ADC Trigger Selective Cancer Cell Death

June 17, 2019 | 24 views

Chemotherapy has been used to treat cancer for almost 80 years now[1] and its side effects are well known and documented. One of the main limitations associated with standard chemotherapy is the unspecific killing of healthy cells (e.g. rapidly dividing cells in the bone marrow) which is associated with high-dose requirement and low therapeutic indices. In order to significantly reduce systemic side effects, it is fundamental to develop a new generation of anticancer drugs, specifically targeting cancer cells and therefore better tolerated by patients. One approach relies on the use of monoclonal antibodies, the so-called “magic bullets” envisioned by Paul Ehrlich more than 100 years ago[2]. Monoclonal antibodies (mAbs) belong to the broad class of biological drugs, or biologics (i.e. products derived from living organisms). MAbs have fueled research in many scientific fields with four dedicated Nobel prize winners in 2018 (https://www.nobelprize.org/nobel-prizes-2018/) and can be considered today a strong clinical reality with over 80 pharmaceuticals already on the market in indications not limited to oncology[3].

Spotlight

NuGEN Technologies

NuGEN is a provider of innovative genomics sample preparation solutions enabling scientists to access true biology in all samples, independent of type, quality and amount for analysis on leading analytical platforms. Committed to advancing the life sciences, NuGEN ensures robust and reproducible results for researchers seeking to predict disease risk and drug response, potentially shortening the path to treatment.

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How to Choose a Reliable Biotech Clinical Trial Management System?

Article | July 12, 2022

Introduction The medical and life-science industries are experiencing a robust transformation with the increasing prevalence of various types of diseases, including infectious diseases, chronic disorders, and acute conditions around the world. As a result, a significant rise in demand for more effective therapeutic drugs and bionics is being witnessed, leading to a swift increase in the number of clinical trials. For a successful trial, it is important for biotech companies to ensure the data submitted to regulatory bodies regarding clinical trials is accurate, reliable, and definitive from an ethical point of view. A reliable clinical trial management system plays a vital role in collecting, monitoring, and managing clinical data. The availability of high-quality clinical data also helps clinical research institutions make efficient treatment decisions and provide proper patient care. Hence, a number of biotech companies and research organizations are focusing on leveraging innovative clinical trial management solutions to handle a large amount of data, particularly in multi-center trials, and generate reliable, high-quality, and statistically sound data from clinical trials. However, selecting the most appropriate and reliable clinical trial management system is vital for the clinical trial's success. Let's see some of the steps that will assist these firms in choosing the right CTMS. Key Steps for Selecting Right Biotech Clinical Trial Management System Prioritize Study Needs Considering and prioritizing study needs is a crucial step in choosing the most reliable clinical trial management system for biotech companies. Prioritizing helps them to identify a solution that improves the study's quality and removes uncertainty for researchers when faced with difficult choices. Hence, biotech and life-science organizations should choose a clinical trial system that is simple to use, well-organized, and suitably designed to minimize the number of clicks required to complete a task. Select CTMS with Multiple Integrations Integrated clinical trial management systems provide the best value for the companies’ funds as they guarantee the smooth functioning of research protocols. In addition, integrations are necessary to fully understand the importance and advantages of clinical trial management software for ensuring smooth transitions between site management and data collection. Biotech and clinical research should look for CTMS platforms that can integrate with electronic medical record (EMR) platforms and clinical research process content (CRPC) billing grids. This will allow them to use the same billing designations and ensure compliance while minimizing the need for duplicate processes. Ensure System Compliance and Security Clinical research organizations need to adhere to a plethora of complex regulations in order to ensure compliance with one of the most challenging environments of principles, which is information security and privacy. Security and system compliance are vital aspects of choosing the right CTMS solutions for biotech firms as they assist in building trust and form a part of the system’s duties. While selecting CTMS systems, it is essential for companies engaged in clinical research to ensure that these platforms are able to configure both, group and individual permissions, along with having a data backup and recovery plan for hosted systems. This will allow companies to assess the privacy and security implications of research and anticipate complications that may arise in each phase of the project. Assess the Scalability Choosing a scalable CTMS that can accommodate various types of fluctuations and expansions enables biotech and clinical firms to quickly adapt to fast-changing trends and demand spikes while reducing maintenance costs and enhancing user agility. As scalability also means secure and expanded data storage, these businesses should instead use SaaS solutions than manually manage an ever-growing collection of hard drives. The right CTMS ensures accommodating the firm’s availability requirements without incurring the capital costs associated with expanding a physical infrastructure. The Closing Thought A well-executed and successful clinical trial involves multiple stages and processes. Several quality controls and stringent adherence to regulations are essential for the steps, along with efficient cross-departmental processes and procedures. Incorporating the right CTMS paves the way for paperless data collection, regulatory filing, and fiscal management tools for biotech researchers and administrative personnel.

