Thermo Fisher Scientific, LifeArc, Pure Storage, & More: News From April 2019

May 1, 2019 | April featured exciting new, products, and partnerships from around the bio-IT community from innovating companies, organizations, and universities, including Thermo Fisher Scientific, LifeArc, Pure Storage, and more.

Researchers and scientists analyzing crystallized protein samples in life sciences and materials research can now benefit from the first commercially released integrated solution for performing micro electron diffraction (MicroED), an advanced technique that enables researchers to quickly resolve structures up to a billion times smaller than those needed using traditional methods. The new Thermo Scientific MicroED solution, compatible with Thermo Scientific transmission electron microscopes (TEMs), enables scientists to perform analyses faster and with greater reproducibility than non-integrated MicroED offerings. The solution includes the CETA-D detector, optimized for diffraction imaging, and specialized MicroED software that automates the entire data acquisition process. The MicroED solution can be configured on multiple Thermo Scientific instruments, including Thermo Scientific Cryo-TEMs used in single particle analysis in life sciences and on high-resolution Thermo Scientific Talos and Themis TEMs commonly used in materials science research. "We developed and then integrated a new detector and automation software into our leading high-performance TEM microscopes to offer customers unprecedented speed and ease-of-use for the MicroED technique," Mike Shafer, president of materials and structural analysis at Thermo Fisher Scientific, in a press release. "This solution allows researchers to accelerate innovation in key areas such as drug discovery and green energy advancements." Press release

Forty Seven announced an extension of its agreement with Genentech. Under the terms of the extension, the companies will initiate a third clinical trial, evaluating Forty Seven’s CD47 antibody 5F9 in combination with Genentech’s anti-CD20 antibody rituximab (Rituxan) and anti-PDL1 antibody, atezolizumab (Tecentriq), in patients with diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin’s lymphoma (NHL). This expands the initial agreement announced by Forty Seven in January 2018, under which Genentech is sponsoring two clinical trials combining 5F9 with atezolizumab in patients with acute myeloid leukemia (AML) and urothelial (bladder) cancer. This third trial studying a triplet regimen aims to build upon the promising results already reported from a Phase 1b study of 5F9 in combination with rituximab in NHL patients by including a third agent, atezolizumab, to further optimize the treatment of DLBCL patients whose tumors are associated with high levels of macrophages expressing PD-L1. CD47 is an immune modulator molecule overexpressed on cancer cells that sends inhibitory signals to macrophages. Binding of 5F9 to CD47 takes the brakes off macrophages enabling them to phagocytose, or swallow, tumor cells. In a Phase 1b study published in the New England Journal of Medicine in November 2018, 5F9 in combination with rituximab showed initial activity in advanced patients with relapsed or refractory DLBCL who had received multiple rounds of previous therapies. In May 2018, 5F9 was granted Fast Track designation by the FDA for the treatment of DLBCL and follicular lymphoma (FL) and is currently being evaluated in combination with rituximab in an ongoing Phase 2 study in these two indications. Forty Seven expects to report updated data from the Phase 2 study in the second quarter of 2019. Press release

Solentim and SAL Scientific announced a new strategic partnership. The collaboration will further optimise CLD workflow by supplying novel supplements which substantially improve cell growth. Solentim will act as the exclusive distributor for the SAL Scientific "Insti" product range. Cells grown in chemically defined, animal component-free media can be susceptible to impaired growth and viability, especially when subjected to stress. The SAL "Insti" range of cell culture media supplements are proven to show improved cell growth, colony formation and cloning efficiency. These supplements are suitable for both CHO and HEK cells. Ian Taylor, Chief Commercial Officer of Solentim, commented in a press release, "We're delighted to partner with SAL Scientific and to become its global channel to market. In cell line development, the viability and recovery from single cell cloning and subsequent outgrowth is widely accepted as an area where significant improvements can be made." Taylor added, “Using the gentle, high efficiency seeding of our VIPS single cell cloning system in combination with the SAL InstiGRO supplements will ensure a much higher number of wells in the cloning plates successfully produce colonies. The inherent value of this is huge as it means potential 'gold nugget' clones stand a much better chance of surviving and being picked." Steve Game, Founding Director at SAL Scientific, added, "The partnership with Solentim will enable our products to reach a wider customer base and combine two powerful innovations. We are excited to work with Solentim as we scale up production and we look forward to using our expertise in cell culture reagent development to further the partnership." Press release

