Press Releases

Targazyme, Inc. Receives FDA Clearance For a Phase 2 Study of Pediatric Cancer Patients Undergoing Stem Cell Transplantation For Treatment of Hematologic Malignancies

SAN DIEGO, March 6, 2017:

Targazyme Inc., a clinical stage biopharmaceutical company developing novel enzyme products to improve clinical efficacy, safety and cost of care outcomes for a variety of cell therapies including stem cell transplantation, cancer immunotherapy and regenerative medicine, announced today that the U.S. Food and Drug Administration (FDA) has granted IND Clearance to begin enrolling patients in a Phase 2 clinical study to evaluate the efficacy of TZ101-fucosylated hematopoietic stem cell transplants in pediatric cancer patients.

“This Phase 2 single cord blood pediatric cancer patient study complements and builds upon the encouraging MD Anderson Cancer Center Phase 2 trial […]

Targazyme Inc. Receives Additional U.S Patent Award Designed to Improve Cell Therapy Clinical Efficacy Outcomes

Targazyme Inc., a clinical stage biopharmaceutical company developing novel enzyme technologies and products to improve clinical efficacy, safety and cost of care outcomes for patients undergoing cancer immunotherapy, stem cell transplantation and regenerative medicine, announced today that the United States Patent & Trademark Office has awarded Targazyme, Patent 9,511,095 entitled “Cells Treated by In-Vitro Fucosylation and Methods of Production and Use Thereof”.

This US 9,511,095 patent covers multiple biomolecules on the surface of all therapeutic blood, cord blood and bone marrow cells and their derivative therapeutic cells such as hematopoietic stem cells, mesenchymal stem cells, regulatory T-cells, Natural Killer Cells and  […]

Targazyme, Inc. Receives FDA Clearance For a Phase 2 Haplo-Identical Transplant Study of Patients Undergoing Bone Marrow Transplantation For Treatment of Hematologic Malignancies

SAN DIEGO, OCTOBER 24, 2016:

Targazyme Inc., a clinical stage biopharmaceutical company developing novel enzyme technologies and products to improve clinical efficacy and cost of care outcomes for a variety of cell therapies including stem cell transplantation, immunotherapy, gene therapy and regenerative medicine, announced today that the U.S. Food and Drug Administration (FDA) has granted IND Clearance to begin enrolling patients in a Phase II clinical study to evaluate the safety and efficacy of TZ101-fucosylated bone marrow stem cells from haplo-identical donors in cancer patients.

The transplantation of blood-forming stem cells from bone marrow is an accepted treatment to restore the […]

Targazyme Enrolls First Patient in Phase 1/2 Study of TZ101 Fucosylated Regulatory T Cells to Treat and Prevent Graft vs Host Disease in the Transplant Setting

SAN DIEGO, July 20, 2016

Targazyme, Inc. a clinical-stage biopharmaceutical company developing novel enzyme technologies and products to improve clinical efficacy outcomes for cancer immunotherapy and stem cell and solid organ transplantation, announced today that it has enrolled the first patient in a Phase 1/2 TZ 101-treated regulatory T cell clinical study. This Phase 1/2 clinical study will evaluate the efficacy and safety of TZ101-treated regulatory T cells in the prevention and treatment of acute and chronic Graft-Versus-Host-Disease (“GVHD”) in stem cell transplants. This clinical milestone will hopefully translate into the clinic the recent preclinical findings published in the journal […]

Targazyme And University Of Minnesota Medical Center Initiate A Collaboration To Improve Regulatory T Cell Immunotherapy Outcomes For The Prevention and Treatment Of Graft-Versus-Host-Disease

SAN DIEGO, November 12, 2015:
Targazyme, Inc. a clinical-stage biopharmaceutical company developing novel enzyme technologies and products to improve clinical efficacy outcomes for stem cell transplantation and cancer immunotherapy, announced today that it has entered into a collaboration with the University of Minnesota Medical Center (“UMMC”) to advance the development of the Company’s clinical product candidate, TZ101 for use with regulatory T cells (“Tregs”). This collaboration builds on positive proof of concept data published in the journal “Blood” demonstrating that ex vivo treatment of Tregs with TZ101 prior to administration is an effective strategy for the prevention of Graft-Versus-Host-Disease (“GVHD”).  […]