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MEDTECH

Top 3 Biotech Clinical Data Management Trends to Watch in 2022

Article | September 22, 2022

Introduction The administration of medical records and data has advanced significantly during the past few decades. Clinical data management, which was once only a small subset of biotech research organizations, has now developed into a mission-critical, specialized unit. In the late 1990s, electronic data capture (EDC) began to alter the traditional function of clinical data management. After that, the data configuration and management of data queries for the EDC system fell under the purview of clinical data management services. Today, clinical data management is not only responsible for managing the clinical data configuration and data queries but also developing and implementing data administration plans, ensuring data accuracy and completeness, and maintaining optimum data security. In recent years, as digital technologies have gained acceptance around the globe, data has become a vital aspect in decision-making across numerous industries, and the life sciences and biotechnology sectors are no exception. Using data has provided granular insights to biotech organizations, assisting them in creating breakthroughs in drug development and medical research and signifying the importance of clinical trial management systems in these medical verticals. The Biggest Biotech Clinical Data Management Trends to Know About Today The future of clinical data management is contingent upon the implementation of systems and regulations. It is imperative for all organizations participating in a medical or life science trial to have transparent rules in place for sharing and retaining patient data. Also, there is a need to have a standardized format for maintaining these records and documents related to trials. This assists biotech organizations in reducing the chances of ambiguity regarding who owns what kind of data or paperwork at any given time. Over the past couple of years, the focus of the life science and biotechnology industries has shifted towards developing more effective medications and therapies, implementing personalized treatment, and finding cures for diseases such as cancer and AIDS. In response to this, a substantial rise in the number of clinical trials is being witnessed globally. As the number of clinical trials continues to accelerate, the spending on these trials rises as well. In response to this, the worldwide cost of conducting clinical trials is anticipated to reach US$ 49.80 billion in 2022. With the transition of the world from traditional to digital, medical professionals and biotech businesses are increasingly shifting towards adopting high-tech and reliable clinical trial management systems for various applications, starting from diagnosis and clinical trials to patient data documentation. But, what are the future trends in biotechnology clinical data management? Let’s discuss. Cloud-Based Clinical Metadata Repositories Automation is emerging as a new frontier in the biotech clinical data management domain, along with other innovative technologies such as artificial intelligence and machine learning. Because of this, life science establishments are witnessing a huge shift from paper-based documentation toward data-based documentation, which is creating mountains of research, compliance, and clinical data. The growing demand for new and more effective medications and drugs is augmenting the need to expedite clinical trials. This is resulting in an increased number of initiatives aimed at optimizing clinical trial processes to prepare and launch successful trials. However, pharmaceutical and biotechnology laboratories are encountering several challenges in collecting, managing, and analyzing metadata due to its complexities. So, what is the best solution to this problem? The answer to this is cloud-based clinical metadata repositories. Clinical research facilities are leveraging advanced, all-in-one, cloud-based clinical metadata repositories to assist them in centralizing and managing metadata; increasing metadata quality, consistency, and accuracy; and speeding up clinical trial management, documentation, and compliance processes. Shift Towards Digital Solutions Electronic Case Report Form Adequate research and accurate data are crucial for a clinical trial to succeed. Whether developing new drugs, medication, or therapies; conducting life science research; or studying the latest clinical trial systems, it is best to use electronic solutions as it reduces the room for mistakes during the transition of clinical data from paper-based format. Realizing this, biotech organizations are shifting towards using electronic case report forms to speed up record retrieval, improve record security, and cut down on operational costs associated with running clinical trials. The electronic case report form assists in lowering the failure rate of the clinical trial, enhancing efficiency, and optimizing security along with improving clinical trial documentation and productivity, further driving its adoption in the medical space. Electronic Clinical Outcome Assessment Electronic clinical outcome assessment is surfacing as one of the fast-growing future trends in biotechnology. It allows clinical trial facilities to automate data entry and improve the reliability of the collected information. The technology enables clinical trial institutions to automatically record patient-provided information about side effects, symptoms, drug timing, and other aspects during the clinical trial for increased precision. It also helps these institutions analyze the results of medication or therapy in clinical trials and lets clinical researchers use medical technologies like biosensor-enabled devices, self-service applications, and medical wearables for evaluation. Hence, biotech