Feb 13, 2023
Angiocrine Bioscience Announces Poster Presentation of AB-205 Trial Data during the Annual Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR
San Diego, CA, February 13, 2023 /PRNewswire/ Angiocrine Bioscience, Inc., a clinical-stage biopharmaceutical company, today 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). AB-205 is an intravenous investigational engineered cell therapy product being developed for multiple indications.
“Our investigators and Angiocrine are honored to be selected by ASTCT & CIBMTR to present at its annual meeting this February,” commented Paul Finnegan, MD, Angiocrine CEO. “We look forward to Dr. Michael Scordo’s presentation on the trial design of our AB-205 Phase 3 multi-center study (E-CELERATE).” E-CELERATE has been designed to evaluate the efficacy and safety of AB-205 as a treatment for damaged organ stem cell vascular niches caused by off-target cytotoxicity of HDT and prevent the progression of severe multi-organ complications, which can be life threatening and prolong hospitalization. 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 this indication. Additionally, the California Institute for Regenerative Medicine (CIRM) has approved investing $15M in this Phase 3 registration study.
Tandem Meetings Info
Poster Session: Acute Regimen-Related Toxicity and Supportive Care
Session Date: Thursday, February 16, 2023
Session Time: 5:45 PM – 6:45 PM EST
Poster Number: 184
Poster Title: 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
About AB-205
AB-205 is an experimental engineered cell therapy consisting of allogeneic E4ORF1+ human umbilical vein endothelial cells (E-CEL® cells). AB-205 is currently being studied in a single, pivotal Phase 3 registration trial, designed to evaluate the efficacy and safety of AB-205 in the treatment of severe multi-organ complications related to systemic, diffuse injury to the stem cell vascular niches of multiple organs sustained during high-dose chemotherapy. More information about the E-CELERATE trial and participating sites may be found at the National Institute of Health’s ClinicalTrials.gov website – NCT05181540.
About Severe Toxicities and Complications during High-Dose Chemotherapy (HDT) and Autologous Hematopoietic Cell Transplant (AHCT)
HDT followed by AHCT is a curative treatment option for eligible patients with aggressive systemic lymphoma. Although highly effective in eradicating aggressive cancer cells, HDT also causes collateral damage to healthy tissue. The initial damage can quickly progress to serious and expensive complications despite state-of-the-art prophylactic measures. Most frequent complications involve the gastrointestinal and immune systems (low blood counts, infections); vital organ involvement can be life-threatening and prolong hospital stay.
About the California Institute for Regenerative Medicine (CIRM)
CIRM was 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, CIRM’s 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 its 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.
About Angiocrine Bioscience, Inc.
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.
For additional information, please contact:
Investor Relations
(877) 784-8496
IR@angiocrinebio.com
Dec 19, 2022
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, CA, December 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 6th 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.
About AB-205
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.
About CIRM
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.
About Angiocrine Bioscience, Inc.
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.
For additional information, please contact:
Investor Relations
(877) 784-8496
IR@angiocrinebio.com
Dec 9, 2022
Angiocrine Bioscience Announces Poster Presentation of AB-205 Trial during the 64th Annual Meeting of the American Society of Hematology (ASH)
San Diego, CA, December 9, 2022 /PRNewswire/ Angiocrine Bioscience, Inc., a clinical-stage biopharmaceutical company 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). AB-205 is an intravenous investigational engineered cell therapy product being developed for multiple indications.
“Our investigators and Angiocrine are honored to be selected by ASH to present at its annual meeting this December,” commented Paul Finnegan, MD, Angiocrine CEO. “We look forward to Dr. Michael Scordo’s presentation on the trial design of our AB-205 Phase 3 multi-center study (E-CELERATE).” E-CELERATE has been designed to evaluate the efficacy and safety of AB-205 as a treatment for damaged organ vascular stem cell niches caused by off-target cytotoxicity of HDT and prevent the progression of severe multi-organ complications, which can be life threatening and prolong hospitalization. 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 this indication.
ASH Meeting Details
Program: Oral and Poster Abstracts
Session Name: 731. Autologous Transplantation: Clinical and Epidemiological Program: Poster III
Session Date: Monday, December 12, 2022
Session Time: 6:00 PM – 8:00 PM ET
Location: Ernest N. Morial Convention Center, Hall D
Poster Number: 4743
Title: 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
About AB-205
AB-205 is an experimental engineered cell therapy consisting of allogeneic E4ORF1+ human umbilical vein endothelial cells (E-CEL® cells). AB-205 is currently being studied in a single, pivotal Phase 3 registration trial, designed to evaluate the efficacy and safety of AB-205 in the treatment of severe multi-organ complications related to systemic, diffuse injury to the vascular stem cell niches of multiple organs sustained during high-dose chemotherapy. More information about the E-CELERATE trial and participating sites may be found at the National Institute of Health’s ClinicalTrials.gov website – NCT05181540.
