IVERIC bio, Inc. | July 06, 2022
IVERIC bio, Inc. and DelSiTech Ltd, announced an exclusive global license agreement providing Iveric Bio with the right to develop and commercialize new formulations of Zimura® using DelSiTech’s silica-based sustained release technology. As part of Iveric Bio’s lifecycle expansion plan for Zimura, the Company is committed to developing sustained release technologies for the treatment of age-related macular degeneration (AMD). These technologies potentially could address patients being treated for geographic atrophy (GA) and intermediate AMD.
“We are thrilled to collaborate with the DelSiTech team on investigating additional sustained release formulations for Zimura with their drug delivery expertise and advanced technology and look forward to evaluating a sustained release formulation in GA and potentially earlier stages of AMD. Previously reported post-hoc analyses from GATHER1 suggest that Zimura may have the potential to impact AMD in early stages before atrophy occurs in patients. We believe Zimura, which is a chemically synthesized RNA aptamer, is amenable to injectable sustained release formulations.”
Pravin U. Dugel, MD, President of Iveric Bio
“As a leading developer of long-acting controlled release formulations for small molecules and biological entities, we are excited about collaborating with Iveric Bio on bringing innovative solutions to patients living with AMD,” stated Lasse Leino, PhD, Chief Executive Officer of DelSiTech. “We are inspired by the opportunity to leverage our drug delivery technology to potentially help AMD patients early and improve their treatment experience.”
“This agreement underscores our commitment to invest in lifecycle initiatives for Zimura,” said Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. “We are excited about the possibilities to expand Zimura into earlier stages of AMD and potentially allow for a next-generation treatment to help patients with GA.”
“We are proud to bring our competencies into this promising alliance and contribute to Iveric Bio’s mission to address unmet needs for patients,” said Dr. Frederic Dargelas, Head of Business Development and Alliance Management for DelSiTech.
Under the terms of the license agreement, Iveric Bio will pay DelSiTech an upfront payment of €1,250,000, as well as development and commercial milestones and royalties on net sales of licensed products.
In addition to working with DelSiTech, Iveric Bio plans to explore the potential for Zimura in earlier stages of AMD by initiating a clinical trial studying the current formulation of Zimura in patients with intermediate AMD in the fourth quarter of 2022. The development strategy in this indication is subject to global regulatory feedback from the U.S. Food and Drug Administration (FDA) and other regulatory authorities, which Iveric Bio plans to obtain before initiating this trial.
About Zimura GATHER1 and GATHER2 Clinical Trials
Iveric Bio previously announced that GATHER1, the Company’s first Phase 3 clinical trial for Zimura (avacincaptad pegol) for GA, met its pre-specified primary efficacy endpoint with statistical significance. The most frequently reported ocular adverse events in this trial were related to the injection procedure. The Company expects topline data for GATHER2, the Company’s second Phase 3 clinical trial for Zimura for GA, to be available in the third quarter of 2022, approximately one year after the enrollment of the last patient in the trial plus the time needed for database lock and analysis. If 12-month results from GATHER2 are positive, the Company plans to submit applications with the FDA and the European Medicines Agency for marketing approval of Zimura for GA. There are no FDA or EMA approved treatments available for patients with GA.
Zimura is an investigational drug product and has not been approved for use anywhere globally. Zimura is designed to target and inhibit the cleavage of complement protein C5 and the formation of its downstream fragments, C5a and C5b. By inhibiting the formation of these fragments, Zimura is believed to decrease or slow the chronic inflammation and cell death associated with the retinal aging process by decreasing the formation of membrane attack complex (MAC) and inflammasome activity, thereby potentially avoiding or slowing the degeneration of retinal pigment epithelial cells. This potential mechanism is the rationale for Zimura as a potential therapy for GA and earlier stages of AMD.
About Iveric Bio
Iveric Bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs. The Company is committed to having a positive impact on patients’ lives by delivering high-quality, safe and effective treatments designed to address debilitating retinal diseases including earlier stages of age-related macular degeneration.
DelSiTech Ltd., located in Turku, Finland, is the leading technology specialist in biodegradable silica-based controlled release of small molecule drugs, biologics, and viral vectors. It develops and commercializes its proprietary, drug delivery technology in collaboration with a number of pharma and biotech companies to turn their ideas into novel drug products.
Indica Labs | May 13, 2022
Lunaphore, a Swiss life sciences company developing technology to enable spatial biology in every laboratory, and Indica Labs, a leading provider of computational pathology software and services, today announced a partnership to co-market an end-to-end solution that combines Lunaphore's flagship COMET™ spatial biology platform and Indica's HALO® and HALO AI™ digital pathology image analysis software.