clinical facilities are increasingly deploying advanced electronic clinical outcome assessment systems to ensure adherence to protocols and regulations. Clinical Trial Customization The success of a new drug is determined by numerous factors other than its effectiveness, safety, and creativity of its developers, such as a successful clinical trial. Each clinical trial involves a number of decision-making points, and one wrong choice in any of these aspects can jeopardize the success of the entire endeavor. A crucial component of making well-informed decisions is data management, which is a part of clinical study as a whole. Clinical trial customization is emerging as one of the most prominent biotech clinical trial management trends. Every clinical trial is unique and needs a tailored approach to be successful. With the emergence of the trend of personalized treatment around the globe, biotech and pharmaceutical organizations are adopting innovative customized clinical trial management solutions to accelerate the pace of clinical trials and approvals. This is giving clinical researchers innovative ways to come up with new medicines for patients and streamline the clinical data as per the requirements for faster approvals. What Are the Key Clinical Data Management Challenges Faced by Biotech Companies? Groundbreaking medical interventions are of no use without reliable, accurate, and extensive clinical trial data. Without the data, biotech and pharmaceutical companies will not be able to provide the assurance of safety and efficacy required to bring the medication to market. Regulatory bodies such as the Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency (MHRA), and others are putting stricter rules in place to ensure the quality of clinical data. In addition, the fast-changing clinical development environment is creating more obstacles for biotech and medical spaces to ensure the accuracy, standard, and completeness of the clinical trial data. Hence, clinical teams are spending valuable time cleaning up data instead of analyzing it. Time spent trying to figure out issues with clinical trial data is detrimental and expensive but also mission-critical. This is because a small issue in the data can lead to numerous consequences, from small delays to calamitous setbacks, making it necessary to rerun clinical trials. This problem will only get more challenging to address as the volume of data and the types of data sources continue to grow. Here are some of the major clinical data management challenges that biotech firms encounter Standardization of Clinical Metadata Stringent Regulatory Compliance Increased Clinical Trial Complexity Mid-Study Changes Why Are Clinical Data Management Systems Garnering Popularity in the Biotech Industry? With the changing regulatory and clinical landscape, biotech and pharmaceutical companies are facing several obstacles in the management of clinical data and clinical trials. In addition, regulatory agencies are moving toward integrated electronic systems, which is making it more and more important for clinical laboratories to change the format of their submissions. Because of this, several biotech clinical labs are focusing on adopting innovative laboratory solutions, such as biotech clinical data management systems, to meet the need for standardized data inputs and replace all manual ways of working with electronic systems. A clinical data management system establishes the framework for error-free data collection and high-quality data submission, resulting in speedier drug discovery and shorter time-to-market. These solutions are gaining huge traction among biotech and pharmaceutical companies, owing to their ability to effectively manage clinical data, accelerate clinical trials, and ensure compliance. Let’s see some of the features of biotech clinical data management software that are most sought after by life-science companies Controlled, standardized data repository. Centralized data analysis and administration. Reduced operational expenditures for clinical data processes. Enhanced process effectiveness. Superior submission quality Compliance with predefined standards. Clinical Data Management Systems: The Future The role of clinical data management systems is evolving at a rapid pace as the life science and medical industries continue to incorporate digital solutions for diverse operations. These systems are being used in a variety of biotech clinical settings, ranging from clinical data compliance to data science and analytics, to help them analyze large and growing volumes of clinical data. Hence, a number of high-tech medical companies are aiming at integrating innovative technologies, such as artificial intelligence and machine learning, into clinical data management software to automate clinical data management tasks, improve clinical data submission, and enhance data quality. These new biotech clinical management technologies are anticipated to help life science laboratories gain a better understanding of diseases and speed up clinical trials in the coming years. FAQ What is a clinical data management system? A clinical data management system (CDMS) is a tool used in clinical research to track, record, and manage clinical trial data across medical establishments such as biotech laboratories. What are the key functions of the biotech clinical data management system? Some of the key functions of biotech clinical data management system are Documentation of Protocols and Regulations Patient Recruitment Real-time Clinical Study Analytics Reporting Investigator Relationship Management Electronic Visit Report Why is a clinical data management system needed for clinical trials today? A clinical data management system helps shorten the time from drug development to marketing by assisting in the collection of high-quality, statistically sound, and accurate data from clinical trials.