About Severe Toxicities and Complications during High-Dose Chemotherapy (HDT) and Autologous Hematopoietic Cell Transplant (AHCT)
HDT followed by AHCT is a curative treatment option for eligible patients with aggressive systemic lymphoma. Although highly effective in eradicating aggressive cancer cells, HDT also causes collateral damage to healthy tissue. The initial damage can quickly progress to serious and expensive complications despite state-of-the-art prophylactic measures. Most frequent complications involve the gastrointestinal and immune systems (low blood counts, infections); vital organ involvement can be life-threatening and prolong hospital stay.
About Angiocrine Bioscience, Inc.
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.
For additional information, please contact:
Investor Relations
(877) 784-8496
IR@angiocrinebio.com
Mar 29, 2022
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
San Diego, CA, March 29, 2022 /PRNewswire/ Angiocrine Bioscience, Inc., a clinical-stage biopharmaceutical company, 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). AB-205 is an intravenous investigational engineered cell therapy product being developed for multiple indications.
E-CELERATE has been designed to evaluate the efficacy and safety of AB-205 as a treatment for damaged organ vascular stem cell niches caused by off-target cytotoxicity of HDT and prevent the progression of severe multi-organ complications, which can be life threatening and prolong hospitalization. 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 this indication.
More information about the E-CELERATE trial and participating sites may be found at the National Institute of Health’s ClinicalTrials.gov website – NCT05181540.
“We expect 2022 to be a transformational year at Angiocrine, and we are excited to initiate this pivotal Phase 3 study,” said Paul Finnegan, MD, Angiocrine’s CEO. “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.”
Series B Financing
Angiocrine Bioscience recently completed a Series B equity financing led by Cobro Ventures along with participation from Angiocrine’s existing stockholders. The newly raised capital will be used to accelerate Angiocrine’s clinical assets and expand its research pipeline. “We are enormously excited about the potential of Angiocrine’s E-CEL ® platform,” said Dennis Klinman, MD, PhD, Chief Scientific Officer at Cobro Ventures. “Angiocrine’s approach is truly innovative and has great potential to regenerate tissues that have been injured or damaged by diseases including degenerative, auto-immune, and ischemic diseases, in addition to high-intensity cancer treatments.”
About AB-205
AB-205 is an experimental, genetically engineered cell therapy consisting of allogeneic engineered human endothelial cells (E-CEL ® cells). AB-205 is being developed for multiple indications and is currently being studied in a single, pivotal Phase 3 registration trial, designed to evaluate the efficacy and safety of AB-205 in the treatment of severe multi-organ complications related to systemic, diffuse injury to the vascular stem cell niches of multiple organs sustained during high-dose chemotherapy.
About Severe Toxicities and Complications during High-Dose Chemotherapy (HDT) and Autologous Hematopoietic Cell Transplant (AHCT)
HDT followed by AHCT is considered a standard-of-care consolidative treatment to cure patients with aggressive systemic lymphoma who have failed 1 st -line chemotherapy and respond to chemotherapy induction. Although highly effective in eradicating aggressive cancer cells, HDT also causes collateral damage to healthy tissue, which can lead to severe toxicities and serious, costly complications. Complication rates and severity increase with age and, thus, many older patients are turned away from this potentially curative therapy due to concerns over complication risks.
About Angiocrine Bioscience, Inc.
Angiocrine Bioscience, Inc. is a clinical-stage biotechnology 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.
For additional information, please contact:
Investor Relations
(877) 784-8496
IR@angiocrinebio.com
Mar 12, 2021
Angiocrine Bioscience Announces Oral Presentation of AB-205 Data during the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation
San Diego, CA, March 12, 2021 /PRNewswire/ Angiocrine Bioscience Inc., a clinical-stage biopharmaceutical company today announced that they have been selected by the European Society for Blood and Marrow Transplantation (EBMT) for an oral presentation on AB-205-001, a Phase 1b/2 study to prevent progression to severe organ toxicities in lymphoma subjects undergoing curative high-dose consolidation therapy with autologous hematopoietic cell transplantation (HDT-AHCT).
“Our investigators and Angiocrine are honored to be selected by EBMT to present at its annual meeting this March,” commented Paul Finnegan, MD, Angiocrine CEO. “We look forward to Dr. Caroline Mulroney’s presentation of AB-205’s efficacy and safety results from our Phase 1b/2 study as well as preparing for the upcoming Phase 3 registration study for this indication.”
