CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Caris Life Sciences | March 09, 2023
Caris Life Sciences®, a leading molecular science and technology firm and Incyte Corporation have recently announced a strategic research partnership to advance precision medicine approaches for Incyte's oncology pipeline.
Caris' innovative technology integrates data from whole exome sequencing, protein analysis, whole transcriptome sequencing and proprietary AI models and signatures to enhance patient outcomes through personalized medicine development. The partnership will initially apply Caris' data and analytics tools, comprehensive molecular liquid and tissue profiling services, and clinical trial enrollment program capabilities spans two therapeutic programs, with the option to expand to four total programs.
Incyte will use Caris' data insights and analytics capabilities to uncover novel biomarkers and enhance clinical positioning strategies for its oncology initiatives. Patients enrolling in Incyte-led clinical trials will be subjected to longitudinal testing with Caris' comprehensive tissue and liquid molecular profiling tests for drug candidates developed as part of the agreement. Incyte will also use Caris' biomarker-driven patient selection for clinical trials, with the possibility of collaborating on creating companion diagnostics for the partnership's programs.
Caris Life Sciences President and Chief Scientific Officer David Spetzler, MS, Ph.D., MBA, commented, "This partnership with Incyte will leverage Caris' leading molecular science and technology solutions to support Incyte's oncology research and development efforts." He further emphasized, "The aggregate strength of our platform, which provides patient level DNA and RNA data both in tissue and blood, may help to better identify and predict patient response to therapy, which in turn may accelerate clinical trial enrollment, optimize clinical positioning and potentially enhance technical and regulatory success."
(Source – PR Newswire)
About Caris Life Sciences
Caris Life Sciences® is a leading molecular science firm that utilizes advanced technologies to revolutionize healthcare. Its suite of molecular profiling offerings, which assess RNA, DNA and proteins, enables patients, researchers and physicians to improve outcomes and save lives by revealing a molecular blueprint. Additionally, it is advancing precision medicine through the use of advanced AI and machine learning algorithms by utilizing its proprietary analytics engine, DEAN™, to develop a better understanding of the molecular mechanisms of cancer. This information helps physicians to better identify and predict patient response to therapy and supports researchers and biopharmaceutical companies in research development, clinical trials, and target identification. With headquarters in Irving, Texas, the company has offices in several locations worldwide, providing services throughout the US, Europe, Asia, and other international markets.
INDUSTRIAL IMPACT, DIAGNOSTICS
Globenewswire | April 10, 2023
Avid Bioservices, Inc. a dedicated biologics contract development and manufacturing organization working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, announced the completion of two expansions within the company’s mammalian cell facilities. The company expects that the first customer for the newly expanded CGMP mammalian cell suites will begin manufacture this month. To celebrate the launch of the newly expanded facilities, Avid is hosting an open house and tour for existing and prospective clients.
“We are proud to unveil our completed expansions and excited to kick off the first customer project within our latest, state-of-the-art mammalian cell manufacturing suites. These build-outs involved great complexity and required exemplary efforts from our entire team. I would like to acknowledge the tremendous work from everyone who played a role in completing these significant projects on schedule,” said Nick Green, president and chief executive officer of Avid Bioservices. “This launch could not be timed any better based on the significant demand we continue to see for our mammalian cell services, highlighted by significant new business wins and the largest backlog in the history of the company.”
The newly expanded manufacturing capacity includes both upstream and downstream CGMP manufacturing suites and serves as complement to Avid’s existing Myford facility, providing increased capacity to address the needs of both existing and future mammalian cell business customers. The addition of the capacity provided by the new manufacturing suites within the Myford facility has the potential to generate approximately an additional $100 million in annual revenue.
In addition to the launch of the newly expanded Myford facility, Avid also announced the completion of its mammalian cell process development expansion, which has doubled the company’s total process development capacity. Now operational, these new capabilities have the potential to support up to an additional $25 million in annual process development revenue.
With the completion of these mammalian cell capacity expansion projects, Avid’s sole ongoing expansion effort involves the build-out of its new cell and gene therapy facility which will support early-stage development through commercial manufacturing. The company has already launched analytical and process development capabilities at this viral vector facility and remains on track to launch the CGMP manufacturing suites by the end of the third quarter of calendar 2023.
Upon completion of the CGT Facility, we estimate that our combined facilities will have the potential to bring our total revenue generating capacity to up to approximately $400 million annually.
About Avid Bioservices, Inc.
Avid Bioservices an S&P SmallCap 600 company, is a dedicated contract development and manufacturing organization focused on development and CGMP manufacturing of biologics. The company provides a comprehensive range of process development, CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 30 years of experience producing monoclonal antibodies and recombinant proteins, Avid's services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. For early-stage programs the company provides a variety of process development activities, including upstream and downstream development and optimization, analytical methods development, testing and characterization. The scope of our services ranges from standalone process development projects to full development and manufacturing programs through commercialization.
Globenewswire | May 15, 2023
TriLink BioTechnologies a Maravai LifeSciences company and global provider of life science reagents and services, has launched its newest cap analog, CleanCap® M6 . The latest CleanCap analog is expected to help developers and researchers maximize the impact of their mRNA therapeutics and vaccines while reducing overall manufacturing costs, bringing life-changing medicines to market faster.
With the introduction of the CleanCap M6 technology, legacy capping methods like enzymatic and ARCA may be a thing of the past. By combining the modification of 3’OMe on the m7-Guanosine and the additional methyl modification on the +1 Adenosine, the CleanCap M6 analog is expected to improve mRNA potency with the highest protein expression of any CleanCap analog yet. Combined with technology’s single-pot reaction capabilities that shrink manufacturing times and increase mRNA yields with a purity profile of >95%, CleanCap analogs are novel mRNA Cap structures, which may improve the benefits of an mRNA therapeutic or vaccine.
“TriLink’s portfolio of CleanCap mRNA capping technology is expected to be the new go-to capping method in the very near future - it is the future,” shared Kate Broderick Ph.D., Chief Innovation Officer at Maravai LifeSciences. “What excites me most about this novel analog is its ability to make mRNA an even more powerful therapeutic than we have seen previously.”
The company’s first CleanCap analog launched in 2017 and this capping technology has been incorporated in one of the first commercially approved COVID-19 vaccines. With the introduction of CleanCap M6, TriLink has developed its most robust analog to date. Studies have shown that the innovative product increases mRNA expression by 30% or more versus enzymatic capping methods and is estimated to reduce manufacturing costs by 20-40%.
“mRNA is clearly an emerging therapeutic modality where mRNA vaccines and therapeutics are expanding rapidly,” added Drew Burch, EVP of TriLink’s Nucleic Acid Products division. “CleanCap M6, and the entire CleanCap portfolio, joins a strong roster of synthesized nucleic acids, NTPs, and more that we expect to continue to grow.”
In addition to the CleanCap mRNA capping portfolio, TriLink has scale-up expertise and unique mRNA, oligonucleotide & plasmid production capabilities for companies focused on therapeutic, vaccine, diagnostic breakthroughs, leaning on its 25-plus years of experience to provide superior CDMO services.
Data and customer insights garnered from a market assessment conducted by a third-party consulting firm on behalf of TriLink BioTechnologies in November 2022.
Maravai is a leading life sciences company providing critical products to enable the development of drug therapies, diagnostics, and novel vaccines. Maravai’s companies are leaders in providing products and services in the fields of nucleic acid synthesis and biologics safety testing to many of the world’s leading biopharmaceutical, vaccine, diagnostics, and cell and gene therapy companies.