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With a market value of 850 million US dollars, the highlight moment of cell therapy in August belongs to this company!
Date: 2025-09-09Read: 1
Sana Biotechnology, with a market value of 850 million US dollars, is a clinical stage American biotechnology company founded in 2018, which ushered in a highlight in August!Left hand articleCell Stem CellOne article on the right handThe New England Journal of MedicineBoth have reached the top tier journals, bringing cell therapy into the field“No need for immune suppression”The era. Why did this company get through two top publications at once?
01. Left hand Cell Stem Cell, CD19 CAR-T can also be "invisible"!
On August 13, 2025, Sana published a clinical research article titled "Hypoimmune CD19 CAR T cell evade allocation in patients with cancer and autoimmune disease" in the Cell journal,Cell Stem Cell (IF=20.4)Verify it in the human bodyHIP (Hypoimmune)Engineering CAR-T (SC291) can evade immune rejection and lay the clinical foundation for universal cell therapy.
Technical route:
(1) Transforming donor T cells → CRISPR-Cas12b triple knockdown:
TRAC: Eliminate your own TCR to prevent graft-versus-host disease GVHD
•B2M+CIITA: Eliminate HLA-I/II and prevent T cell recognition
(2)Double Shunzi Slow Virus → Simultaneous Import
•CD19-CAR: Targeting B-cell tumors/Autoimmunity
•High expression of CD47: Apply brakes to NK/macrophages
(3)Single infusion of SC291, no need for strong immunosuppression, only receiving low-dose lymphatic clearance chemotherapy
Clinical results:
HIP edited CAR-T cells did not elicit an immune response in all patients. Partially edited cells are still recognized and cleared by the immune system, proving that HIP editing is effective rather than the patient's immune system being incompetent. This universal CD19 CAR-T cell therapy is suitable for cancer and autoimmune diseases.
02. The New England Journal of Medicine on the right hand, islet transplantation does not require immunosuppression!
On the same day, Sana published an article titled "Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression" in The New England Journal of Medicine (IF: 96.3). Type 1 diabetes patients rely on insulin injection for life, treatmentThe method is to transplant pancreatic beta cells. However, traditional transplantation requires long-term use of immunosuppressants, which brings risks such as infection, tumors, and renal dysfunction.
This research is Sana's UP421 pipeline based on the HIP platform, which can achieve "no immunosuppressive" allogeneic islet cell transplantation in human body, that is, without using immunosuppressive agents, gene edited allogeneic islet β cells can be successfully transplanted to treat type 1 diabetes.
Technical route:
(1) After isolating human pancreatic islets from cadaveric pancreas, CRISPR-Cas12b double knockout was performed on primary pancreatic islet cells
•B2M+CIITA: Eliminate HLA-I/II and prevent T cell recognition
(2) Using lentivirus to introduce CD47 overexpression (braking NK/macrophages)
(3) Inject UP421 product into the human body through multiple points of forearm muscle without using immunosuppressive drugs, and follow up for 12 weeks
Clinical results:
A 42 year old T1D patient with persistent positive C-peptide and good blood glucose response. And zero immune response (no T cells, antibodies, NK cells)!
03. What is the HIP (Hypoimune) platform that can be used simultaneously by both hands?
The biggest challenge faced by traditional allogeneic cell therapy is immune rejection. The patient's immune system recognizes and attacks foreign cells, leading to treatment failure. For this reason, patients usually need to receive strong immunosuppressive therapy, which poses risks such as infection. Sana Company has developed a HIP platform through gene editing technology, known as the "Cell Invisibility Technique" three piece set:
•CRISPR double knocking HLA: cutting off all HLA-I/II on the cell surface, making T cells "unrecognizable".
•High expression of CD47: Coat cells with a "don't eat me" coat and discourage NK/macrophages.
•Delivery using lentiviral vectors: CD19-CAR or pancreatic islet genes are loaded along the way, and the therapeutic function is achieved in one step.
Realize that patients do not need lifelong use of immunosuppression, truly "spot" universal cell drugs!In both studies, the in vitro gene editing electroporation steps were performed using the MaxCyte ExPERT series flow cytometry platform
•Under GMP conditions, efficient delivery of CRISPR-Cas12b+gRNA in one go achieves efficient multi-target knockout
•Cell viability>90%
•Enable Sana to complete the manufacturing of HIP finished products from donor cells within 7-9 days
MaxCyte's' Non viral Lightning Efficient Delivery 'provides critical support for the clinical production of HIP cells!This company, founded in 2018, signed a strategic platform authorization license with MaxCyte in 2021!
Sana, with the support of HIP platform and MaxCyte flow cytometry technology, not only solves the problem of immune rejection in allogeneic cell transplantation, but also opens up a new era of "universal" cell therapy. 850 million US dollars market value? Perhaps it's just the starting point.
*Reference:
1. Hu et al., Hypoimmune CD19 CAR T cells evade allorejection in patients with cancer and autoimmune disease, Cell Stem Cell (2025). DOI: 10.1016/j.stem.2025.07.009
2. Carlsson et al., Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression, The New England Journal of Medicine (2025). DOI: 10.1056/NEJMoa2503822
▍More product details:
MaxCyte was founded in 1999 and is headquartered in Maryland, USA. It is a provider of cell engineering electroporation technology solutions. Utilize its ExPERT ™ The electroporation platform can efficiently and stably achieve engineering processing of large-scale cells, meeting the full stage of cell transfection needs from early research, clinical development to commercial production. It widely serves fields such as antibody protein expression, vaccine development, gene editing, and cell and gene therapy. As the general agent of MaxCyte in the southern region of China, Shanghai Haoxuan will provide you with professional solutions and technical support that meet your cell transfection requirements at different stages of research and development, clinical practice, and commercial production.
▍Regarding Shanghai Haokuan:
Shanghai Haokuo Scientific Equipment Co., Ltd. was established in 2019 and is headquartered in Shanghai. It is a professional service provider of laboratory equipment/consumables and analytical instruments. The company is committed to providing high-tech professional equipment and technical consulting services to customers in the fields of biology, medicine, physical property testing, chemical analysis, food, industrial production, and other related fields at home and abroad.