Molecular Analysis of Elephantiasis Post-Treatment Adverse Events

GEN | September 27, 2019

Close to a billion people worldwide remain threatened by lymphatic filariasis, a neglected tropical disease commonly referred to as elephantiasis. This parasitic infection, which is caused by a nematode spread by mosquitoes, impairs the lymphatic system and can lead to the abnormal enlargement of body parts, causing pain, severe disability, and social stigma. The painful and profoundly disfiguring visible manifestations of the disease, such as lymphoedema, elephantiasis, and scrotal swelling occur later in life and can lead to permanent disability. Sadly, these patients are not only physically disabled, but suffer mental, social, and financial losses contributing to stigma and poverty. While programs such as the Global Program to Eliminate Lymphatic Filariasis seeks to eradicate this disease through mass drug administration to more than 500 million people each year, invariable some patients will experience adverse events following treatment. Now, a team of investigators at Washington University School of Medicine set out to better understand the pathogenesis of adverse effects for treating this debilitating disease.

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INDUSTRIAL IMPACT

Achiko AG Reports Breakthrough Calibration Results for its AptameX™ Covid-19 Rapid Test Technology

Achiko AG | January 15, 2022

Achiko AG is pleased to report that new optimizations during recent calibration testing of its affordable, non-invasive Covid-19 saliva-based rapid test AptameX™ correctly differentiated 100% of test samples up until a comparable reverse transcription polymerase chain reaction cycle threshold value of 33, indicating the system’s ability to deliver a > 97% sensitive and > 97% specific rapid test at a wider range of viral loads than most other rapid tests. “The data we’re reporting today shows that our technology allows for more sensitive and affordable tests compared to antigen-based tests. These high-fidelity calibration testing results suggest not only that AptameX has potential as a very compelling alternative to rapid antigenic tests, but also may be used as an accurate alternative in many mass market applications to slow and expensive RT-PCR technology. This is particularly important in Lower to Middle Income Countries where vaccination rates are lower and the leading testing technologies are impractically expensive for the vast majority of people.” Achiko CEO Steven Goh New data announced for the first time show that, after the recent improvements, AptameX achieved 100% sensitivity and specificity in a controlled experiment in 58 human Covid-19 samples. These gains both confirm AptameX’s ability to perform at low viral loads. The experiment was conducted in Indonesia using samples that were confirmed positive or negative for SARS-CoV-2. AptameX delivered a sensitivity of 100% across a range of CT values below 25 and CT values within the 25-33 range, which is important as the sensitivity of other rapid tests typically drops dramatically in the 25-33 CT value range. The results are consistent and extend earlier work in Spain and other testing in Indonesia. Achiko is looking forward to replicating the study internationally as it moves to complete its CE Mark. These results compare favorably to other testing technologies. Because of its accuracy, RT-PCR technology has become the gold standard for detecting Covid-19 infection. However, RT-PCR is often not the most practical for large-scale testing because it requires specialized equipment, is relatively slow and expensive. Using RT-PCR technology, scientists have established a benchmark for detecting Covid-19 infection: a healthy person is considered Covid-19 negative if their RT-PCR CT value is greater than 33. If, however, the CT value is below 33, the person is Covid-19 positive. Most rapid tests may tout a high sensitivity result where the CT values are under 25. However, according to Euro surveillance, more recent work on Omicron indicates the mean value for Covid-19 infection is around 28, hence the frequent reports of lower sensitivity in the majority of antigenic rapid test kits. Therefore, the AptameX result is important as it presents a viable alternative to other testing. "The improved sensitivity and specificity results announced by Achiko following completion of calibration testing on its SARS-CoV2 rapid test kit is a significant milestone,” stated AptameX inventor Dr. Michael Edel. "AptameX has the capability to meet the increasing global need for frequent mass testing that is fast, low-cost and non-invasive.” Furthermore, the AptameX test has completed and tested its first few hundred thousand kits in production and is now moving to produce one million kits a month. From there, the format is highly amenable to large-scale manufacturing and offers a considerable production cost advantage. Late last year the Company optimized the first-generation test kit using a simpler supply and manufacturing chain in Taiwan and Indonesia, that can easily be replicated to other geographies. In a matter of months and subject to financing, production capacity can rapidly be scaled to hundreds of millions of kits per month. The Company is looking to finance scale production primarily through trade finance. Production of the second-generation rapid test kits is underway and will ramp up further this quarter. Shipments of AptameX kits within Indonesia have been completed to meet prior sales orders as the Company expects to be able to provide 3-4 tests per months for 5% of Indonesia’s 270 million population by mid-year. Additionally, a CE Mark registration is expected in early 2022, allowing the Company to respond to inquiries and move towards commercialization in Europe, the Middle East and Asia and elsewhere. “It’s evident that as we move to the endemic phase of Covid-19, regular vaccinations and mass testing will become a part of our daily lives,” added Goh. “We are enormously pleased with the great results we are able to share today. They confirm the competitive positioning of the platform and the role we can play in getting us all back to a ‘normal’ life.” ABOUT ACHIKO AG Achiko AG is developing disruptive diagnostic solutions that puts people first. The company’s lead product is a rapid, reliable Covid-19 test with a companion app offering a user-friendly digital health passport. The test and companion app were launched in Indonesia in mid-2021 and an application for CE Mark approval in Europe will be submitted in 2022.