Lunaphore's COMET™ platform provides superior multiplex staining and image acquisition capabilities facilitating the automated detection of up to 40 separate spatial markers per tissue slide without human intervention. In contrast to other spatial biology solutions, COMET™ works with off-the-shelf, label-free antibodies and is designed to provide researchers with flexibility for their workflow. COMET™ has a wide range of research applications across immuno-oncology, neuroscience, and infectious diseases.
Indica Labs' industry-leading HALO® and HALO AITM software enable fast, AI-based quantitative analysis of whole slide images. In combination with the COMET™ platform, the HALO Highplex FL module allows researchers to quantify an unlimited number of fluorescent markers and cell phenotypes defined by their biomarker expression. HALO Spatial Analysis and HALO AI deep learning classifiers are used in combination with Highplex FL to explore the distribution and spatial relationships between different cell phenotypes in the context of the tissue, such as tumor and immune cells. This additional spatial data is particularly important in immuno-oncology and neuroscience disease research.
We are excited to partner with Lunaphore to address the growing needs of our research customers for highly multiplexed assays, Combining Lunaphore's superior multiplexing technologies upstream with our powerful AI-based analysis downstream, together we provide a streamlined workflow for high dimensional imaging and image analysis."
Steven Hashagen, CEO of Indica Labs.
Our partnership with Indica Labs is another key aspect of our strategy to combine our COMET™ technology with industry-leading image analysis technologies, Indica Labs' solutions are used by a large set of researchers in the field, thanks to their ease of use and analysis capabilities. Combining Indica's solutions with the class-leading capabilities of COMET™ will help us pursue our shared goal of making tissue image analysis easier and more accessible to labs around the world."
Deborah Heintze, Chief Marketing Officer of 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 which 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 Indica Labs
Indica Labs is the world's leading provider of computational pathology software and image analysis services. Our flagship HALO® and HALO AI™ platform facilitates quantitative evaluation of digital pathology images. HALO Link™ facilitates research-focused image management and collaboration while HALO AP® enables collaborative clinical case review. Our Pharma Services team leverages all our image analysis platforms to partner with you to advance tissue-based research, clinical trials, and diagnostics.
Dover | May 11, 2022
Dover (NYSE: DOV) announced today that it has entered into a definitive agreement to acquire Malema Engineering Corporation ("Malema"), a designer and manufacturer of high-precision, mission-critical flow-measurement and control instruments serving customers in the biopharmaceutical, semiconductor, and industrial sectors. Malema will become part of the PSG business unit within Dover's Pumps & Process Solutions segment.
Malema's products will expand Dover's biopharma single-use production offering, which already includes Quattroflow pumps, CPC connectors, and em-tec flowmeters. Based in Boca Raton, FL, and with facilities in San Jose, CA, Singapore, South Korea, and India, Malema expects to generate approximately $40-45 million in revenue during the full year 2022 and has a robust growth outlook.
Over the past four decades, Malema has cultivated a loyal base of blue-chip customers, OEMs, and end-users with substantial aftermarket and recurring revenue streams. Malema's first-of-its-kind single-use flow sensor using Coriolis technology offers superior flow-measurement performance and accuracy versus alternative technologies, reducing the potential for measurement error and eliminating the need for calibration in time-sensitive and contamination-intolerant environments.
We see a tremendous long-term growth opportunity in the bioprocessing industry driven by a strong and growing pipeline of effective novel biologic drugs, biosimilars, protein therapies, non-COVID mRNA vaccines, as well as budding cell & gene therapies. Additionally, the growing adoption of more efficient single-use production processes supports a robust outlook for our offerings of single-use components to end-customers. We believe that pairing Malema's technology with our existing portfolio of single-use pumps for biopharma processing will greatly enhance the accuracy and value proposition of our solutions to our customers.
PSG's President, Karl Buscher.
We are methodically building out our biopharma platform through proactive capacity additions, new product development, and opportunistic acquisitions of highly-attractive niche component technologies, Malema represents a strategic and highly-complementary flow-control and sensing technology and further strengthens our sensor portfolio with new proprietary technology. In addition to attractive biopharma applications, we expect strong growth in the semiconductor space on the capacity expansion and re-shoring tailwinds."
Richard J. Tobin, President and Chief Executive Officer of Dover.
