New instrument provides greater sensitivity to enable additional applications for discovery and characterization of novel therapeutics with unrivaled throughput and efficiency
Carterra Inc., the world leader in innovative technologies enabling high-throughput biology, launched its latest HT-SPR instrument, the LSAXT, at the Society for Laboratory Automation and Screening (SLAS) Conference and Exhibition in San Diego, CA. The LSAXT brings augmented sensitivity to Carterra’s highly successful LSA platform enabling additional applications throughout drug discovery and development at throughput levels unseen in any other instrument. Carterra will be showcasing the new LSAXT platform for high-throughput SPR at the SLAS event (booth 2127) with a launch program that includes a user presentation by Dragonfly Therapeutics on February 27 at 2:00 pm.
The LSAXT instrument boasts additional hardware and software features that build upon the capabilities of Carterra’s original and highly successful LSA instrument while maintaining its impressive throughput and sample efficiency. The LSA delivers 100 times the data in 10% of the time-to-answer and uses 1% of the sample required by other label-free platforms. The LSAXT enables an expanded range of applications that include some of the most exciting and growing areas in drug discovery such as proteolysis-targeting chimeras (PROTAC®s), membrane proteins, DNA-Encoded Library (DEL) compounds, and rapid kinetic systems such as cytokines, protein-protein inhibitors, and Fc gamma receptors. Additionally, the increased performance in the LSAXT allows measurement of lower molecular weight analytes including kinase inhibitors.
Since its launch in 2018, Carterra’s LSA antibody discovery and characterization platform has penetrated 19 of the largest 20 pharmaceutical companies, CROs, and biotechs on four continents. Characterizing binding kinetics and epitope coverage of large numbers of antibodies early in the drug discovery process has been transformative. The speed at which antibodies can now be identified and characterized as candidate therapeutics has vastly improved compared to traditional methods. The LSA platform has been profiled in multiple Science, Nature, and Cell peer-reviewed papers, one of which profiled the development of a novel monoclonal antibody therapeutic, bamlanivimab, which was the world’s first COVID-19 therapeutic and the fastest biologic ever to reach clinical trials thanks to Eli Lilly and AbCellera.
At SLAS, scientists from Dragonfly Therapeutics will discuss the benefits of running the Fc gamma receptor (Fc?R) binding application which is a critical component of ADCC, ADCP, and CDC and an important feature to measure in Fc-containing molecules. Data will be presented showcasing the ability to characterize a full panel of biotinylated Fc?Rs now possible with the Carterra LSAXT’s throughput and greater flexibility, resulting in significantly faster time to results and sample efficiency than currently available 8-channel biosensor instruments in the market.
Speaking about the launch of the LSAXT at SLAS 2023, Christopher Silva, Vice President of Marketing and Product at Carterra added, “This is a great day for biologics discovery scientists and for Carterra. You always run the risk of missed expectations when you launch a follow-on product after a game changer like the LSA. But we’ve proved that with the LSAXT the story only gets better for us and our customers.”
Jorge, left, and Julio Brea of Symphonic Distribution
Photo: Zaccardo/Rick Visuals Inc.
Jorge and Julio Brea were just little boys when their family immigrated from the Dominican Republic to Tampa in the early 1990s. As teenagers growing up at the dawn of digital age, they loved both music and technology, and they figured out a way to bring the two together.
Jorge didn’t play an instrument, but he could compose electronic dance music on his computer and by 16 was working as a DJ and producer, going on to release original music and remixes. When he got the entrepreneurial “itch,” Jorge started uploading mp3 files of his music on Myspace, and by his own account was making $100 a day. He turned to helping other artists do the same in the rapidly emerging digital world of music distribution.
In 2006, with no venture capital or outside funding, he founded Symphonic Distribution out of his parent’s home, a company that made it easier for music creators to reach as many outlets and as wide an audience as possible, along with providing marketing, rights management and other services. Julio joined him in the company as did Jorge’s wife, marketing executive Janette Berrios. Their roster of artists eventually expanded to more than 100 in a range of genres, from Latin to electronic and country to classical.
