Top 5 Companies Developing Allogeneic Cell Therapies

Allogeneic cell therapies represent a promising and rapidly advancing paradigm of the healthcare industry, with the potential to revolutionize the regenerative medicines industry We analyzed more than 190 allogeneic cell therapy developers. In this article, discover the top 5 companies engaged in developing allogeneic cell therapies.

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Cell therapy refers to the introduction of engineered cells into a patient's body to treat, replace or repair damaged / dysfunctional tissues. The cell therapies can either be derived from the patient’s own body (autologous therapy) or from a healthy donor (allogeneic therapy). Specifically, in case of allogeneic cell therapy, the cells are collected from a suitable donor’s bone marrow, peripheral blood, placenta or cord blood. The selected cells can be directly given to the patient or engineered in order to elicit a suitable therapeutic response. Once the optimal phenotype is achieved, the selected cells undergo in-vitro amplification. The final cells are cryopreserved to ensure long-term viability and availability for future use. 

Some of the advantages of allogeneic cell therapy includes easy availability, enhanced product quality, less product variability, potential to treat all the eligible patients, scalable manufacturing process, reduced processing time and cost-effectiveness. Further, the different types of allogeneic cell therapies include Chimeric Antigen Receptor (CAR T Cell Therapy), Dendritic cell therapies, T-cell Receptor (TCR Therapy) therapies, Tumor Infiltrating Lymphocyte (TIL Therapy), Natural Killer (NK) cell therapies, Novel T-cell therapy and Stem cell therapy. 

Some examples of recently approved allogeneic cell therapies include:

• Ebvallo™ (developed by Atara Biotherapeutics) - Allogeneic T-cell immunotherapy used to treat relapsed/refractory Epstein?Barr virus positive post?transplant lymphoproliferative disease
• Omisirge (developed by Gamida Cell) - Nicotinamide modified allogeneic hematopoietic progenitor cell therapy used to treat hematologic malignancies
• Stempeucel® (developed by Stempeutics Research) - Allogeneic mesenchymal stem cells (MSC) derived therapy used to treat knee osteoarthritis

Driven by the rising prevalence of chronic diseases, rapid progress in clinical development initiatives and the introduction of new reforms in legislation pertaining to cell therapies, the field has gained significant traction in the last few years.

Roots Analysis has conducted an exhaustive study on Allogeneic Cell Therapy Market, featuring the current market landscape and future opportunities for companies developing allogenic cell therapies over a span of 12 years.

Table of Contents

Below, we have listed (in decreasing order of the number of allogeneic cell therapies developed), the top 5 allogenic cell therapy developers:
1. Fate Therapeutics
2. Allogene Therapeutics
3. Artiva Biotherapeutics
4. CHABiotech
5. Cellenkos

Interested in exploring all 190+ allogeneic cell therapies developers across various regions?

Fate Therapeutics Uses Induced Pluripotent Stem Cells as a Renewable Source for Mass Production of Cellular Treatments; Pipeline Re-evaluated in 2022

Fate Therapeutics is a clinical-stage biopharmaceutical firm, focusing on the development of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to treat autoimmune and oncological disorders. As per the company website, the company’s iPSC platform is supported by an intellectual property portfolio of more than 400 issued patents and 450 pending patent applications. Further, it is currently evaluating various allogeneic NK cell therapy as monotherapy or in combination with other anti-cancer agents (such as monoclonal antibodies).

The following table presents the details of the allogeneic cell therapies under development by Fate Therapeutics.

S. No	Therapy Name	Phase of Development	Therapeutic Area
1	FT576	Phase I	Multiple Myeloma
2	FT819	Phase I	B-cell Malignancies
3	FT522	Preclinical	B-cell Lymphoma
4	FT825	Preclinical	Solid Tumors
5	FT522	Preclinical	Undisclosed Autoimmune Disorder

The company soon plans to initiate phase I trial in B-cell lymphoma patients evaluating FT522, a CAR NK targeting CD19. Additionally, IND submission for FT825, HER 2 targeted CAR T being co-developed with Ono Pharmaceutical, is planned for 2023.

Recent Developments: 

• In January 2023, Fate Therapeutics discontinued the development of multiple programs including FT516, FT538, FT536 and FT596, citing expense reduction and pipeline prioritization.¹ 
• In December 2022, the company participated in the 64th American Society of Hematology (ASH) Annual Meeting and Exposition to present the different innovative approaches to administer allogeneic cell-based oncological therapies, without the requirement of conditioning chemotherapy.
• In June 2022, the company expanded its collaboration with ONO Pharmaceutical to develop allogeneic, CAR-NK cell therapy candidates to treat solid tumors.

Further information related to the company’s allogeneic cell therapies is available in the full report.

