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
Aldevron | January 20, 2023
Aldevron®, a worldwide leader in the custom development and production of plasmid DNA, RNA, and proteins for the biotech sector, recently announced the launch of Eureca-V™ nuclease.
Eureca-V™, licensed from Inscripta®, is the wild-type MAD7® CRISPR Type-V nuclease at research grade, with GMP to follow.
The launch of Aldevron's Eureca-V nuclease at advanced therapies week expands the toolkit of accessible CRISPR nucleases for therapeutic, diagnostic, and agricultural workflows. In addition, a pass-through license for research use is conveyed with the purchase of Eureca-V nuclease, allowing customers to thoroughly examine the product without committing to a long-term licensing agreement.
Vice President and General Manager of Aldevron's Protein Business Unit, Tom Foti, said, "The availability of Eureca-V drives forward the entire genomics medicine industry and enhances Aldevron's position as a supplier of choice for CRISPR drug substances and drug products." He added, "We are proud to work alongside our partners at Inscripta to bring the innovative, off-the-shelf catalog product to market now as well as provide a clear path to GMP in 2023."
(Source – Cision PR Newswire)
Eureca-V at the research grade level ensures the acceleration of CRISPR translational research. In addition, the product will assist academic and commercial scientists seeking a wild-type Type-V CRISPR nuclease that targets T-rich regions of the genome.
Venkata Indurthi, Chief Scientific Officer at Aldevron, expressed, "We are thrilled to offer Eureca-V product at research grade starting today, and later this year, our clients can expect a smooth transition to our GMP product." He further added, "Aldevron's extensive history in CRISPR nucleases allows researchers to develop therapies that will eventually address global health issues."
(Source – Cision PR Newswire)
It will be the third GMP CRISPR nuclease by Aldevron and the first Type-V nuclease available as a GMP catalog product. It is a leader in supplying vital raw materials and reagents used for cell and gene therapy manufacturing. The company's portfolio of CRISPR nucleases is applied globally in preclinical and clinical research applications.
Aldevron is a pioneer in advancing biological science. Its custom development and manufacturing services have provided scientists all across the world with the components they need to accelerate research and create labs for revolutionary science and breakthrough discoveries. The company aims to deliver products and services that contribute significantly to global biological research. It seeks to be the partner of choice forproducing high-quality plasmid DNA, proteins, enzymes, and other biologicals to support its clients' goals.
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
ImmunoGen, Inc. | March 02, 2023
On March 1, 2023, ImmunoGen, Inc., a leading firm specializing in antibody-drug conjugates (ADCs), announced a global, multi-target license and option agreement with Vertex Pharmaceuticals. The deal provides Vertex with the rights to use ImmunoGen's ADC technology to research and discover targeted conditioning agents to be used in gene editing.
After each research period, Vertex will have the option to obtain an exclusive worldwide license to research, develop, and commercialize conditioning agents using ImmunoGen's technology for that target. ImmunoGen will hol full rights to the ADC technology for any targets not covered by the Vertex license.
Vertex will pay an upfront payment of $15 million as part of the agreement. In addition, ImmunoGen is eligible to receive up to $337 million in option exercise fees, development, and commercial milestone payments for each target. ImmunoGen will also receive tiered royalties as a percentage of worldwide commercial sales of licensed targeted conditioning agents by Vertex. Vertex will be responsible for all research, development, and commercialization costs.
ImmunoGen's Executive Vice President, Research, Development, and Medical Affairs, Michael Vasconcelles, MD, commented, "Given Vertex's extensive experience discovering and developing transformative medicines for patients with serious diseases, we are thrilled they have chosen to explore ImmunoGen's technology to develop ADCs for transplant conditioning in connection with gene editing." He further emphasized, "This agreement reflects our continued innovation in the ADC space and demonstrates the value of our technology platform and related intellectual property."
(Source – Business Wire)
About ImmunoGen, Inc.
ImmunoGen is dedicated to improving the lives of people with cancer by developing precise, targeted cancer therapies. Its lead product candidate is a first-in-class ADC called mirvetuximab soravtansine, which targets folate receptor alpha (FRα) and is being studied in multiple ovarian cancer trials. The company's second program, IMGN632, is a CD123-targeting ADC being studied for the treatment of BPDCN and AML. ImmunoGen is also developing two earlier-stage assets: IMGC936, an ADAM9-targeting ADC co-developed with MacroGenics, and IMGN151, a next-generation anti-folate receptor alpha ADC. The company aims to keep cancer from disrupting people's lives and get them back to living today, tomorrow, and beyond.