Independent artists can’t just call up streaming services like iTunes and Spotify and ask them to carry their music, so Symphonic Distribution developed proprietary technology that allows artists to distribute music, videos and ringtones through one of the largest global networks of digital partners. And even though Tampa isn’t a city most associate with the music industry, Symphonic Distribution’s presence expanded to Africa, Brazil, Colombia, the Dominican Republic, Mexico and Spain, and the company’s innovative team — now numbering 145 employees — attracted music industry veterans.
The family’s technological know-how has been a perfect match for an industry where streaming and social media have become dominant forms of music distribution, and where independent artists alternately have unprecedented opportunities but also barriers as big tech companies like Apple and Amazon and the three major labels — Universal Music Group, Sony Music Entertainment and Warner Music Group — put up roadblocks to reaching audiences. Jorge Brea made Billboard Magazine’s Indie Power Players list in 2018 and has stayed there since.
Early in 2022, after raising $37 million from Philadelphia’s NewSpring Capital and Tampa’s Ballast Point Ventures, Symphonic Distribution acquired Nashville-based marketing agency Streaming Promotions and joined with a division of Canada’s Higher Reign Music Distribution, which not only allows it to expand its presence but puts Symphonic on an entirely new level within the industry. For a company that had grown steadily and quietly in Tampa — along the way drawing on local resources and business development expertise from resources like Florida’s Small Business Development Centers — there was one last hometown hill to conquer. In January, Symphonic Distribution was recognized with the Alliance of M&A Advisors Tampa Bay Chapter’s Deal of the Year Award.
I can tell you firsthand that the selection process was more competitive than might be obvious. I was honored to serve as a judge for this year’s competition and was astounded at the complexity and the impact of the deals put before us. Florida has always had a strong entrepreneurial streak, but the deals vying for this year’s award reflect two very important features about the strength of midmarket mergers and acquisitions: The ability of homegrown companies to take the leap to the next level and the interest of outside firms, including multinationals, in acquiring the thriving businesses born here. The community is doing something right when those two things happen with frequency and scale.
The two other finalists for the award were Millian Aire Enterprises, a family-owned commercial and residential heating, ventilation and air-conditioning company that was acquired by Ontario-based global facilities management firm BGIS, and Lake Michigan Credit Union’s acquisition of Tampa-based Pilot Bank. In all three cases, the deals are producing hundreds of high-wage jobs in the area.
As for Symphonic Distribution, the creativity and artistry keeps flowing in big and small ways. In addition to its major moves, it also is partnering with platforms like Pinterest to add music clips to posts. The same week we celebrated with Symphonic at the Deal of the Year Awards (Florida Secretary of Business and Professional Regulation Melanie Griffin and Tampa Mayor Jane Castor joined in the honors), the company announced a music video distribution partnership with Canela Media, a leading Spanish-language streaming service. The Brea brothers leave little doubt that they’re just getting started on a steady drumbeat of success.
The combination of forward-looking market insights will produce the industry’s most accurate view of worldwide air, hotel, and alternative accommodations bookings.
As travel trends continue to evolve, so have the lodging options available to travelers. From hotels to short-term rentals, travelers have more choices than ever. For hoteliers, property managers, and tourism organizations trying to understand what’s happening in their market and how they are performing against their competitive set, a full picture of accommodation bookings and air traffic is necessary to make accurate, data-driven revenue decisions.
With this in mind, Amadeus, a global leader in travel data intelligence and hospitality technology, and Key Data, a global leader in short-term rental data, have announced a partnership to combine forward-looking business intelligence data for air, hotels, vacation rentals, and other alternative accommodations. The blended data sets will fully integrate to produce a best in class, single view of travel data.
For the first time, this single view of data will also be available to Destination Marketing Organizations (DMOs) and Convention & Visitor Bureaus (CVBs), ushering in a new, more comprehensive view of travel trends and insights with an easy-to-use set of dashboards and tools.
Jason Sprenkle, CEO, Key Data Dashboard, said, “Customers and businesses that rely on travel data need a single solution that offers a full view of their market, regardless of where travelers choose to stay. By partnering with Amadeus, we not only make it easier for our customers to access travel data, but we also unlock new insights and trends to help these businesses and destinations make decisions earlier, and with more confidence.”