AMO Pharma announced the presentation of a new clinician-completed rating scale to assess features of congenital myotonic dystrophy type 1 (CDM1). CDM1 is a genetic disease caused by a large tri-nucleotide expansion repeat adjacent to the DMPK gene. Symptoms usually present shortly after birth and include difficulty with thinking and problem solving, speech impairment, symptoms of autism and weakened muscles. There are currently no approved therapies for CDM1. Patients are often treated with a combination of medical interventions designed to address individual symptom as they arise. The fit-for-purpose scale identifies 11 observable characteristics of CDM1 and rates each on a four-point Likert scale, using information from natural history studies, consultation with therapeutic area experts and feedback from regulatory agencies. An evaluation of the scale's use in clinical study found it has potential to effectively assess the CDM1 phenotype in a low-burden manner, is change-sensitive, can detect treatment effects and may provide useful outcome measure for future clinical trials. "This is a major milestone for researchers looking to enhance our understanding of this disorder, drawing insight from the experiences of other patients and caregivers in a reproducible manner and incorporating advice from the FDA," said Joseph Horrigan, AMO Pharma's chief medical officer, in a press release. "We look forward to broadening the scope of this scale so that we may better address the current and future needs of this largely underserved community." This clinician-completed rating scale will serve as the primary outcome measure in a Pharma Phase 2/3 registration-caliber study in children and adolescents with CDM1 being planned by AMO Pharma. It is also being validated in an ongoing natural history study in children and adolescents with CDM1. Press release

LifeArc and the Association of University Technology Managers (AUTM) Foundation has announced that recruitment is open for their Technology Transfer Fellowship 2019-2020. The LifeArc-AUTM Fellows Programme is a one-year training fellowship that trains promising life scientists to become the next generation of highly skilled technology transfer specialists. The deadline for applications is 7 July 2019. The Fellowship is suitable for academic life scientists at graduate or post-doctoral level from across the European Union. Importantly, applicants must be passionate about innovation and aspire to have a career in technology transfer. If successful, fellows will be put through a curriculum which combines formal training with networking, mentoring and practical experience in the field. Fellows will also receive a two-year AUTM membership and be sponsored to attend three major technology transfer meetings, two taking place in the US and one in Europe. Press release

Pure Storage announced that it has entered into a definitive agreement to acquire Compuverde, a leading developer of file software solutions for enterprises and cloud providers based in Sweden. Compuverde will expand Pure Storage's file capabilities, enabling enterprises to take advantage of advanced file offerings. The additional functionality reinforces Pure's strategy to empower customers to implement true hybrid architectures -- whether they choose to leverage data on-prem, in the cloud, or increasingly a mix of both. Within enterprises, there is a growing demand for file-based shared storage in the public cloud. According to IDC, 79% of end users leverage file-based storage for unstructured data associated with mission-critical workloads. As more enterprise applications are deployed in a hybrid cloud architecture, file-based storage that offers the same advanced functionality as the on-prem environment can help reduce challenges to movement. Compuverde brings a robust ecosystem of technology partnerships and the company's highly scalable software solution is deployed across global organizations in telecom, financial services, and media industries. "We're excited about the opportunities that the Compuverde team and technology bring to Pure's existing portfolio," said Charles Giancarlo, Chairman and CEO, in a press release. "As IT strategies evolve, enterprises look to leverage the innovations of the public cloud in conjunction with their on-prem solutions. Through our expanding suite of hybrid data solutions such as Cloud Data Services, we continue to help our customers make the most of their data assets." Press release

