Access Biologicals Completes the First-ever Commercially Available COVID-19 Seroconversion Panel to Confirm SARS-CoV-2 Antibody Assays

PR Newswire | September 07, 2020

Access Biologicals, a market leader in the collection and manufacturing of biologicals products, today announced it has completed the first-ever commercially available COVID-19 seroconversion panel to confirm the presence of anti-SARS-CoV-2 antibodies. Efforts to contain the spread of COVID-19 rely in part on serological tests to identify the presence of anti-SARS-CoV-2 antibodies in people who have had the illness. Until now, however, many of these tests have been developed rapidly and without the independent data to help assess their analytical performance and enable comparisons between different testing methods. With Access Biologicals' seroconversion panel, diagnostic manufacturers, clinical laboratories and researchers will have a reliable benchmark against which they can develop, validate and troubleshoot other COVID-19 serological assays and testing. "An effective, sensitive and specific way to identify and confirm the SARS-CoV-2 infection is urgently needed," said Mike Crowley, Managing Director Access Biologicals. "Our COVID-19 seroconversion panel will help serological assays bridge the gap through precise validation, establishing sensitivity and helping determine the pre-seroconversion window period, which is the time after infection and before seroconversion, when antibodies appear." Collected in a longitudinal series, the Access Biologicals COVID-19 seroconversion panel consists of 14 members (units) of a unique human plasma sample drawn from a single donor during a developing SARS-CoV-2 infection. The panel illustrates the onset and decline of IgM, IgG and Ig total SARS-CoV-2 virus antibody titers over a period of 87 days.

Spotlight

We don’t typically think of the wastewater collection system as a biological process, but biological processes are in fact occurring in sewer lines and in related systems such as lift or pump stations. Fecal bacteria are the largest biological inputs into the system. Fecal bacteria are primarily facultative (surviving with or without oxygen sources) and obligate anaerobes (surviving only in the absence of oxygen sources). Microbes are also being contributed from everyday activities (bathing, laundry, food preparation and cleanup, floor mopping, etc.). These microbes may be aerobic (surviving only in the presence of molecular oxygen), facultative, or obligate anaerobes.

Spotlight

We don’t typically think of the wastewater collection system as a biological process, but biological processes are in fact occurring in sewer lines and in related systems such as lift or pump stations. Fecal bacteria are the largest biological inputs into the system. Fecal bacteria are primarily facultative (surviving with or without oxygen sources) and obligate anaerobes (surviving only in the absence of oxygen sources). Microbes are also being contributed from everyday activities (bathing, laundry, food preparation and cleanup, floor mopping, etc.). These microbes may be aerobic (surviving only in the presence of molecular oxygen), facultative, or obligate anaerobes.

Related News

CELL AND GENE THERAPY

iXCells Biotechnologies Secures Strategic Growth Investment from Great Point Partners

iXCells Biotechnologies | September 30, 2022

iXCells Biotechnologies a high growth provider of cell-based products and discovery services to the academic, biotech and pharmaceutical communities worldwide, with special focus on primary and induced pluripotent stem cell derived cellular models, today announced receiving a growth investment from Connecticut-based Great Point Partners a private investment firm focusing on the healthcare industry. “iXCells is delighted to join GPP’s portfolio of companies operating within the rapidly growing biotech manufacturing and DD&D services space. We’re grateful for GPP’s support of our vision to translate human cell technology into innovative solutions that advance cell biology research and drug discovery. Our partnership with GPP is a critical step forward for our Company’s growth journey.” Dr. Lynn Zhang, CEO and co-founder iXCells President and co-founder, Dr. Nianwei Lin added, “Our customers will clearly benefit from the deployment of additional capital towards key growth initiatives that will increase iXCells’ operational capacity, expand our product/service offering and bioanalytical capabilities. In particular, we’ll be strengthening our ability to service unmet market needs in areas of personalized medicine including rare diseases. We’re very much looking forward to collaborating with GPP’s management team and broad network to advance iXCells’ mission for the benefit of all stakeholders.” Noah Rhodes, Managing Director at GPP, commented, “Lynn and Nianwei have done an exceptional job building a rapidly growing company serving academic, biotech and pharma clients with best-in-class drug discovery solutions and disease-relevant cellular models. We were extremely impressed by the scientific expertise the management team has built within the organization, and we look forward to helping them expand their product and service offering into adjacent high-growth end markets.” About iXCells Biotechnologies Founded in 2014 and based in San Diego, CA, iXCells Biotechnologies is an innovative cell biology and cell technology company that provides preclinical drug discovery solutions with the focus on disease relevant cellular models enabling technologies and services to the academic, biotech and pharma communities to accelerate the pace of drug discovery. iXCells offers customers access to high quality primary and iPSC derived cells, custom iPSC services, functional bioassay development and drug screening. About Great Point Partners Great Point Partners, founded in 2003 and based in Greenwich, CT, is a leading health care investment firm with 30 professionals, investing in the United States, Canada, and Western Europe. GPP is currently making new minority and majority private equity investments from GPP IV. Great Point manages $1.5B of capital in its private funds and public life sciences equity strategy (BioMedical Value Fund). Great Point Partners has provided growth equity, growth recapitalization, and management buyout financing to more than 200 growing health care companies. The private equity funds invest across all sectors of the health care industry with a particular emphasis on biopharmaceutical services and supplies, alternate site care, medical device and information technology enabled businesses. The firm pursues a proactive and proprietary approach to sourcing investments and tuck-in acquisitions for its portfolio companies.

