Dosed With Angiocrine’s Reparative Cell Therapy for Lymphoma Treatment Regimens

The first patient with lymphoma undergoing high-dose chemotherapy (HDT) and autologous hematopoietic cell transplantation (AHCT) has been dosed in the phase 3 AB-205-301 (E-CELERATE) registration study (NCT05181540) of AB-205.¹

AB-205 is an allogeneic human endothelial cell (CEL) therapy developed using Angiocrine’s engineered CEL (E-CEL) cell technology. It is being developed for multiple indications. The FDA has previously granted regenerative medicine advanced therapy and orphan drug designations to AB-205.

"We expect 2022 to be a transformational year at Angiocrine, and we are excited to initiate this pivotal Phase 3 study," Paul Finnegan, MD, chief executive officer, Angiocrine, said in a statement.¹ "We look forward to continuing to work with many of the leading cancer centers in the United States as we advance into the final clinical stages of this exciting program."

The E-CELERATE study is evaluating the therapy’s efficacy and safety in treating organ vascular stem cell niches damaged by off-target cytotoxicity of HDT as well as its ability in preventing the progression of severe multi-organ complications. The study is currently recruiting for a target enrollment of 148 participants.

The study will primarily assess oral and gastrointestinal severe regimen-related toxicities (SRRT). Secondary outcomes will assess the duration of these, symptom burden per MD Anderson Symptom Inventory, febrile neutropenia (FN), and time to neutrophil engraftment.

Angiocrine previously presented positive data from the phase 1 study (NCT03925935) of AB-205 at the virtual 47th Annual Meeting of the European Society for Blood and Marrow Transplantation, March 14-17, 2021.²

These data demonstrated a dose-dependent reduction of oral/GI SRRT (Figure) and all-grade oral/GI toxicities, with no oral/GI SRRTs observed with the highest dose, compared with a 60% rate of at least grade 3 SRRTs in the control cohort. Investigators also observed a trend of dose-dependent decreases in FN. Most participants (71%) had accelerated platelet engraftment within 1 day after neutrophil engraftment compared with 16% in the control cohort. No maximum tolerated dose was reached and only mild –tomoderate treatment-related adverse events occurred.

“Highest dose AB-205 eliminated oral/GI SRRT compared to 50-60% event rate seen in contemporary control cohort and previously published reports... Severe infection rate was low which may reflect the accelerated repair of oral/GI mucosal lining,” first author Carolyn Mulroney, MD, associate professor of medicine, University of California – San Diego Health, and colleagues concluded.

REFERENCES

1. Angiocrine Bioscience announces first patient dosed in pivotal phase 3 clinical trial of AB-205 in patients with lymphoma undergoing autologous hematopoietic cell transplantation (E-CELERATE) and completion of series B financing. News release. ANgiocrine Biosciences. March 29, 2022. https://www.prnewswire.com/news-releases/angiocrine-bioscience-announces-first-patient-dosed-in-pivotal-phase-3-clinical-trial-of-ab-205-in-patients-with-lymphoma-undergoing-autologous-hematopoietic-cell-transplantation-e-celerate-and-completion-of-series-b-financing-301511823.html
2. Mulroney C, Scordo M, Abedi M, et al. Open label dose escalation trial of AB-205 (E-CEL® cells) in adults with systemic lymphoma undergoing high-dose therapy and autologous hematopoietic cell transplantation (HDT-AHCT). Presented at 27th Annual EBMT Meeting, March 14-17. Abstract # OSS-5