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Sartorius Stedim Biotech Closes Acquisition of Slovenian Purification Specialist BIA Separations

Sartorius | November 03, 2020

Sartorius Stedim Biotech (SSB), a leading partner of the biopharma industry, successfully closed the acquisition of the Slovenian purification specialist BIA Separations. The transaction was completed on November 2, 2020, after receiving the required approvals. "BIA's portfolio is highly complementary to Sartorius Stedim Biotech. We are thus creating an excellent offering for the manufacturing of gene therapies and other advanced therapies, and are pleased to welcome 120 new employees," said Dr. Joachim Kreuzburg, Chairman of the Board and CEO of Sartorius Stedim Biotech. The total purchase price of the transaction is 360 million euros of which 240 million euros were paid in cash and 120 million euros in SSB shares. Both parties have further agreed on three tranches of earn-out payments based on performance over the next five financial years. SSB has been preparing to integrate BIA Separations so this can now be initiated despite the special conditions prevailing during the pandemic. BIA Separations develops and manufactures market-leading products for purification and analysis of large biomolecules, such as viruses, plasmids and mRNA, which are used in cell and gene therapies and other advanced therapies. BIA's technology for manufacturing-scale purification is already used in production of the first commercialized advanced therapeutics, and the company also has a strong presence with such novel drug candidates in the clinical pipeline. Expecting continued very strong double-digit sales growth over the next few years, BIA is forecasted to earn sales revenue of approx. 25 million euros in 2020 at profit margins that will be accretive to the underlying EBITDA margin of the Sartorius Stedim Biotech Group. The transaction is not expected to have any material impact on Sartorius Stedim Biotech's 2020 results.

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INDUSTRIAL IMPACT

Kane Biotech Announces New Collaboration Agreements for Prosthetic Joint Infection, expanding its DispersinB® applications

Kane Biotech Inc. | February 11, 2022

Kane Biotech Inc. announces that it has signed collaboration agreements with Dr. James Doub, MD, Assistant Professor of Medicine, University of Maryland School of Medicine’s Institute of Human Virology, and the University of Texas Medical Branch (UTMB) to study the use of DispersinB® with Prosthetic Joint Infection (PJI) patients. The group is securing funding from the National Institutes of Health (NIH) for pre-clinical work to be done by Josh Wenke, a Professor in the Department of Orthopedic Surgery and Rehabilitation at UTMB. PJI’s are one of the most serious complications of joint replacement surgery. Conservative estimates are that approximately 1–2% of all prostheses will become infected over the life of the implant [1]. The financial burden of treating these infections is staggering. It is estimated that they will cost the US healthcare system $1.62 billion in 2020 [1]. In addition, patients have significant morbidity and mortality as a direct result of our current medical and surgical management to treat these infections [2]. In one study, the five-year mortality for prosthetic joint infections is over 20% [2]. “These collaborations are of utmost importance given our shared strategies for managing complex musculoskeletal infections and finding cures for the debilitating morbidity associated with PJI. We are highly optimistic of advancing this field scientifically and clinically for the benefit of patients across the globe” Marc Edwards, CEO of Kane Biotech “The Institute of Human Virology has been testing the use of bacteriophage therapeutics in treating recalcitrant PJIs with some early signals of success,” explained Dr. Doub, who is also Director of Infectious Diseases Ambulatory Practice at the University of Maryland Medicine Center. “However, DispersinB®, has properties that bacteriophages do not have which include superior application as a preventative therapeutic, broader spectrum of activity, and a much easier regulatory (FDA) path.” Dr. Doub is a consultant for Kane Biotech. Dr. Nanda Yakandawala, Vice President of Research and Development at Kane, in collaboration with Dr. Doub and Josh Wenke, Ph. D, recently submitted a R-21 grant application to NIH to fund pre-clinical work to be performed by Dr. Wenke. About University of Texas Medical Department Established in 1891 as the University of Texas Medical Department, UTMB was the nation's first public medical school and hospital under unified leadership and has evolved into a modern academic health science center with multiple campus locations and almost 1,000 faculty members educating approximately 3,500 students. Since the beginning, UTMB has been at the forefront of medical research, with researchers studying the viruses common to a sub-tropical island climate. Today, our world-renowned investigators generate a portfolio exceeding $160 million, and work in state-of-the-art laboratories developing diagnostic tools, cures and vaccines to benefit the global community. About Kane Biotech Kane Biotech is a biotechnology company engaged in the research, development, and commercialization of technologies and products that prevent and remove microbial biofilms. The company has a portfolio of biotechnologies, intellectual property (81 patents and patents pending, trade secrets, and trademarks) and products developed by the company's own biofilm research expertise and acquired from leading research institutions. StrixNB™, DispersinB®, Aledex™, bluestem™, bluestem®, silkstem™, goldstem™, coactiv+™, coactiv+®, DermaKB™ and DermaKB Biofilm™ are trademarks of Kane Biotech Inc.

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