AB-205 / Angiocrine - LARVOL DELTA

ECEL UVEC Cell Therapy for the Treatment of Cryptoglandular PeriAnal Fistula (ASCRS 2025) - "Our recent ASCRS membership survey (n=223) demonstrated that the natural healing rate of peri-anal fistulas was estimated to be 3-5% (median), and a healing rate of 40-50% would be the criteria for routine adoption by colorectal surgeons. A multi-center, randomized Phase 2 study is warranted for further investigation of this novel approach to treating intractable peri-anal fistulas."

Late-breaking abstract • Anesthesia • Gastrointestinal Disorder

E-CELERATE: A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation (clinicaltrials.gov) - P3 | N=130 | Terminated | Sponsor: Angiocrine Bioscience | Trial completion date: Jan 2024 ➔ Jan 2025

Trial completion date • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

E-CEL UVEC Cells As an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults (clinicaltrials.gov) - P1 | N=20 | Enrolling by invitation | Sponsor: Hospital for Special Surgery, New York | Active, not recruiting ➔ Enrolling by invitation | Trial completion date: Oct 2024 ➔ Oct 2025 | Trial primary completion date: Oct 2024 ➔ Oct 2025

Enrollment open • Trial completion date • Trial primary completion date • Muscular Atrophy • Orthopedics

E-CEL UVEC Treatment for Anal Fissures (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Weill Medical College of Cornell University | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Disorder

E-CEL UVEC Treatment for Anal Fissures (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Weill Medical College of Cornell University

New P1 trial • Gastrointestinal Disorder

E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas (clinicaltrials.gov) - P1 | N=33 | Recruiting | Sponsor: Weill Medical College of Cornell University | Phase classification: P1b ➔ P1 | N=12 ➔ 33 | Trial completion date: Dec 2031 ➔ Jun 2032 | Trial primary completion date: Dec 2024 ➔ Sep 2025

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Gastrointestinal Disorder

E-CELERATE: A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation (clinicaltrials.gov) - P3 | N=130 | Terminated | Sponsor: Angiocrine Bioscience | Trial completion date: Dec 2025 ➔ Jan 2024 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2025 ➔ Dec 2023; Interim analysis showed lack of efficacy

Trial completion date • Trial primary completion date • Trial termination • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Hospital for Special Surgery, New York

Trial completion date • Trial primary completion date • Muscular Atrophy • Orthopedics

E-CELERATE: A Phase 3 Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation (clinicaltrials.gov) - P3; N=148; Not yet recruiting; Sponsor: Angiocrine Bioscience

Clinical • New P3 trial • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

E-CELERATE: A Phase 3 Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation (clinicaltrials.gov) - P3 | N=148 | Recruiting | Sponsor: Angiocrine Bioscience | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jan 2022 ➔ Jan 2023

Enrollment open • Trial primary completion date • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

E-CELERATE: A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation (clinicaltrials.gov) - P3 | N=148 | Recruiting | Sponsor: Angiocrine Bioscience | Trial completion date: Jan 2023 ➔ Dec 2025 | Trial primary completion date: Jan 2023 ➔ Jun 2025

Trial completion date • Trial primary completion date • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Hospital for Special Surgery, New York | Trial completion date: Mar 2023 ➔ Oct 2023 | Trial primary completion date: Jan 2023 ➔ Oct 2023

Trial completion date • Trial primary completion date • Muscular Atrophy • Orthopedics

A Phase 3 Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of AB-205 Plus Standard of Care (SOC) Versus Placebo Plus SOC in Adults with Lymphoma Undergoing High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (E‑CELERATE; NCT05181540): Trial in Progress (TCT-ASTCT-CIBMTR 2023) - P1, P3 | "Secondary endpoints include the duration of oral/GI SRRT; patient-reported symptom burden; duration of febrile neutropenia; time to engraftment. Approximately 140 adult patients will be enrolled across 30 sites in the U.S. Active recruitment and enrollment are on-going [NTC05181540]."

Clinical • P3 data • CNS Lymphoma • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Mucositis • Neutropenia • Oncology • Stomatitis • Transplantation

[VIRTUAL] Results of a Phase 1 Open Label Dose Escalation Trial of AB-205 (Allogeneic Engineered Endothelial Cell Therapy) in Adults with Lymphoma Undergoing High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT) (ASH 2020) - "AB-205 appears to be safe and potentially effective in subjects undergoing HDT-AHCT for lymphoma. Compared to published rates of 24-41% for G ≥3 OM (Singer 2019; Colita 2109) and 86% for FN (Caimi 2105) in subjects with systemic lymphoma, we observed 0% SRRT and 31% FN with the highest dose of AB-205 tested. AB-205 has significant potential to address a serious unmet medical need in patients undergoing HDT-AHCT and will be assessed in a forthcoming pivotal, double-blinded, placebo-controlled, randomized clinical trial for potential registration."

