New Results from BabySeq, Pharmacogenomic Updates, New Products

September 1, 2021 | Harvard-Israel and Sema4-Avera launch precision medicine partnerships, Rice announces new Genetic Design and Engineering Center, Foundation Medicine partners with Epic, and Amgen and USC provide cryo-TEMs. Plus new products from BioIVT, BD.

Pluto Biosciences has launched its cloud-based, collaborative life sciences platform that leverages technology developed at the Wyss Institute for Biologically Inspired Engineering at Harvard University. The Pluto platform simplifies secure, collaborative data sharing and bioinformatics analysis for academic, biotech, and pharmaceutical organizations. The Pluto platform was built to be a comprehensive digital lab space for life sciences teams of all sizes, enabling them to perform research more efficiently while reducing the need for multiple digital communication and project management tools to make scientific discoveries. The features it touts include intuitive interface and robust bioinformatics, simplified sharing and collaboration functionality, and project management to expedite discoveries. Press release.

BC Platforms and Sentieon have launched their new integrated next generation sequencing (NGS) genetic analytics software, known as BC|GENOME X-10. BC|GENOME X-10 has been developed specifically for commercial laboratories offering NGS data production-based clinical genetic testing following American College of Medical Genetics (ACMG) guidelines or American Society of Clinical Oncology (ASCO) guidelines. BC|GENOME X-10 provides a full end-to-end solution for commercial laboratories to run highly efficient and automated processes enabling high quality testing serving multiple end customers. Press release.

CellChorus has announced that Y Combinator has invested $125,000 and accepted CellChorus into its Summer 2021 batch. Y Combinator, which is based in Silicon Valley, now funds more seed stage biotech companies than any other investor. CellChorus “watches” thousands of videos of individual cell-cell interactions so scientists can develop and deliver better cell therapies, antibody therapeutics, and vaccines. CellChorus's approach is important for two reasons. First, cells must move and interact to fight disease—so we need to evaluate cell movement over time. Second, cells are diverse—so we need to evaluate thousands of cells individually, not in bulk. Press release. 

FDB (First Databank), has announced the results of a study by FDB pharmacists that sheds new light on information from the U.S. Food and Drug Administration (FDA) on how patients’ genes affect their response to prescribed medications. The study, "Characterization of Pharmacogenetic Information in Food and Drug Administration Drug Labeling and the Table of Pharmacogenetic Associations," was published in the peer-reviewed journal Annals of Pharmacotherapy. The authors created a new categorization schema for pharmacogenetic information and clinical outcomes associated with drug-gene pairs recognized in the FDA resources. Press release.

BioIVT has announced the launch of its human AB serum product line to supplement cell culture media and facilitate cell and gene therapy development. Human AB serum contains many compounds that are vital for cell growth, including growth factors, vitamins, nutrients, trace elements and transport factors. As a result, human AB serum produces biologically relevant conditions that allow many human cell lines to grow at a faster rate. In addition, a smaller percentage of this serum is required than mixed blood type human serum. BioIVT is offering both plasma-derived and off-the-clot serum collected from healthy, male AB blood type donors. All products are sterile, filtered, and ready for cell culture. Customers also have the option to heat-inactivate their serum, to deactivate complement and improve lot-to-lot reliability. Press release.

Vizgen has begun shipping its MERSCOPE platforms, the beginning of its limited summer release program. MERSCOPE is the first commercially available high-plex single-cell spatial genomics platform, and the only platform for MERFISH technology. These first platforms are being purchased by leading research institutes including the Salk Institute, the University of California, Irvine, and the Beth Israel Deaconess Medical Center. Vizgen will continue shipping a limited number of commercial instruments for the next several months before releasing MERSCOPE to the U.S. market at large in late 2021. Press release.

Foundation Medicine has announced a partnership to integrate its comprehensive genomic profiling (CGP) and other testing services with Epic’s electronic medical record (EMR) system. Once completed, all providers who use Foundation Medicine’s instance of Epic will be able to electronically order Foundation Medicine tests within the Epic network. The integration is designed to support oncology practices, academic medical centers and other health systems by providing easy access to clinical and genomic information in one place to better enable more streamlined clinical decision making. This integration is one of many updates Foundation Medicine is making across its portfolio to help expand precision oncology through efficient and high-quality, data-driven insights. This integration will enable clinical teams to place orders for Foundation Medicine’s CGP tests, and receive and view results directly within their existing workflow in Epic’s EMR platform. The enhancement will also target to reduce data entry with the aim of accelerating delivery of actionable insights to physicians to help guide treatment planning. Press release.