Presentation Name: 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)
Session Date: Sunday-Wednesday, March 14-16, 2021 (On-Demand Library)
Session Name: OS05 – Oral Session 5: Cellular Therapy, Gene Therapy and New Drugs II
Presentation Times:
Sunday – 09:10 AM Central European Time
Monday – 09:55 AM Central European Time
Tuesday – 09:55 AM Central European Time
Wednesday – 09:55 AM Central European Time
About Severe Regimen-Related Toxicities
High-dose therapy and autologous hematopoietic cell transplantation is considered a standard-of-care method to cure aggressive systemic lymphoma. High dose therapy effectively eradicates cancer cells but also damages healthy tissue, which can lead to severe toxicities. Severe toxicities can involve multiple organs (oral-alimentary tract, bone marrow, lung, kidney, heart liver and brain). Most affected is the lining of the oral-gastrointestinal (GI) tract. The oral GI tract continually renews its mucosal lining on a daily basis. Because of the collateral damage from high dose chemotherapy, the oral GI tract loses its ability to renew its lining, leading to inflammation (mucositis) and breakdown, causing nausea, vomiting and diarrhea that are refractory to available medications and require prolonged hospitalization. Severe oral GI toxicities can occur as frequently as 50% and cause profound misery to patients. The rates and severity increase with age and, thus, many older patients are turned away from the curative high dose therapy due to the risks of severe toxicities.
About AB-205
AB-205 represents a new and unique advanced cell-and-gene therapy product. AB-205 consists of allogeneic (off-the shelf) ‘universal’ E-CEL® (human engineered cord endothelial) cells. Intravenous AB-205 is given after chemotherapy/radiation (high-dose therapy) conditioning and on the same day as autologous (patient’s own) hematopoietic (blood stem) cell transplant. AB-205 was recently granted both the Regenerative Medicine Advanced Therapy (RMAT) Designation and Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA). Angiocrine is actively planning to advance AB-205 into a multi-center single registration Phase 3 trial based on the results of the Phase 1b/2 study.
About Angiocrine Bioscience, Inc.
Angiocrine Bioscience is a clinical-stage biotechnology company developing a novel and distinct approach to biologically repairing damaged and diseased tissues and organs affected by various diseases and serious conditions. Based on its E-CEL® Platform, Angiocrine is creating a pipeline of Advanced Reparative Medicines clinically applicable to multiple conditions with significant unmet medical need.
For additional information, please contact:
Angiocrine Bioscience, Inc.
John R. Jaskowiak
(877) 784-8496
IR@angiocrinebio.com
Feb 5, 2021
Angiocrine Bioscience Announces Oral Presentation of Intravenous AB-205 Data during the Annual Transplantation & Cellular Therapy Meetings of ASCT and CIBMTR
San Diego, CA, February 5, 2021 /PRNewswire/ Angiocrine Bioscience Inc., a clinical-stage biopharmaceutical company today announced that the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) has selected Angiocrine’s AB-205 Phase 1b/2 study results for an oral presentation.
Intravenous AB-205 is being developed to treat diffuse damage of vascular niches of multiple organs caused by off-target cytotoxicity from high-dose chemotherapy (HDT) in the course of conditioning patients undergoing autologous hematopoietic cell transplantation to effect a cure of aggressive lymphomas. Treating the damaged vascular niches enable prompt repair of multiple organs. In case of HDT, the most severely and frequently affected organ systems are oral-gastrointestinal and hematopoietic. By enabling multi-organ repair, AB-205 has the potential of substantially reducing the incidence of severe transplant-related complications that can be life-threatening and prolong hospitalization.
“Our investigators and Angiocrine are honored to be selected by ASTCT & CIBMTR to present at its annual meeting this February,” commented Paul Finnegan, MD, Angiocrine’s CEO. “We look forward to Dr. Lihua Budde’s presentation of AB-205’s efficacy and safety results from our Phase 1b/2 study as well as preparing for the upcoming Phase 3 registration study for this indication.”
Session Name: Oral Abstract – Session D – Acute Regimen-Related Toxicity and Supportive Care
Title of Abstract: Results of an Open Label Dose Escalation Trial of AB-205 (E-CELÒ cells) in Adults with Lymphoma Undergoing High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT)
Session Date: Monday, February 8, 2021
Session Time: 2:30 PM – 4:00 PM CST
Presentation Time: 3:00 PM CST
About Severe Toxicities and Complications during High-Dose Chemotherapy (HDT) and Autologous Hematopoietic Cell Transplant (AHCT)
HDT followed by AHCT is considered a standard-of-care consolidative treatment to cure patients with aggressive systemic lymphoma who have failed 1st-line chemotherapy and respond to chemotherapy induction. Although highly effective in eradicating aggressive cancer cells, HDT also causes collateral damage to healthy tissue, which can lead to severe toxicities and serious, costly complications. The most affected organ system is the lining of the oral-gastrointestinal (GI) tract. The oral GI tract renews its mucosal lining every 3 to 7 days. Because of the collateral damage from HDT, the oral GI tract loses its ability to renew its lining, leading to inflammation (mucositis) and breakdown. The patient suffers from debilitating nausea, vomiting and diarrhea, refractory to medications and prolonging hospitalization. Severe oral GI complications can occur as frequently as 50% and cause profound misery. The rates and severity increase with age and, thus, many older patients are turned away from this potentially curative therapy due to concerns over complication risks.
