Allogeneic cell therapy

• Bristol Myers Squibb
• Century Therapeutics

Allogeneic cell therapy is a type of cell therapy in which a patient recieves cells from a donor. Bone marrow transplants are a type of allogeneic cell therapy. Allogenic therapy products may also be called universal cell therapy product or off-the-shelf cell therapy products. Autologous cell therapy uses cells which are derived from a patient’s own cells. Allogeneic cell therapies carry the risk of immune rejection but also have potential advantages over autologous cell therapy. Since cells do not need to be extracted from the patient and prepared, allogeneic cell therapy products are more immediately available to the patient. Allogeneic cell therapy products could potentially allow less variability, more standardization and allow for an industrialized process to decrease the cost of production.

• CARTISTEM, an allogeneic umbilical cord blood–derived MSC product used in treating patients with degenerative arthritis, approved in Republic of Korea
• Ebvallo (Atara Biotherapeutics), an allogeneic T-cell immunotherapy and has been approved for EU patients with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease.
• Stempeucel® (developed by Stempeutics Research), allogeneic mesenchymal stem cells (MSC) derived therapy used to treat critical limb ischemia, approved by DCGI (India FDA)

Mesenchymal stromal cells (MSCs) are a heterogeneous population of cells that when expanded in vitro include stem, progenitor and differentiated cells. MSCs have been have regenerative potential and anti-inflammatory properties. However, MSC treatments in clinical trials have produced mixed results. No cell therapies using MSCs have been FDA approved.

• Allogeneic limbal transplantation for treatment of limbal stem cell deficiency (LSCD), a disease of the eye

• Appia Bio
• Artiva Biotherapeutics
• Fate Therapeutics
• Fortress Biotech
• Kite Pharma
• Mustang Bio
• Pfizer
• Precision BioSciences
• Poseida Therapeutics
• Sorrento Therapeutics
• Ziopharm Oncology

• Cellenkosis
• CHABiotech
• ElevateBio
• Fate Therapeutics
• Mesoblast (MSCs)

Allogeneic cell therapy is a type of cell therapy in which a patient recieves cells from a donor. Allogenic therapy products may also be called universal cell therapy product or off-the-shelf cell therapy products. Autologous cell therapy uses cells which are derived from a patient’s own cells. Allogeneic cell therapytherapies carry the risk of immune rejection but also have potential advantages over autologous cell therapy. Since cells do not need to be extracted from the patient and prepared, allogeneic cell therapy products are more immediately available to the patient. Allogeneic cell therapy products could potentially allow less variability, more standardization and allow for an industrialized process to decrease the cost of production.

Cancer immunotherapies are treatments that activate or strengthen immune response to cancer cells or preventing tumor cells from suppressing the body’s immune response. T cells and natural killer (NK) cells are among the immune cells with antitumour activity. Chimeric antigen receptor-engineered (CAR) T cell therapy treats a patient with T cells that are modified to have enhanced targeting toward cancer cells. CAR NK cells are NK cells with enhanced cancer targeting.

Allogene Therapeutics developed ALLO-715 and ALLO-647, two allogeneic CAR T cell therapies in cancer clinical trials as of 2023.ALLO-715 is an allogeneic, anti-BCMA CAR T cell therapy developed to treat multiple myeloma. ALLO-715, manufactured by Allogene is prepared from peripheral blood mononuclear cells from healthy donors. ALLO-715 targets BCMA, a protein expressed on the surface of mature B lymphocyte and plasma cells that plays a role in myeloma cell survival and proliferation. BCMA is a target for multiple myeloma because it is overexpressed and activated in multiple myeloma.

• ABBVie

• Allogene Therapeutics developed ALLO-715 and ALLO-647, two allogeneic CAR T cell therapies in cancer clinical trials as of 2023.ALLO-715 is an allogeneic, anti-BCMA CAR T cell therapy developed to treat multiple myeloma. ALLO-715, manufactured by Allogene is prepared from peripheral blood mononuclear cells from healthy donors. ALLO-715 targets BCMA, a protein expressed on the surface of mature B lymphocyte and plasma cells that plays a role in myeloma cell survival and proliferation. BCMA is a target for multiple myeloma because it is overexpressed and activated in multiple myeloma.
• Atara Biotherapeutics
• Bellicum Pharmaceuticals
• CARsgen Therapeutics
• Cell Design Labs
• Cellectis
• Cell Medica
• Celularity
• Celyad Oncology

TheAs firstof 2021 most CAR T therapies developed toin treatclinical cancertrials were autologous CAR T cell therapies. All FDA approved CAR T therapies (Abecma, Breyanzi, Carvykti, Kymriah, Yescarta) are autologous cell therapies. Allogeneic CAR T therapies are in preclinical and clinical development.

