Genome Engineered B-cell Therapeutics
Innovative B-cell Immunotherapy for HER2-positive Cancers and B-cell Gene Therapy for Those with Severe Hemophilia A
Innovative B-cell Immunotherapy for HER2-positive Cancers and B-cell Gene Therapy for Those with Severe Hemophilia A
Bespoke Biotherapeutics was created to overcome obstacles to the effective natural immune response and limitations of currently approved immunotherapies against cancer by inventing novel, customized (i.e., bespoke) "living drugs" called engineered B-cell therapeutics. Most recently and because of Bespoke's focus on the non-viral integration of large (greater than 5kb) transgene cargo into B-cells, Bespoke has added a program focused on chronic coagulation factor VIII replacement therapy for persons with severe hemophilia A.
Bespoke is built upon customized B-cell sourcing, isolation, activation, culture expansion, and non-viral genetic engineering methodologies uniquely suited to optimize commercial B-cell products for infusion. As illustrated in the manufacturing process figure below, we avoid the costs and limitations of apheresis procedures, chemotherpy conditioning, and virus-based technologies.
Bespoke is focused on utilizing its platform technologies including NINJA engineering (non-viral, large transgene, homology-mediated end-joining using CRISPR/Cas9) to create a pipeline of autologous and allogeneic (off-the-shelf) products to address the needs of persons with solid tumor cancers and those with severe (i.e., associated with spontaneous bleeding) hemophilia A.
Bespoke's innovative technology and impactful pipeline are supported by intellectual property (IP) including eleven (11) granted US and three (3) granted international B-cell engineering patents plus multiple pending B-cell engineering patent applications. This IP position favorably positions the company and serves as a foundation upon which additional new patent applications will be generated.
Steven is a results-driven biotechnology leader and entrepreneur with over 25 years of academic and business experience, including private and public company CEO roles. He has led successful INDs, NDAs, product approvals, fundraising, and exits. Prior to industry, he held leadership clinical, science, and education roles at the Cleveland Clinic and St. Jude Children's Research Hospital.
Branden is a pioneer and expert in viral and non-viral immune cell genome engineering. He leads a robust academic research program focused on engineering B-cells and other immune cells into immunotherapies for clinical trial. He co-founded B-MoGen Biotechnologies (acquired by Bio-Techne) and Catamaran Bio, a company focused on engineered NK-cell therapies against cancer.
Kirk has over 25 years of pharmaceutical and biotechnology drug development experience, specializing in bio-manufacturing technical operations, including all aspects of chemistry, manufacturing, and controls. He has extensive FDA regulatory experience related to a broad array of personalized autologous and off-the-shelf, allogeneic cellular therapies, including CAR-T products.
Tullia is a leader in the fields of intra-tumoral B-cell function, spatial imaging, and transcriptomics. Her research lab is focused on the study of how B-cells impact T-cells in the tumor microenvironment within tumor-associated (tertiary) lymphoid structures. Tullia is an Assistant Professor of Immunology at the University of Pittsburgh and a faculty member in the Tumor Microenvironment Center and Cancer Immunology and Immunotherapy Program at the UPMC Hillman Cancer Center. She completed her doctoral training at Johns Hopkins and post-doctoral training at the University of Colorado - both with a focus in tumor immunology. Tullia is active in the Society for Immunotherapy of Cancer and a co-organizer of the B-cells in Cancer Consortium (BC^3).
Brad is a distinguished scientist and inventor of immune-based strategies to prevent, detect, and treat cancer. His laboratory uses
genomic technologies, bioinformatics, clinical specimens, and animal models to map the immune response to solid tumors such as breast, ovarian, and prostate cancers.
Brad is the scientific co-director of British Columbia's Cancer's Immunotherapy Program, Professor of Biochemistry/Microbiology at the University of Victoria, Professor of Medical Genetics at the University of British Columbia, and founding Director of the Deeley Research Centre. He completed his doctoral training at the UC Berkeley and post-doctoral training at the Fred Hutchinson Cancer Research Center. Brad is a co-organizer of BC^3 along with Tullia Bruno.
Justin is a rising star in the fields of B-cell immunology, antibody production, and B-cell engineering. His laboratory uses advanced genome editing techniques to produce engineered B-cells capable of producing protective antibodies against viral pathogens, some of which are associated with cancer development. Justin is an Associate Professor in the Department of Medicine and Member of the Beirne B. Carter Immunology Center at the University of Virginia. He completed his doctoral training in immunology at the University of Pennsylvania and post-doctoral training at the University of Minnesota.
Yuliya is well-known for her groundbreaking and innovative research in the field of regulatory B-cells and the role of interleukin-35 in cancer. Her laboratory specifically focuses on immune response evasion and the role of B-cells in Kras driven pancreatic cancer as well as evolution of the tumor microenvironment. Yuliya is an Associate Professor of Genetics and Member of the Lineberger Cancer Center at the University of North Carolina, Chapel Hill. She completed her doctoral training at Weill Cornell Graduate School of Medical Sciences / Sloan-Kettering Division and post-doctoral training at New York University School of Medicine.
Bespoke is reprogramming human, peripheral blood-derived B-cells into intuitive "living drug" immunotherapies. Our unique anti-cancer and hemophilia A platforms, described below, involve different combinations of engineered functions in order to target the particular needs of persons with specific solid tumor cancers, specific cancer stages, and different hemophilia A treatment needs. Engineered functions can include specific tissue homing, tumor-associated antigen binding, tumor antigen presentation to T-cells, tumor reactive antibody secretion, immuno-modulatory cytokine secretion, T-cell co-stimulation, secretion of biomarker molecules, and actuatable (i.e., inducible or conditional) coagulation factor VIII expression and secretion.
Cancer Sentinels are designed to seek and destroy residual and recurrent cancer cells following completion of primary surgical and adjuvant therapy in select, high-risk Stage II and Stage III solid tumor cancer patient populations. The goal is to prevent clinical relapse, especially as metastatic disease, extend survival, and mitigate the emotional distress associated with standard "watch and wait" cancer surveillance.
Cancer Rangers are designed to engage and eliminate measurable and occult cancer in select patients with metastatic solid tumor cancers. The B-cells in Cancer Rangers are engineered to provide a tumor-localized and multimodal attack on the cancer cells. Cancer Rangers are being developed as a standalone therapy and to be used in combination with other immunotherapy, such as immune checkpoint inhibitors and CAR-T.
"Boostable" Gene Tx is a platform that supports the constitutive and conditional (i.e., inducible) expression and secretion, thus replacement, of a deficient enzyme or protein co-factor, like coagulation factor VIII. The B-cells in "boostable" gene Tx are engineered to chronically produce the desired protein. If an increase in the basal production of such a protein is desired for any reason, the patient need only receive an inoculation instead of a repeat injection of more engineered B-cells. The inoculation stimulates an engineered B-cell receptor that causes an increase in the number of factor VIII producing B-cells, for example. This saves time, reduces cost, and addresses the individualized needs of patients.
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Nat Biomed Eng 2023; Epub ahead of print.
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To learn more about Bespoke Biotherapeutics and communicate directly with a member of the company's leadership team, please use the email links below.
San Carlos, California, United States
steven@bespokebiotx.com (General, Medical, and Finance Inquiries) branden@bespokebiotx.com (Scientific Operations Inquiries) kirk@bespokebiotx.com (Technical Operations and PD Inquires)
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