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MEDTECH

Top 10 biotech IPOs in 2019

Article | July 13, 2022

The big question at the start of 2019 was whether the IPO window would stay open for biotech companies, particularly those seeking to pull off ever-larger IPOs at increasingly earlier stages of development. The short answer is yes—kind of. Here’s the long answer: In the words of Renaissance Capital, the IPO market had “a mostly good year.” The total number of deals fell to 159 from 192 the year before, but technology and healthcare companies were standout performers. The latter—which include biotech, medtech and diagnostics companies—led the pack, making up 43% of all IPOs in 2019. By Renaissance’s count, seven companies went public at valuations exceeding $1 billion, up from five the year before

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Cell Out? Lysate-Based Expression an Option for Personalized Meds

Article | February 18, 2020

Cell-free expression (CFE) is the practice of making a protein without using a living cell. In contrast with cell line-based methods, production is achieved using a fluid containing biological components extracted from a cell, i.e., a lysate. CFE offers potential advantages for biopharma according to Philip Probert, PhD, a senior scientist at the Centre for Process Innovation in the U.K.

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Spotlight

NuGEN Technologies

NuGEN is a provider of innovative genomics sample preparation solutions enabling scientists to access true biology in all samples, independent of type, quality and amount for analysis on leading analytical platforms. Committed to advancing the life sciences, NuGEN ensures robust and reproducible results for researchers seeking to predict disease risk and drug response, potentially shortening the path to treatment.

