Contrasting of Gamida Cell Ltd. (GMDA) and Aridis Pharmaceuticals Inc. (NASDAQ:ARDS)

LAUREN FAIRCHILD | April 11, 2019 | 53 views

Gamida Cell Ltd. (NASDAQ:GMDA) and Aridis Pharmaceuticals Inc. (NASDAQ:ARDS) have been rivals in the Biotechnology for quite some time. Below is a review of each business including various aspects such as dividends, analyst recommendations, profitability, risk, earnings and valuation, institutional ownership. Gamida Cell Ltd., a clinical stage biopharmaceutical company, focuses on developing cell therapies to cure cancer, and rare and serious hematologic diseases in the United States, the European Union, and internationally. The company's lead product candidate is NiCord, a nicotinamide (NAM)-expanded cord blood cell therapy that is in Phase 3 clinical trials for use as a curative stem cell graft for patients in hematopoietic stem cell transplant.

Spotlight

Brammer Bio

Brammer Bio is a best-in-class viral vector contract development and manufacturing organization (CDMO) for companies developing gene-modified cell therapies and in vivo gene therapies. Brammer offers end-to-end CDMO services from Phase I/II in Florida through commercial manufacturing in Massachusetts. Brammer Bio provides clinical and commercial supply of viral vectors for in vivo gene and ex vivo modified-cell based therapies, process and analytical development, and regulatory support, enabling large pharma and biotech clients to accelerate the delivery of novel medicines to improve patient health. The Brammer team consists of extraordinary employees focused exclusively on serving the gene therapy needs of clients and their patients. We are Helping to Cure.® The management team is led by President and CEO Mark Bamforth; Chief Scientific Officer Dr. Richard Snyder, the founder of Florida Biologix, which was spun out of the University of Florida in 2015; and Chief Operating Officer Chri

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MEDTECH

Top 10 biotech IPOs in 2019

Article | July 12, 2022

The big question at the start of 2019 was whether the IPO window would stay open for biotech companies, particularly those seeking to pull off ever-larger IPOs at increasingly earlier stages of development. The short answer is yes—kind of. Here’s the long answer: In the words of Renaissance Capital, the IPO market had “a mostly good year.” The total number of deals fell to 159 from 192 the year before, but technology and healthcare companies were standout performers. The latter—which include biotech, medtech and diagnostics companies—led the pack, making up 43% of all IPOs in 2019. By Renaissance’s count, seven companies went public at valuations exceeding $1 billion, up from five the year before

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MEDTECH

Cell Out? Lysate-Based Expression an Option for Personalized Meds

Article | July 16, 2022

Cell-free expression (CFE) is the practice of making a protein without using a living cell. In contrast with cell line-based methods, production is achieved using a fluid containing biological components extracted from a cell, i.e., a lysate. CFE offers potential advantages for biopharma according to Philip Probert, PhD, a senior scientist at the Centre for Process Innovation in the U.K.

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MEDTECH

Closing bacterial genomes from the human gut microbiome using long-read sequencing

Article | October 7, 2022

In our lab, we focus on the impact of the gut microbiome on human health and disease. To evaluate this relationship, it’s important to understand the particular functions that different bacteria have. As bacteria are able to exchange, duplicate, and rearrange their genes in ways that directly affect their phenotypes, complete bacterial genomes assembled directly from human samples are essential to understand the strain variation and potential functions of the bacteria we host. Advances in the microbiome space have allowed for the de novo assembly of microbial genomes directly from metagenomes via short-read sequencing, assembly of reads into contigs, and binning of contigs into putative genome drafts. This is advantageous because it allows us to discover microbes without culturing them, directly from human samples and without reference databases. In the past year, there have been a number of tour de force efforts to broadly characterize the human gut microbiota through the creation of such metagenome-assembled genomes (MAGs)[1–4]. These works have produced hundreds of thousands of microbial genomes that vastly increase our understanding of the human gut. However, challenges in the assembly of short reads has limited our ability to correctly assemble repeated genomic elements and place them into genomic context. Thus, existing MAGs are often fragmented and do not include mobile genetic elements, 16S rRNA sequences, and other elements that are repeated or have high identity within and across bacterial genomes.

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Selexis Cell Line Development Strategies

Article | February 11, 2020

In today’s biotechnology landscape, to be competitive, meet regulations, and achieve market demands, “we must apply Bioprocessing 4.0,” said Igor Fisch, PhD, CEO, Selexis. In fact, in the last decade, “Selexis has evolved from cloning by limiting dilution to automated cell selection to nanofluidic chips and from monoclonality assessment by statistical calculation to proprietary bioinformatic analysis,” he added. Single-use processing systems are an expanding part of the biomanufacturing world; as such, they are a major component of Bioprocessing 4.0. “At Selexis, we use single use throughout our cell line development workflow. Currently, we have incorporated single-use automated bioprocessing systems such as ambr® and the Beacon® optofluidic platform for accelerated cell line development. By using these systems and optimizing our parameters, we were able to achieve high titers in shake flasks. Additionally, the Beacon systems integrate miniaturized cell culture with high-throughput liquid handling automation and cell imaging. This allows us to control, adjust, and monitor programs at the same time,” noted Fisch.