About AB-205
AB-205 represents a new and unique approach to repairing damaged tissues through advanced cell-and-gene therapy. AB-205 consists of allogeneic (off-the shelf) ‘universal’ E-CEL® (human engineered cord endothelial) cells. Intravenous AB-205 is given after completion of HDT and on the same day as AHCT. AB-205’s immediate action repairs damaged tissue and thereby prevents (reduces) the extent of breakdown of tissues, which is the root cause of severe toxicities experienced by patients. Reducing or preventing severe toxicities can lead to better quality of life and shorter stay in the hospital—i.e., savings to the healthcare system. AB-205 was recently granted both the Regenerative Medicine Advanced Therapy (RMAT) Designation and Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA). Angiocrine is currently advancing intravenous AB-205 into a multi-center single registration Phase 3 trial.
About Angiocrine Bioscience, Inc.
Angiocrine Bioscience is a clinical-stage biotechnology company developing a radically new way to biologically repair damaged and diseased tissues and organs. Based on its novel and proprietary E-CEL® platform, Angiocrine is developing multiple E-CEL therapies designed to repair damaged tissue from age-related degenerative disease of the musculoskeletal system; immune diseases that attack vessels and tissues; and ischemic diseases involving soft tissue, central nervous system and the heart.
For additional information, please contact:
Angiocrine Bioscience, Inc.
John R. Jaskowiak
(877) 784-8496
IR@angiocrinebio.com
Dec 3, 2020
Angiocrine Bioscience Announces Oral Presentation of AB-205 Data during the 62nd Annual Meeting of the American Society of Hematology (ASH)
San Diego, CA, December 3, 2020 /PRNewswire/ Angiocrine Bioscience Inc., a clinical-stage biopharmaceutical company today announced that they have been selected by the American Society of Hematology (ASH) for an oral presentation on the preliminary results of a Phase 1b/2 study of AB-205 to prevent or reduce severe organ toxicities associated with high-dose therapy followed by autologous hematopoietic cell transplantation used with curative intent in patients with aggressive systemic lymphoma.
“Our investigators and Angiocrine are honored to be selected by ASH to present at its annual meeting this December,” commented Paul Finnegan, MD, Angiocrine CEO. “We look forward to Dr. Michael Scordo’s presentation of AB-205’s efficacy and safety results from our Phase 1b/2 study as well as preparing for the upcoming Phase 3 registration study for this indication.”
Session Name: 723. Clinical Allogeneic and Autologous Transplantation: Late Complications and Approaches to Disease Recurrence I
Session Date: Saturday, December 5, 2020
Session Time: 7:30 AM – 9:00 AM ET
Presentation Time: 7:45 AM ET
About Severe Regimen-Related Toxicities
High-dose therapy and autologous hematopoietic cell transplantation is considered a standard-of-care method to cure aggressive systemic lymphoma. High dose therapy effectively eradicates cancer cells but also damages healthy tissue, which can lead to severe toxicities. Most affected is the lining of the oral-gastrointestinal (GI) tract. The oral GI tract renews its mucosal lining every 3 to 7 days. Because of the collateral damage from high dose chemotherapy, the oral GI tract loses its ability to renew its lining, leading to inflammation (mucositis) and breakdown, causing nausea, vomiting and diarrhea that are refractory to available medications and require prolonged hospitalization. Severe oral GI toxicities can occur as frequently as 50% and cause profound misery to patients. The rates and severity increase with age and, thus, many older patients are turned away from the curative high dose therapy due to the risks of severe toxicities.
About AB-205
AB-205 represents a new and unique approach to repairing damaged tissue through advanced cell-and-gene therapy. AB-205 consists of allogeneic (off-the shelf) ‘universal’ E-CEL® (human engineered cord endothelial) cells. Intravenous AB-205 is given after chemotherapy/radiation (high-dose therapy) conditioning and on the same day as autologous transplant. AB-205’s immediate action repairs damaged tissue and thereby prevents (reduces) the extent of breakdown of tissues, which is the root cause of severe toxicities experienced by patients. Reducing or preventing severe toxicities means better quality of life and shorter stay in the hospital—i.e., savings to the healthcare system. AB-205 was recently granted both the Regenerative Medicine Advanced Therapy (RMAT) Designation and Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA). Angiocrine is actively planning to advance AB-205 into a multi-center single registration Phase 3 trial based on the results of the Phase 1b/2 study.
About Angiocrine Bioscience, Inc.