Michael Yeomans, Executive Vice President , Business Intelligence and Data Solutions , Hospitality, Amadeus, commented, “We are very pleased to add this unique data to Amadeus’ robust business intelligence suite. As the travel landscape continues to evolve, we are committed to offering the best breadth and depth of data and insights to our customers. We’re excited about this new partnership which supports our offer expansion as the hospitality industry’s most trusted travel data source.”
careviso, a healthcare technology company and market leader in molecular diagnostic patient access technology (the “Company”), today announced that it has raised over $17 million in Series B funding led by Ballast Point Ventures with participation from existing investors Mercury and Lytical Ventures. The new funding will enable careviso to broadly expand its existing technology platform into the diagnostic space providing patients with clarity around their cost of care while reducing administrative burdens for physicians.
Founded upon the mission of improving healthcare transparency and access, careviso’s technology platform delivers real-time cost estimates, administrative requirements, and approvals, supporting providers, payors, labs, and patients alike. Since 2017, the Company has sustained substantial growth, providing solutions for over 1,000,000 patients and over 120,000 physicians, and has since expanded beyond a focus on support for prior authorizations. careviso’s propriety technology solutions help healthcare professionals navigate the complexities of diagnostic testing and improve the patient care experience. Previously known as CMT Solutions, careviso recently unveiled a new brand identity reflecting their pivot towards providing a more holistic approach to overall patient access.
careviso’s technology platform, seeQer, is directly aligned with the No Surprises Act, which protects individuals covered under a variety of health plans from receiving surprise medical bills months after a service or procedure. The product solves the requirements surrounding the Good Faith Estimate and the Advanced Explanation of Benefits, for diagnostic services, at the point of care or ahead of time. The Company plans to utilize the funding to support the growth of the platform so that it can be used to satisfy the No Surprises Act throughout the entire diagnostic space.
“Despite the evolution of our healthcare system, one of the largest challenges continues to exist around prior authorizations and transparency around costs, plaguing both physicians and patients alike,” said Andrew Mignatti, Co-Founder and CEO of careviso. “Through this latest fundraise, careviso will grow beyond its core focus on physicians as we pivot towards a broader part of the diagnostic testing process to solve the growing challenges for patients – reducing complexity and providing a clear picture of costs. With the support of our dedicated investors, we are excited for our next phase of development as we execute on our mission to remove the barriers associated with this critical area of the healthcare industry.”
careviso currently serves a substantial customer base in the women’s healthcare space, with over 50% of OBGYN clinics in the U.S. working with careviso. While OBGYN and oncology remain careviso’s core therapeutic areas, the Company is prioritizing expansion into other therapeutic areas with an increased focus on patient access, including radiology and endoscopy.
“The careviso team has an unwavering commitment to improving patient access with unique, innovative, and turnkey technology solutions,” said Matt Rice, Partner at Ballast Point. “We are proud to partner with such a dynamic and purpose-driven team that is well-positioned to scale its innovative technology and robust clinical database to new areas of the healthcare market.”
“careviso’s innovative platform has revolutionized the overall diagnostic process for healthcare professionals and we’ve been thrilled to watch this expertise and technology come to bear on the patient side,” said Aziz Gilani, Managing Director at Mercury. “We are excited to continue our strong support of Andrew and his team in their ongoing mission to inject transparency and efficiency in this complicated aspect of the healthcare spectrum.”
Combined Company Forms a Powerful Growth Platform for Omnichannel Sellers Worldwide
LONDON, England, Sept. 01, 2022 (GLOBE NEWSWIRE) — Linnworks, a leading e-commerce enablement software and order management systems (“OMS”) provider, has announced its formal agreement to acquire SkuVault, a leading U.S.-based provider of inventory management software (“IMS”) and warehouse management systems (“WMS”) solutions. The deal brings together two companies with a shared vision of accelerating growth for omnichannel sellers. Marlin Equity Partners (“Marlin”), a global investment firm with over $8.1 billion of capital commitments under management, will be the majority shareholder of the combined company.
“We are very excited for the combination of our local and global talent that will drive significant value to our customers, employees and partners,” said Callum Campbell, CEO of Linnworks. “We deeply appreciate SkuVault’s leading position within the North American market, driven by its highly differentiated product that offers rich features and functionality across the IMS and OMS value chain, as well as its deep WMS and third-party logistics (“3PL”) capabilities. We look forward to the depth of experience and spirit of innovation that the SkuVault team will bring to the shared company.”