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Spotlight

Brammer Bio

Brammer Bio is a best-in-class viral vector contract development and manufacturing organization (CDMO) for companies developing gene-modified cell therapies and in vivo gene therapies. Brammer offers end-to-end CDMO services from Phase I/II in Florida through commercial manufacturing in Massachusetts. Brammer Bio provides clinical and commercial supply of viral vectors for in vivo gene and ex vivo modified-cell based therapies, process and analytical development, and regulatory support, enabling large pharma and biotech clients to accelerate the delivery of novel medicines to improve patient health. The Brammer team consists of extraordinary employees focused exclusively on serving the gene therapy needs of clients and their patients. We are Helping to Cure.® The management team is led by President and CEO Mark Bamforth; Chief Scientific Officer Dr. Richard Snyder, the founder of Florida Biologix, which was spun out of the University of Florida in 2015; and Chief Operating Officer Chri

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MEDTECH

Entos and BioMarin Enter into Agreement for Product Candidates Incorporating Entos' Fusogenix Drug Delivery Platform

Entos Pharmaceuticals, Inc., BioMarin | November 16, 2021

Entos Pharmaceuticals, Inc. (Entos), a clinical-stage biotechnology company developing genetic medicines with its Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, and BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that they have entered into an agreement that will see Entos apply its Fusogenix nucleic acid delivery technology to promising gene therapy candidates in the BioMarin pipeline. Under the agreement, Entos will create specially formulated product candidates for BioMarin, a world leader in developing and commercializing innovative biopharmaceuticals for genetic diseases driven by genetic causes. Entos' Fusogenix platform utilizes a PLV formulation with a novel mechanism of action to deliver molecular payloads, intact and unmodified, directly into target cells. By combining well-tolerated neutral lipids with proprietary fusion-associated small transmembrane (FAST) proteins, the Fusogenix platform efficiently delivers mRNA or DNA to target tissue with excellent tolerability. Fusogenix technology has been applied to a wide range of therapeutic approaches, including vaccines, gene therapy, and gene editing. "As a company committed to addressing the unmet therapeutic needs of patients living with genetic diseases, BioMarin values novel technologies that enable the development of transformative therapies," said Brinda Balakrishnan, M.D., Ph.D., Group Vice President, Corporate and Business Development at BioMarin. "We believe that Entos' Fusogenix platform offers potentially unique benefits for safe and effective tissue targeting compared with other lipid-based delivery systems. The Fusogenix PLV formulations generated under this agreement are a critical first step in determining how we may incorporate this promising platform into our drug development efforts." "With a 20-year track record of successfully discovering, developing, and commercializing first- or best-in-class therapies for diverse rare diseases, the BioMarin team has extensive expertise in harnessing the potential of breakthrough technologies. We believe this licensing agreement helps validate the potential of our Fusogenix platform. It also provides additional opportunities for incorporating our technology into cutting-edge treatments that may have significant clinical and commercial value." John Lewis, Ph.D., Founder and Chief Executive Officer of Entos Under the terms of the agreement, Entos will use its Fusogenix nucleic acid delivery system to specially formulate BioMarin products directed at multiple undisclosed genetic disease indications. BioMarin will conduct preclinical studies of the Fusogenix-formulated candidates to evaluate their potential as therapies to prevent or treat these conditions. Entos' most advanced clinical program is Covigenix VAX-001, a COVID-19 DNA vaccine encoding SARS-CoV-2 Spike protein and two genetic adjuvants engineered to stimulate host adaptive and innate immune systems. Formulated using the Fusogenix platform, Covigenix VAX-001 is the subject of an ongoing phase 2 clinical trial in South Africa, with additional trials planned in other regions. Licensees of the Fusogenix platform include Oisín Biotechnologies and OncoSenX, which are using the technology for age-related diseases and oncology applications, respectively. pH Partners, LLC served as financial advisor to Entos. About BioMarin BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare genetic diseases. The company's portfolio consists of seven commercialized products and multiple clinical and preclinical product candidates. About Entos Pharmaceuticals, Inc. Entos develops next generation nucleic acid-based therapies using its proprietary Fusogenix proteolipid vehicle (PLV) drug delivery system. Fusogenix is formulated with FAST proteins to deliver mRNA or DNA directly into the cytosol of target cells for translation into protective and therapeutic vaccines and medicines.