Using its Proprietary AlloCAR T™ Platform, The Company Aims to Offer Safe and Efficacious off-the-shelf Cell Therapies 

Allogene Therapeutics specializes in the development of off-the-shelf CAR-T cell therapies in order to treat blood cancers and solid tumors. Through its 136,000 square-foot facility located in California, US, the company offers clinical and commercial manufacturing, analytical testing and distribution of cell products.

The following table presents the details of the allogeneic cell therapies under development by Allogene Therapeutics.

S. No	Therapy Name	Phase of Development	Therapeutic Area
1	ALLO-501A	Phase II	B-Cell Lymphoma (3rd Line)
2	ALLO-605	Phase I / II	Multiple Myeloma
3	ALLO-501A + ALLO-647	Phase I / II	B-Cell Lymphoma
4	ALLO-715	Phase I	Multiple Myeloma
5	ALLO-316	Phase I	Renal Cell Carcinoma
6	ALLO-182	Preclinical	Gastric Cancer, Pancreatic Cancer
7	ALLO-213	Preclinical	Small Cell Lung Cancer
8	ALLO-316	Preclinical	Unspecified Hematological Malignancy
9	ALLO-316	Preclinical	Unspecified Solid Tumor
10	ALLO-501A	Preclinical	B-Cell Lymphoma
11	ALLO-819	Preclinical	Acute Myeloid Leukemia

Recent Developments: 

• In September 2023, the company participated in Society for Immunotherapy of Cancer (SITC) Annual Meeting, held in California, US to showcase its next generation AlloCAR T™ platform and product candidates.
• In February 2023, the company participated in Emerging Cellular Therapies at the Forefront of Cancer Immunotherapy Keystone Symposia in Alberta, Canada, to present preclinical data for the company’s next generation Dagger™ platform technology.
• FDA granted RMAT designation (in June 2022) to its allogeneic CAR T therapy targeting CD19, namely ALLO-501A.
• FDA granted Orphan Drug Designation (in April 2022) and Fast Track Designation (in July 2021) to its allogeneic CAR T therapy targeting BCMA, namely ALLO-605.
• FDA granted Fast Track Designation (in March 2022) to its allogeneic CAR T therapy targeting CD70, namely ALLO-316.
• FDA granted Orphan Drug Designation (in August 2021) and RMAT Designation (in April 2021) to its allogeneic CAR T therapy targeting BCMA, namely ALLO-715.

Further information related to the company’s allogeneic cell therapies is available in the full report.

Artiva Biotherapeutics has Collaborated with Several Leading Pharmaceutical Companies to Progress the Clinical Application of Allogeneic NK Cell Therapy

Artiva Biotherapeutics focuses on the development of allogeneic NK cell therapies and CAR-NK cell therapies, from umbilical cord blood of healthy donors. The company’s non-genetically modified NK cells are useful in enhancing antibody-dependent cellular cytotoxicity (ADCC) in patients undergoing monoclonal antibody therapy. Further, its genetically modified CAR-NK cell therapies couple the efficacy of CARs with the safety features of NK cells. It is worth mentioning that the firm has established exclusive partnerships with GC Cell and Merck to evaluate novel NK cell therapies in clinical trials.
    
The following table presents the details of the allogeneic cell therapies under development by Artiva Biotherapeutics.

S. No	Therapy Name	Phase of Development	Therapeutic Area
1	AB-101	Phase I / II	Non-Hodgkin's Lymphoma
2	AB-101 + AFM-13	Phase II	Hodgkin's Lymphoma and CD30+ PTCL
3	AB-101 + Rituximab	Preclinical	Lupus Nephritis
4	AB-201	Preclinical	Breast Cancer, Gastric Cancer
5	AB-205 / CD5 CAR-NK	Preclinical	T-Cell Lymphoma
6	AB-MK-001	Preclinical	Unspecified Solid Tumor
7	AB-MK-002	Preclinical	Unspecified Solid Tumor

The company soon plans to initiate phase I trial of AB-101 in Systemic Lupus Erythematosus in patients with active lupus nephritis, IND clearance for which was received in August 2023.²

Recent Developments: 

• In January 2023, FDA granted Fast Track Designation to cord blood-derived, allogeneic, NK cell therapy, namely AB-101 (for the treatment of relapsed/refractory non-Hodgkin lymphoma).
• In November 2022, the company entered into a partnership with Affimed to evaluate the combination of its allogeneic cell therapy, AB-101 with the latter company’s Innate Cell Engager (ICE®) AFM13.
• In June 2022, the company opened a research and development laboratory in San Diego, California to support NK and CAR-NK cell production.
• In April 2022, Artiva Biotherapeutics entered into a partnership with Merck to evaluate the combination of NK cells (generated from Artiva’s AlloNK™ platform) with tri-specific NK-cell engagers.

Further information related to the company’s allogeneic cell therapies is available in the full report.