Angiocrine Bioscience is a clinical-stage biotechnology company developing a radically new way to biologically repair damaged and diseased tissues and organs. Based on its novel and proprietary E-CEL® platform, Angiocrine is developing multiple E-CEL therapies designed to repair damaged tissue from age-related degenerative disease of the musculoskeletal system; immune diseases that attack vessels, and ischemic diseases involving soft tissue, central nervous system and the heart.
For additional information, please contact:
Angiocrine Bioscience, Inc.
John R. Jaskowiak
(877) 784-8496
IR@angiocrinebio.com
Nov 11, 2020
Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205 (Universal E-CEL® Cell Therapy) to Treat Organ Vascular Niche Injuries for the Prevention of Severe Toxicities in Lymphoma Patients undergoing Curative High-Dose Therapy with Autologous Stem Cell Transplantation
San Diego, CA, November 11, 2020 /PRNewswire/ Angiocrine Bioscience Inc., a clinical-stage biopharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) granted the Regenerative Medicine Advanced Therapy (RMAT) designation for AB-205, for “the treatment of organ vascular niche injuries to prevent or reduce severe regimen-related toxicities (SRRT) in patients with Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL) undergoing high-dose therapy (HDT) and autologous hematopoietic stem cell transplantation”. Based on its Phase 2 trial results, Angiocrine expects to initiate a single pivotal registration Phase 3 trial in 2021 involving leading cancer centers in North America and Europe.
“The RMAT designation speaks to the clinical meaningfulness and the promising efficacy data and safety profile of AB-205 based on our Phase 1b/2 study. This is an important step in accelerating the development of AB-205 towards its first market approval,” commented Paul Finnegan, MD, Angiocrine’s CEO. “We appreciate the thorough assessment provided by the FDA reviewers and the support from our partner, the California Institute for Regenerative Medicine.” Angiocrine was awarded a $6 million grant from CIRM in 2019 for the clinical development of AB-205.
About Regenerative Medicine Advanced Therapy (RMAT) Designation
Established under the 21st Century Cures Act, the RMAT designation was established to facilitate development and expedite review of cell therapies and regenerative medicines intended to treat serious or life-threatening diseases or conditions. Advantages include the benefits of the FDA’s Fast Track and Breakthrough Therapy Designation programs, such as early interactions with the FDA to discuss potential surrogate or intermediate endpoints to support accelerated approval.
About HDT-AHCT
High-dose therapy and autologous hematopoietic cell transplantation (HDT-AHCT) is considered a standard-of-care therapy for patients with aggressive systemic Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). Although efficacious and considered a potential cure, HDT-AHCT is associated with severe regimen-related toxicities (SRRT) that increase patient morbidity and risk for mortality, especially in the aging population. Effective prevention of SRRT may lead to more patients being eligible for a potential cure through HDT and stem cell transplantation.
About SRRT – Consequences of Diffuse Injury to the Organ Vascular Niches
The human body is capable of renewing, healing and restoring organs. For example, the human oral-GI tract renews its lining every 3 to 7 days. Both the organ renewal and healing processes are dependent on organ stem cell vascular niches made up of stem cells, endothelial cells (cells that line blood vessels) and supportive cells. When tissues are injured, the vascular niche endothelial cells direct the stem cells, via angiocrine factor expression, to repair and restore the damaged tissue. This restorative capacity is most active during childhood and youth but starts to diminish with increasing age. HDT provided to eradicate cancer cells also cause diffuse, collateral damage to vascular niches of multiple healthy organs. In particular, the organs with the highest cell turnover (ones with most active vascular niches) are severely affected. Specifically, the oral-GI tract, dependent on constant renewal of its mucosal lining, starts to break down upon vascular niche injury. The mucosal breakdown can cause severe nausea, vomiting and diarrhea. In addition, the bacteria in the gut may escape into the circulation, resulting in patients becoming ill with endotoxemia, bacteremia or potentially lethal sepsis. HDT-related vascular niche damage can also occur in other organs resulting in severe or life-threatening complications involving the lung, heart, kidney, or the liver. Collectively, these complications are known as severe regimen-related toxicities or SRRT. SRRT can occur as frequently as 50% in lymphoma HDT-AHCT patients, with increased rate and severity in older patients.
About AB‑205
AB-205 is a first-in-class engineered cell therapy consisting of proprietary ‘universal’ E-CEL (human engineered cord endothelial) cells. The AB-205 cells are intravenously administered after the completion of HDT on the same day as when the patient’s own (autologous) blood stem cells are infused. AB-205 acts promptly to repair injured vascular niches of organs damaged by HDT. By repairing the vascular niches, AB-205 restores the natural process of tissue renewal, vital for organs such as oral-GI tract and the bone marrow. Successful and prompt organ restoration can prevent or reduce SRRT, an outcome that is beneficial to quality of life and cost reductive to the healthcare system.
