Unlike autologous cell therapy, where the patient’s own cells are used, allogeneic cell therapy companies leverage donor cells, which can come from various sources such as bone marrow or umbilical cord blood.
In allogeneic cell therapy, healthy donor cells are harvested, processed, and then infused into the patient. These donor cells can differentiate into various types of cells needed to replace or repair damaged tissues. The harvested cells are processed to isolate the desired cell type, often stem cells or immune cells like T cells. These cells may be expanded and activated in the lab to increase their numbers and efficacy.
The allogeneic cell therapy’s ability to provide off-the-shelf solutions makes it a promising option for scalable and timely treatments. In this article, we discover eight allogeneic cell therapy companies.
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A2 Biotherapeutics
A2 Biotherapeutics is developing targeted cell therapies for cancer treatment. Based in Agoura Hills, California, the company is focused on leveraging its Tmod (targeted modulation) platform to create therapies for solid tumors.
A2 Biotherapeutics’ Tmod platform is designed to address a significant challenge in cancer therapy: distinguishing cancer cells from normal cells to minimize damage to healthy tissues. The Tmod system involves a two-step process. First, it uses a ‘blocking’ receptor to identify a target antigen found on both cancerous and normal cells. This receptor effectively ‘blocks’ the action of the therapy on normal cells. Second, a ‘killing’ receptor specifically recognizes and attacks the cancer cells, which express both the target antigen and an additional tumor-specific marker. This dual-receptor approach ensures that the therapy selectively targets cancer cells while sparing normal cells.
A2 Biotherapeutics’ lead candidates are engineered T cells designed to express the Tmod receptors, enabling them to differentiate between cancerous and non-cancerous cells. This selective targeting aims to reduce off-target effects and improve the safety profile of the treatments. A2B530 is in phase 1 clinical trials and targets colorectal, lung, and pancreatic cancers while A2B694 is still in preclinical stages for ovarian, mesothelioma, pancreatic, colorectal, and lung cancers.
A2 Biotherapeutics has secured significant funding to advance its research and development efforts with its most notable funding round being a series B round in 2021, where A2 Biotherapeutics raised $71.5 million.
Adicet Bio
This California-based company is focused on developing allogeneic cell therapies for cancer. Adicet Bio’s approach centers on the use of gamma-delta T cells, a subset of T cells with innate and adaptive immune properties. Unlike conventional alpha-beta T cells, gamma-delta T cells can recognize and kill cancer cells without the need for prior sensitization to specific tumor antigens. This allows for a broader application across different cancer types. Adicet’s proprietary technology involves engineering these gamma-delta T cells to express chimeric antigen receptors (CARs), enhancing their ability to target and destroy cancer cells.
The company’s lead candidate, ADI-001, is an allogeneic gamma-delta CAR T cell therapy targeting CD20, a protein commonly found on the surface of B-cell lymphomas and leukemias. ADI-001 is currently in phase 1 clinical trials for treating relapsed or refractory B-cell malignancies.
Another notable candidate in Adicet’s pipeline is ADI-002, which targets GPC3, a protein overexpressed in several solid tumors, including hepatocellular carcinoma and lung cancer. ADI-002 is in preclinical development, with plans to advance to clinical trials shortly.
Caribou Biosciences
Caribou Biosciences, co-founded by Nobel laureate Jennifer Doudna, is also headquartered in California. The company specializes in CRISPR genome editing technology and aims to develop allogeneic cell therapies to treat cancer and other diseases.
Caribou Biosciences utilizes a proprietary CRISPR-Cas9 technology platform to create precise and durable edits in the genome. This platform, known as CRISPR hybrid RNA-DNA (chRDNA), enhances the specificity and reduces the off-target effects commonly associated with traditional CRISPR systems. The company’s approach involves engineering T cells and natural killer (NK) cells to enhance their ability to recognize and destroy cancer cells.
Caribou Biosciences has a diversified pipeline targeting various cancer types. Its lead candidate, CB-010, is an allogeneic anti-CD19 CAR-T cell therapy designed to treat B cell malignancies, such as non-Hodgkin lymphoma. CB-010 is currently in phase 1 clinical trials.
Another key candidate in Caribou’s pipeline is CB-011, an allogeneic CAR-T cell therapy targeting BCMA (B-cell maturation antigen), which is being developed for the treatment of multiple myeloma. CB-011 is in preclinical development, with plans to advance to clinical trials soon.
Coeptis Therapeutics
Coeptis Therapeutics is a company headquartered in Wexford, Pennsylvania focused on developing allogeneic cell therapy platforms for cancer, autoimmune, and infectious diseases.
One of its key technologies is the SNAP-CAR platform, which enables the creation of universal, multi-antigen CAR T and NK cell therapies. This platform is designed to enhance the targeting and killing of cancer cells while reducing the risk of immune rejection.
The SNAP-CAR system allows for the modular design of CAR constructs that can target multiple antigens, providing flexibility and applicability across different types of cancers. Additionally, Coeptis is developing the GEAR (Genetically Engineered Antigen Receptor) cell therapy platform, which integrates gene editing techniques to further optimize the therapeutic potential of allogeneic cells.
Coeptis Therapeutics’ pipeline includes several promising programs:
- SNAP-CAR NK cells: A universal allogeneic NK cell therapy designed to target multiple tumor-associated antigens. The therapy is currently in preclinical development, with plans to advance to clinical trials to evaluate its efficacy in treating various cancers.
- DVX201: This unmodified natural killer cell therapy is another key candidate in Coeptis’ pipeline. DVX201 is being developed to enhance the innate immune response against cancer cells and is advancing in phase 2 after a successful phase 1 trial.