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MEDICAL

TeselaGen Biotechnology Announced the Launch of a New Protein Optimization Toolkit for Automated Biotherapeutic Drug Design and Development

TeselaGen Biotechnology | May 21, 2021

TeselaGen Biotechnology today announced the launch of a new protein optimization toolkit for biotherapeutic drug design and development, introducing significant enhancements to the company’s flagship TeselaGen® OS to form designing and developing pharmaceuticals and biotherapeutics faster and fewer expensive. The new capabilities, easily accessible via the cloud-based platform, simplify the planning of highly complex combinatorial protein libraries and support AI models for optimizing new peptides and proteins. New application programming interfaces (APIs) and integration tools have also been extended to further enhance users’ access to the new capabilities. TeselaGen integrates the facility of AI with one end-to-end platform for design, construction, data gathering, and analysis of bioproduct performance, from pharmaceuticals to food and fabrics, significantly accelerating time to plug and reducing costs. The platform’s DESIGN, BUILD, TEST, and find out modules enable researchers to effectively collaborate across an organization's development pipeline to style and build experiments, standardize and share data, and learn and preserve project results by embedding them during a machine learning model. TeselaGen’s DESIGN is an intuitive, user-interface-driven module that permits scientists to style highly complex combinatorial libraries. With this new release, the planning now supports aminoalkanoic acid parts which will be efficiently mapped to DNA. TeselaGen can then automatically generate biology protocols for efficiently synthesizing and assembling the corresponding DNA libraries. TeselaGen’s DISCOVER now supports AI models which will recommend new peptides and proteins supported by the training of supervised and unsupervised learning models. The platform also supports the modeling of unnatural amino acids and multicriteria optimization of proteins. R&D groups can utilize the TeselaGen OS to hurry the invention process. Datasets are uploaded and arranged within the platform and immediately useful for model building within TeselaGen’s DISCOVER module. TeselaGen has demonstrated that it can increase the planning and build speed of biological products and reduce the prices related to research & development by an order of magnitude. Current partnering companies are using the new capabilities for designing antibodies and optimizing their binding affinity, titer, specific productivity, immunogenicity, or other phenotypic variables of interest. Researchers also are looking to TeselaGen for rapidly engineering new vaccines - using methods like virus-like particles (VLPs), DNA, and RNA vaccines - opening the door to attacking rapidly mutating RNA and retroviruses like influenza, HCV, HIV, or coronaviruses. About TeselaGen Biotechnology TeselaGen Biotechnology has developed the primary artificial intelligence-enabled OS for biotechnology, enabling the event and commercialization of high-performance bioproducts – from pharmaceuticals to food to fabrics – faster and easier than ever. TeselaGen® connects biologists, lab technicians, and bioinformaticians so that they will collaboratively design and build experiments, organize and standardize data then test and continually learn from the info. TeselaGen has been deployed by Fortune 50 companies and emerging innovators in biopharmaceuticals, agriculture, and specialty chemicals. the corporate is privately held and based in San Francisco, California.

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MEDTECH

Entos and BioMarin Enter into Agreement for Product Candidates Incorporating Entos' Fusogenix Drug Delivery Platform