FSD Pharma is acquiring 100% of the issued and outstanding shares of Lucid Psycheceuticals, a Canadian-based specialty psychedelic pharmaceutical company focused on the development of therapies to treat critical neurodegenerative diseases, for approximately US$9 million (CAD$11.3 million) in FSD Pharma stock. Founded in 2020, Lucid has exclusive worldwide licensing rights from the University Health Network, North America’s largest health research organization, to a patent-protected family of new chemical entities (NCEs), on which Lucid’s development platform is based. In addition, Lucid’s pipeline includes a psychedelic drug candidate targeting mental health disorders, and it is also investigating certain cannabinoids. Press release.

OceanDAO’s ninth round is now open for submissions with $300,000 available and up to $17,500 per project. Proposals are due by September 7 at midnight GMT. The community voting period begins on September 10. OceanDAO is a grants initiative to help fund projects oriented towards the emerging data economy. The end of the eighth round marks the first time OCEAN, the means of exchange within Ocean Protocol, has been removed from circulation or burned after not being captured by submissions. As a result of this burn, the total amount of OCEAN in circulation decreases, indicating that the OceanDAO mechanism design is working, with the community as its backbone. Press release.

Shape Therapeutics has announced a multi-target strategic collaboration and license agreement with Roche. Through this partnership ShapeTX will apply its proprietary RNA editing platform RNAfix and potentially leverage its AAVid technology platform for next-generation tissue-specific adeno-associated viruses (AAVs) for the development of gene therapy for certain targets in the areas of Alzheimer’s disease, Parkinson’s disease, and rare diseases. During the course of the partnership, ShapeTX will conduct preclinical research to identify and deliver development candidates discovered by its AI-powered platforms RNAfix and, potentially, AAVid. Roche will be responsible for the development and worldwide commercialization of any potential products resulting from the collaboration. Under the terms of the agreement, ShapeTX is eligible to receive an initial payment as well as development, regulatory and sales milestone payments, potentially exceeding $3 billion in aggregate value. ShapeTX is also eligible to receive tiered royalties on future sales of products resulting from the collaboration. Press release.

Harvard Medical School in Boston and Clalit Research Institute in Tel Aviv are launching a joint precision medicine effort, enabled by a donation from the Berkowitz family. The gift—the amount of which remains undisclosed at the donors’ request—will establish The Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute. The program will have two arms: The Ivan and Francesca Berkowitz Family Living Laboratory at HMS and The Ivan and Francesca Berkowitz Family Precision Medicine Clinic at Clalit. The two arms will work together to conduct joint research. The Clalit arm also will feature a clinical component that, in addition to research, will provide diagnosis and care for patients with rare, undiagnosed, and hard-to-treat conditions. The research arm of the initiative will focus on generating insights from data and translating them into frontline clinical interventions. Under its educational arm, it will train the next generation of biomedical informaticians and computational biologists. The work will be led jointly by Isaac Kohane, chair of the Department of Biomedical Informatics in the Blavatnik Institute at HMS, and Ran Balicer, founding director of the Clalit Research Institute and chief innovation officer of Clalit Health Services. Press release.

Boston Healthcare is now a part of Veranex, a new global solutions provider for MedTech and Life Sciences innovators, bringing together four complementary solution providers: Ximedica, Quartesian, Experien Group, and Boston Healthcare Associates. The combined company brings deep experience in the areas of devices, in vitro diagnostics, precision medicine, digital health, and combination products/drug delivery among other technology areas. Disease areas of focus include cardiovascular, orthopedic, women’s health, wound care, ophthalmology, neurology, oncology, and gastrointestinal among others. Veranex is the first concept-to-commercialization global service provider built for medical technology innovators. The Veranex platform is designed to provide the global medical technology industry with comprehensive, integrated, and technology-enabled product development and commercialization solutions. Press release.

Tohoku University researchers have developed a new analytical method that visualizes cell functions in a microphysiological system (MPS), also known as an organ-on-a-chip, using scanning probe microscopy (SPM). SPM differs from optical microscopy since it employs fine probe scanning over a sample surface and then exploits the local interactions between the probe and the surface. In this study, SPMs evaluated a vascular model (vasculature-on-a-chip) by scanning electrochemical microscopy (SECM) and scanning ion conductance microscopy (SICM). Using these SPMs, the researchers quantified the permeability and topographical information of the vasculature-on-a-chip. Press release.

Standigm has opened a new office in Cambridge, United Kingdom, to accommodate the company’s rapid growth in the European market. Founded in 2015, Standigm has proprietary technology including AI platforms encompassing novel target identification to novel compound design to generate commercially valuable drug pipelines. The company now collaborates with multiple global partners, including Milner Therapeutics Institute, University of Cambridge. With its corporate headquarters in Seoul, South Korea, the opening of this new office in Cambridge is consistent with Standigm’s growth strategy to deepen its global footprints and it will enable Standigm to have a physical presence in the European market. This office will cover the European region for Standigm, to discover global partners for its target identification research. Press release.