“We are thrilled to be partnering with the Linnworks team to drive strategy and innovation in our industry and increase value for our customers,” said Andy Eastes, CEO and Co-Founder of SkuVault. “Together, we intend to address the most difficult challenges growing omnichannel sellers face and help our customers seamlessly integrate their sales channels and warehouses, fulfill orders more efficiently, and ultimately, grow their respective businesses faster.” Upon closing, Linnworks and SkuVault will combine their strengths to offer robust IMS/OMS solutions in the market, with an excellent user experience, extensive breadth and depth of functionality, and globally available implementation and support services.
“We look forward to working with both the Linnworks and SkuVault teams to establish a global category leader in a fast-growing market segment with increased platform breadth and global coverage of customer profiles,” said Peter Chung, a managing director at Marlin. “We believe the businesses are highly complementary, not only from a geographic perspective, but also with each bringing strengths across a number of key product capabilities in order management, inventory management, analytics & forecasting, warehouse management and 3PL support,” said Grant Schachter, a principal at Marlin. “The acquisition of SkuVault underscores Linnworks’ mission to build a leading global provider of e-commerce enablement and OMS solutions,” said Roland Pezzutto, a managing director at Marlin. “Both companies have exhibited strong growth historically, and this transformative merger creates a unique opportunity to accelerate growth through investment in product innovation, go-to-market strategy, account management and support.”
Raymond James & Associates served as SkuVault’s financial advisor. SkuVault’s legal advisor was Wyatt, Tarrant & Combs, LLP. DC Advisory acted as financial advisor and Goodwin Procter LLP and Mayer Brown International LLP served as legal advisors to Linnworks and Marlin. Financial terms were not disclosed.
About Linnworks
Linnworks is a leading commerce automation platform that enables the world’s major marketplaces and sales channels to manage their multi-channel inventory, orders and fulfillment from a single dashboard while providing deep insights across operations. By equipping brands and retailers to conduct commerce wherever their customers are, Linnworks powers businesses to drive growth and boost brand success. Linnworks processes over $8 billion in gross merchandise value each year globally and serves some of the world’s largest, recognizable brands. For more information, please visit www.linnworks.com.
About SkuVault
SkuVault’s warehouse and inventory management platform solves one of the biggest challenges in omnichannel retail: managing and tracking inventory at scale. By integrating with critical shipping, e-commerce and channel management platforms, SkuVault delivers inventory quantity, location and velocity with certainty. Today, over 1,200 of the world’s best product sellers trust SkuVault to ensure the success of their businesses. For more information, please visit www.skuvault.com.
About Marlin Equity Partners
Marlin Equity Partners is a global investment firm with over $8.1 billion of capital under management. The firm is focused on providing corporate parents, shareholders and other stakeholders with tailored solutions that meet their business and liquidity needs. Marlin invests in businesses across multiple industries where its capital base, industry relationships and extensive network of operational resources significantly strengthen a company’s outlook and enhance value. Since its inception, Marlin, through its group of funds and related companies, has successfully completed over 200 acquisitions. The firm is headquartered in Los Angeles, California, with an additional office in London. For more information, please visit www.marlinequity.com.
Medical device company Theragen is pleased to announce the issuance of a U.S. Patent acknowledging its innovative approach to the development of the ActaStim-S Spine Fusion Bone Growth Stimulator system.
ActaStim Sync Digital Companion App
Theregen’s ActaStim-S Spine Bone Growth Stimulator
The first new Spine Fusion Stimulator on the market in decades, ActaStim-S blends clinically proven therapeutic stimulation with modern design and a data-rich digital health platform. The system not only promotes healing, it encourages patient compliance, engagement, and informed dialogue with healthcare providers during the critical — and lengthy — post-operative fusion process.
“Spinal fusion is a healing process, often characterized as a race to achieve solid fusion before failure of the implanted hardware,” says co-inventor and Theragen CEO Chris McAuliffe. “Electrical stimulation is a clinically proven, safe and effective post-operative adjunct therapy that can help patients win that race, however its clinical effectiveness requires regular use over several months.”
“That’s why we’ve taken a user-centric approach, designing a more wearable device that also offers a digital health component that gives patients the unique opportunity to engage in, follow, and truly impact their own recovery.”
COO, VP of R&D, and co-inventor Richard Pearce explains further: “The system includes a remarkably discreet, unobtrusive wearable unit that is very well received by patients. It includes utilization tracking, on-board activity sensing, Bluetooth smartphone connectivity, and an intuitive app that helps patients visualize their progress over time.”