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INDUSTRIAL IMPACT

iNtRON Confirms Efficacy of CDL200 Against CDI Clinical Isolates

iNtRON Biotechnology | July 12, 2022

iNtRON Biotechnology announced that CDL200, a novel biological drug candidate under the development of the world's first enteric colon-targeted capsule formulation for the treatment of intractable and recurrent CDI confirmed the strong efficacy against clinical isolates from CDI patients. A company official explained that the antibacterial activity of CDL200 was evaluated for 20 clinical isolates from patients in Europe and Korea, and rapid lysis effect within few minutes after treatment was confirmed from all of the tested strains. In particular, even though majority of the tested strains are resistant strains to the commonly used antibiotics such as Metronidazole, Vancomycin, and Rifaximin, CDL200 showed very potent and rapid bactericidal activity. CDL200 is an endolysin-based novel biological drug candidate for the treatment of Clostridioides difficile infection, a hard-to-treat and recurrent bowel diseases. CDL200 has innovative drug properties that can eradicate bacteria much faster than the conventional antibiotics in the market, and also can be used for the infection caused by antibiotic-resistant bacteria and/or highly virulent bacteria. CDI patient population has been increasing globally and resulting in high mortality rate due to resistance to the existing antibiotics and serious complications such as toxic megacolon, sepsis, and intestinal perforation. Although there is growing interest in refractory CDI that does not respond well to primary treatment, there are only few studies on effective treatment yet. The more serious problem is the frequency of recurrent CDI is increasing, since the risk of subsequent recurrence is over 45% in patients who have had at least one recurrence. The conventional treatment based on Metronidazole and Vancomycin is not effective for CDI with severe intractability and repeating recurrence. And the recently attempted FMT (fecal microbiota transplantation), that is, the treatment of administering donor feces to the patient's intestinal tract, has advantages such as not suppressing the intestinal flora and not creating resistant strains, but the treatment brings objection to the general public and is limited in that there is a possibility that other pathogens from the donor may be transmitted. The mortality rate of CDI was about 3-4% in the past, but due to intensification of antibiotic-resistant bacteria and the emergence of highly virulent strain (NAP1/027), the recent mortality rate has been rapidly increased to over 10%, which makes global awareness growing. Dr. KANG, Sang Hyeon, CTO of iNtRON, said, "We have a number of new endolysin pipelines under the development utilizing our unique itLysin® technology for the serious infection that the development of effective therapeutic agents are urgently needed." "Based on the development experience of SAL200, we will strive to enhance the value of our rich itLysin® pipelines and will continue to secure global competitiveness in the endolysin field." Mr. YOON, Kyung Won, CEO of iNtRON About CDL200 CDL200 is a novel endolysin-based anti- Clostridioides difficile causes an infection of the large intestine which is often referred to as C. difficile or C. diff. CDL200 showed potent and rapid activity against 100% clinical isolates from multi-nation and has no disturbance of the normal flora in human's gut. The potential clinical usage and indications are CDI and IBD (Inflammatory Bowel Disease), and the targeted administration route of CDL200 is oral in capsule formulation. CDL200 is under non-clinical stage development and IND enabling studies will be conducted throughout the year. About iNtRON Biotechnology, Inc. iNtRON is a leader in bacteriophage-based technology with aim to develop and investigate into the 'Immune & Immunotherapeutics' market. While pursuing global research and business development investments since their foundation and accelerated development after entering its IPO in KOSDAQ, the company honed in on innovating BIO New Drugs by developing various 'First-in-Concept' bio-drugs and conducting clinical studies in phases. The Company is committed to development of innovative innovation in the infectious diseases and 'Immune & Immunotherapeutics' area. About iNtODEWORLD, Inc. iNtRON has established its wholly owned US subsidiary, iNtODEWORLD, Inc. in 2017. iNtODEWORLD was initially registered in Delaware and the headquarter office is currently located in Boston. iNtODEWORLD provides news, updates and platform development progresses of iNtRON to its potential global partners and collaborators along with its own R&BD works in the US.

