MEDTECH, INDUSTRIAL IMPACT
QIAGEN | January 06, 2023
QIAGEN recently announced an exclusive strategic partnership with Helix, a California population genomics leader, to advance companion diagnostics for hereditary diseases.
The requirement for companion diagnostic devices and tests capable of detecting clinically relevant genetic abnormalities grows along with the accelerated development of precision medicines. These tests helps in making decisions by showing patients that are most likely to benefit from a specific therapeutic product or be at risk. Although companion diagnostics that use whole exome sequencing have primarily been used in oncology so far, they are widely believed to have a great deal of potential in hereditary disease areas like cardiovascular, metabolic, neurodegenerative, and auto-immune diseases.
According to the agreement, QIAGEN will be Helix’s exclusive marketing and contracting partner in the United States. This partnership will use the Helix® Laboratory Platform, the first whole exome sequencing platform, to get a de novo class II authorization from the U.S. Food and Drug Administration.
As a leader in precision medicine, QIAGEN has more than 30 master partnership agreements with multinational pharma and biotech firms to develop and commercialize companion diagnostic tests for their drug candidates. Its companion diagnostic offerings include next-generation sequencing (NGS), polymerase chain reaction (PCR), and digital polymerase chain reaction (dPCR), sample types ranging from liquid biopsy to tissue, and disease areas such as cancer and Parkinson's, including 11 FDA-approved PCR-based companion diagnostics.
Helix has developed an end-to-end platform that enables health systems, life sciences firms, and payers to enhance genomic research and expedite the integration of genomic data into clinical care. It has teamed with major health systems to enable population genomics programs across the United States. These programs significantly improve the identification and recruitment of patients for clinical trials in hereditary diseases such as Parkinson's and cardiovascular or inflammatory diseases such as non-alcoholic steatohepatitis (NASH).
QIAGEN is a leading provider of sample-to-insight solutions, enabling clients to get significant molecular insights from samples containing life's building elements. Its sample technologies are used to isolate and process DNA, RNA, and proteins from blood, tissue, and other materials. The company serves over 500,000 customers worldwide in molecular diagnostics (human healthcare) and life sciences (academia, pharma R&D, and industrial applications, primarily forensics).
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Azenta Life Sciences | February 28, 2023
On February 27, 2023, Azenta Life Sciences, a leading provider of life sciences solutions, announced the launch of its latest automated cryogenic storage system, the Cryo Store PicoTM. This new product is designed to store high-value biological samples used throughout various stages of the life sciences industry, from research and development to clinical use.
Azenta is already known for providing innovative automated cryogenic solutions such as the BioStore™ III Cryo and the CryoPod™ Carrier, and the Pico is the latest addition to its lineup. The product offers automated cryogenic solutions that are configured for laboratory and clinical procedures.
The Pico offers a variety of features for cell and gene therapy developers and manufacturers, including end-stage deployment in hospitals and clinics. It offers controlled access and traceability to support regulatory compliance with a compact footprint and is also user-friendly for laboratory personnel.
Interested parties can order the Pico now, and a live demonstration will take place at the Society for Laboratory Automation and Screening (SLAS) 2023 International Conference in San Diego, California.
Pico's Product Manager Erica Waller commented, "Pico takes our proven automation capabilities and scales it down for the lab or the clinic, bringing the sample integrity and process rigor of automation closer to the point of use,"
(Source – PR Newswire)
About Azenta Life Sciences
Azenta is a leading life sciences solutions provider that helps to accelerate the development and delivery of impactful therapies to market. The company offers a comprehensive suite of cold-chain sample management solutions and genomic services for areas such as clinical research, drug development and advanced cell therapies. These solutions are trusted by some of the top biotech, pharmaceutical, academic, and healthcare institutions worldwide. Headquartered in Chelmsford, MA, Azenta has a global presence with operations across Europe, North America, and Asia. The company is committed to providing reliable, innovative, and high-quality solutions to meet the needs of its clients in the life sciences industry.
MEDTECH, INDUSTRIAL IMPACT
Janux | December 29, 2022
Janux Therapeutics, Inc. is a clinical-stage biopharmaceutical company that uses its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms to develop a diverse pipeline of novel immunotherapies. On December 27, 2022, the company announced that it had submitted an investigational new drug (IND) application for JANX008 to U.S. Food and Drug Administration, an EGFR-TRACTr in (SCCHN).
The company is pleased to announce its second IND. It considers this a big step forward for its TRACTr platform, which has also helped many next-generation immunotherapies move forward.
JANX008 is made in a particular way to avoid cytokine release syndrome and the known harmful effects of EGFR in on-target healthy tissue. As a result, the company thinks it could be easier to treat EGFR-expressing cancers in many ways.
JANX008 is a double-masked TRACTr that conceals both the EGFR-binding and T-cell-specific binding domains (CD3). JANX008 exhibited minor cytokine release syndrome and healthy tissue toxicity in preclinical studies. Besides, it demonstrated superior safety and pharmacokinetic (PK) qualities compared to unmasked TCEs. These data and JANX008's strong manufacturability qualities justify its continued development as a potential therapy for solid tumors.
Janux Therapeutics is a clinical-stage business developing immunotherapies that target cancers without affecting healthy tissue. The company uses platform masking to generate innovative therapeutic candidates that address T-cell engager toxicity and efficacy limitations. It develops next-generation cancer therapeutics using TRACTR platform. Janux Therapeutics focuses on developing medically-validated T cell engagers (TCEs). Its pipeline includes PSMA, EGFR, and TOP2 efforts. All of its programs are IND-enabling or discovery.