Read More

CELL AND GENE THERAPY

Lunaphore and Nucleai announce a partnership to provide AIpowered spatial biology analysis to accelerate drug development

Lunaphore and Nucleai | September 09, 2022

Lunaphore, a Swiss life sciences company developing technology to enable spatial biology in every laboratory, and Nucleai, a leader in AI-powered spatial biology transforming precision medicine by unlocking the power of pathology data announced a collaboration to accelerate the discovery of novel biomarkers and drug targets using the latest spatial imaging and machine learning technologies. “We are thrilled to announce the partnership with Lunaphore and combine Lunaphore’s best-in-class flagship COMET™, a hyperplex staining and imaging platform, with Nucleai’s ATOM platform that uniquely supports multiplex, IHC, and H&E data. This strategic partnership will allow us to utilize multiplex technology and provide a complete, actionable, and scalable solution to improve drug target discovery and development of our pharma and biotech partners.” Avi Veidman, Chief Executive Officer of Nucleai Mapping biological microenvironments with spatial mapping technology is an exciting area of discovery. Lunaphore’s novel COMET™ technology unlocks the power of immunofluorescence spatial biology with a robust and user-friendly system, permitting the use of any non-conjugated antibodies and enabling the wide adoption of spatial biology in laboratories. Nucleai has built a platform that makes spatial analysis scalable and operational, enabling the next generation of actionable insights from massive pathology data sets that have not been analyzed to their fullest potential and could provide significant value to pharmaceutical companies and diagnostic labs. The partnership will utilize Lunaphore’s innovative COMET™ platform for hyperplex staining and imaging with Nucleai’s cutting-edge AI spatial models to derive new insights from tissue biopsies, including novel drug targets, mechanisms of action, and biomarkers to advance the field of precision medicine. The combined solutions will provide laboratories with an integrated end-to-end spatial biology workflow from automated, hyperplex sequential immunofluorescence staining and imaging to AI-enabled, state-of-the-art image processing, and data analytics. As part of the partnership, the companies also plan to develop predictive and prognostic spatial biomarker assays. “Our partnership with Nucleai is based on our shared vision to advance next-generation spatial multiplex immunofluorescence imaging to accelerate drug and biomarker discovery and development,” said Déborah Heintze, Chief Marketing Officer of Lunaphore. “Connecting Nucleai’s solution with COMET™, we have the potential to more precisely characterize the immune system and disease microenvironment to provide deeper biological insights to drug developers.” “Nucleai brings innovative spatial biology and machine learning platform (ATOM) to empower researchers with novel insights into drug discovery,” said Mridula Iyer, Ph.D., Vice President of Strategic Partnerships at Nucleai. “The technology is designed to unlock and analyze valuable data from pathology slides previously inaccessible, leading to the development of new precise targeted therapy that is important for patient outcomes. This collaboration is another example of how both Lunaphore and Nucleai are accelerating efforts to partner with pharmaceutical and biopharmaceutical companies, as well as medical research institutions and other biomedical organizations.” About COMET™ COMET™ is a fully automated sequential immunofluorescence instrument, able to perform hyperplex staining and imaging, producing high-quality data in a robust and reproducible manner. With superior tissue profiling capabilities, the system allows multiplex analysis of up to 40 different spatial markers per tissue slide without human intervention. COMET™ has a wide range of research applications, allowing for a dramatic improvement in the understanding of disease pathology in areas such as immuno-oncology, neuroscience, and infectious diseases. The technology has the ability to revolutionize clinical applications such as drug discovery and biomarker development. About Lunaphore Lunaphore Technologies S.A. is a Swiss company born in 2014 with the vision of enabling spatial biology in every laboratory. Lunaphore has developed a game-changing chip technology that can extract spatial proteomic and genomic data from tumors and transform any simple assay into multiplex spatial biology without complexity. Lunaphore empowers researchers to push the boundaries of research to ultimately develop the next generation personalized therapies. About Nucleai Nucleai is an AI-powered spatial biology company with a mission to transform drug development and clinical treatment decisions by unlocking the power of pathology data. Nucleai provides pharmaceutical companies, Contract Research Organizations, and diagnostics laboratories with a state-of-the-art AI platform to improve clinical trials and clinical decision-making.