Rice University has established the Genetic Design and Engineering Center (GDEC) thanks to a $4 million grant by the Cancer Prevention and Research Institute of Texas (CPRIT). Rice’s first CPRIT Core Facility will provide a one-stop shop for Houston’s Texas Medical Center, of which the university is a member, and other institutions that require custom DNA constructs but have neither the expertise nor the facilities to design and validate them. Space for the GDEC is expected to be configured for the GDEC over the next few months while equipment is ordered and staff are hired. The goal is to dramatically accelerate the pace, scale and impact of cancer research through access to state-of-the-art tools for the design, construction and optimization of the DNA constructs at the heart of developing innovative approaches to treat disease. Press release.

New results from the BabySeq Project, published in JAMA Pediatrics, showed no negative impact on families during the infant’s first year of life as a result of genome sequencing, even if monogenic disease risk or carrier status findings were returned to families. The study focused on the psychosocial effects of DNA testing by looking at the impact on the parent-child relationship, parent psychological distress and the parents’ relationship with each other. Parents completed surveys measuring those domains for about a year and a half after birth. Although minor differences between the study arm and the control arm appeared at different points, the results did not show meaningful differences in family impact over time. Researchers also found lower self- and partner-blame in the study arm compared to the control, possibly because sequencing information provided some degree of peace of mind. The researchers point out that their study consists of volunteer participants mostly of European descent and from affluent, educated families. This volunteer group may be more open to receiving genetic information. Next, the BabySeq Project team will seek to expand their study to a larger and more diverse population. The researchers also want to follow families for a longer period of time to capture long-term impacts. DOI:10.1001/jamapediatrics.2021.2829

HiberCell has acquired Genuity Science, a life science technology company that provides world-leading genomics and multi-omic analytics bolstered by an advanced artificial intelligence (AI) and machine learning (ML) platform to illuminate the underlying cause of cancer and other diseases. The combined company brings together powerful tools that will enhance the company’s probability of clinical success through an in-depth analysis of clinical samples, a validation of pharmacodynamic biomarkers, and a deeper understanding of the responsive phenotype in patients. The combined company will also leverage the multi-omic AI/ML capabilities to exhaustively compare primary tumor biology with paired metastatic lesions to better identify the targets and mechanisms that drive metastatic disease. The stock acquisition of the Genuity Science business provides HiberCell with approximately $100 million in cash, as well as the existing partnership agreements with Ionis and AbbVie. It is expected that future earnouts of these partnerships will support HiberCell’s growth as a clinical stage biotechnology company. Press release.

Vyant Bio and Cyclica have announced a non-exclusive strategic collaboration combining Vyant Bio’s patient-derived complex organoid biology alongside Cyclica’s proteome-wide, Artificial Intelligence enabled discovery platform to identify new treatments for CDKL5 Deficiency Disorder (“CDD”), a severe neurodevelopmental epilepsy disorder with no effective treatments or cure. Vyant Bio’s human-first approach to novel drug discovery incorporates patient biology into the earliest steps of the process with highly functional, disease-based neural organoids, while Cyclica’s proprietary machine learning platforms marry knowledge and structure-based approaches to find novel targets, uncover new uses for existing drugs, and design new molecules with therapeutic potential. Combined, the technologies aim to identify, validate, and progress new targets as well as new and existing compounds for streamlined and de-risked CDD-based drug discovery. Press release.

Digital Science has launched a new version of its popular Dimensions platform—Dimensions Life Sciences & Chemistry (Dimensions L&C)—focused on life sciences and chemistry research activities. Dimensions L&C analyzes more than 120 million scientific publications, millions of patents, grants and clinical trial documents. It is both larger than other databases, and unlike traditional manually-curated tools, applies up-to-the-minute semantic text analysis tools and ontologies, providing powerful up-to-date discovery functionality previously unavailable at such scale. Press release.

Telix Pharmaceuticals has entered a pan-cancer clinical collaboration with Merck KGaA to conduct combination studies with one of Merck’s investigational proprietary DNA Damage Response Inhibitor (DDRi) molecules in combination with each of Telix’s TLX591 (177Lu-rosopatamab) and TLX250 (177Lu-girentuximab) molecularly targeted radiation (MTR) therapeutic programs. This clinical collaboration builds on the success of a strategic research collaboration agreement between Telix and Merck announced in August 2019. TLX591 and TLX250 are late-stage products in development for prostate and renal cancer therapy, respectively. Under the terms of the collaboration and based on encouraging pre-clinical data derived from the initial strategic research collaboration, the two parties have agreed to investigate the synergy of these investigational assets with Merck’s DDRi compound across a wide variety of oncology indications in the clinic. Press release.

