PanGIA Biotech, Inc. | January 05, 2024
PanGIA Biotech, a US based biotechnology company with a mission to develop true liquid biopsy technology that is scalable for global impact, today announced that it is finalizing its three-year, prospective, multicenter, clinical study on prostate cancer liquid biopsy. This announcement comes as the company prepares to launch additional clinical studies in multi-cancer early detection using the PanGIA® Liquid Biopsy Platform. “The PanGIA urine based true liquid biopsy technology has been developed for global impact by diagnosing, monitoring, and managing cancers earlier to save lives using urine as the sample type to create vastly improved availability and scalability in cancer diagnostics,” according to PanGIA Biotech’s CEO, Holly Magliochetti.
In 2020, the company received IRB approval and launched a novel AI integrated urine based liquid biopsy study. The company immediately began recruiting urologists in US-based academic as well as large and small group community practices to enroll men who were scheduled for prostate biopsy. Results of the study are pending publication.
“Based on the high sensitivity and high specificity of the PanGIA prostate study, PanGIA Biotech is now preparing to significantly expand the platform by launching follow-on studies in ten additional cancer types,” said Tricia Schumann, Chief Investment Officer of PanGIA Biotech. Additional cancer types in the PanGIA follow-on study will include breast, ovarian, lung, renal, bladder, colorectal, stomach, pancreas, liver, and brain. The company will begin recruiting experienced medical professionals across the United States as clinical study sites as well as listing the study on ClinicalTrials.gov.
PanGIA Biotech intends to launch the expanded study in mid-2024. Interested researchers may contact the company for additional information.
About PanGIA Biotech, Inc.
PanGIA Biotech develops novel, AI integrated, true liquid biopsy technology that is scalable for global impact. The PanGIA® platform allows rapid development of non-invasive testing for detecting, monitoring response to therapy, and managing a variety of diseases and disorders, including cancers as early as Stage 1. The company combines expertise in molecular biology with advanced computational biology and machine learning to detect disease-associated patterns using proprietary technology.
Cell and Gene Therapy
Solvias | January 23, 2024
Solvias, a global provider of chemistry, manufacturing, and control (CMC) analytics, announced that it will perform analytical release testing services on the world's first CRISPR/Cas9 genome-edited cell therapy. The company has signed a long-term agreement with Vertex Pharmaceuticals for CASGEVY™ (exagamglogene autotemcel or exa-cel) which received U.S. Food & Drug Administration (FDA) approval for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso-occlusive crises.
Solvias and Vertex Pharmaceuticals have worked together for several years to develop and validate test methods that are critical for the final release of patients' own edited cells, so that they can be delivered back to patients. The companies' collaboration included establishing the testing methods that will be scaled for commercializing CASGEVY. Solvias also has invested significantly in preparing one of its global facilities to support the commercial release work for this transformative therapy.
Archie Cullen, Chief Executive Officer, Solvias, stated
"Solvias is honored to be playing a critical role in delivering this breakthrough therapy to patients. Our decades of experience offering comprehensive GMP analytical services uniquely positions us to partner with companies in bringing their therapies to market. This collaboration highlights our deep scientific knowledge and creative solutions serving to advance even the most cutting-edge therapies."
In addition to gaining FDA approval, CASGEVY recently received a positive opinion from the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use for conditional approval of the treatment of severe SCD and transfusion-dependent beta thalassemia (TDT).
Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the pharmaceutical, biotech, material science, and cosmetic industries. Its team of scientists and regulatory experts have years of experience in small molecules, biologics, and cell and gene therapies. The company offers comprehensive solutions from raw materials to drug products to final release testing, as well as API development and manufacturing for small molecules. Headquartered near Basel, Switzerland, Solvias operates five facilities to the highest standards and in accordance with ISO, GMP, GLP and FDA regulations.
Personalis, Inc. | February 05, 2024
Personalis, Inc. a leader in advanced genomics for cancer, and ClearNote Health, Inc., a pioneer in epigenomic technologies, today unveiled an alliance through which Personalis will expand its pharmaceutical service offerings by distributing ClearNote’s cutting-edge epigenomic 5-hydroxymethylcytosine (5hmC) platform.
“We have built a unique pharma channel based on our industry-leading tissue and MRD assays and ClearNote Health’s blood-based epigenomic approach is complementary to our offering as it helps our customers deepen their understanding of a patient’s response to immunotherapies,” said Chris Hall, CEO and President of Personalis. “Commercial partnerships such as this broaden our portfolio and are expected to appeal to a wide range of biopharma customers and accelerate our revenue growth.”
Echoing this sentiment, Dave Mullarkey, CEO of ClearNote Health, remarked, “Partnering with Personalis presents an excellent opportunity to bring our 5hmC technology to the forefront of cancer research. This alliance is a testament to the synergy between our two companies, enabling us to expand our reach and significantly impact the biopharmaceutical industry. Together, we can accelerate the development of personalized therapies and make a real difference in the lives of patients.”
ClearNote Health’s Epigenomics Platform represents a groundbreaking advance in cancer detection, offering real-time insights into disease-specific pathways. By tracking changes in 5hmC levels coupled with artificial intelligence-based analytical methods, the platform can detect cancer earlier, monitor disease progression, understand mechanisms of resistance, and identify promising drug targets and biomarkers. These insights are invaluable for optimizing drug development programs and delivering more effective treatments to patients. The Epigenomics Platform identifies changes in gene activation and gene regulation by labeling specific changes in the 5hmC landscape from plasma-derived cell-free DNA. This rich biological information, as part of clinical trials, enables the monitoring of cancer therapies in real time and contributes to an understanding of drug resistance mechanisms. The partnership marks a pivotal moment in cancer research, leveraging the strengths of both companies to offer unparalleled solutions in the biopharmaceutical industry.
About ClearNote Heath, Inc.
ClearNote Health is a cancer detection company focused on enabling people at risk for high-mortality cancers to live longer, healthier lives. Utilizing a standard blood draw, the company applies its proprietary epigenomic platform, combining biology and artificial intelligence, to identify DNA-based changes in biology as cancer develops. With lead programs in non-invasive early detection of pancreatic and ovarian cancers in patients at the highest risk for these diseases, ClearNote Health identifies cancers before they progress and when patients are most likely to benefit from treatment. ClearNote Health’s first commercially available test is the Avantect™ Pancreatic Cancer Test, which detects the presence of pancreatic cancer signals in patients at high risk of the disease, including those recently diagnosed with Type 2 diabetes. ClearNote Health is headquartered in San Diego, with additional presence in the San Francisco Bay area and internationally. The company’s CLIA- and CAP-accredited laboratory is located in San Diego, Calif.
About Personalis, Inc.
At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest time points, enable the selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California.