Entos Pharmaceuticals, Inc., BioMarin | November 16, 2021

Entos Pharmaceuticals, Inc. (Entos), a clinical-stage biotechnology company developing genetic medicines with its Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, and BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that they have entered into an agreement that will see Entos apply its Fusogenix nucleic acid delivery technology to promising gene therapy candidates in the BioMarin pipeline. Under the agreement, Entos will create specially formulated product candidates for BioMarin, a world leader in developing and commercializing innovative biopharmaceuticals for genetic diseases driven by genetic causes. Entos' Fusogenix platform utilizes a PLV formulation with a novel mechanism of action to deliver molecular payloads, intact and unmodified, directly into target cells. By combining well-tolerated neutral lipids with proprietary fusion-associated small transmembrane (FAST) proteins, the Fusogenix platform efficiently delivers mRNA or DNA to target tissue with excellent tolerability. Fusogenix technology has been applied to a wide range of therapeutic approaches, including vaccines, gene therapy, and gene editing. "As a company committed to addressing the unmet therapeutic needs of patients living with genetic diseases, BioMarin values novel technologies that enable the development of transformative therapies," said Brinda Balakrishnan, M.D., Ph.D., Group Vice President, Corporate and Business Development at BioMarin. "We believe that Entos' Fusogenix platform offers potentially unique benefits for safe and effective tissue targeting compared with other lipid-based delivery systems. The Fusogenix PLV formulations generated under this agreement are a critical first step in determining how we may incorporate this promising platform into our drug development efforts." "With a 20-year track record of successfully discovering, developing, and commercializing first- or best-in-class therapies for diverse rare diseases, the BioMarin team has extensive expertise in harnessing the potential of breakthrough technologies. We believe this licensing agreement helps validate the potential of our Fusogenix platform. It also provides additional opportunities for incorporating our technology into cutting-edge treatments that may have significant clinical and commercial value." John Lewis, Ph.D., Founder and Chief Executive Officer of Entos Under the terms of the agreement, Entos will use its Fusogenix nucleic acid delivery system to specially formulate BioMarin products directed at multiple undisclosed genetic disease indications. BioMarin will conduct preclinical studies of the Fusogenix-formulated candidates to evaluate their potential as therapies to prevent or treat these conditions. Entos' most advanced clinical program is Covigenix VAX-001, a COVID-19 DNA vaccine encoding SARS-CoV-2 Spike protein and two genetic adjuvants engineered to stimulate host adaptive and innate immune systems. Formulated using the Fusogenix platform, Covigenix VAX-001 is the subject of an ongoing phase 2 clinical trial in South Africa, with additional trials planned in other regions. Licensees of the Fusogenix platform include Oisín Biotechnologies and OncoSenX, which are using the technology for age-related diseases and oncology applications, respectively. pH Partners, LLC served as financial advisor to Entos. About BioMarin BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare genetic diseases. The company's portfolio consists of seven commercialized products and multiple clinical and preclinical product candidates. About Entos Pharmaceuticals, Inc. Entos develops next generation nucleic acid-based therapies using its proprietary Fusogenix proteolipid vehicle (PLV) drug delivery system. Fusogenix is formulated with FAST proteins to deliver mRNA or DNA directly into the cytosol of target cells for translation into protective and therapeutic vaccines and medicines.

Read More

MEDICAL

TeselaGen Biotechnology Announced the Launch of a New Protein Optimization Toolkit for Automated Biotherapeutic Drug Design and Development

TeselaGen Biotechnology | May 21, 2021

TeselaGen Biotechnology today announced the launch of a new protein optimization toolkit for biotherapeutic drug design and development, introducing significant enhancements to the company’s flagship TeselaGen® OS to form designing and developing pharmaceuticals and biotherapeutics faster and fewer expensive. The new capabilities, easily accessible via the cloud-based platform, simplify the planning of highly complex combinatorial protein libraries and support AI models for optimizing new peptides and proteins. New application programming interfaces (APIs) and integration tools have also been extended to further enhance users’ access to the new capabilities. TeselaGen integrates the facility of AI with one end-to-end platform for design, construction, data gathering, and analysis of bioproduct performance, from pharmaceuticals to food and fabrics, significantly accelerating time to plug and reducing costs. The platform’s DESIGN, BUILD, TEST, and find out modules enable researchers to effectively collaborate across an organization's development pipeline to style and build experiments, standardize and share data, and learn and preserve project results by embedding them during a machine learning model. TeselaGen’s DESIGN is an intuitive, user-interface-driven module that permits scientists to style highly complex combinatorial libraries. With this new release, the planning now supports aminoalkanoic acid parts which will be efficiently mapped to DNA. TeselaGen can then automatically generate biology protocols for efficiently synthesizing and assembling the corresponding DNA libraries. TeselaGen’s DISCOVER now supports AI models which will recommend new peptides and proteins supported by the training of supervised and unsupervised learning models. The platform also supports the modeling of unnatural amino acids and multicriteria optimization of proteins. R&D groups can utilize the TeselaGen OS to hurry the invention process. Datasets are uploaded and arranged within the platform and immediately useful for model building within TeselaGen’s DISCOVER module. TeselaGen has demonstrated that it can increase the planning and build speed of biological products and reduce the prices related to research & development by an order of magnitude. Current partnering companies are using the new capabilities for designing antibodies and optimizing their binding affinity, titer, specific productivity, immunogenicity, or other phenotypic variables of interest. Researchers also are looking to TeselaGen for rapidly engineering new vaccines - using methods like virus-like particles (VLPs), DNA, and RNA vaccines - opening the door to attacking rapidly mutating RNA and retroviruses like influenza, HCV, HIV, or coronaviruses. About TeselaGen Biotechnology TeselaGen Biotechnology has developed the primary artificial intelligence-enabled OS for biotechnology, enabling the event and commercialization of high-performance bioproducts – from pharmaceuticals to food to fabrics – faster and easier than ever. TeselaGen® connects biologists, lab technicians, and bioinformaticians so that they will collaboratively design and build experiments, organize and standardize data then test and continually learn from the info. TeselaGen has been deployed by Fortune 50 companies and emerging innovators in biopharmaceuticals, agriculture, and specialty chemicals. the corporate is privately held and based in San Francisco, California.

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