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CELL AND GENE THERAPY

iTolerance to Collborate with LyGenesis for Joint Research

iTolerance | July 01, 2022

iTolerance, Inc., an early-stage privately held regenerative medicine company developing technology to enable organoid, tissue, and cell therapy, announced entering into a joint collaboration with LyGenesis, Inc., a clinical-stage biotechnology company with an organ regeneration technology platform. The joint collaboration is aimed at evaluating the potential of iTOL-201, a product candidate being developed combining LyGenesis' LYG-LIV-100 liver cell therapy and iTolerance's SA FasL microgel immune tolerance platform to permit the growth of ectopic livers without the requirement for immune suppression. The joint research effort of iTolerance and LyGenesis has produced in vitro data using iTOL-201 and is now moving toward small animal proof of concept work to assess the potential of the combined technology for producing ectopic livers capable of saving the animals from fatal liver disorders without the requirement for immune suppression. With our lead therapy now in the clinic in a Phase 2a trial in patients with End Stage Liver Disease, we have turned our attention toward a second-generation therapy capable of growing ectopic organs without the need for immune suppression. iTolerance's platform holds enormous promise in this respect and we look forward to the results from our joint proof of concept work." Dr. Michael Hufford, Co-Founder and Chief Executive Officer of LyGenesis. While long-term immunosuppression continues to be an obstacle for the use of cell and regenerative therapies, the research being conducted between both LyGenesis and iTolerance could allow for a major advancement in organ regeneration, As we advance our own pipeline of therapies focused on supporting pancreatic islet engraftments, I believe this synergistic collaborative research with LyGenesis has the potential to successfully combine technologies to drive significant value for both biotech companies and importantly, the patients we work to serve." Dr. Anthony Japour, Chief Executive Officer of iTolerance.

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MEDICAL

Anitoa Launches Molecular Test (PCR) for Monkeypox

Anitoa | June 30, 2022

Anitoa Systems, market leader in fast, portable molecular testing, today announced the availability of a CE-marked turn-key PCR solution for testing Monkeypox. This portable solution includes one of a family small foot-print real time PCR instruments called the Maverick qPCR, with an extraction-free multiplex PCR reagent that tests OPXV/MPXV gene-targets in the skin lesion sample from patients suspected of infection with Monkeypox. Anitoa's Monkeypox test is designed to be carried out on-site, near patient, thus avoiding the need to transport patient samples to central labs for testing. The World Health Organization reported that over 2,100 people in 42 countries have been diagnosed with monkeypox as of June 15, nearly all during the past two months. As of June 17, the CDC reports 24 confirmed monkeypox cases in California, US. Although The CDC reports that the threat to the general U.S. population is considered low, it is important for healthcare providers worldwide to have a preparedness plan. Already having a presence in Africa, Anitoa Systems has started deloying its near-patient Monkeypox test in selected clinics in Africa. Anitoa is prepared to deliver its Monkeypox test solution world-wide when the need arises. Anitoa's Maverick line of multiplex real time PCR devices are lab-accurate, fast, portable and calibration-free. They can operate on battery power (including car battery) and takes up very little bench space. Maverick qPCR instruments are built on Anitoa's proprietary CMOS biosensor technology. They have been used widely for on-site testing of food, environment samples and agriculture products due to its rugged all solid-state design, small form factor, and lower operation cost. Anitoa's Monkeypox detection solution is part of an on-going program at Anitoa to develop tests to help combat a series of neglected tropical diseases in low resource settings. These tests currently include IVDR tests for Dengue, Yellow Fever, and Malaria We are closely monitoring the situation of Monkeypox infections around the world and tailoring our test solutions to the needs of the people affected." Zhimin ding, CEO of Anitoa Systems, LLC About Anitoa Anitoa Systems, a medical device technology start-up established in 2013 with headquarter in Sunnyvale, California, develops highly integrated and portable bio-sensor devices for molecular detection, based on its unique CMOS image sensor-based fluorescence and chemiluminescence molecular imaging. By replacing the traditional bulky and costly photon-multiplier tube (PMT) and CCD-based optical sub-systems, Anitoa's ultra-low-light CMOS sensor technology enables a new generation of compact and inexpensive molecular testing platforms targeting infectious, oncology and cardio-vascular markers. Anitoa manufactures its qPCR instruments and test kits in Hangzhou, China and Fremont, California.

