Biological Dynamics Expands Biomarkers Research to Develop Assays for Detection and Quantification of Blood-based Biomarkers

Biological Dynamics | July 30, 2020

Biological Dynamics, Inc., an innovative diagnostic company committed to improving global health, announces a new biomarkers program designed for drug development applications in Alzheimer's Disease (AD). The company will use its proprietary Verita™ platform to develop a portfolio of assays for detection and quantification of blood-based biomarkers associated with AD and other neurodegenerative conditions. The program is funded by the Alzheimer's Drug Discovery Foundation's (ADDF) Diagnostics Accelerator, an initiative that aims to fast-track the development of novel biomarkers for the early detection of Alzheimer's disease and related dementias. It is estimated that AD affects approximately 50 million people globally. In 2018, the official failure rate associated with developing AD-targeting therapeutics stood at 99%, with a 100% failure rate for disease-modifying therapies for AD. One of the critical unmet needs in drug development is the lack of tools to measure brain-derived biomarkers in blood. Recently, analysis of neural extracellular vesicles (EVs) has emerged as an area of interest due to their ability to traverse the blood-brain barrier. The protein and nucleic cargo that is transported by EVs has been shown to be reflective of underlying physiological and pathological states for many diseases, including AD. The new program will focus on developing Verita-based assays for detection of AD-associated biomarkers in plasma EVs and evaluating the feasibility of using these assays in drug development.

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CELL AND GENE THERAPY

Gracell Biotechnologies Unveils Innovation Center in U.S.

Gracell Biotechnologies Inc | January 13, 2022

Gracell Biotechnologies Inc. a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that its newly established research facility, the Innovation Center, is scheduled to open in San Diego, California, during the first quarter of 2022. As a pivotal part of Gracell's global strategy, the company is fully committed to expanding its operations in the U.S. to enhance and diversify its in-house drug discovery, pre-clinical research, and translational capabilities to further complement its proprietary platforms and extensive early-stage pipeline. After a thorough nationwide search, Gracell chose to establish its Innovation Center within the Cornerstone Research Center in San Diego. The new hub includes a state-of-the-art laboratory, along with office space. Gracell is also expanding its R&D team through the recruitment of high-caliber biotech talent in the San Diego area. "We are delighted to start 2022 with the opening of our U.S. Innovation Center in San Diego, which will strengthen our R&D capabilities and further expand our presence in the U.S. market. This marks another solid step in Gracell's journey of becoming a leading global cell therapy company. By innovating and expanding upon our proprietary FasTCAR and TruUCAR platforms, we remain focused on solving the challenges of conventional CAR-T cell therapies and advancing innovative, highly differentiated programs from our robust pipeline to benefit cancer patients all around the world." Dr. William (Wei) Cao, Founder, Chairman and Chief Executive Officer of Gracell About Gracell Gracell Biotechnologies Inc. is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR, TruUCAR and SMART CARTTM technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.

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CELL AND GENE THERAPY

Taysha Gene Therapies Added to the Nasdaq Biotechnology Index

Taysha Gene Therapies | December 16, 2021

Taysha Gene Therapies Inc. a patient-centric, pivotal-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations, announced that it has been added to the Nasdaq Biotechnology Index in accordance with the annual reconstitution of the index, effective prior to the U.S. market open on Monday, December 20, 2021. “We are pleased to announce Taysha’s inclusion in the Nasdaq Biotechnology Index. As we continue to advance our broad pipeline and execute on our near-term clinical and regulatory milestones, inclusion in this index will enhance our visibility and expand awareness of our story with investors.” RA Session II, President, Founder and CEO of Taysha The Nasdaq Biotechnology Index is designed to track the performance of a set of securities listed on The Nasdaq Stock Market® that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. The Nasdaq Biotechnology Index is calculated under a modified capitalization-weighted methodology. Companies in the Nasdaq Biotechnology Index must meet eligibility requirements, including minimum market capitalization, average daily trading volume and seasoning as a public company, among other criteria. Nasdaq selects constituents once annually in December. About Taysha Gene Therapies Taysha Gene Therapies is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our team’s proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platform—an engine for potential new cures—with a goal of dramatically improving patients’ lives.