Allogeneic NK cells do not cause graft-versus-host disease (GVHD), giving them an advantage over allogeneic CAR T-cell therapies. Other advantages of NK cell therapies over CAR T-cell therapies include reduced cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome toxicity.

The first CAR T therapies developed to treat cancer were autologous cell therapies. All FDA approved CAR T therapies (Abecma, Breyanzi, Carvykti, Kymriah, Yescarta) are autologous cell therapies. Allogeneic CAR T therapies are in preclinical and clinical development.

Allogene Therapeutics developed ALLO-715 and ALLO-647, two allogeneic CAR T cell therapies in cancer clinical trials as of 2023.ALLO-715 is an allogeneic, anti-BCMA CAR T cell therapy developed to treat multiple myeloma. ALLO-715, manufactured by Allogene is prepared from peripheral blood mononuclear cells from healthy donors. ALLO-715 targets BCMA, a protein expressed on the surface of mature B lymphocyte and plasma cells that plays a role in myeloma cell survival and proliferation. BCMA is a target for multiple myeloma because it is overexpressed and activated in multiple myeloma.

Allogeneic cell therapy is a type of cell therapy in which a patient recieves cells from a donor. Allogenic therapy products may also be called universal cell therapy product or off-the-shelf cell therapy products. Autologous cell therapy uses cells which are derived from a patient’s own cells. Allogeneic cell therapy have potential advantages over autologous cell therapy. Since cells do not need to be extracted from the patient and prepared, allogeneic cell therapy products are more immediately available to the patient. Allogeneic cell therapy products could potentially allow less variability, more standardization and allow for an industrialized process to decrease the cost of production.

• Stratagraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat), manufactured by Stratatech Corporation, is used for treatment of deep partial-thickness burns.

Congenital athymia is disease characterized by the absence of a functioning thymus, which results in profound immunodeficiency, increased susceptibility to infections and an increased risk of graft-versus-host disease (GVHD). Most infants with congenital athymia have CHARGE syndrome or have a deletion of genetic material at chromosome 22q11.2. Infants have a higher risk of congenital athymia if they were exposed to retinoic acid during pregnancy or were born to diabetic mothers.

• Rethymic (allogeneic processed thymus tissue-agdc), manufactured by Enzyvant Therapeutics GmbH, is indicated for immune reconstitution in pediatric patients with congenital athymia.

• Clevecord, manufacturesmanufactured by Cleveland Cord Blood Center
• Hemacord, manufactured by New York Blood Center, Inc.
• HPC/Cord blood, manufactured by Clinimmune Labs, University of Colorado Cord Blood Bank
• HPC/Cord blood, manufactured by MD Anderson Cord Blood Bank
• HPC/Cord blood, manufactured by LifeSouth Community Blood Centers, Inc.
• HPC/Cord blood, manufactured by Bloodworks
• Omisirge, manufactured by Gamida Cell Ltd., is a nicotinamide modified allogeneic HPC therapy to treat hematologic malignancies as part of myeloablative treatment.

• Lantidra is an allogeneic pancreatic islet cellular therapy manufactured by CellTrans Inc.

The following products are hematopoietic progenitor cells (HPC) derived from umbilical cord blood used for treatment of disorders affecting the hematopoietic system that are inherited, acquired or resulting from myeloablative treatment.

• Allocord, manufactured by SSM Cardinal Glennon Children’s Medical Center
• Clevecord, manufactures by Cleveland Cord Blood Center
• Ducord, manufactured by Duke University School of Medicine

• GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen), manufactured by Organogenesis Incorporated is an allogeneic cellularized scaffold product indicated for topical use in a surgically created vascular wound bed in treatment of mucogingival conditions.

Natural killer (NK) cells are a type of lymphocyte, or white blood cell, that control viral infections and recognize and kill malignant cells. NK cells also produce cytokines and chemokines, secreted signaling molecules that regulate other cells in inflammatory and immune responses. The three main sources of allogeneic NK cells are 1) donor peripheral blood, 2) Cord blood or differentiation from cord blood hematopoietic stem and progenitor cells (HSPCs) or 3) induced pluripotent stem cells (iPSCs).

Allogeneic NK cells do not cause graft-versus-host disease (GVHD), giving them an advantage over CAR T-cell therapies. Other advantages of NK cell therapies over CAR T-cell therapies include reduced cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome toxicity.