Denovo Biopharma Announces Breakthrough Discovery of a Novel Genetic Biomarker for DB104 (Liafensine) for Depression

BioSpace | March 12, 2020

Denovo Biopharma LLC LLC, a pioneer in applying precision medicine to develop innovative therapies, today announced it has successfully discovered a novel genetic biomarker associated with DB104 response to treat depression using its proprietary biomarker discovery platform. DB104 was licensed from Albany Molecular Research, Inc. following its return from Bristol-Myers Squibb, who had conducted two phase 2b clinical trials in treatment-resistant depression with this first-in-class triple reuptake inhibitor targeting transporters for dopamine, serotonin, and norepinephrine.

Spotlight

NIBIB-funded researchers at the Massachusetts Institute of Technology (MIT) have created an ingestible sensor to non-invasively monitor indicators of disease in the stomach and intestines. The capsule carries genetically engineered bacteria that sense specific substances in the gut. The other components built into the one-and-a-half-inch capsule include phototransistors, a custom integrated circuit, a small battery, and a radio transmitter.


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MEDICAL

PacBio transforms access to the epigenome and streamlines workflows

PacBio | April 23, 2022

PacBio (NASDAQ: PACB), a leading developer of high-quality, highly accurate sequencing solutions, today announced the release of a transformative capability to detect DNA methylation using the Sequel IIe and Sequel II Systems. This extends PacBio’s unique and highly capable HiFi sequencing technology to now include access to the epigenome, a second layer of genomic information often left unexplored due to fundamental limitations of common sequencing technologies. PacBio’s single-molecule approach provides a much more holistic view of molecular behavior during sequencing. Subtle patterns in this rich information allow detection of modified bases in native DNA during standard HiFi sequencing. As a result, scientists gain access to the epigenome with zero additional cost, effort, or complexity. This advance will unlock important new opportunities across a broad range of applications in fundamental and applied biological science. This update also includes a wide range of workflow improvements to enhance customer experience, such as simplified, unified, and accelerated library preparation workflows and consumables, live instrument performance monitoring, and on-instrument analysis support for recombinant adeno-associated virus (rAAV) genome sequencing, a rapidly growing biopharmaceutical application relevant to gene therapy and vaccine development research. With each product release we continue to improve the utility and value of the Sequel II and IIe platform, providing researchers with unique capabilities that differentiate PacBio HiFi sequencing from all other sequencing technologies, Our latest enhancements to the Sequel II and IIe platform, including 5-base sequencing and improved workflows are expected to both simplify the ability to generate high quality data and enable deeper insights into the complexity of the genome.” Christian Henry, President and Chief Executive Officer of PacBio. Multiple tests are currently required to evaluate rare disease cases for sequencing and methylation variation. HiFi sequencing has the potential to change that by measuring both genetic and epigenetic variation across the full genome in a single experiment. We have had success using 5-base HiFi sequencing at Children’s Mercy Kansas City to identify abnormal methylation in repeat expansion cases, and we plan to apply it to all the future genomes we sequence. It is exciting to access another aspect of the genome without needing to change sample handling or sequencing procedures.” Emily Farrow, PhD, CGC, Director of Laboratory Operations at Children’s Mercy Kansas City and Associate Professor of Pediatrics at University of Missouri Kansas City School of Medicine. We found that the CpG methylation patterns detected in tomato and maize genomes using HiFi sequencing are highly concordant to standard bisulfite sequencing but bring power to resolve transposable elements and other sequences that are out of reach with short reads. When combined with the incredible capabilities of HiFi sequencing for genome assembly and variation analysis, this creates an unmatched opportunity for ultra-high-quality genome and epigenome analysis of plant and vertebrate genomes from a single datatype.” Michael Schatz, PhD, Bloomberg Distinguished Professor of Computer Science and Biology at Johns Hopkins University. PacBio’s HiFi sequencing technology offers a comprehensive view of genomes and transcriptomes. But DNA contains much more information subtly encoded as “epigenetic” modifications to DNA bases. This epigenome influences how genes are expressed and plays a major role in determining biological function in both health and disease. Historically, access to the epigenome has been difficult and required sacrifices in read lengths, accuracy, and completeness while adding workflow complexity. By including automatic detection of the key modified base in humans and many other species (5mC in CpG motifs) PacBio sequencing technology provides access to the combined genome and epigenome without sacrificing read lengths, accuracy, or completeness, and without requiring additional workflow steps. Streamlining workflows is a key focus for PacBio, and this latest update makes it easier to perform HiFi sequencing. The company’s new SMRTbell prep kit 3.0 is capable of reducing workflow time for whole-genome sequencing applications by 50 percent or more and reducing required DNA inputs by 40 percent (to three micrograms per human genome). SMRTbell prep kit 3.0 is suitable for a wide range of applications and supports automation and batch processing of samples. PacBio also introduced a new single-reaction sequencing plate and SMRT Cell 8M tray that better enables customers to run samples at their convenience. About PacBio Pacific Biosciences of California, Inc. (NASDAQ: PACB) is empowering life scientists with highly accurate sequencing platforms. The company’s innovative instruments are based on Single Molecule, Real-Time (SMRT®) Sequencing technology, which delivers a comprehensive view of genomes, transcriptomes, and epigenomes, enabling access to the full spectrum of genetic variation in any organism. Cited in thousands of peer-reviewed publications, PacBio® sequencing systems are in use by scientists around the world to drive discovery in human biomedical research, plant and animal sciences, and microbiology.

