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.
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.
MOMA Therapeutics | January 04, 2024
MOMA Therapeutics, a biotechnology company focused on identifying and targeting highly dynamic, difficult to drug targets in cancer and other diseases, is pleased to announce a strategic collaboration and licensing agreement with Roche. This partnership provides Roche with access to MOMA’s proprietary KnowledgeBase platform for the identification and prosecution of a certain number of novel drug targets involved in promoting cancer cell growth and survival.
MOMA’s KnowledgeBase comprises integrated structure-function capabilities, advanced lead-finding technologies and computation-enabled lead optimization. It was built upon the concept that functionally related targets lacking sequence homology still possess three dimensional structural motifs that can be exploited to produce highly impactful therapies. To date, MOMA has utilized this bespoke platform to accelerate drug discovery in the ATPase target class, a class with a high number of genetically validated targets for which industry efforts to identify therapeutically viable drugs have been hampered by the extent of dynamic protein motion.
“Given its deep expertise and global footprint in oncology, Roche represents an ideal collaborator with whom to further advance the application of MOMA’s platform in a way that impacts patients’ lives. The vision for this collaboration was crafted jointly with Roche to enable each party to bring its strengths in pursuit of this shared goal. It also contributes to the long-term sustainability of MOMA’s core focus as we advance our rich pipeline of precision oncology programs to the clinic,” said Asit Parikh, M.D., Ph.D., chief executive officer of MOMA.
Through the collaboration, MOMA will receive $66 million as an upfront cash payment and is also eligible to receive discovery, development, and commercialization milestone payments potentially exceeding US$2 billion, as well as tiered royalties. MOMA will be primarily responsible for all activities for selected targets through to development candidate confirmation, whereas Roche will be responsible for IND-enabling activities and clinical development and commercialization. Additionally, if multiple collaboration assets reach pivotal clinical studies, MOMA will receive a right to co-fund late-stage development of one product in exchange for increased royalties in the US on this product.
“We are excited to join forces with MOMA, combining our leadership in oncology with MOMA’s deep expertise in drug discovery for difficult-to-drug and novel targets in oncology. The broader field of cancer dependencies is of high importance for Roche and we are looking forward to further deepening our knowledge and discovering novel targets involved in cancer cell growth and survival leveraging MOMA’s innovative platform,” said James Sabry, M.D., Ph.D., global head of pharma partnering, Roche.
“It is exciting to utilize our industry-leading knowledge in how to identify and drug highly dynamic proteins to deliver on a breadth of discovery programs in partnership with Roche,” added Peter Hammerman, M.D., Ph.D., chief scientific officer and head of development at MOMA. “Along with bringing two MOMA-owned high-impact programs to the clinic next year, we are making exciting progress towards our goal of addressing key unmet needs for patients living with advanced cancer.”
About MOMA Therapeutics
MOMA Therapeutics is committed to discovering the next generation of precision medicines by targeting highly dynamic proteins that underlie human disease. Bringing together seminal scientific advancements in biochemistry, biophysics, structural biology, chemistry, computation, and functional genomics, the company has established the KnowledgeBase platform to exploit a key vulnerability inherent to all dynamic proteins: their dependence on well-coordinated, stepwise changes in protein conformation. By focusing this platform on disease-causing targets, MOMA aims to develop high impact, precision medicines for patients with unmet medical needs. MOMA Therapeutics is a private company launched in 2020 with seasoned leadership, a highly specialized workforce with deep expertise in oncology discovery, world-class scientific founders, and financed by leading biotech investors.