About CIRM
The California Institute for Regenerative Medicine (CIRM) was established in November, 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure provided $3 billion in funding for California universities and research institutions. With over 300 active stem cell programs in their portfolio, CIRM is the world’s largest institution dedicated to stem cell research. For more information, visit www.cirm.ca.gov.
About Angiocrine Bioscience Inc.
Angiocrine Bioscience is a clinical-stage biotechnology company developing a new and unique approach to treating serious medical conditions associated with the loss of the natural healing and regenerative capacity of the body. Based on its novel and proprietary E-CEL® platform, Angiocrine is developing multiple therapies to address unmet medical needs in hematologic, musculoskeletal, gastrointestinal, soft-tissue, and degenerative/aging-related diseases. A Phase 3 registration trial is being planned for the intravenous formulation of AB-205 for the prevention of severe complications in lymphoma patients undergoing curative HDT-AHCT. This AB-205 indication is covered by the Orphan Drug Designation recently granted by the US FDA. In addition, Angiocrine is conducting clinical trials of local AB-205 injections for the treatment of: (1) rotator cuff tear in conjunction with arthroscopic repair; and, (2) non-healing perianal fistulas in post-radiation cancer patients.
For additional information, please contact:
Angiocrine Bioscience, Inc.
John R. Jaskowiak
(877) 784-8496
IR@angiocrinebio.com
Sep 10, 2019
First Study Testing Cell Therapy for Rotator Cuff Surgery Launches at HSS
Scott A. Rodeo, MD, a sports medicine surgeon and clinician-scientist at Hospital for Special Surgery (HSS) has launched a clinical trial of an experimental engineered cell therapy that aims to promote better healing of rotator cuff tears after surgery.
The rotator cuff is a collection of muscles and tendons at the shoulder joint that allows it to move. Overuse from repetitive overhead activities like swimming, tennis, or pitching a baseball, or acute injuries, can cause tears in the muscles or tendons of the rotator cuff.
“Arthroscopic shoulder surgery for rotator cuff tears is effective for relieving pain, restoring function and improving quality of life, but up to 25% of patients show incomplete or failed healing on imaging,” says Dr. Rodeo. “The frequency of incomplete or failed healing is more pronounced in patients over the age of 60. That matters because more people today want to stay active as they age.”
Many tissues in the body, including muscles and tendons, harbor stem cells that have the ability to form new tissues. The new clinical trial will test whether injecting an experimental cell therapy into both the muscle and the tendon of an injured rotator cuff will stimulate stem cell activity and promote better repair.
The engineered cell therapy product is E-CEL UVEC®, produced by San Diego based Angiocrine Bioscience, Inc. The investigational product consists of endothelial cells derived from the walls of the blood vessels of human umbilical cords that have been genetically modified to maintain their stability and their regenerative properties. The US Food and Drug Administration has granted the cell therapy Investigational New Drug (IND) status.
In a previous basic science study led by Dr. Rodeo, the cell therapy showed accelerated healing and an increase in the strength of the tendon attachment at the repair site, with no observable side effects, compared to surgery alone.
In the new clinical trial, patients with full-thickness rotator cuff tears who undergo arthroscopic surgical repair will receive two injections of the cell therapy: one into the tendon and one into the adjacent muscle. The study is open-label, meaning that all volunteers will know that they received the cell therapy.
The primary objective of the trial is to evaluate the safety of the cell therapy over 12 months. Dr. Rodeo and his research team will use blood tests to check whether the experimental cells have migrated away from the rotator cuff repair site. The investigators will also evaluate patients’ symptoms as well as shoulder strength, motion and healing as measured by MRI, ultrasound and patients’ reports about their progress.
“Improving patients’ symptoms with standard rotator cuff surgery is good, but strength improvements are less predictable,” Dr. Rodeo says. “Identification of new ways to improve healing and muscle function would represent a significant advance in the treatment of rotator cuff tendon tears.”
“We continue to enjoy working with Dr. Rodeo and his team on this long-term collaborative effort and look forward to providing support for this exciting new therapeutic application of E-CEL UVEC cells,” commented Paul Finnegan, MD, Angiocrine’s CEO.
The study opened September 1, 2019, with the goal of recruiting up to 20 patients ages 45 to 70 with full-thickness rotator cuff tears confirmed by physical examination and MRI. Eligible participants must already have tried and failed standard non-operative approaches, including a minimum of three months of physical therapy, oral anti-inflammatory medications, or a steroid injection.
For more information about the clinical trial (NCT04057833), please contact Camila Carballo, PhD, at carballoc@hss.edu or Daniel Edon, MS, at edond@hss.edu.