“The essence of this new U.S. Patent (#11,394,919) is focused on ensuring that this connectivity does not interfere with ease of use — and that data collection and transfer can happen quickly and effectively.” Learn more about Theragen’s user-centric approach in Pearce’s recent Med Device Online article, 3 Lessons Learned Designing Our Digital Health App.
Theragen, Inc. is a leader in the development and manufacture of non-invasive, electrical stimulation DME products that deliver therapeutic energy for healing and empower patients to play an active role in their recovery. We’re committed to continuous innovation and expanding our reach to help improve outcomes for more patients. To learn more, please visit theragen.com.
Key Data Dashboard, the leading provider of trusted vacation and short-term rental data, today announced that it has secured a $5 million credit facility from Signature Bank, a New York-based full-service commercial bank with a dedicated Venture Banking Group serving venture-backed startups and their investors nationwide. This new credit facility will complement a $5 million Series B round led by Ballast Point Ventures and is intended to support several key initiatives.
“We’ll use this new capital to fund Key Data’s high growth initiatives, which include our new direct-to-consumer platform, an expansion of our enterprise data offerings, and an acceleration of our growing international presence,” said Jason Sprenkle, Chief Executive Officer of Key Data.
“We’ve effectively doubled our team, revenue, and customer base over the past twelve months, and we are excited to be leaning further into the explosive growth that the short-term rental industry has been experiencing. The pandemic, the shifting economy, and the overall growth of the space have fueled tremendous demand for our data, as has the recent confluence of real estate and short-term rental data for investors, REITs, and underwriters. We’re eager to keep pace by delivering new tools, expanded offerings, and an unwavering commitment to providing the most accurate, timely, and trusted data available.”
“The hospitality industry continues to evolve as online marketplaces for vacation rentals and investment properties are on the rise. Key Data’s innovative vacation rental data products provide real-time insights and analytics to drive revenue — not only for individual investors but also large-scale property managers and tourism organizations,” explained Dhruv Patel, Senior Vice President in Signature Bank’s Venture Banking Group.
“Jason and his experienced team are no strangers to success. After two prior exits, Glad To Have You™ and 360 Blue, the team was ready to make their mark in another venture and we welcomed the opportunity to be involved. We look forward to working with Key Data and their investors, including Ballast Point Ventures, as the company continues to expand and serve this growing market,” added Patel.
New Capability Enables Individuals Identified as High-Risk by Participating Health Plans to Access Screening through a Quest Diagnostics Site
Builds on Quest’s Extended Care Services to Improve Care Quality and Outcomes in Diabetes and Other Chronic Diseases
Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, today announced a collaboration with IRIS (Intelligent Retinal Imaging Systems) to deliver diabetic retinal imaging services through designated Quest Diagnostics patient service centers across the United States to aid in screening patients for retinal assessment by a healthcare provider. The collaboration aims to increase convenience and improve screening rates for diabetic retinopathy, the leading cause of blindness in the United Statesi, for members of population health management programs sponsored by health plans.
According to the Centers for Disease Control and Prevention, nearly one-third of patients with diabetes over 40 years old have diabetic retinopathy.ii Screening to aid early detection and treatment may help prevent the disease from progressing to blindness.iii While an annual diabetic retinal screening is medically recommended for patients with diabetes, barriers to care can limit access to this service.
In 2018, Quest Diagnostics, through its Quest HealthConnect (QHC) business, began to provide diabetic retinal imaging for use in screening using the IRIS platform. This platform involves the use of a portable, handheld camera that captures a patient’s retinal images as part of its risk evaluation and care services for participating health plan members. The new collaboration with IRIS extends the use of the IRIS platform at Quest’s patient service centers.
New service builds on Quest’s vision to aid in closing gaps in care for patients with diabetes The new service expands on the Quest Diagnostics Extended Care portfolio of services designed to facilitate access to care beyond traditional healthcare settings. These services feature home-based risk assessment and monitoring tools through Quest HealthConnect and coaching for chronic conditions through Pack Health, which Quest Diagnostics acquired in January 2022. It also includes services provided by Quest Healthcare Analytics, which utilizes the company’s database of 60 billion laboratory test results to help identify and engage at-risk members for health plans to close screening gaps and improve care quality and outcomes.