- GEAR T cells: These are genetically engineered T cells that leverage the GEAR platform to improve the specificity and potency of allogeneic CAR T cell therapies.
Cytovia Therapeutics
Cytovia Therapeutics is headquartered in New York and specializes in developing gene-edited allogeneic NK and CAR-NK cell therapies for cancer treatment.
Cytovia employs CRISPR and TALEN (Transcription Activator-Like Effector Nucleases) gene-editing technologies to modify NK and CAR-NK cells. TALEN is a gene-editing technology used to precisely alter DNA sequences within the genome. This technology combines the DNA-binding ability of transcription activator-like effectors (TALEs) with the DNA-cleaving capability of nucleases, allowing them to target and modify specific DNA sequences in the genome. These technologies improve the cells’ ability to target and destroy cancer cells while minimizing off-target effects.
The company has several collaborative programs in preclinical development using GPC3-CAR-NK cells. These cells target glypican-3 (GPC3), a protein overexpressed in hepatocellular carcinoma and other solid tumors. The company also works with CD38-CAR-NK cells targeting CD38.CD38 is a surface protein commonly found on the surface of multiple myeloma cells and other hematologic malignancies. The company has several preclinical projects leveraging these cells.
IN8Bio
IN8Bio, headquartered in New York, specializes in developing gamma-delta T cell therapies for cancer treatment, particularly effective at targeting and killing cancer cells without the need for prior sensitization to specific tumor antigens.
The company’s lead candidate, INB-400, is a genetically modified gamma-delta T cell therapy designed to target glioblastoma (GMB), an aggressive form of brain cancer. INB-400 is currently in phase 2 clinical trials.
Other key candidates include INB-200 and INB-100, both in phase 1 trials. INB-200 also targets GMB, while INB-100 is being developed for the treatment of hematologic malignancies such as leukemia. IN8Bio also has a preclinical candidate in its pipeline, INB-300 focused on solid tumors including ovarian and pancreatic cancers.
Poseida Therapeutics
Poseida employs two key proprietary technologies: the PiggyBac DNA Modification System and the Cas-CLOVER gene-editing platform. These systems are integral to the development of the company’s allogeneic CAR-T cell therapies, allowing for stable integration of large genetic payloads and gene editing with minimal off-target effects.
The company’s pipeline is focused on both hematologic malignancies and solid tumors, utilizing allogeneic CAR-T cells.
One of the company’s most promising candidates is P-BCMA-ALLO1, which targets B-cell maturation antigen (BCMA). This therapy is in phase 1 clinical trials for relapsed and refractory multiple myeloma and has shown promising early results. Patients have experienced high response rates, with no dose-limiting toxicities or severe adverse effects like graft-versus-host disease.
Another significant candidate, currently in phase 1, is P-MUC1C-ALLO1, targeting the MUC1-C protein, commonly found in various epithelial-origin solid tumors, such as breast, ovarian, and pancreatic cancers.
Poseida is also developing P-CD19CD20-ALLO1, an allogeneic CAR-T therapy targeting both CD19 and CD20 antigens. This dual-targeting approach addresses the challenge of single antigen loss and tumor variability, making it a versatile option for treating B-cell malignancies. This therapy is being developed in partnership with Roche.
TC BioPharm
TC BioPharm, headquartered in Edinburgh, Scotland, is a clinical-stage biotechnology company specializing in the development of allogeneic gamma-delta T cell therapies. The company employs both unmodified and CAR-modified gamma-delta T cells, which are engineered to enhance their targeting capabilities.
The company’s lead candidate, OmnImmune (TCB-008), is an allogeneic unmodified gamma-delta T cell therapy for treating acute myeloid leukemia (AML). OmnImmune is currently in phase 2/3 clinical trials. Early results have shown a strong safety profile with no dose-limiting toxicities, and the therapy is designed to be a potential alternative for patients who do not respond well to first-line treatments.
TC BioPharm is also developing CAR-modified gamma-delta T cell therapies targeting both solid and hematological cancers. These programs are in the preclinical and early clinical stages.
Allogeneic cell therapy, an expanding market
The global allogeneic cell therapy market is experiencing significant growth, driven by the increasing incidence of chronic diseases such as cancer, cardiovascular diseases, autoimmune disorders, and genetic diseases. The market size was valued at $255.6 million in 2022, and is expected to grow at a compound annual growth rate (CAGR) of 27.4% from 2023 to 2030, potentially reaching $1.72 billion by 2030. This growth is fueled by advancements in gene editing technologies, increased funding for research, and a rising number of clinical trials demonstrating the efficacy of allogeneic therapies.
The market is segmented into hematological disorders, solid tumors, and other applications such as autoimmune and infectious diseases. Hematological disorders hold the largest share, driven by the success of allogeneic stem cell transplants in treating leukemia and lymphoma.
North America dominates the market but Europe and the Asia-Pacific region are also witnessing substantial growth due to increased investments and favorable government policies.
Although promising allogeneic cell therapy comes with its set of challenges. One of the primary challenges in allogeneic cell therapy is the risk of immune rejection and graft-versus-host disease (GVHD), where the donor cells attack the recipient’s tissues. This can lead to severe complications and limits the widespread use of allogeneic therapies. Techniques like CRISPR and TALEN are used to modify donor cells to reduce immunogenicity, making them less likely to be rejected by the recipient’s immune system. Immunosuppressive drugs can help mitigate the risk of GVHD, although this comes with its own set of side effects and complications.