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INDUSTRIAL IMPACT

Calyxt Announces Pricing of Offering Of Common Stock and Warrants and Updates Business and Risk Factor Disclosure

Cellectis Inc. | February 19, 2022

Cellectis, a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, and Calyxt, Inc. , a majority-owned subsidiary of Cellectis S.A., announced the placement to an institutional investor in an underwritten offering of (i) 3,880,000 shares of Calyxt common stock, (ii) pre-funded warrants to purchase up to 3,880,000 shares of its common stock, and (iii) common warrants to purchase up to 7,760,000 shares of its common stock. The shares of common stock and the pre-funded warrants were each sold in combination with corresponding common warrants, with one common warrant to purchase one share of common stock for each share of common stock or each pre-funded warrant sold. The pre-funded warrants will have an exercise price of $0.0001 per share of Calyxt common stock and the common warrants will have an exercise price of $1.41 per share of Calyxt common stock. The pre-funded warrants will be immediately exercisable and remain exercisable until exercised, while the common warrants will be exercisable six months after the date of issuance and will have a term of five years from the date of exercisability. The aggregate public offering price for each share of common stock or each pre-funded warrant and, in each case, an accompanying common warrant was $1.41. All securities sold in the Offering were sold by Calyxt. In connection with the Offering, Calyxt disclosed certain preliminary estimated financial information as of December 31, 2021: Calyxt’s cash and cash equivalents was $13.7 million, restricted cash was $0.6 million, total current liabilities were $4.1 million, and financing lease obligations, including current portion, were $17.9 million. This preliminary financial information, which has not been audited, is based on information currently available to Calyxt and is subject to the completion of Calyxt’s year-end financial closing procedures. It is possible that Calyxt’s independent registered public accounting firm may identify items that require Calyxt to make adjustments to the preliminary estimates set forth above and those changes could be material. In connection with the Offering, Calyxt also provided an updated description of certain aspects of its business and updated the risk factor disclosure from Calyxt’s prior filings with the U.S. Securities and Exchange Commission. About Cellectis  Cellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. Cellectis utilizes an allogeneic approach for CAR-T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR-T cells to treat cancer patients, and a platform to make therapeutic gene editing in hemopoietic stem cells for various diseases. As a clinical-stage biopharmaceutical company with over 21 years of expertise in gene editing, Cellectis is developing life-changing product candidates utilizing TALEN®, its gene editing technology, and PulseAgile, its pioneering electroporation system to harness the power of the immune system in order to treat diseases with unmet medical needs. As part of its commitment to a cure, Cellectis remains dedicated to its goal of providing lifesaving UCART product candidates for multiple cancers including acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL) and multiple myeloma (MM). .HEAL is a new platform focusing on hemopoietic stem cells to treat blood disorders, immunodeficiencies and lysosomal storage diseases.   Cellectis headquarters are in Paris, France, with locations in New York, New York and Raleigh, North Carolina. Cellectis is listed on the Nasdaq Global Market and on Euronext Growth.   About Calyxt Calyxt is a plant-based synthetic biology company. The Company leverages its proprietary PlantSpring™ technology platform to engineer plant metabolism to produce innovative and high value plant-based chemistries for use in customers' materials and products. As plant-based solutions, the Company's synthetic biology products can be used in helping customers meet their sustainability targets and financial goals. Calyxt's diversified offerings are primarily delivered through its proprietary BioFactory™ production system.

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INDUSTRIAL IMPACT

Cyclica launches Perturba Therapeutics, a spin out from the University of Toronto, creating the next-generation oncology biotech