With training developed by IRIS, designated personnel at Quest patient service centers will transmit a patient’s retinal image to a credentialed, licensed ophthalmologist to interpret the images. The IRIS Program returns a diagnostic and patient report to Quest HealthConnect. The results are also transmitted to the health plan as well as the patient’s primary care physician or eye specialist for follow-up diagnosis and care.
“Limited access to important screenings has allowed the undetected, sight-threatening progression of diabetic retinopathy to grow,” said Christopher Grant, Vice President & General Manager, Quest HealthConnect. “Through this collaboration with IRIS, we can now provide a new opportunity to help prevent sight loss. Leveraging our network of patient service centers will increase access to screenings for many, ultimately leading to better health outcomes.”
“IRIS is thrilled to be joined by Quest Diagnostics, the nation’s leading provider of diagnostic information services, to help mitigate preventable blindness,” said Steve Martin, IRIS CEO. “Through this expanded care network, it will make it much easier to reach the estimated 60% of people with diabetes that are currently skipping their annual diabetic retinopathy check.iv”
Diabetic retinopathy is caused by damage to the blood vessels in the retina and can lead to vision loss or blindness in diabetics. Early detection and treatment of diabetic retinopathy is crucial to slowing disease progression and preventing patients from losing their eyesight.
Malvern, PA, February 8, 2022 – YPrime, LLC, a global leader in cloud-based eClinical solutions, announced today the strategic acquisition of Tryl, a software development company with a unique patient engagement solution that brings together beautiful design, dynamic personalization, and applied behavioral science that is designed to boost engagement, reduce dropouts, and deliver outcomes in clinical trials. The acquisition includes the transfer of all staff, development capabilities, and intellectual properties to YPrime, and will integrate with YPrime’s Patient Engagement Technologies solutions.
“YPrime’s major priority has always been to anticipate the needs of tomorrow’s clinical trials and create powerful eClinical tools that simplify the lives of sponsors, sites, and patients,” says Shawn Blackburn, CEO, YPrime. “This combination with Tryl helps us leap ahead in fulfilling our vision of creating the industry’s first-of-its-kind solution to help keep patients more informed and engaged throughout the entire clinical trial process, especially as our industry accelerates toward decentralized clinical trial models.”
“An ever-increasing focus on patient centricity demands an integrated approach to how patients are engaged,” says Ian Greenfield, CEO of Tryl. “This starts from the moment patients are recruited and continues throughout the entire patient journey. YPrime has a strong vision for the future and by bringing together offerings from our two companies, we can create a novel solution that takes head on the most pressing challenges associated with attracting, engaging, and retaining patients.”
Tryl’s tools provide an experience that is personalized, predictive, empathetic, and relative to the overall patient journey. Tryl’s proprietary engagement score is designed to reduce patient dropout rates. Rooted in consumer experience, the Tryl team applies proven behavioral principles from other industries (such as professional sports and consumer finance) to seek to improve patient adherence to study protocols.
Mark Maietta, President, YPrime expressed his enthusiasm, “The addition of the Tryl team and their innovative solutions will boost patient compliance and reduce attrition, and the timing is perfect. YPrime has built an enviable market position with its strong eCOA and IRT capabilities. Now we can seamlessly layer on complementary solutions to our innovative technology stack for running successful decentralized trials.”
About Tryl
Tryl applies a consumer-grade UX and proven behavioral techniques like design thinking, empathy, and social proof, to increase study compliance and guide participants through complex protocols. Predictive analytics prompt clinicians to step in before subjects drop out. This approach minimizes participants’ burden while maximizing value for sponsors and researchers.
Source: GEN – Genetic Engineering & Biotechnology News
Neutralizing antibodies represent an important class of therapeutics that could provide immediate benefit in the treatment of SARS-CoV-2 or as a passive prophylaxis before vaccination. Passive prophylaxis also could be an alternative to vaccination in populations where vaccines have been found to be less efficacious.1
When AbCellera became a participant in DARPA’s P3 (Pandemic Prevention Platform) program in 2018, the aim was to build a pandemic-ready, rapid response, antibody discovery platform capable of developing field-ready medical countermeasures within 60 days of isolation of an unknown viral pathogen. At the time, AbCellera didn’t know that within two years its platform and team would be mobilized to react in record time to a real-life global health scenario, the COVID-19 pandemic.