About HSS
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the tenth consecutive year), No. 3 in rheumatology by U.S. News & World Report (2019-2020), and named a leader in pediatric orthopedics by U.S. News & World Report “Best Children’s Hospitals” list (2019-2020). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State. In addition, HSS will be opening a new facility in Florida in early 2020. In 2018, HSS provided care to 139,000 patients and performed more than 32,000 surgical procedures, and people from all 50 U.S. states and 80 countries travelled to receive care at HSS. There were more than 37,000 pediatric visits to the HSS Lerner Children’s Pavilion for treatment by a team of interdisciplinary experts. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The HSS Education Institute is the world’s leading provider of education on musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. www.hss.edu.
About Angiocrine Bioscience, Inc.
Angiocrine Bioscience is an innovative, early clinical stage biotechnology company harnessing the power of engineered endothelial cells to heal and rejuvenate patients with serious medical conditions. The company is developing a line of engineered endothelial cell (E-CEL® ) therapies for treating numerous life-threatening hematology and oncology conditions, as well as, in the field of organ and tissue regeneration. The core technology is founded on breakthroughs in vascular biology and stem cell research honed from decades of research by Professor Shahin Rafii and his laboratory at the Ansary Stem Cell Institute at Weill Cornell Medical College in New York City. Angiocrine Bioscience is at the front line in the next great medical revolution of utilizing living cells to improve the health and quality of life for patients in need.
May 17, 2017
Weill Cornell Medicine Creates a Renewable Supply of Blood Stem Cells That Hold the Promise of Treatment and Potential Cures for Multiple Disorders
Technology Offers New Approach to Regenerating the Blood and Immune System
SAN DIEGO, CA –A team of researchers at Weill Cornell Medicine have discovered an innovative method to make an unlimited supply of healthy blood and immune cells from the readily available cells that line blood vessels. The work published in Nature today is the culmination of efforts by a team of researchers led by Professor Shahin Rafii MD, director of the Ansary Stem Cell Institute, chief of the Division of Regenerative Medicine and the scientific founder of Angiocrine Bioscience.
Stem cells that produce cells that comprise the blood and immune system (hematopoietic stem cells) are not only critical to human vitality and health but also can be used therapeutically to treat and even cure various diseases from cancer to devastating genetic diseases, such as sickle cell anemia and primary immune deficiency (a.k.a. bubble baby syndrome). Ample, high-quality generation of hematopoietic stem cells has been a ‘holy grail’ of modern medical science.
As described in the publication, the team at Weill Cornell Medicine have discovered a novel system for reprogramming endothelial cells into hematopoeitic stem cells that can regenerate the blood cells and the immune system. Endothelial cells line the blood vessels throughout the body and are easily obtainable. Two distinct methodologies are used to accomplish this feat: a) reprogramming of endothelial cells with four genes that encode proteins into hematopoeitic stem cells; and, b) utilizing another specialized type of endothelial cell (E-CELTM) that enables clinical and commercial scale production of blood and immune system forming stem cells. Both technologies were invented by Professor Rafii and his team, and exclusively licensed by Angiocrine Bioscience, Inc.
“The potential clinical applications of this new powerful technology is vast,” commented Paul Finnegan MD, Chief Executive Officer of Angiocrine Bioscience. “Just imagine the possibilities generated by a process that can produce your own stem cells, for example skin, so you can treat or even cure yourself. We applaud the groundbreaking work that Professor Rafii and his team continues to produce at Weill Cornell Medical, to bring the future of regenerative medicine within our reach, near-term.”
About Angiocrine Bioscience Inc.
Angiocrine Bioscience is a privately held San Diego based biopharmaceutical company and a world-leader in regenerative engineered endothelial cells. Angiocrine’s proprietary E-CEL™ cells simulate the vascular stem cell niche, special locations within vital organs where certain endothelial cells work with the organ’s stem cells to start the regenerative and repair process in our body. The Ψ Psi-CEL™ technology enables the production of blood and immune system forming (hematopoietic) stem cells from endothelial cells. Together, they represent a potentially transformative new approach to treatment and cure of various diseases. Angiocrine’s approach is unique and based on over twenty years of research in vascular and regenerative biology by its scientific founder, Professor Shahin Rafii MD of Weill Cornell Medical.
For additional information, please contact:
Angiocrine Bioscience, Inc.
John R. Jaskowiak
(408) 646-2265
jjaskowiak@angiocrinebio.com
Jan 11, 2016
Angiocrine Bioscience Announces Collaboration for Clinical Cell Manufacturing Platform with Terumo BCT
Improved Scalability for E-CEL™ Manufacturing with Quantum® Cell Expansion System
SAN DIEGO, CA—(Business Wire) Angiocrine Bioscience Inc. today announced a three-year collaboration agreement with Terumo BCT Inc., a global leader in blood component, therapeutic apheresis and cellular technologies, to implement Terumo BCT’s Quantum Cell Expansion System as a manufacturing platform for its E-CEL™ technology and therapeutic candidates. The Quantum system, a state-of-the-art, functionally closed hollow-fiber bioreactor technology, streamlines the cell culture process and furthers the research and development of Angiocrine’s cell therapy products by enhancing process scalability, increasing reproducibility and reducing costs. “As we advanced our discovery and pre-clinical therapeutic programs, it was critical to identify a key collaborator that would help us streamline our processes and enable manufacturing scale up in a predictable and effective manner. The early adoption of an automated cell expansion platform, the Quantum system, in our research and development activities will accelerate our pace as we work to rapidly advance our therapeutic candidates into the clinic, and we are keen to work with Terumo BCT to leverage their expertise in cell culture automation and scale up,” commented Paul Finnegan, MD, Angiocrine’s CEO.