Owing to its State-of-the-Art Facilities and Technical Expertise, CHABiotech Contributes to the Regenerative Medicine Industry

CHABiotech is a biotechnology company engaged in the development of cell and gene therapies (derived from embryonic stem cells, adult stem cells and immune cells) for the treatment of aging-related diseases, cancer and incurable diseases. The company states to have registered around 90 patents for cell technologies. In addition, the firm offers (safe and reliable) cord blood banking service as well as conducts research on cord blood-based therapies. 

The following table presents the details of the allogeneic cell therapies under development by CHABiotech.

S. No	Therapy Name	Phase of Development	Therapeutic Area
1	CordSTEM-ST	Phase II	Stroke
2	MA09-hRPE / hESC-RPE	Phase II	Age-Related Macular Degeneration
3	CordSTEM-DD	Phase I / II	Degenerative Disc Disease
4	CordSTEM-DD	Phase I	Degenerative Disc Disease
5	MA09-hRPE / hESC-RPE / ASP7316	Phase I	Stargardt Disease
6	CordSTEM-POI	Phase I	Ovarian Insufficiency
7	Allo-NK	Preclinical	Unspecified Cancer
8	FMD-NPC	Preclinical	Parkinson's Disease

Recent Developments: 

• In March 2023, the company entered into a technology transfer agreement with Astellas Institute for Regenerative Medicine (AIRM) for its retinal pigment epithelial cells (RPE) and embryonic cells (blastomere) technologies.

The company aims to develop novel treatments by conducting basic research and clinical studies up to commercialization stage. In 2021, CHA Biolab received permission to develop advanced biopharmaceutical products, and approval of cell processing facility.

Further information related to the company’s allogeneic cell therapies is available in the full report.

Leveraging its Cord Blood T-Regulatory Cells; Activated And Enriched (CRANE™) Platform, Cellenkos aims to advance research in the clinical domain

Cellenkosis is a patient-centric, allogeneic T-regulatory cell (Treg therapy) therapy developer. The Tregs developed by the company are suppressor cells that treat inflammation through various direct as well as indirect interactions; some of their advantages include low immunogenicity, surplus availability and large-scale expansion. Further, its GMP manufacturing facility (established in 2017) is located in Texas, US and has expertise in technology transfer, process development and scale up.

The following table presents the details of the allogeneic cell therapies under development by Cellenkos.

S. No	Therapy Name	Phase of Development	Therapeutic Area
1	CK0801	Phase I	Bone Marrow Failure Syndrome
2	CK0802	Phase I	Acute Respiratory Distress Syndrome
3	CK0803	Phase I	Amyotrophic Lateral Sclerosis
4	CK0804	Phase I	Myelofibrosis
5	CK0805	Preclinical	Graft versus Host Disease
6	CK0806	Preclinical	iPEX Syndrome
7	CK0807	Preclinical	T-Cell Lymphoma
8	CK0808	Preclinical	Lupus Nephritis
9	CK0803	Preclinical	Parkinson’s Disease

Recent Developments: Leveraging its umbilical cord blood proprietary platform, Cellenkos strives to develop Tregs to treat autoimmune and inflammatory disorders. In September 2022, the company received clearance from the FDA to conduct Phase 1 clinical trial followed by a Phase 1b randomized, double blind, placebo control study of CK0803. Further, in November 2021, the company secured USD 15 Million through Series A financing to accelerate the development of its Treg therapies.

• In May 2023, the company dosed first patient in its phase I clinical trial for CK0803, an allogeneic Treg therapy for treatment of Amyotrophic Lateral Sclerosis.³
• In January 2023, the first patient was dosed with CK0804 in phase I clinical trial for treatment of myelofibrosis.

Further information related to the company’s allogeneic cell therapies is available in the full report. 

What About the Other Allogeneic Cell Therapies Developers?

The above presentation features the top 10 allogeneic cell therapies developers selected from a pool of over 190 firms that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.

About Author

Simran Kaur

Simran, a Senior Business Analysis, has been an integral part of the Roots Analysis team since 2020. Holding a Master’s and Bachelor’s in pharmacy from a prestigious institution, she embarked on her professional journey with a strong academic foundation and an interest in life sciences domain. Her keenness to learn more about the emerging trends, regulatory dynamics and technological advancements enables her to provide comprehensive analyses. Till date, she has diligently contributed to over 15 comprehensive research reports on trending topics, ranging from anti-aging therapeutics, allogeneic cell therapies, lipid nanoparticles, pre-sterilized pharmaceutical packaging to next generation sequencing kits.

Sources:1 https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-announces-termination-collaboration-agreement
Sources:2 https://www.businesswire.com/news/home/20230815559406/en/Artiva-Biotherapeutics-Announces-FDA-Clearance-of-IND-for-AlloNK%C2%AE-Cell-Therapy-Candidate-in-Combination-with-Rituximab-in-Lupus-Nephritis
Sources:3 https://cellenkosinc.com/articles/https-www-prnewswire-com-news-releases-cellenkos-announces-first-patient-dosed-with-ck0803-cell-therapy-for-treatment-of-amyotrophic-lateral-sclerosis-301812682-html