In every person’s body, billions of antibodies exist, each with unique properties and functions. AbCellera’s full-stack AI-powered antibody discovery platform deeply searches natural immune responses to identify antibodies with desired properties such as virus neutralization, safety, longevity, and manufacturability.
The company’s mission is to make its technology stack available and to empower all antibody-based drug discovery programs. To date, the technology stack has been used in over 100 programs to address a wide range of indications in addition to COVID-19 and other infectious disease.
Putting a plan into action
At the end of February 2020, AbCellera obtained a single blood sample from a recovered COVID-19 patient. Close to six million peripheral blood mononuclear cells (PBMCs) were screened in three days, and thousands of therapeutic antibody potentials eventually narrowed to a final subset of 500 unique antibodies that recognized the interaction between the SARS-CoV-2 spike protein’s receptor binding domain (RBD) and the angiotensin converting enzyme 2 (ACE2) cellular receptor.
These candidates underwent extensive analysis and characterization—approximately 500 data points per molecule. An important aspect of the technology stack is the machine learning/artificial intelligence (ML/AI) tool that allows analysis of large data clouds comprised of approximately 250,000 data points for this data set.
“We were able to visualize the analysis and down selection process using our custom in-house visualization software, Celium,” said Ester Falconer, PhD, chief technology officer at AbCellera, who led the AI-powered antibody discovery platform’s development.
Bryan Jones, PhD, senior research fellow at Eli Lilly and Company, co-led most of the discovery activities that took place at Lilly, in close partnership with AbCellera. His group played a large role analyzing and transitioning the initially discovered set of hundreds of antibodies—through selection, production, and characterization of a narrowed set of antibodies—that ultimately led to the identification of LY-CoV555 (bamlanivimab) for clinical development.
This image depicts LY-CoV555 (bamlanivimab), an antibody that engages the receptor-binding domain (RBD) of the SARS-CoV-2 virus’s spike protein, and thereby blocks the RBD’s interaction with the host cell’s angiotensin converting enzyme 2 (ACE2) receptor. Notice that three LY-CoV555 Fab fragments bind to one spike trimer. LY-CoV555 was discovered by AbCellera Biologics, which is developing the antibody with Eli Lilly and Company.
“Due to the rapidly evolving and geographically diverse nature of the SARS-CoV-2 virus, continued scientific innovation remains critical to develop additional treatments,” said Jones, who adds that Lilly remains committed to developing complementary neutralizing antibodies to address potential SARS-CoV-2 variants that undoubtedly will arise. Currently, a next-generation antibody, LY-CoV1404, is in the preclinical pipeline.
Eli Lilly and Company is developing neutralizing antibodies that can address SARS-CoV-2 variants. One such antibody is LY-CoV1404, which Lilly is developing in collaboration with AbCellera Biologics. LY-CoV1404 is a next-generation antibody, and it has entered clinical trials in patients with mild-to-moderate COVID-19. Lilly has expanded its ongoing BLAZE-4 trials to evaluate LY-CoV1404 alone and together with other monoclonal antibodies.
Intense pressure and challenges
“Our platform and the extended team were ready,” said Falconer. “But in reality, this was a new virus that the world was racing against. We had no experience with it and did not know what type of immune response it would elicit. To develop an antibody database to mine, we had only one blood sample from one of the first recovered patients in the United States.
“Plus, this was an early immune response. The blood was drawn 20 days after onset of symptoms. It was not clear what we were going to find. We had one shot, it had to work, and it had to be the fastest discovery ever. The pandemic-ready platform and team had to deliver.”
The speed at which things needed to progress was the biggest challenge. “Because of the urgency,” Jones recalled, “we were making decisions based on little data and testing a new virus, while simultaneously trying to coordinate these activities across multiple organizations ranging from Lilly and AbCellera, to the Vaccine Research Center (VRC) at the National Institutes of Health (NIH), to the numerous academic collaborators who were providing critical data.”
All of these efforts played out against a backdrop of everyone trying to learn how to work nearly completely remotely.
Antibodies were characterized deeply to ensure that any data points that could direct the team in the right direction would not be overlooked. The number of data points per antibody highlights the importance of the visualization software Celium and the infrastructure AbCellera developed to generate, aggregate, and process the data. High-stakes decision making was made in real time.