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CELL AND GENE THERAPY

Brooklyn ImmunoTherapeutics Added to ICE Biotechnology Index

Brooklyn ImmunoTherapeutics, Inc. | December 18, 2021

Brooklyn ImmunoTherapeutics, Inc. on exploring the role that cytokine and gene editing/cell therapy can have in treating patients with cancer, blood disorders, and monogenic diseases, announces that Brooklyn has been added to the ICE Biotechnology Index following the December 20, 2021 reconstitution. “The continued recognition of Brooklyn among key biotechnology indices is encouraging and we continue to believe that our value proposition and approach to our business are being rewarded with these inclusions. We look forward to beginning the new year strong and are grateful to be included among the key players in the biotech sector,” Brooklyn’s Chief Executive Officer and President Howard Federoff, M.D., Ph.D The ICE Biotechnology Index tracks the performance of qualifying U.S.-listed biotechnology companies classified within the Biotechnology Sub-Industry Group of the ICE Uniform Sector Classification schema, which is a multi-asset class industry classification taxonomy developed by ICE. The index includes companies that are engaged in the research and development of therapeutic treatments but are not focused on the commercialization and mass production of pharmaceutical drugs. The index also includes companies that are engaged in the production of tools or systems that enable biotechnology processes. About Brooklyn ImmunoTherapeutics Brooklyn is focused on exploring the role that cytokine, gene editing, and cell therapy can have in treating patients with cancer, blood disorders, and monogenic diseases. Brooklyn’s most advanced program is IRX-2, a human cell-derived cytokine therapy, studying the safety and efficacy of IRX-2 in patients with head and neck cancer in Phase 2B. In a Phase 2A clinical trial in head and neck cancer, IRX-2 demonstrated an overall survival benefit. Additional studies are either underway or planned in other solid tumor cancer indications. Brooklyn has multiple next-generation cell and gene-editing therapies in preclinical development for various indications including acute respiratory distress syndrome, solid tumor indications, as well as in vivo gene-editing therapies for rare genetic diseases.