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INDUSTRIAL IMPACT

iNtRON Confirms Efficacy of CDL200 Against CDI Clinical Isolates

iNtRON Biotechnology | July 12, 2022

iNtRON Biotechnology announced that CDL200, a novel biological drug candidate under the development of the world's first enteric colon-targeted capsule formulation for the treatment of intractable and recurrent CDI confirmed the strong efficacy against clinical isolates from CDI patients. A company official explained that the antibacterial activity of CDL200 was evaluated for 20 clinical isolates from patients in Europe and Korea, and rapid lysis effect within few minutes after treatment was confirmed from all of the tested strains. In particular, even though majority of the tested strains are resistant strains to the commonly used antibiotics such as Metronidazole, Vancomycin, and Rifaximin, CDL200 showed very potent and rapid bactericidal activity. CDL200 is an endolysin-based novel biological drug candidate for the treatment of Clostridioides difficile infection, a hard-to-treat and recurrent bowel diseases. CDL200 has innovative drug properties that can eradicate bacteria much faster than the conventional antibiotics in the market, and also can be used for the infection caused by antibiotic-resistant bacteria and/or highly virulent bacteria. CDI patient population has been increasing globally and resulting in high mortality rate due to resistance to the existing antibiotics and serious complications such as toxic megacolon, sepsis, and intestinal perforation. Although there is growing interest in refractory CDI that does not respond well to primary treatment, there are only few studies on effective treatment yet. The more serious problem is the frequency of recurrent CDI is increasing, since the risk of subsequent recurrence is over 45% in patients who have had at least one recurrence. The conventional treatment based on Metronidazole and Vancomycin is not effective for CDI with severe intractability and repeating recurrence. And the recently attempted FMT (fecal microbiota transplantation), that is, the treatment of administering donor feces to the patient's intestinal tract, has advantages such as not suppressing the intestinal flora and not creating resistant strains, but the treatment brings objection to the general public and is limited in that there is a possibility that other pathogens from the donor may be transmitted. The mortality rate of CDI was about 3-4% in the past, but due to intensification of antibiotic-resistant bacteria and the emergence of highly virulent strain (NAP1/027), the recent mortality rate has been rapidly increased to over 10%, which makes global awareness growing. Dr. KANG, Sang Hyeon, CTO of iNtRON, said, "We have a number of new endolysin pipelines under the development utilizing our unique itLysin® technology for the serious infection that the development of effective therapeutic agents are urgently needed." "Based on the development experience of SAL200, we will strive to enhance the value of our rich itLysin® pipelines and will continue to secure global competitiveness in the endolysin field." Mr. YOON, Kyung Won, CEO of iNtRON About CDL200 CDL200 is a novel endolysin-based anti- Clostridioides difficile causes an infection of the large intestine which is often referred to as C. difficile or C. diff. CDL200 showed potent and rapid activity against 100% clinical isolates from multi-nation and has no disturbance of the normal flora in human's gut. The potential clinical usage and indications are CDI and IBD (Inflammatory Bowel Disease), and the targeted administration route of CDL200 is oral in capsule formulation. CDL200 is under non-clinical stage development and IND enabling studies will be conducted throughout the year. About iNtRON Biotechnology, Inc. iNtRON is a leader in bacteriophage-based technology with aim to develop and investigate into the 'Immune & Immunotherapeutics' market. While pursuing global research and business development investments since their foundation and accelerated development after entering its IPO in KOSDAQ, the company honed in on innovating BIO New Drugs by developing various 'First-in-Concept' bio-drugs and conducting clinical studies in phases. The Company is committed to development of innovative innovation in the infectious diseases and 'Immune & Immunotherapeutics' area. About iNtODEWORLD, Inc. iNtRON has established its wholly owned US subsidiary, iNtODEWORLD, Inc. in 2017. iNtODEWORLD was initially registered in Delaware and the headquarter office is currently located in Boston. iNtODEWORLD provides news, updates and platform development progresses of iNtRON to its potential global partners and collaborators along with its own R&BD works in the US.