Read More

CELL AND GENE THERAPY

Sesen Bio and Carisma Therapeutics Announce Merger Agreement

Sesen Bio and Carisma Therapeutics | September 22, 2022

Sesen Bio, Inc. and Carisma Therapeutics Inc. a privately held, clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on the advancement of Carisma’s proprietary cell therapy platform that utilizes engineered macrophages and monocytes to potentially transform the treatment of cancer and other serious disorders. Carisma is pioneering the development of chimeric antigen receptor macrophage therapies and is believed to be the only company developing CAR-M therapies with demonstrated proof of mechanism and safety data in clinical trials. The combined company is expected to operate under the name Carisma Therapeutics Inc. and trade on Nasdaq under the ticker symbol “CARM”. Carisma has also secured commitments from a syndicate of investors for a $30 million financing, including HealthCap, AbbVie, Wellington Partners, SymBiosis, Penn Medicine, TPG Biotech, MRL Ventures Fund, the therapeutics-focused corporate venture arm of Merck & Co., Agent Capital, Solasta, Livzon, Pictet Alternative Advisors and 4Bio, which is expected to close concurrently with the completion of the merger. With the cash expected from both companies at closing and the proceeds of the concurrent financing, the combined company is expected to have approximately $180 million in cash, cash equivalents and marketable securities. These cash resources are expected to be used to advance Carisma’s pipeline through multiple ongoing and planned key data readouts across several clinical trials and to fund operating expenses and capital expenditure requirements through 2024. The merger and related financing are expected to close in the next three to four months. “The proposed merger represents an exciting opportunity for shareholders of each company, and we believe it gets us one step closer to our goal of revolutionizing the field of immunotherapy. This transaction will provide us with financial strength to not only continue to develop our lead candidate CT-0508, but also allow us to accelerate the growth of our platform and pipeline within and outside of oncology and develop additional strong strategic partnerships beyond those we already have with Moderna and Novartis. Carisma is focused on delivering cutting-edge technology for patients in a way that has never been done before, and we look forward to advancing this important mission.” Steven Kelly, President and Chief Executive Officer of Carisma “This transaction represents the result of a thoughtful and careful review of strategic alternatives over the past four months, during which Carisma’s clinical programs, management team, and corporate strategy stood out amongst the 42 bids reviewed,” said Dr. Thomas Cannell, President and Chief Executive Officer of Sesen Bio. “Carisma is an exciting clinical-stage company with groundbreaking science and an impressive management team, which we believe makes them the optimal partner to provide value for our shareholders. Our mission at Sesen Bio has always been to save and improve the lives of patients with cancer, and we believe Carisma has the science and the unwavering patient focus required to make that mission a reality.” About the Proposed Merger Pre-merger Sesen Bio stockholders are expected to own approximately 41.7% and pre-merger Carisma stockholders are expected to own approximately 58.3% of the combined company, in each case before giving effect to the concurrent financing described above and the conversion of the outstanding Moderna convertible note. Under the terms of the merger agreement, stockholders of Carisma will receive newly issued shares of Sesen Bio common stock pursuant to an exchange ratio formula set forth in the merger agreement. The percentage of the combined company that Sesen Bio stockholders will own upon the closing of the merger is further subject to adjustment based on the amount of Sesen Bio’s net cash at the time of closing. Immediately prior to the closing of the proposed merger, Sesen Bio stockholders of record will be issued a contingent value right (CVR) for each outstanding share of Sesen Bio common stock held by such Sesen Bio stockholder as of such date, representing the right to receive certain cash payments from proceeds received by Sesen Bio related to the Roche Asset Purchase Agreement, if any, subject to customary deductions, including for expenses and taxes. SVB Securities is acting as exclusive financial advisor to Sesen Bio for the transaction and Hogan Lovells US LLP is serving as its legal counsel. Evercore Group LLC is serving as lead financial advisor to Carisma for the transaction and BofA Securities, Inc. is also serving as financial advisor to Carisma for the transaction. Wilmer Cutler Pickering Hale and Dorr LLP is serving as legal counsel to Carisma. BofA Securities, Inc. and Evercore Group L.L.C. are serving as co-placement agents for Carisma’s concurrent financing and Shearman & Sterling LLP is serving as the placement agents’ legal counsel. About Sesen Bio Sesen Bio, Inc. is a late-stage clinical company focused on targeted fusion protein therapeutics for the treatment of patients with cancer. Sesen Bio’s most advanced product candidate, Vicineum™, also known as VB4-845, is a locally-administered targeted fusion protein composed of an anti-epithelial cell adhesion molecule antibody fragment tethered to a truncated form of Pseudomonas exotoxin A for the treatment of non-muscle invasive bladder cancer. On July 15, 2022, Sesen Bio made the strategic decision to voluntarily pause further development of Vicineum in the US. The decision was based on a thorough reassessment of Vicineum, which included the incremental development timeline and associated costs for an additional Phase 3 clinical trial, following Sesen Bio’s discussions with the United States Food and Drug Administration. Sesen Bio has turned its primary focus to assessing potential strategic alternatives with the goal of maximizing shareholder value. Additionally, Sesen Bio intends to seek a partner for the further development of Vicineum. About Carisma Therapeutics Carisma Therapeutics Inc. is a biopharmaceutical company dedicated to developing a differentiated and proprietary cell therapy platform focused on engineered macrophages, cells that play a crucial role in both the innate and adaptive immune response. The first applications of the platform, developed in collaboration with the University of Pennsylvania*, are autologous chimeric antigen receptor (CAR)-macrophages for the treatment of solid tumors. Carisma Therapeutics is headquartered in Philadelphia, PA.

Read More