Targazyme, Inc. Receives National Cancer Institute SBIR Award for Phase 2 Clinical Study for TZ101-Treated Regulatory T Cell Therapy for Prevention/Treatment of GVHD

SAN DIEGO, July 27, 2015:

Targazyme, Inc., a clinical-stage biopharmaceutical company developing novel enzyme technologies and products to improve efficacy outcomes for stem cell transplantation, immunotherapy, gene therapy and regenerative medicine, announced today the award of a $2MM SBIR PHASE II grant from the National Cancer Institute (NCI). This award will fund a Phase 2 clinical study at The University of Texas MD Anderson Cancer Center and mechanism studies at the University of Minnesota with TZ101-treated regulatory T cells (Tregs) for the prevention and reduction of graft versus host disease (GVHD) in patients eligible for a hematologic stem cell transplantation.

GVHD […]

Targazyme, Inc., Announces FDA Concurrence On Targazyme’s Special Protocol Assessment For A Planned Phase 3 Registration Trial For The Treatment Of Patients With Hematologic Malignancie

SAN DIEGO, April 23, 2015:

Targazyme, Inc., announced today that the U.S. Food and Drug Administration (FDA) and Targazyme have reached concurrence on the company’s Special Protocol Assessment (SPA) application for its Phase 3 registration trial. This pivotal trial is designed to evaluate the efficacy of TZ101-treated cells in patients with hematologic malignancies undergoing hematopoietic stem cell (cord blood) transplantation with the primary outcome measure being time to neutrophil engraftment. The trial is expected to begin in 2016.

“This pivotal Phase 3 multicenter study complements and builds upon the encouraging MD Anderson Cancer Center Phase 2 trial efficacy data for leukemia […]

Targazyme, Inc. And M.D. Anderson Cancer Center Receive FDA IND Clearance For Phase I/II Study of TZ101-Treated Regulatory T Cells to Prevent Graft VS. Host Disease In Patients Eligible for Hematologic Stem Cell Transplantation

SAN DIEGO, March 17, 2015:
Targazyme Inc., a clinical stage biopharmaceutical company developing enzyme technologies and products to improve efficacy outcomes for a variety of cell therapies including stem cell transplantation, immunotherapy, gene therapy and regenerative medicine, announced today that the U.S. Food and Drug Administration (FDA) has granted IND Clearance to M.D. Anderson Cancer Center to start enrolling patients in a Phase I/II clinical study to evaluate the safety and efficacy of TZ101-fucosylated regulatory T cells (Tregs) in preventing and reducing the severity and incidence of graft vs. host disease (GVHD) in patients eligible for hematologic stem cell transplant.

GVHD […]

TargaZyme, Inc. Receives Orphan Drug Designation To TZ101 For Use With Regulatory T Cells To Prevent & Reduce The Severity Of Graft Versus Host Disease In Patients Eligible For Hematologic Stem Cell Transplantation

SAN DIEGO, February 10, 2015:

Orphan designation provides 7-year post approval marketing exclusivity, tax credits and elimination of FDA prescription drug user fees

Targazyme Inc., a clinical-stage biopharmaceutical company developing enzyme technologies and products to improve efficacy outcomes for stem cell transplantation, immunotherapy, gene therapy and regenerative medicine, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to TZ101 to prevent and reduce the severity and incidence of graft vs. host disease (GVHD) in patients eligible for hematologic stem cell transplant.

GVHD is a serious, life-threating complication of stem cell transplantation.  Orphan drug status confirms […]

TargaZyme, Inc. Announces Receipt of An SBIR Award from the National Institute of Dental and Craniofacial Research

TargaZyme, Inc. Announces  Receipt of An SBIR Award from the National Institute of Dental and Craniofacial Research For the Development of TZ 101 Treated Mesenchymal Stem Cells for Treatment of Oral Mucositis

San Diego, CA August 26, 2014 – TargaZyme, Inc. (formerly America Stem Cell, Inc.)  a clinical-stage biopharmaceutical company developing novel enzyme technologies and products to improve efficacy outcomes for cancer immunotherapy and cell therapy, announced today the receipt of an SBIR award to fund  the  development of genetically-modified mesenchymal stem cells treated with Targazyme’s lead product, TZ101 for treatment of oral mucositis. This SBIR award is from the […]