Cell culture processes can be optimized and configured on the Quantum system manufacturing platform to expand several cell types, including some used in ongoing clinical trials in Europe. Angiocrine believes this helps develop various potential therapeutic indications being addressed by Angiocrine’s E-CEL technology. The combination of protocol flexibility and process control through automation provides a significant advantage over manual flask-based methods and positions the Quantum system ideal for a range of production scenarios from bench top research to commercial manufacturing. “Angiocrine Bioscience has a novel approach to regenerative medicine with its E-CEL technology and we are excited about working with them to achieve clinical scale production”, added Dave Flaten, Vice President, Cell Processing, Terumo BCT.
About Angiocrine Bioscience Inc.
Angiocrine Bioscience is a world-leader in genetically-modified endothelial cell-based technology (the E-CEL™ Technology) which has multiple applications in regenerative medicine. Angiocrine’s approach is unique and based on over twenty years of research in vascular and regenerative biology. We aim to transform the standards of medical practice through our rationally designed, inspired by nature, therapeutic platforms designed to drive resident stem cell renewal in a variety of disease settings. Angiocrine’s core technology is licensed from Weill Cornell Medical College and was invented and developed by Professor Shahin Rafii, MD. His work related to Angiocrine technology has been published in numerous peer-reviewed journals, including Nature, Cell and Blood.
About Terumo BCT
Terumo BCT is a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.
For additional information, please contact:
Angiocrine Bioscience, Inc.
John R. Jaskowiak
(408) 646-2265
jjaskowiak@angiocrinebio.com
Aug 21, 2014
Angiocrine Bioscience Licenses New Stem Cell Technology From Weill Cornell Medical College
Technology Offers Safer Approach to Stem Cell Transplantation
NEW YORK, NY – (Business Wire) Angiocrine Bioscience, Inc. announced today that it has licensed the rights to a new technology developed by a team of researchers at the Ansary Stem Cell Institute at Weill Cornell Medical College. The team was led by Dr. Shahin Rafii, director of the Ansary Stem Cell Institute, professor of medicine, genetic medicine and reproductive medicine, and a founder of Angiocrine Bioscience. This scientific advance, reported in the July 2 issue of Nature, could potentially lead to therapies for patients with blood disorders from their own cells.
This technology provides a means of converting a patient’s own vascular cells, known as endothelial cells, directly into blood stem cells. The endothelial cells are acquired from a biopsied piece of skin and are then “educated” on a bed of VeraVecTM cells (proprietary to Angiocrine Bioscience) to form multipotent blood cells that are capable of producing red cells that carry oxygen, white cells that provide immunity, and platelets to prevent bleeding. This approach could potentially provide an abundant and safe source of new blood stem cells capable of treating a variety of diseases without the risk of graft versus host disease, a serious, life-threatening complication often associated with stem cell transplants derived from a donor.
“We hope that our method will offer the first safe technology to treat a wide spectrum of serious disorders. The VeraVecTM cells form a nurturing niche for the survival and growth of the reprogrammed blood cells, similar to what happens developmentally during blood production. A particularly important aspect of this study was that the reprogrammed cells engrafted in the bone marrow when implanted into rodents and morphed into the various types of blood cells,” said Dr. Rafii.
“This technology nicely complements our efforts in applying our VeraVecTMplatform to the expansion of umbilical cord blood stem cells, another approach toward making stem cell transplant safer and more broadly available to patients in need, ” added Geoff Davis, Angiocrine’s CEO.
About Angiocrine Bioscience, Inc.
Angiocrine Bioscience is a privately held biotech company focused on applying vascular biology to new therapeutic applications. Angiocrine’s VeraVecTM technology platform is based on endothelial cells that have been genetically modified such that they can be rapidly and durably expanded in culture. Because these cells secrete and display factors essential for stem cell growth and proliferation, they can be used to support cell-based therapies, stem cell transplant, and regenerative medicine applications. VeraVecTM products are currently marketed for research-use only purposes to academic laboratories, medical research institutes, and pharmaceutical and biotechnology companies.
For additional information, please contact:
Angiocrine Bioscience, Inc.
John R. Jaskowiak
(302) 475-8645
jjaskowiak@angiocrinebio.com