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.
INDUSTRIAL IMPACT, MEDICAL
Twist Bioscience | March 10, 2023
On March 9, 2023, Twist Bioscience Corporation, a leading firm providing high-quality synthetic DNA through its silicon platform, announced the launch of integrated antibody discovery services. This premium offering combines the company's synthetic libraries and AI machine learning with an in vivo immunization approach acquired through its acquisition of Abveris, also known as Twist Boston. This service provides customers with optimized, development-ready antibody candidates.
The combined team, now called Twist Biopharma Solutions, is led by Tracey Mullen, MBA, the senior vice president of biopharma for Twist Bioscience. This newly formed entity leverages years of industry expertise, scientific excellence, and proprietary technology to discover the best antibody candidate for therapeutic targets of interest.
Twist Biopharma Solutions offers an end-to-end workflow for centralized antibody discovery and optimization, including target validation, hit generation, lead selection, lead optimization, and lead characterization. Twist, supported by high-throughput DNA synthesis and IgG antibody production, constructs extensive and particular synthetic antibody libraries with discovery starting with either in vivo or in vitro diversity.
The newly integrated in vivo discovery approach from Abveris of single B cell screening and hybridoma discovery enables parallel paths where multiple technology methods can be leveraged to build a panel of highly diverse antibody leads with broad epitope coverage. In addition, this multi-pronged approach can increase the likelihood of discovering highly specific, high-affinity functional antibodies by sampling synthetic and natural diversity.
The South San Francisco and Boston biopharma teams were combined to create Twist Biopharma Solutions, led by Tracey Mullen. Aaron Sato, Ph.D., remains integrally involved in Twist Biopharma Solutions and, as a chief scientific officer of Twist Bioscience, extends his expertise across the organization. Tracey Mullen joined Twist Bioscience in November 2021 through the acquisition of Abveris. In April 2022, she took on the position of senior vice president of operations, driving the completion of the Factory of the Future in Wilsonville, Oregon, which began shipping products in January 2023. Before joining Twist, she served as CEO of Abveris and worked on the antibody discovery team at Biogen.
About Twist Bioscience
Twist Bioscience is a leading biotechnology company specializing in synthetic biology and genomics. It has developed a proprietary DNA synthesis platform that enables the production of custom-designed DNA strands faster, more accurately, and at a lower cost than traditional methods. In addition, Twist collaborates with partners across industries to develop customized DNA sequences for specific applications and offers a range of other products and services, such as oligonucleotides, synthetic genes, and custom panels for next-generation sequencing. The company has also developed a library of over 100 billion synthetic antibodies, which can be used for diagnostic and therapeutic applications.
CELL AND GENE THERAPY, MEDICAL
QIAGEN | January 11, 2023
QIAGEN recently announced its acquisition of Verogen, a leader in utilizing next-generation sequencing (NGS) technologies to advance the future of human identification (HID) and forensic investigation.
QIAGEN, which introduced the first commercial kits to purify DNA from forensic casework samples in the late 1990s, is one of the leaders in the HID/forensics sector.
Verogen, a privately-owned company launched in 2017, provides NGS tools and professional services to the worldwide human identification community to assist in resolving criminal and missing-person situations.
Thierry Bernard, CEO of QIAGEN, said, “Bringing together Verogen and QIAGEN creates a unique opportunity to better help investigators and researchers to advance forensic science and to find missing persons, accurately identify suspects and exonerate the innocent.”
(Source: Business Wire)
Brett Williams, CEO of Verogen, stated, “We are proud to take our successful partnership with QIAGEN to the next level in a combination that we believe creates significant advantages for all stakeholders.”
(Source: Business Wire)
Verogen's sequencing and analysis solutions are optimized for Illumina's MiSeq FGx® Sequencing System. Due to this acquisition, QIAGEN receives exclusive distribution rights for this version of the MiSeq sequencer designed exclusively for forensics applications.
So far, more than 300 MiSeq FGx Sequencing Systems have been placed, making a strong debut in this market segment. The Verogen portfolio of kits for use on this sequencer includes the ForenSeq suite of kits, consisting of the DNA Signature Prep, Kintelligence, Imagen, and MainstAY product lines, which provide forensics professionals with better answers to aid in the resolution of the most difficult unsolved cases.
Additionally, QIAGEN gains complete access to Verogen's leading GEDmatch database and GEDmatch PRO™ interface. GEDmatch, which presently has more than 1.8 million genealogical profiles, is continuously expanding and enabling users to upload genetic profiles created by other genealogy websites to broaden the search for familial connections. In addition, GEDmatch PRO™ is designed to assist law enforcement and forensic teams with investigative comparisons of data submitted by GEDmatch users with their consent.
QIAGEN is a leading worldwide provider of Sample to Insight solutions, which allow clients to get valuable molecular insights from samples containing biomolecules. Its sample technologies isolate and process RNA, DNA, and proteins from blood, tissue, and other materials. In addition, the assay technologies make these biomolecules visible and accessible for analysis.