INDUSTRIAL IMPACT, DIAGNOSTICS
Kite Pharma and Arcellx | January 31, 2023
On January 30, 2023, Kite and Arcellx, Inc. informed that they have completed their previously-announced global strategic collaboration to co-develop and co-market CART-ddBCMA.
CART-ddBCMA is Arcellx's lead late-stage candidate for treating patients with relapsed or refractory multiple myeloma.
For the majority of patients, multiple myeloma is an incurable disease; hence, there is a continuing demand for treatments that are not only effective but also secure and easily available.
Arcellx's T-cell treatment, CART-ddBCMA, uses the company's unique synthetic binder, the D-Domain, and is now being studied in Phase 2 pivotal trials. Kite and Arcellx will work together to develop and market the CART-ddBCMA asset in the United States, while Kite will handle sales and marketing for the product in all other regions.
About Kite Pharma
Kite, a Gilead company, is a global biopharmaceutical company with its headquarters in Santa Monica (California). Cell therapy, which aims to treat and maybe even cure cancer, is the company's main area of research and development. Kite, the industry leader in cell therapy, has successfully administered CAR T-cell treatment to more patients than any other company. Process development, vector production, clinical trial supply, and commercial product manufacturing are all part of Kite's expansive in-house cell therapy manufacturing network, the most extensive in the world.
Clinical biotechnology firm Arcellx, Inc. is rethinking cell treatment by developing novel immunotherapies for patients with cancer and other fatal diseases. The company considers cell therapies one of the most promising areas of modern medicine. Its goal is to improve the quality of life for people everywhere by creating safer, more effective, and widely available cell therapies. CART-ddBCMA is the principal product candidate being developed by Arcellx and is now in Phase 2 pivotal trials for treating relapsed or refractory multiple myeloma (r/r MM). The FDA has recognized CART-potential ddBCMAs by designating them as a regenerative medicine advanced therapy, an orphan drug, and a fast-track product.
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Evaxion Biotech A/S | January 23, 2023
Evaxion Biotech A/S, a leading clinical-stage biotechnology firm focused on the development of AI-driven immunotherapies, recently announced that FDA has granted fast-track designation for the Company's customized cancer therapy, EVX-01, in conjunction with KEYTRUDA®.
In December 2022, Evaxion gained FDA clearance to proceed with its phase 2b clinical test, where patients with metastatic melanoma are given EVX-01 in combination with KEYTRUDA®. In addition, Evaxion obtained fast-track designation for the vaccine candidate on January 17, 2023. The fast track is developed to expedite FDA's assessment of innovative, novel medications with the potential to meet an unfulfilled medical need.
EVX-01, a peptide-based immunotherapy for cancer, is Evaxion's most advanced clinical asset. The program generates a unique medicine for each patient based on gene analysis of their malignancies and matching with their immune system. The Company's proprietary AI platform, PIONEER, helps facilitate this process.
Per Norlén, CEO at Evaxion, commented," We are extremely pleased that our cancer vaccine candidate EVX-01 has received the FDA fast track designation, as it enables a potentially faster approval of the vaccine. This is first and foremost to the benefit of the patients. And it is a great validation of our AI platform, PIONEER, and our drug development candidate."
(Source – Globe Newswire)
The ongoing Phase 2b clinical trial is being done at sites in Europe, the United States, and Australia. It is conducted in partnership with Merck, which supplies its PD-1 inhibitor KEYTRUDA®. The trial was launched in Australia when the first patient was enrolled in September 2022.
About Evaxion Biotech A/S
Evaxion is a clinical-stage AI-immunology™ platform company using AI, engineering expertise and drug development knowledge to identify and develop novel immunotherapies for the treatment of various cancers, bacterial diseases and viral infections. It has utilized artificial intelligence to build a diverse pipeline of candidate immunotherapies that target two of the most critical unmet medical needs in the world, cancer and infectious diseases. Its three proprietary AI platforms include PIONEER, EDEN and RAVEN.
Genomic Vision | March 08, 2023
On March 7, 2023, Genomic Vision, a leading biotech company that develops products and services for the analysis and control of genome changes, launched FiberSmart®, an AI-based technology for automating the quantification and detection of fluorescent signals on combed DNA molecules.
Initially available for the analysis of Replication Combing Assays (RCA), Genomic Vision's proprietary method for directly visualizing DNA replication kinetics at the single molecule level. FiberSmart uses advanced AI methods to detect, visualize, and analyze DNA replication kinetics up to 3x more accurately and up to 10x faster than Genomic Vision's existing software solutions.
The technology offers a simple and user-friendly interface, facilitating quick analysis of DNA replication signals to deduce essential parameters describing replication kinetics.
It is compatible with Genomic Vision's FiberVision® and FiberVision-S® scanners for the RCA assay of the company's proprietary DNA combing technology with various potential applications, including in gene and cell therapy quality control.
FiberSmart has been successfully tested and validated by AstraZeneca and the Fritz Lipmann Institute in Germany.
Genomic Vision's CEO Aaron Bensimon said, "The launch of FiberSmart® is an important milestone for Genomic Vision as we bring the benefits of powerful AI technology to our users, who can now perform faster and more accurate genomic analysis seamlessly. Our proprietary DNA combing technique has multiple potential applications, particularly in the cell and gene therapy space, where highly accurate genomic analysis is paramount to ensure robust quality standards are met. With the launch of this software we are making it easier for users to exploit the full potential of our proprietary advanced genomic analysis technique."
(Source – Business Wire)
About Genomic Vision
GENOMIC VISION is a leading biotechnology company specializing in the analysis of genome modifications, with a focus on ensuring their quality and safety in genome editing technologies and biomanufacturing processes. It utilizes advanced nanotechnology for DNA analysis to develop cutting-edge diagnostic and drug discovery solutions for cancer and acute diseases at the intersection of genome dynamics and human diseases. The company's approach employs Molecular Combing Technology, a powerful technique that directly visualizes single DNA molecules to detect and quantify changes in the genome landscape and their contribution to pathology.