The purchase price is comprised of $225 million in cash at closing, subject to customary purchase price adjustments, and up to $50 million in contingent consideration dependent on the achievement of certain financial objectives over a two-year period. The transaction is expected to close in the second quarter and is subject to the satisfaction of customary closing conditions, including applicable regulatory approvals.
Dover is a diversified global manufacturer and solutions provider with annual revenue of approximately $8 billion. We deliver innovative equipment and components, consumable supplies, aftermarket parts, software and digital solutions, and support services through five operating segments: Engineered Products, Clean Energy & Fueling, Imaging & Identification, Pumps & Process Solutions, and Climate & Sustainability Technologies. Dover combines global scale with operational agility to lead the markets we serve. Recognized for our entrepreneurial approach for over 65 years, our team of over 25,000 employees takes an ownership mindset, collaborating with customers to redefine what's possible. Headquartered in Downers Grove, Illinois, Dover trades on the New York Stock Exchange under "DOV."
PSG is a global pump solution expert and leading manufacturer of pumps, systems, and related flow-control technology for the safe and efficient transfer of critical and valuable fluids and materials. Headquartered in Oakbrook Terrace, IL, PSG is comprised of several world-class brands, including Abaque®, All-Flo®, Almatec®, Blackmer®, Ebsray®, em-tec®, Griswold®, Hydro Systems™, Mouvex®, Neptune™, Quantex™, Quattroflow®, and Wilden®. PSG products are manufactured in three continents – North America, Europe, and Asia – in state-of-the-art facilities that practice lean manufacturing and are ISO-certified. PSG is part of the Pumps & Process Solutions segment of Dover Corporation.
WuXi Biologics | July 08, 2022
WuXi XDC, a global leading CRDMO dedicated to end-to-end bioconjugates services, and AbTis, a Korean biotechnology company dedicated to the development of antibody drug conjugates announced that a Memorandum of Understanding was signed to form a strategic partnership in AbTis' portfolio of ADC products.
Under the partnership, AbTis will have access to WuXi XDC's integrated services for linker and payload manufacturing, ADC conjugation process development, ADC formulation and drug product manufacturing process development, as well as drug substance and drug product manufacturing. This full range of development and manufacturing services will be provided by WuXi XDC at facilities that are all located within a two-hour drive of each other.
"We are glad to be collaborating with WuXi XDC. This partnership will allow us to leverage WuXi XDC's world-class expertise in both innovative conjugation technologies and comprehensive capabilities for ADC development and manufacturing. We look forward to making more ADC products accessible to patients."
Dr. Sang Jeon Chung, CEO of AbTis
"With our integrated services and know-how, we are pleased to be enabling AbTis to develop and manufacture its portfolio of ADC products," said Dr. Jimmy Li, CEO of WuXi XDC. "This strategic partnership demonstrates the trust and confidence our clients have in our end-to-end services, maintained even during the COVID-19 lockdown period, when WuXi XDC teams showcased the strong execution and reflected our commitment to a culture of 'Putting the Customer First.' We will continue to accelerate and transform the discovery, development and manufacturing of bioconjugates, enabling our global partners and benefiting patients worldwide."
AbTis is a biotechnology company that specializes in antibody-drug conjugates platform technology with its own proprietary patents and its own pipelines in developments in oncology areas.
AbTis pipelines are designed to enhance the safety and efficacy of the current antibody-drug conjugates by applying AbTis linker to the mAbs. Its platform ADC linker technology is site-specific and applicable to the native antibodies, commercial antibodies, or novel antibodies under development as it requires no mutation or engineering to antibody itself. Its stable, hydrophilic and cleavable linkers can be attached to various payloads, too.
Under the moto of "Patients First", AbTis has been striving to advance its ADC technology and to develop its pipelines with several other antibody and payload companies. AbTis' advanced ADC technology enables partners to co-develop pipelines together in a real open innovation setting.
About WuXi XDC
WuXi XDC, a joint venture between WuXi Biologics and WuXi STA, provides end-to-end contract research, development and manufacturing of bioconjugates, including antibody drug conjugates (ADCs). The company's services cover antibodies and other biologics, chemical payloads and linkers, as well as bioconjugated drug substance and drug product. WuXi XDC has been successful in bringing multiple ADC projects to the Investigational New Drug (IND) filing stage in 15 months or less, nearly cutting in half the traditional development timeline. As of April 30, 2022, over 240 projects – from early stage to late-stage clinical – are being developed at WuXi XDC, including 26 IND-completed projects and eight projects in phase II/III.