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.
CELL AND GENE THERAPY, MEDTECH
Pear Therapeutics | January 09, 2023
Pear Therapeutics, Inc., the leader in commercializing and developing software-based medicines known as prescription digital therapeutics (PDTs), announced the expansion of its collaboration with Spero Health, an integrated healthcare services organization.
Spero Health, which has adopted reSET® and reSET-O® at 14 locations in Kentucky, plans to expand access to eligible patients at its remaining 99 locations in Kentucky, Indiana, Ohio, Tennessee, Virginia, and West Virginia. Offering new FDA-approved treatment options is a part of Spero Health's mission to promote patient engagement and retention in recovery.
Steve Priest, Spero Health’s CEO said, “Spero Health continues to find innovative ways with new technologies to bring solutions to our communities that have been devastated by drug overdose, and we are looking forward to our collaboration with Pear Therapeutics to pursue even better outcomes in treatment.”
Adding to this, he further said, “Pear’s technology equips our clinicians with vital measurements via a clinician dashboard that allows us to provide quality care to our patients who suffer from substance use disorders. We believe having access to patient reported data via Pear’s clinician dashboard gives us better insight into patient behaviors. We expect that this approach will help to increase compliance and create efficiencies in how our treatment teams deliver care.” (Source: BusinessWire)
Spero Health's two implemented products, reSET® and reSET-O®, have been measured in real-world use, and their therapeutic content has been evaluated in randomized controlled trials, with the results published in peer-reviewed medical journals. reSET® is used for patients aged 18 or older with substance use disorder as a monotherapy, whereas reSET-O® is used in combination with buprenorphine-based medication-assisted treatment for patients 18 and older with opioid use disorder.
About Pear Therapeutics
Pear Therapeutics, Inc., the parent firm of Pear Therapeutics (US) Inc., is a leader in the development and marketing of software-based pharmaceuticals, also known as prescription digital therapeutics (PDTs). The company intends to transform care through the widespread adoption of clinically validated software-based therapeutics to provide improved patient outcomes, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers.
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.