BDO USA announced the acquisition of BioProcess Technology Consultants, a provider of chemistry, manufacturing and controls (CMC) consulting services to the global biopharmaceutical industry. The acquisition of BPTC bolsters BDO's capabilities in the life sciences industry within the biopharmaceutical product development space and is effective as of April 1, 2019. "We are pleased to welcome BPTC's knowledge and resources to enhance our focus in the life sciences industry and deepen our biopharmaceutical product development offerings," Eric Jia-Sobota, national leader of BDO's Industry Specialty Services and Life Sciences practices, said in a press release. "Joining forces with BPTC strengthens our ability to assist life sciences companies in managing risk, maximizing profitability and fostering continued innovation to unlock new value and deliver improved outcomes." Press release

Penn State researchers and the applied science company Protochips have collaborated to enhance the substrate in Cryogenic-Electron Microscopy (cryo-EM). The new substrates, called Cryo-Chips, gives researchers the potential to get all their data on the samples in as little as an hour, as opposed to what would currently take days. "Only having to set initial focus parameters saves a tremendous amount of time during data acquisition," said Cameron Varano, research assistant professor in the CSO and the co-lead author on a new paper just published online in the journal Small, in a press release. "The Protochips substrates are made from silicon nitride, a more rigid material than the carbon grids, which makes them less apt to have local deformities. And the wells in the chips can be customized for various ice thicknesses and applications." In their paper, "Cryo-EM-on-a-Chip: Custom-designed Substrates for the 3D Analysis of Macromolecules," the researchers chose three case studies for which this type of imaging could be useful. The first study was a comparison of the carbon grid with holes and the Cryo-Chip using rotavirus particles, a standard model in cryo-EM studies because of its large size and symmetrical shape. They saw enhanced contrast with the Cryo-Chip substrate, as well as more specimen retention in the custom wells. Full Article

Imaging Biometrics recently unveiled its latest software, IB Server. IB Server is an application that provides immediate access to IB’s clinically-validated processing algorithms available in IB products: IB Neuro, IB Diffusion, IB DCE, and IB Delta Suite (Delta T1 maps). The automated generation of IB’s quantitative parameter maps eliminates the post-processing steps frequently performed by neuroradiologists or MR technologists. IB Server can be installed on any existing computer platform and can be readily integrated within a site’s network. Once integrated, relevant studies are automatically detected, the appropriate IB software algorithm is executed, and the processed parameter maps and QA information are sent to the resident PACS for viewing and interpretation. "We are very excited for the clinical workflow benefits offered by IB Server," said David Smith, CEO of IB, in a press release. "The automated generation of IB's quantitative parameter maps will obviously save valuable post-processing time. In addition, the recently announced ability to eliminate the pre-load dose of Gadolinium contrast agent for MR dynamic susceptibility contrast (MR DSC) perfusion maps (IB Neuro) will help streamline patient workflows as well." Press release

Fusion Pharmaceuticals announced the completion of a $105 million Series B financing led by Varian and new investor OrbiMed. Additional investors participating in the round are Perceptive Advisors, Pivotal bioVenture Partners, and Rock Springs Capital, along with the existing group of leading international investors, that include HealthCap, Adams Street Partners, Johnson & Johnson Innovation, TPG Biotech, Seroba Life Sciences, Genesys Capital, and FACIT. In conjunction with the new financing, Deepak Khuntia, Senior Vice President (SVP) and Chief Medical Officer (CMO) at Varian, Chau Q. Khuong, Partner at OrbiMed, and Heather Preston, Managing Director at Pivotal bioVenture Partners, will join Fusion’s Board of Directors. The financing will be used to advance and broaden the scope of Fusion’s ongoing clinical program in targeted alpha therapeutics, and accelerate a pipeline of new radiopharmaceuticals and combination therapy strategies. The company’s lead product candidate [²²⁵Ac]-FPI-1434, combines the precision targeting of an antibody with the potency of alpha-particle emitting medical isotopes to specifically attack and eradicate cancer cells across multiple tumor types. "Fusion is delighted to welcome this group of preeminent healthcare investors to our existing and highly distinguished series A investors. We have made tremendous progress in the last two years, and this financing reflects strong support for our platform, people and pipeline," said John Valliant, Fusion's Chief Executive Officer, in a press release. "The investment positions us to implement our clinical and partnering strategies around [²²⁵Ac]-FPI-1434, expand our team and fully exploit the unique advantages of our linker technology." Press release