Read More

CELL AND GENE THERAPY

iTolerance to Collborate with LyGenesis for Joint Research

iTolerance | July 01, 2022

iTolerance, Inc., an early-stage privately held regenerative medicine company developing technology to enable organoid, tissue, and cell therapy, announced entering into a joint collaboration with LyGenesis, Inc., a clinical-stage biotechnology company with an organ regeneration technology platform. The joint collaboration is aimed at evaluating the potential of iTOL-201, a product candidate being developed combining LyGenesis' LYG-LIV-100 liver cell therapy and iTolerance's SA FasL microgel immune tolerance platform to permit the growth of ectopic livers without the requirement for immune suppression. The joint research effort of iTolerance and LyGenesis has produced in vitro data using iTOL-201 and is now moving toward small animal proof of concept work to assess the potential of the combined technology for producing ectopic livers capable of saving the animals from fatal liver disorders without the requirement for immune suppression. With our lead therapy now in the clinic in a Phase 2a trial in patients with End Stage Liver Disease, we have turned our attention toward a second-generation therapy capable of growing ectopic organs without the need for immune suppression. iTolerance's platform holds enormous promise in this respect and we look forward to the results from our joint proof of concept work." Dr. Michael Hufford, Co-Founder and Chief Executive Officer of LyGenesis. While long-term immunosuppression continues to be an obstacle for the use of cell and regenerative therapies, the research being conducted between both LyGenesis and iTolerance could allow for a major advancement in organ regeneration, As we advance our own pipeline of therapies focused on supporting pancreatic islet engraftments, I believe this synergistic collaborative research with LyGenesis has the potential to successfully combine technologies to drive significant value for both biotech companies and importantly, the patients we work to serve." Dr. Anthony Japour, Chief Executive Officer of iTolerance.

Read More

MEDICAL

Anitoa Launches Molecular Test (PCR) for Monkeypox

Anitoa | June 30, 2022

Anitoa Systems, market leader in fast, portable molecular testing, today announced the availability of a CE-marked turn-key PCR solution for testing Monkeypox. This portable solution includes one of a family small foot-print real time PCR instruments called the Maverick qPCR, with an extraction-free multiplex PCR reagent that tests OPXV/MPXV gene-targets in the skin lesion sample from patients suspected of infection with Monkeypox. Anitoa's Monkeypox test is designed to be carried out on-site, near patient, thus avoiding the need to transport patient samples to central labs for testing. The World Health Organization reported that over 2,100 people in 42 countries have been diagnosed with monkeypox as of June 15, nearly all during the past two months. As of June 17, the CDC reports 24 confirmed monkeypox cases in California, US. Although The CDC reports that the threat to the general U.S. population is considered low, it is important for healthcare providers worldwide to have a preparedness plan. Already having a presence in Africa, Anitoa Systems has started deloying its near-patient Monkeypox test in selected clinics in Africa. Anitoa is prepared to deliver its Monkeypox test solution world-wide when the need arises. Anitoa's Maverick line of multiplex real time PCR devices are lab-accurate, fast, portable and calibration-free. They can operate on battery power (including car battery) and takes up very little bench space. Maverick qPCR instruments are built on Anitoa's proprietary CMOS biosensor technology. They have been used widely for on-site testing of food, environment samples and agriculture products due to its rugged all solid-state design, small form factor, and lower operation cost. Anitoa's Monkeypox detection solution is part of an on-going program at Anitoa to develop tests to help combat a series of neglected tropical diseases in low resource settings. These tests currently include IVDR tests for Dengue, Yellow Fever, and Malaria We are closely monitoring the situation of Monkeypox infections around the world and tailoring our test solutions to the needs of the people affected." Zhimin ding, CEO of Anitoa Systems, LLC About Anitoa Anitoa Systems, a medical device technology start-up established in 2013 with headquarter in Sunnyvale, California, develops highly integrated and portable bio-sensor devices for molecular detection, based on its unique CMOS image sensor-based fluorescence and chemiluminescence molecular imaging. By replacing the traditional bulky and costly photon-multiplier tube (PMT) and CCD-based optical sub-systems, Anitoa's ultra-low-light CMOS sensor technology enables a new generation of compact and inexpensive molecular testing platforms targeting infectious, oncology and cardio-vascular markers. Anitoa manufactures its qPCR instruments and test kits in Hangzhou, China and Fremont, California.

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