The discovery efforts, which have been detailed in Science Translational Medicine, included the rapid identification and characterization of the potent anti-spike neutralizing antibody, LYCoV555, derived from PBMCs isolated from a patient after recovery from COVID-19.1
The Carterra LSA, a high-throughput monoclonal antibody characterization platform, combines microfluidic flow technology and high-throughput surface plasmon resonance detection. The LSA helped AbCellera and Eli Lilly and Company evaluate binding affinity and epitope coverage for over 500 patient-derived antibodies including LY-CoV555. In this image, the LSA is being operated by Josh Eckman, founder and CEO of Carterra, and Rebecca Rich, PhD, a senior scientist at the company.
It takes a village
“With the right team and technology, what seems impossible is achievable. With Lilly, we broke the mold for the fastest discovery through IND for any drug, challenging the current drug development process,” Falconer said. “It does not need to take years and years. Nearly six million cells were screened in three days, antibody genes were sequenced in an additional two days, and antibodies were generated and tested a week later—an incredible feat.”
“There really was not a tremendous difference in the workflow of discovery, clinical development, and manufacturing, except that everyone was singularly focused,” Jones added. “But a key difference was partnership with the FDA to identify innovative approaches to get treatments to patients as quickly as possible. We learned that a large and committed group of people concentrated on a sole objective can do amazing things.”
Pandemics are unpredictable
Bamlanivimab proceeded from sample to Emergency Use Authorization (EUA) in just over eight months, a groundbreaking achievement in the development of antibody therapeutics. In November 2020, the FDA granted an EUA for bamlanivimab alone, and subsequently granted an EUA in February 2021 for bamlanivimab together with etesevimab (LY-CoV016), for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Due to the sustained increase of SARS-CoV-2 variants that are resistant to bamlanivimab alone, Lilly requested and received in April 2021 a revocation of the EUA for bamlanivimab used alone. The EUA remains in effect for the combined use of bamlanivimab and etesevimab.
Enabling technology
The Carterra LSA facilitated the rapid kinetic characterization of the selected recombinantly expressed antibodies to the SARS-CoV-2 spike protein and the RBD.
Spike protein–dependent viral entry is initiated by upward movement of the RBD at the apex of the protein, allowing access to bind the ACE2 cellular receptor. Upon receptor engagement, coordinated proteolytic cleavage and shedding of the S1 subunit occur, and conformational rearrangement of the S2 subunit leads to viral fusion with the cell and transfer of genetic material.1
“The LSA allowed for an extensive epitope analysis to be performed on the antibody panel which demonstrated broad epitope coverage, distinct classification into known binder categories such as S1 and S2, and the determination of neutralization of ACE2 binding,” said Dan Bedinger, PhD, applications scientist team lead at Carterra.
These assessments were key elements in the ranking and selection of the subset of leads for further characterization.
The ability to rapidly complete these analyses in a parallel, unattended fashion with minute amounts of recombinant antigen—a scarce and valuable resource—made it possible to characterize the full candidate panel in an extremely accelerated development timeline, 90 days from initiation to first in human.
According to Bedinger, no other bioanalytical platform could have provided this rich picture of epitope binning classification, a picture that delivered a deep understanding of the interaction between sequence diversity and epitope recognition.
Coronavirus Immunotherapy Consortium
As variants of SARS-CoV-2 emerge, Carterra is collaborating with the Coronavirus Immunotherapy Consortium (CoVIC), a Gates Foundation–sponsored program. CoVIC has collected nearly 300 antibodies from a wide variety of sources that target the SARS-CoV-2 spike protein.
In a highly interdisciplinary effort across many institutions, these antibodies are being evaluated for a variety of properties including viral neutralization and escape, effector function, epitope recognition, and binding specificity. The LSA is being utilized to characterize the relative binding of each antibody to a variety of spike mutants and to create a comprehensive epitope binning profile.
“Data show that these antibodies can be clustered into epitope communities which map to various regions or faces of the spike protein when analyzed by cryo-EM,” said Bedinger. “Clones within these communities often share properties like neutralization and binding sensitivities to certain types of mutations.”
With a high-throughput approach, new antibodies can be rapidly binned into relevant communities and compared against the existing antibody population to understand their novelty and to predict their behavior.
