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.
Read More
INDUSTRIAL IMPACT, MEDICAL
Kymanox | February 06, 2023
Kymanox, a leading life science-focused professional services firm, recently announced the acquisition of anteris medical GmbH and anteris helvetia AG (collectively anteris). Anteris specializes in assisting the commercialization and development of medical equipment, combination and in-vitro diagnostic products.
This acquisition enables both firms to achieve their common organizational goal of geographic expansion while enhancing their service capabilities by offering clients a greater range of highly specialized services. Customers who bring essential biologics, such as pharmaceuticals, cell and gene therapies (C>s) and biosimilars, medical devices, and drug/device combos to global markets will benefit significantly from the combined service offerings and office locations of the combined firms. In addition, by merging the technological, scientific, and regulatory expertise of both organizations, customers will actually benefit from this synergy to ensure FDA, EMA, Notified Bodies, and other health authorities' compliance and submission excellence.
Anteris, with its offices in Holzkirchen, Germany, and Küssnacht a.R., Switzerland, offers resource-efficient and innovative solutions for end-to-end development, technical documentation, and compliance to the life science and medical device sectors. Members of Anteris' technical, quality, and regulatory teams have decades of collective expertise in combination product and device development, with a focus on biosimilar development and registration, MDR, EU, CE marking, 510(k) submissions, and quality systems regulations across all key markets.
About Kymanox
Founded in 2004, Kymanox is a life science professional services firm that provides scientific, engineering, project management, quality, human factors, testing/CQV, QC, and regulatory assistance to firms in the biotechnology, pharmaceutical, medical device, and combination product sectors. It assists in getting products from the bench to the patient and distinguishes itself by providing a wide variety of technical services and products as well as comprehensive project implementation. The company offers its services to clients worldwide from its headquarters in Raleigh (RTP), North Carolina, as well as offices throughout the United States.
Read More
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)
Read More