Novel Fluorescence Lifetime Imaging Tool May Advance Cancer Care

GEN | November 14, 2019

Improving the detection, diagnosis, and treatment of diseases like cancer will require more detailed, rapid, and agile imaging technology that can show doctors not just what a specific organ looks like, but also what’s happening within the cells that make up those tissues, according to a research team from Rensselaer Polytechnic Institute. The scientists just published an article (“Fast fit-free analysis of fluorescence lifetime imaging via deep learning”) in the Proceedings of the National Academy of Sciences that described and demonstrated a new technique for fluorescence lifetime imaging of tissue and cells in a fast and comprehensive manner, thus laying the groundwork for use in a clinical setting. “We are providing tools that are going to be far more amenable for the end users, meaning the biologists, but also the surgeon,” said Xavier Intes, PhD, a professor of biomedical engineering who led this research for Rensselaer.

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CELL AND GENE THERAPY

Innovent Announces First Patient Dosing of Universal Modular CAR-T Cell product IBI345

Innovent Biologics | February 21, 2022

Innovent Biologics, Inc. a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, today announced the first patient dosing for its first-in-class IgG-based universal "modular" Claudin 18.2-targeting chimeric antigen receptor T (CAR-T) cell product (development code: IBI345) for the treatment of advanced Claudin18.2-positive solid tumors in an investigator-initiated-trial (IIT). Since Innovent announced its strategic cooperation with Roche on June 9, 2020, this is the first disclosure of the development milestone for the cell therapy products based on Roche's proprietary innovative technology platform. CAR-T cell therapy has established a meaningful role in the treatment of hematological tumors with 5 products approved by the FDA, and 2 by the NMPA in China, respectively; however, antitumor efficacy for solid tumors remains a challenge calling for technological breakthroughs. As the world's first universal "modular" CAR-T cell product, IBI345 has potentially differentiated advantages over conventional CAR-T cell therapy products, including: 1) leveraging antibody function to target tumor antigens and consequently amplifying the tumor antigen signal to guide CAR-T cells to enter the tumor, thus aiding in the initiation of tumor recognition and killing; 2) controlling the functional activity of the CAR-T cells via concomitantly administered antibodies which act as a bridge between the target cell and CAR-T cell, potentially providing a better safety profile; 3) allows for the sequential or simultaneous administration of more than one antibody targeting different antigen targets without changing CAR-T cells, to treat tumors with highly heterogeneous antigen expression or relapsed tumors due to antigen-loss, thereby improving the accessibility and increasing the flexibility of CAR-T cell therapy for patients. The principal investigator of the study, Professor Weichang Chen, the Secretary of the Party Committee and Chief Physician of the Department of Gastroenterology of the First Hospital Affiliated to Soochow University, pointed out: "As gastric and pancreatic cancer are highly aggressive tumors with high incidence rates in the world, patients are in urgent need of novel treatment options to improve clinical outcomes. IBI345, with its unique design to control CAR-T functional activity through the antibody bridging, will likely provide improved safety and efficacy. We look forward to the positive results of the safety, tolerability and efficacy data of IBI345 in patients with solid tumors, which will potentially provide a new option for the treatment of patients with advanced gastric or pancreatic cancer." "IBI345 is a highly differentiated CAR-T cell product with a new mechanism of action developed by Innovent based on Roche's proprietary technology. As a universal "modular" CAR-T cell therapy product, equipped with a precisely targeted antibody switch, it regulates the expansion of CAR-T cells to control side effects, potentially providing an opportunity to switch to another antibody that targets different antigens to prevent recurrence and treat different tumors. Our preclinical studies have validated this "modular" CAR-T technology, which provides us with the sufficient scientific data to initiate clinical studies. In the following clinical studies, we will explore the safety, tolerability, pharmacokinetics and preliminary efficacy of IBI345, and optimize the clinical dosage and regimen to support the subsequent IND application. We firmly believe that Innovent will be able to introduce more innovative cell therapies through platform technology innovation, product transformation and in-depth collaboration with the clinical academic community that will ultimately benefit more patients and families." Dr. Xu Wei, VP of Innovent, R&D Head of Cell Therapy About Claudin 18.2 Claudin protein is a critical component of tight junction complex molecules which play an important role in the life activities of the human body. On the one hand, tight junctions can function as a "barrier" to select the size and charge of substances, thereby regulating the transport of substances in the para-cellular pathway. For example, brain vascular endothelial cells can pass through this barrier, preventing blood from mixing with the extracellular fluid in the brain. On the other hand, tight junctions can also function as "fences", maintaining cell polarity by regulating the free diffusion of lipids and proteins between the apical and the basolateral membrane. About Gastric and Pancreatic adenocarcinoma Gastric and pancreatic cancer are both malignant tumors of the digestive system that seriously endanger human life and health. The latest global cancer statistics show that there will be about 1.089 million new cases of gastric cancer worldwide in 2020, accounting for 5.6% of the global cancer incidence, and about 768,000 deaths, accounting for 7.7% of the global cancer deaths. There are about 495,000 new cases of pancreatic cancer, accounting for 2.6% of the global cancer incidence, and about 466,000 deaths, accounting for 4.7% of the global cancer deaths. According to the national cancer statistics released by the National Cancer Center of China in 2019, the incidence of gastric cancer in China in 2015 was about 403,000, accounting for 10.26% of the total cancer incidence, second only to lung cancer at 20.03%, with an incidence rate of 29.31/100,000 people, and about 291,000 deaths, accounting for 12.45% of the total cancer deaths, behind lung and liver cancer, with a mortality rate of 21.16/100,000 people. In 2015, the number of cases and deaths of pancreatic cancer nationwide were 95,000 and 85,000 respectively, ranking the 10th and 6th in the incidence and mortality of malignant tumors. The mortality ratio of pancreatic cancer was 0.89, making it a true "King of Cancer". Despite the treatment progress in recent years, drug resistance, recurrence and metastasis are still inevitable. The 5-year survival rate of patients with advanced gastric cancer is about 5-20%, and the median survival rate is about 10 months. Pancreatic cancer has a worse prognosis, with a 5-year survival rate of only 6 to 8%. About IBI345 IBI345 is the first universal "modular" CAR-T cell product developed by Innovent based on Roche's proprietary technology. It is an internationally pioneered highly differentiated CAR-T cell product with a new mechanism of action. Different from conventional CAR-T cells that directly recognize and kill tumor cells, IBI345 comprises of two components, anti-Claudin18.2 antibodies and "modular" CAR-T cells where anti-Claudin18.2 antibody recognizes tumor antigen, thus calibrating and amplifying the antigen signal, and guides "modular" CAR-T cells to enter the tumor to initiate the cytotoxic and antitumor activity of CAR-T cells. Compared with conventional CAR-T cells, IBI345 has a variety of potential advantages, including dual effects of antibodies and CAR-T cells to increase antitumor efficacy, and flexible control of side effects by regulating CAR-T cell activity through antibodies; in addition, as having a universal CAR molecule, "modular" CAR-T cells can be easily switched to different antibodies without changing CAR-T cells, by sequentially or simultaneously administering more than one antibody targeting different antigen targets, to treat tumors with highly heterogeneous antigen expression or antigen-loss relapsed tumors, which holds a great potential to reduce the cost of CAR-T cell therapy and improve the accessibility of CAR-T cell therapy for patients. Innovent announced that first patient dosing has been completed in February 2022 in the investigator-initiated clinical trial of IBI345 for the treatment of advanced Claudin18.2-positive solid tumors, and enrollment is currently ongoing. The safety, tolerability, pharmacokinetics and preliminary efficacy of IBI345 will be explored, and the clinical dosage and regimen will be explored to provide clinical data support for the subsequent IND application. About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