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INDUSTRIAL IMPACT

SkylineDx raises new capital from Novalis LifeSciences and Van Herk Investments

SkylineDx | December 22, 2021

SkylineDx announced it received a capital investment from USA based investment and advisory firm Novalis LifeSciences, and one of Benelux' largest biotech investors Van Herk Investments, to further solidify its position in the USA dermatology diagnostics market. SkylineDx is at a critical growth stage in their development now that the first products are introduced to the USA market, and Novalis LifeSciences has demonstrated impressive successes with their strategic and operational advice to their portfolio companies. Marijn E. Dekkers, founder and chairman of Novalis LifeSciences, will be named board member of SkylineDx' Board of Directors. He brings a long track record of industry-related strategic leadership experience as the former CEO of Bayer AG, CEO of Thermo Fisher Scientific and his role in the recent 600M USD acquisition of Decipher Biosciences by Veracyte. SkylineDx' dermatology program, often referred to as the Falcon R&D Program, currently overarches four dedicated dermatology initiatives, focused on prognostic and predictive biomarker development covering two skin cancers: melanoma and squamous cell carcinoma. These indications affect approximately 1.9 million patients annually in the United States only. One of these initiatives generated its first commercially available product, branded as Merlin Test, for which SkylineDx aims to accelerate the clinical adoption with this joint investment. "It is a great honor to have Marijn and Novalis LifeSciences as our first specialized USA investor on board, with all their incredible experience and know-how. Together we aim to further extend SkylineDx' USA investor base and continue expanding our strong footprint there. Our mission is to improve a patient's quality of life by enabling them to benefit from personal insights at the genomic level of their disease. We are excited to be working with Marijn and his team to continue fulfilling this mission." Dharminder Chahal, CEO SkylineDx Marijn Dekkers comments: "I have monitored the progress of SkylineDx for several years now, and I am excited about the leading edge position the company has built in predictive biomarkers for melanoma and various other cancers. I very much look forward to working with the SkylineDx team to bring these sophisticated diagnostic tests to patients around the globe." About SkylineDx SkylineDx is a biotechnology company, focused on research & development of molecular diagnostics in oncology and inflammatory diseases. The company is headquartered in Rotterdam and complemented with a field medical and scientific affairs team in the USA and a CAP/CLIA certified laboratory in San Diego. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predict a patient's response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. About Novalis LifeSciences Novalis LifeSciences LLC is a boutique investment and advisory firm that was founded in 2017 by Marijn E. Dekkers, and is based in Hampton, NH, USA. With a team of experienced operating executives from the Life Science industry, Novalis funds and advises visionary Life Science entrepreneurs. The firm has approximately USD 500M under management in two investment funds.

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MEDICAL

ILC Dover Announces Liquid Single-Use Bioprocessing Bags for Rapidly Growing Biotherapeutics and Cell & Gene Therapy Markets

ILC Dover | March 30, 2022

ILC Dover LP ("ILC Dover" or the "Company"), specializing in innovative single-use solutions for biotherapeutics and pharmaceutical processing, announced its launch of liquid single-use bioprocessing bags, representing the first of many new products for handling and supply of sterile liquids for the biotherapeutics market. This expansion is a continuation of ILC Dover's solution set across the entire biotherapeutic and pharmaceutical manufacturing workflow, from powder containment and handling, through sterile liquid handling and pre-filled liquid and powder bags. ILC Dover manufactures its high-quality, single-use bioprocessing bags in Frederica DE, but ultimately will utilize its growing cGMP global footprint to support its customers and partners worldwide. The Company maintains manufacturing for its pharmaceutical and biotherapeutic customers in Frederica DE, Durham NC, Stockport UK, Rossens Switzerland, and Blarney Ireland, with a large, planned expansion in Juarez, Mexico coming online later in 2022. ILC Dover's differentiated value proposition comes during a time of unprecedented disruption in the life science supply chain amidst significant industry growth. ILC Dover is committed to providing comprehensive solutions customized to our customers unique needs. Additionally, the Company's overall global footprint, quality, and supply reputation ensure that it can meet customer needs at scale with speed. In addition to the launch of ILC Dover's single-use bioprocessing bags, the Company is also rapidly expanding its offering of sterile liquids and (pre-filled and non pre-filled) powder offerings. ILC Dover will be providing updates throughout the year on these launches. In the past two weeks, we've made two large investments in our customers' success: our Juarez capacity expansion and transformation, and the official launch of our exciting single-use bioprocessing bags, We will continue to innovate to serve our pharmaceutical, biotherapeutic, and cell & gene therapy customers across the entire processing and manufacturing workflow." Corey Walker, CEO of ILC Dover. About ILC Dover ILC Dover is a world-leader in the innovative design and production of solutions for biopharmaceutical, pharmaceutical, medical device markets as well as a leading supplier for the (aero)space industries. Our customers will attest to our relentless dedication to high value products, advanced technology, and responsive service, as our visionary solutions have improved efficiency while safeguarding people, product, and infrastructure in hazardous conditions through flexible protective solutions since 1947.

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Spotlight

NIBIB-funded researchers at the Massachusetts Institute of Technology (MIT) have created an ingestible sensor to non-invasively monitor indicators of disease in the stomach and intestines. The capsule carries genetically engineered bacteria that sense specific substances in the gut. The other components built into the one-and-a-half-inch capsule include phototransistors, a custom integrated circuit, a small battery, and a radio transmitter.

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