Angiocrine Bioscience Announces it has been awarded a $15M Grant from the California Institute for Regenerative Medicine for AB-205 Phase 3 Clinical Trial

Positively impact patients' lives through the reparative powers of E-CEL^® Therapies

SAN DIEGO, Dec. 19, 2022 /PRNewswire/ -- Angiocrine Bioscience, Inc., a clinical-stage biopharmaceutical company today announced that the California Institute for Regeneration Medicine (CIRM) has approved investing $15M in the 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). AB-205 is an intravenous investigational engineered cell therapy product being developed for multiple indications.

Lymphoma is the most common blood cancer and one of the most common cancers in the United States, accounting for about 4% of all cancers according to the American Cancer Society and the 6^th most commonly diagnosed cancer among men and women in California.  It is estimated that there will be 89,010 new cases of lymphoma and 21,170 lymphoma related deaths in the US in 2022 alone.  In California, it is estimated that there will be over 9,250 new cases of lymphoma with over 2,100 deaths.

Efficacious cancer therapies for lymphoma employ a highly cytotoxic combination of chemical agents to achieve durable remission.  However, this same mechanism frequently causes severe unintended damage to healthy tissue and organs.  The cytotoxic effects related to high-dose chemotherapy (HDT) are pervasive, affecting all patients, with no known association with the patient's race, ethnicity, sex or gender. These toxicities are even more prevalent and more severe in patients 40 and older, who represent >90% of patients undergoing HDT-AHCT.  Dr. Maria T. Millan, President and CEO of CIRM, a former pediatric transplant surgeon states "that there is a high unmet medical need to both improve quality of life and reduce the risks of severe toxicities related to high-dose cancer therapy in this population".

"Angiocrine Bioscience is honored to be awarded this grant from CIRM to support our AB-205 Phase 3 trial," commented Paul Finnegan, MD, Angiocrine CEO.  "CIRM has been an instrumental partner in our development of AB-205, a novel therapeutic that acts on the patients' endogenous stem cell niches.  The grant award will considerably aid in our effort to bring forth a solution to the unmet need of transplant-related complications."  The US Food and Drug Administration has conferred special regulatory status to AB-205 via the Regenerative Medicine Advanced Therapy and Orphan Drug designations for the indication related to the Phase 3 trial.

AB-205 is an experimental engineered cell therapy consisting of allogeneic E4ORF1⁺ human umbilical vein endothelial cells (E-CEL^® cells).  AB-205 is an Advanced Reparative Medicine product being developed by Angiocrine and is currently being studied in a single, pivotal Phase 3 registration trial.  This late-stage trial is designed to evaluate the efficacy and safety of AB-205 in the treatment of systemic multi-organ stem cell niche damage from high dose chemotherapy and prevent the emergence of severe transplant-related complications.  More information about the E-CELERATE trial and participating sites may be found at the National Institute of Health's ClinicalTrials.gov website - NCT05181540.

At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission.

To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today's most promising stem cell technologies.

With $5.5 billion in funding and more than 150 active stem cell programs in our portfolio, CIRM is one of the world's largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality.

For more information go to www.cirm.ca.gov.

Angiocrine Bioscience, Inc. is a clinical-stage biopharmaceutical company developing Advanced Reparative Medicines consisting of engineered human endothelial cells (E-CEL cells).  Angiocrine utilizes its proprietary E-CEL Platform to create multiple versions of E-CEL cells to repair damaged tissues and organs and to treat serious medical conditions.

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SOURCE Angiocrine Bioscience, Inc.