Cyclica Inc. | February 10, 2022

Cyclica Inc. a neo-biotech with the vision to advance the most robust and sustainable drug discovery pipeline, launches Perturba Therapeutics Inc. a spin out from the Stagljar Lab at the University of Toronto, Donnelly Centre for Cellular and Biomolecular Research. Perturba is advancing a rich pipeline of assets from undrugged protein-protein interactions (PPIs). Only a small subset of biologically important drug targets are currently being explored within the pharma industry. Perturba is taking this challenge on by integrating Cyclica’s comprehensive AI-augmented proteome-wide drug design technology with two first-in-class live cell-based assays from the Stagljar Lab. With this integrated AI-augmented drug design and empirical phenotypic approach, Perturba is developing precision therapies that modulate PPIs and PPI-mediated biological processes with a focus on difficult-to-treat cancers. Perturba will initially focus on advancing two EGFR triple mutant inhibitors for non-small cell lung cancer, and four programs targeting small GTPases for various intractable cancers. Naheed Kurji, Co-Founder, CEO and President of Cyclica indicates that “More than half of all human disease-related proteins are considered undruggable using conventional approaches. As a result, patients suffering from life threatening diseases are left waiting for treatment. What others view as “undruggable”, we see as potential. Perturba represents an important franchise in the pursuit of our cancer strategy. We’re so excited to partner with Professor Stagljar and the world class Stagljar Lab in driving forward our shared vision.” "over the past two years, my lab has developed two high impact, live cell-based technologies for studying protein-protein interactions and identifying novel drug molecules – MaMTH-DS and SIMPL. Combining these two technologies with Cyclica’s world-class AI-drug design approach will usher in a new way to conduct drug discovery for highly intractable targets in an unprecedented way at scale. I’ve known Naheed and the team at Cyclica for years and jointly have shown multiple proof points using our platforms with a program targeting an osimertinib resistant EGFR triple mutant that we will be progressing in Perturba, and a program targeting an oncogenic KRAS in a separate collaboration that gave us confidence to target other small GTPases in Perturba.” Dr. Igor Stagljar, Professor at University of Toronto’s Temerty Faculty of Medicine and Principal Investigator at the Donnelly Centre Seasoned drug developer Rick Panicucci, PhD, SVP at BridgeBio Pharma and a long time advisor at Cyclica has been appointed as non-executive Chairman of Perturba to help oversee the company's strategy. Su Dharmawardhane Flanagan, PhD, Tony Hunter, PhD and Ming Tsao, MD, have been appointed to Perturba’s Scientific Advisory Board. Cyclica will provide initial funding for Perturba and will seek external funding from strategic partners as required. “I’ve been involved in drug discovery & development for over 25 years. What I can say with certainty is that the way things will be done going forward is going to be very different from how it was done before. I’ve been an advisor at Cyclica for 6 years and have witnessed first hand the power of AI and data-first approaches to drive drug discovery fast and with quality. Now, with Perturba and integrating AI drug design and phenotypic assays opens a whole new way of design-make-test-analyze at scale for target classes that have been ignored for too long,” shares Panicucci. About Perturba An integrated oncology focused biotech company for unaddressable and undrugged targets. Founded in 2021 as a venture between Cyclica and the Stagljar Lab at the University of Toronto, Perturba integrates Cyclica’s AI-augmented drug discovery platform with sensitive, live-cell drug screening assays, MaMTH-DS and SIMPL from the Stagljar lab. Perturba is developing precision therapies at scale that modulate PPIs and PPI-mediated biological processes. About Cyclica Cyclica advances molecules that embrace the complexity of disease. A neo-biotech whose work spans dozens of collaborations with large pharma, biotech and several joint ventures. We are a passionate team of biotech and pharma professionals, biologists, chemists, and computer scientists who live and labour at the intersection of our collective expertise. About the Stagljar Lab and the Donnelly Centre The Stagljar lab at the University of Toronto is one of the world leading labs in the field of proteomics/chemical genomics, developing high-throughput technologies to facilitate the study of the protein-protein interactions (PPIs) of various human membrane proteins involved in cancer and rare genetic diseases such as cystic fibrosis. The Stagljar lab is currently directing major proteomics/chemical genomics projects to map how integral membrane proteins interact to produce either healthy or diseased cells, to identify novel therapeutic targets, and to screen for novel drugs using artificial intelligence platforms, in particular to target lung, colon, breast and pancreatic cancer. In close collaboration with medicinal chemists and clinical investigators, the Stagljar lab investigates the molecular mechanisms behind challenging, unexplained observations on drugs and on pathological events.

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