CELL AND GENE THERAPY, MEDICAL
Be The Match BioTherapies® | January 18, 2023
On January 17, 2023, Be The Match BioTherapies, a company that provides solutions for organizations that develop and commercialize cell and gene therapies, introduced its offering of CIBMTR® clinical research organization services (CRO services), which significantly reduces the time needed to launch and execute high-impact clinical trials.
These CRO services are the outcome of a collaboration between Be The Match BioTherapies and CIBMTR, resulting in expertise and access to unmatched research, sites, donors, partnerships, scientific and operational knowledge, and other resources.
CIBMTR CRO services offer unique capabilities such as
Established relationships with over 225 clinical locations domestically
Nearly 20 years of expertise in transplant and cellular therapy trials and study management, as well as clinically-trained staff
On-staff transplant physicians provide direct contact with patients and donors for clinical and research insights.
A link to the CIBMTR outcomes database for over 575,000 patients
The new CRO services offer turn-key solutions, including protocol development and approval oversight, site selection, project management, site start-up, research sample/laboratory coordination, data management, study monitoring, patient-reported outcomes, statistical analysis, and financial administration. For certain services, such as data analysis, surveys, site selection and administration, and sample management, businesses may instead rely on the expertise of CIBMTR CRO services.
About Be The Match BioTherapies®
Be The Match BioTherapies is the sole supplier of cell and gene therapy solutions with fully configurable services to assist the cell therapy supply chain. It is committed to accelerating patient access to life-saving cell and gene treatments by delivering the best-quality cellular source material from Be The Match Registry®, the most-varied registry of prospective blood stem cell donors in the world, with over 7 million potential blood stem cell donors. Through global collaborations with apheresis, bone marrow collection, and transplant centers, the firm creates, onboards, trains, and maintains extensive collection networks to advance cell treatments.
INDUSTRIAL IMPACT, MEDICAL
Inscripta, Inc. | January 24, 2023
Inscripta®, a leading global life science technology firm, recently announced the acquisition of two synthetic biology pioneers, Infinome Biosciences and Sestina Bio, which will advance Inscripta's strategy of developing and commercializing biomanufactured products for a wide expanse of industrial and consumer markets.
The acquisitions show Inscripta's belief in the bioeconomy's commercial potential and the power of genome engineering to expedite biomanufacturing innovation. Inscripta's CEO, Sri Kosaraju, commented, "Tackling the unprecedented opportunity to improve global health and sustainability through biomanufacturing requires a strong combination of talent, experience, technology, and commercial assets." He added, "Infinome and Sestina Bio allow us to advance our strategy and complement our technological innovation and capabilities needed for creating the next generation of biobased manufacturing products and processes."
(Source- PR Newswire)
Before the acquisition, Infinome was closely associated with Inscripta. By utilizing Inscripta's genome engineering technology, it created the GenoScaler™, a proprietary strain engineering platform designed to optimize microorganisms for biomanufacturing rapidly.
Sestina Bio brings an innovative, data-driven approach to developing and identifying strains that survive the rigors of commercial scale-up.
Inscripta is building on its tradition of technological innovation with the inclusion of Infinome and Sestina Bio and has already begun applying its cutting-edge technology to develop products for a diverse set of industrial and consumer markets. In addition, Inscripta has a number of collaborative and proprietary products in various phases of development. One such example of an announced partnership to develop and commercialize multiple bio-manufactured goods is Kalsec® Inc., a food and beverage ingredient solutions firm. Separately, Inscripta is engaging in commercial discussions about its previously announced development of a ready-to-scale microbial strain that produces Bakuchiol, a natural retinol alternative.
About Inscripta, Inc.
Founded in 2015, Inscripta is a life science technology firm dedicated to using biomanufacturing to create a cleaner, healthier, and more sustainable world. It enables scientists to strengthen and expand domestic biomanufacturing and encourages the development of novel, safe, and secure biotechnology technologies. Its automated OnyxTM platform, which includes an instrument, consumables, tests, and software, makes CRISPR-based genome engineering accessible to any research lab. Inscripta supports customers globally through its facilities in Boulder (Colorado), San Diego and Pleasanton (California) and Copenhagen (Denmark)
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.