BlueAllele Corporation has been granted U.S. Patent No. 11,091,756, directed to the use of BlueAllele’s foundational PALIDON technology. BlueAllele’s PALIDON repair templates feature a palindromic, bi-directional structure that is designed to leverage the high rate of non-homologous end joining (NHEJ) repair observed in cells, while preserving the ability to achieve precise correction of damaged mRNA and protein. PALIDON repair templates are designed to be compatible with existing gene editing nucleases and delivery systems, making PALIDON particularly suitable for targeting an expansive number of loss-of-function and gain-of-function monogenic diseases. The palindromic design of PALIDON converts what was previously a byproduct (reverse integration) into a functional event that contributes to enhanced efficacy. By integrating PALIDON within introns, any potential error introduced by the NHEJ pathway can be tolerated, thereby minimizing unwanted byproducts. PALIDON captures the natural expression from an endogenous gene, resulting in exceptional control of protein levels with stable and durable edits. Press release.

Nurosene Health has entered an arm’s length non-binding term sheet with NetraMark Corp., a private Ontario corporation, to acquire all of its issued and outstanding ‎shares. NetraMark has developed proprietary artificial intelligence ("AI") and machine learning solutions to accelerate drug discovery for pharmaceutical companies. Their deep tech AI engine has the ability to leverage small to large datasets from user populations. This allows for the extraction of meaningful insights, designed to have a deep impact on precision treatments, leading to improved patient outcomes and discoveries. Nurosene will not be assuming any long-term debt, and no finder’s and/or other fees are payable, in conjunction with the transaction. The non-binding Term Sheet was executed on July 9, 2021, and both parties completed their mutual due diligence investigations, and waived all remaining due diligence conditions, on August 6, 2021. The Term Sheet is expected to close on or before September 15, 2021 (subject to extension by mutual agreement between the parties) which will contain customary terms and conditions for transactions of this nature. Press release.

BD has launched a new benchtop cell analyzer that brings sophisticated flow cytometry capabilities to laboratories of all sizes. The BD FACSymphony A1 Cell Analyzer is a fluorescence-activated cell analyzer that offers advanced research capabilities in a compact design, which helps improve access to instrumentation for complex scientific research to more labs. Fluorescence-activated cell sorter (FACS) technology enables the precise isolation of selected single cells from complex samples. This new BD cell analyzer offers researchers and scientists, regardless of their experience and level of expertise, access to proven technology to conduct a variety of flow cytometry experiments, helping them save time by using lab resources more efficiently and expand research capabilities in their own laboratories. The compact size of the system makes it ideal for individual laboratories with limited space. Press release.

Avera Health, an integrated regional health care system that serves 300 locations across the Upper Midwest, and Sema4, a patient-centered health intelligence company, have announced a new collaboration launching a precision medicine initiative. This initiative will initially focus on advancing oncology care, enabling Avera Health’s providers and patients to benefit from data-driven insights that inform targeted cancer treatments. Avera Cancer Institute has had a robust precision oncology program for several years in which the patient’s tumor has been genetically sequenced to guide individualized cancer treatment. This collaboration will take that a step further by leveraging Centrellis, Sema4’s health intelligence platform, to curate, structure and integrate clinical and genomic data to support both cancer research and clinical care at Avera Health. Sema4 will deliver predictive disease network models and clinically actionable insights, empowering Avera Health’s providers to further improve the prevention, detection, and treatment of cancer for their patients. Sema4 will also offer digital tools, which give Avera Health’s providers the ability to readily search for cohorts of patients based on clinical criteria, view a patient’s treatment history that is contained in the curated data as an interactive timeline, and more systematically match patients to clinical trials. Press release.

Amgen and the University of Southern California are teaming up to provide researchers with access to two leading-edge Thermo Scientific cryo-transmission electron microscopes (cryo-TEMs): the Thermo Scientific Krios and Glacios Cryo-TEMs. Housed at the Michelson Center for Convergent Bioscience at USC’s University Park Campus, these instruments offer built-in connectivity that will enable researchers from both institutions to increase their disease research productivity. Using these two instruments as part of their workflow, researchers will be able to pre-screen samples at moderate resolutions on the Glacios, and then transfer the best-quality samples for imaging at the highest resolutions on the Krios. Press release.

TeselaGen Biotechnology has announced a collaboration with the Agile BioFoundry (ABF) to lay the groundwork for deploying machine learning models on community-generated data to accelerate biomanufacturing and commercialization of bioproducts. Under terms of the collaborative research and development agreement, funded by the U.S. Department of Energy (DOE), TeselaGen will assist in the creation of a set of interoperable, data acquisition and sharing tools to enable machine learning in the fermentation process. The development of Phycus Biotechnology's sustainable bioproduct alternatives to petroleum-based chemicals used in cosmetics will be used as a real-world test case. Press release.