Medical
CCM Biosciences | January 01, 2024
Diversified biotechnology company CCM Biosciences (CCM Bio) announced the launch of its business unit CCM 5Prime Sciences (5Prime) focused on the development and application of proprietary technology in the domain of DNA biotechnology. 5Prime’s technology platform includes multiple patent-protected, globally commercialized compositions and methods for molecular cloning, next-generation DNA sequencing and molecular diagnostics.
5Prime has two focus areas: 1) in vitro diagnostic (IVD) tests: a wide array of companion diagnostics (CDx) tests for targeted cancer, rare disease, and prenatal/preimplantation diagnostics, developed using the droplet digital Polymerase Chain Reaction (ddPCR) and Next-Generation Sequencing (NGS) methodologies, which accompany the personalized medicine therapeutic (Rx) pipeline of CCM Bio; 2) synthetic biology: engineered DNA- and RNA-manipulating enzymes that improve upon the enzymes used in IVD tests, in PCR reagents, and also in enzymatic DNA/RNA synthesis.
Proven technology behind market-leading DNA sequencing products and diagnostic tests; including one of the 5 highest revenue-generating technologies invented in the history of Princeton University
Focus areas 1 and 2 are based on the company’s patented technology originating in the PhD thesis work of Co-Founder and CEO Dr. Raj Chakrabarti at Princeton University. According to the Princeton University Office of Technology Licensing, patents in this portfolio, which are now controlled by 5Prime, are among the top 5 revenue-generating patents in the history of the university, having been commercialized in collaboration with companies such as Celera Diagnostics, Quest Diagnostics, Abbott, New England Biolabs, and Toyobo Life Sciences. Diagnostic tests and products based on the company’s intellectual property include the XSense test from Quest Diagnostics, which is the leading DNA-based carrier screening test for autism (Fragile X syndrome); and the Q5 polymerase kit marketed by New England Biolabs, which is the leading high-fidelity polymerase kit for DNA sequencing.
In the context of molecular diagnostics, NGS is typically applied to diagnose in high-throughput the patterns of DNA mutations in genes. A related method called RNA-Seq, which applies NGS to RNA rather than DNA to measure real-time gene expression levels, has emerged as a foundation for modern personalized medicine. However, a notorious difficulty in both traditional NGS and RNA-Seq is sequence bias, which results in inaccurate estimates of the relative copy numbers of different genes and associated disease-causing mutations, and which has limited the transformative potential of these methods. ddPCR is a sensitive method for diagnosing mutations in specific disease-associated genes that is also limited by problems of sequence bias.
5Prime’s technology enables the efficient polymerization and amplification of nearly any DNA or RNA sequence to overcome sequence bias in nucleic acid amplification and associated diagnostic methods like NGS and ddPCR, the global markets for which were valued at $10B and $6B, respectively, in 2022 and expected to surpass $44B and $14B, respectively, by 2032. Its state-of-the-art synthetic biology platform for polymerase enzyme engineering generates proprietary polymerases with optimal properties for NGS or PCR-based diagnostic tests, by applying machine learning algorithms to the big data generated from ultrahigh-throughput, microfluidic experimental screening of enzyme activity. In addition, the company’s technology platform applies proprietary nonaqueous media and computational systems biology methods in conjunction with such enzymes to dramatically improve nucleic acid polymerization and amplification efficiency.
About CCM Biosciences
CCM Biosciences, Inc. is a biotechnology company dedicated to discovering and developing novel drugs - including small molecules, gene therapies, biologics, and nanomedicines - as well as associated companion diagnostics. CCM Bio’s patented molecular discovery platforms were developed at Chakrabarti Advanced Technology, a privately funded R&D institute founded in 2010 with scientists in the US, France and India and with publications in leading scientific journals including PNAS, Nucleic Acids Research, American Chemical Society journals and Nature Publishing Group journals. CCM Bio is partnered with the global chemical and pharmaceutical services company PMC Group, Inc. for fully integrated discovery, development and manufacturing of drugs and diagnostics.
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Medical
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.
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Medical
Andelyn Biosciences, Inc. | January 16, 2024
Andelyn Biosciences, Inc., a pioneering and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has partnered with Armatus Bio to accelerate manufacturing of their gene therapy treatment for Charcot-Marie-Tooth Type 1A (CMT1A), a rare genetic neurological disease associated with independence-limiting disability and risk of fatal complications that has no approved therapies today. The partnership will seek to maximize program efficiency and speed to clinical studies of this novel, precision approach.
As part of the agreement, Armatus will leverage Andelyn's extensive experience in adeno-associated virus (AAV) production and its proprietary suspension platform for development activities, plasmid manufacturing, and viral vector toxicology and GMP clinical manufacturing. The partnership strengthens the working relationship and offers great hope for patients suffering from neuromuscular disease.
Both organizations, located in the well-established and growing biotech hub of Columbus, Ohio, are aligned in their belief that the rise of gene therapies will continue to advance human health.
Matt Niloff, Chief Commercial Officer at Andelyn Biosciences said, "We are extremely moved by Armatus Bio's commitment to address the urgent unmet needs in CMT1A and are impressed by its innovative therapeutic technology for the disease. We look forward to scaling up the process in our program-specific, configurable suspension platform, and accelerating the therapy into the clinic with the highest degree of quality."
"Andelyn has demonstrated its strong capabilities in manufacturing complex genetic medicines with high quality and consistency, which will be critical to accelerating our development efforts," said Brian Price, PhD, Chief Technical Officer of Armatus. "We look forward to collaborating with Andelyn on this program as we work toward supporting this population that urgently awaits innovative solutions."
From its time-tested experience, Andelyn is proud to offer its clients exceptional development, plasmid production, and quality manufacturing at its three Columbus, Ohio facilities. Andelyn is advancing client discoveries and manufacturing life-altering cell and gene therapies for rare and prevalent diseases.
About Andelyn Biosciences, Inc.
Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on the development, characterization and production of viral vectors for gene therapy. With more than 20 years of experience, Andelyn's deep scientific expertise has resulted in the production of cGMP material for more than 450 clinical batches and 75 global clinical trials. Operating out of three Columbus, Ohio facilities, Andelyn supports its clients in developing curative cell and gene therapies from concept through plasmid development and manufacturing, process development, and cGMP clinical and commercial manufacturing. Andelyn's versatile capabilities include cGMP manufacturing capacity for both adherent and suspension processes up to a 2,000-liter capacity. An advanced digital model, quality system, full regulatory support and supply chain vertical integration help Andelyn accelerate the development and manufacturing of its clients' innovative cell and gene therapies.
About Armatus Bio
Armatus Bio is a privately held late preclinical stage biotechnology innovator leveraging vectorized RNAi to address urgent unmet medical needs in genetically-driven neurological diseases. Based in Columbus, Ohio, the company is led by a seasoned team with expertise in drug development and delivery, and partnered with world renowned experts in vector biology, genomics, and neurology. The company's lead candidate for Charcot Marie Tooth Type 1A (CMT1A) has received Orphan Drug Designation and Rare Pediatric Drug Designation, and is advancing toward IND-enabling studies. The company is also developing a preclinical vectorized RNAi asset for the rare neuromuscular disease Facioscapulohumeral Muscular Dystrophy (FSHD).
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MedTech
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.
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