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BGN Technologies Announces Research Collaboration Agreement with ECOIBÉRIA in the Field of Plastic Recycling by Bacteria

BGN Technologies | November 05, 2020

BGN Technologies, the technology transfer company of Ben-Gurion University of the Negev (BGU), announced today that it had signed a research collaboration agreement with ECOIBÉRIA in the field of plastic recycling by bacteria, based on research from the team of Prof. Ariel Kushmaro and Prof. Alex Sivan, both from the Laboratory of Environmental Biotechnology and Avram and Stella Goldstein-Goren Department of Biotechnology Engineering at BGU. Polyethylene terephthalate (PET) is the most abundantly used polymer in the world, with multiple applications in the textile industry as well as in food and beverage packaging. It is estimated that about 56 million tons of PET are produced yearly worldwide, mostly as single use packaging material. Therefore, intense efforts are directed towards recycling and reuse of the PET plastic materials. Prof.'s Kushmaro and Sivan and their team have been studying plastic biodegradation and have discovered several bacteria species that are able to biodegrade polyethylene, which was previously considered a non-biodegradable plastic mainly because of the highly stable carbon−carbon (C−C) bonds of the polymer backbone. Based on these findings, the research collaboration project will assess the biodegradation of PET by previously identified bacteria as well as novel ones, with the aim of developing an efficient biodegradation process of PET whose products will be used as raw materials for recycled PET in the future.

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Bioclinica Announces That It Will Leverage Bioclinica's Interactive Response Technology (IRT) for Their EXIT COVID-19 Study

Bioclinica | September 10, 2020

Bioclinica, an integrated solutions provider of clinical life science and technology expertise, delivering powerful insight into clinical trial development in bringing new therapies to people worldwide, announced today that Direct Biologics, a market leading innovator and science-based manufacturer of regenerative products, will leverage Bioclinica's Interactive Response Technology (IRT) for their EXIT COVID-19 study — a multi-center FDA phase II clinical trial for the use of ExoFlo™ to treat COVID-19 acute respiratory distress syndrome (ARDS). "We are a dynamic and innovative biotechnology company that can engage synergistically with vendor partners who are willing and able to match our speed and adaptability in our efforts to deliver solutions for highly complex and pressing real world problems," said Dr. Vik Sengupta, Chief Medical Officer of Direct Biologics. "Bioclinica's ability to rapidly configure their highly robust and functional IRT made them the natural choice to meet our accelerating timeline in the fight against COVID-19. The Bioclinica team rose to the occasion, scaling with demand, and accommodating our specific randomization and supply chain requirements." Bioclinica's IRT is the industry's only system that provides advanced visibility to working study prototypes within just a few days - letting you build, implement, test, and deploy new protocols in as little as two to three weeks, with or without customization.

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