Clinical • P1 data • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Lymphoma • Mucositis • Nephrology • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Stomatitis • Thrombocytopenia • Transplantation • CD31 • CD34

A Phase 3 Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of AB-205 Plus Standard of Care (SOC) Versus Placebo Plus Standard of Care in Adults with Lymphoma Undergoing High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (E‑CELERATE) (NCT05181540) - Trials in Progress (ASH 2022) - P1, P3 | "Key inclusion criteria: Age ≥ 40; diagnosis of Hodgkin or non-Hodgkin lymphoma who are candidates for HDT-AHCT with one of the following myeloablative conditioning regimens: carmustine, etoposide, cytarabine, melphalan (BEAM); bendamustine, etoposide, cytarabine, melphalan (BeEAM); achieved complete response (CR) or partial response (PR) prior to planned HDT; ECOG ≤ 2; serum bilirubin ≤ 2 mg/dL; AST, ALT, and alkaline phosphatase < 3 × ULN. Daily assessments of oral/GI SRRT will occur from start of HDT to Day +21 post AHCT (Figure 1). Current status: Active recruitment and enrollment ongoing [NCT05181540]."

Clinical • P3 data • CNS Lymphoma • Febrile Neutropenia • Gastrointestinal Disorder • Hematological Malignancies • Hodgkin Lymphoma • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Mucositis • Neutropenia • Non-Hodgkin’s Lymphoma • Stomatitis • Transplantation

Angiocrine Bioscience Announces Poster Presentation of AB-205 Trial Data during the Annual Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR (PRNewswire) - "Angiocrine Bioscience...announced that it has been selected by the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) for a poster presentation on its Phase 3 registration study AB-205-301 (E- CELERATE), a multi-center, randomized, double-blind, placebo-controlled study of AB-205 in adults with lymphoma undergoing high-dose chemotherapy (HDT) and autologous hematopoietic cell transplantation (AHCT)."

P3 data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas (clinicaltrials.gov) - P1b | N=12 | Recruiting | Sponsor: Weill Medical College of Cornell University | Trial primary completion date: Dec 2022 ➔ Dec 2024

Trial primary completion date • Gastrointestinal Disorder

Angiocrine Bioscience Announces Poster Presentation of AB-205 Trial during the 64th Annual Meeting of the American Society of Hematology (ASH) (PRNewswire) - "Angiocrine Bioscience, Inc...today announced that it has been selected by the American Society of Hematology (ASH) for a poster presentation on its Phase 3 registration study AB-205-301 (E-CELERATE), a multi-center, randomized, double-blind, placebo-controlled study of AB-205 in adults with lymphoma undergoing high-dose chemotherapy (HDT) and autologous hematopoietic cell transplantation (AHCT)....'We look forward to Dr. Michael Scordo's presentation on the trial design of our AB-205 Phase 3 multi-center study (E-CELERATE).'"

Clinical protocol • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AB-205 (E-CEL®) Cell Therapy in Older Subjects with Lymphoma Undergoing High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT) (ASH 2021) - "AB-205 appears to be safe and effective, particularly in subjects ≥ 40 yo that are known to have increased rates and severity of regimen-related toxicities. Beneficial effects included elimination of severe oral/GI SRRT with a dose response for all-grade oral/GI RRT and in the incidence and duration of febrile neutropenia. In addition, neutrophil and particularly platelet recoveries were timely."

Clinical • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Mucositis • Neutropenia • Oncology • Stomatitis • Transplantation

E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Hospital for Special Surgery, New York | Recruiting ➔ Active, not recruiting | N=15 ➔ 20 | Trial completion date: Jul 2023 ➔ Mar 2023

Enrollment change • Enrollment closed • Trial completion date • Muscular Atrophy • Orthopedics

E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas (clinicaltrials.gov) - P1b | N=12 | Recruiting | Sponsor: Weill Medical College of Cornell University | Trial completion date: Dec 2022 ➔ Dec 2031 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • Gastrointestinal Disorder

E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Hospital for Special Surgery, New York | Trial completion date: Jul 2022 ➔ Jul 2023 | Trial primary completion date: Feb 2022 ➔ Feb 2023

Trial completion date • Trial primary completion date • Muscular Atrophy • Orthopedics

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 (PRNewswire) - "Angiocrine Bioscience...today announced that the first patient has been dosed in its Phase 3 registration study AB-205-301 (E-CELERATE), a multi-center, randomized, double-blind, placebo-controlled study of AB-205 in adults with lymphoma undergoing high-dose chemotherapy (HDT) and autologous hematopoietic cell transplantation (AHCT)."

Trial status • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

HDT-AHCT: Trial of AB-205 in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation (clinicaltrials.gov) - P1; N=42; Completed; Sponsor: Angiocrine Bioscience; Active, not recruiting ➔ Completed; Trial completion date: Mar 2022 ➔ Nov 2021

Clinical • Trial completion • Trial completion date • Bone Marrow Transplantation • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

[VIRTUAL] Results of an Open Label Dose Escalation Trial of AB-205 (E-CEL® cells) in Adults with Lymphoma Undergoing High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT). (TCT-ASTCT-CIBMTR 2021) - "Highest dose AB-205 eliminated G ≥ 3 oral/GI SRRT in patients with systemic lymphoma undergoing HDT-AHCT, along with dose-dependent reductions in all-grade oral/GI toxicities.. These results compare favorably to the event rate of the historical control cohort as well as reported in literature (Singer 2019; Colita 2019; Perales MA, BBMT 2017). AB-205 will be assessed in a forthcoming pivotal randomized clinical trial for potential registration."

Clinical • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Lymphoma • Mucositis • Neutropenia • Oncology • Transplantation