Denovo Biopharma Announces Breakthrough Discovery of a Novel Genetic Biomarker for DB104 (Liafensine) for Depression

BioSpace | March 12, 2020

Denovo Biopharma LLC LLC, a pioneer in applying precision medicine to develop innovative therapies, today announced it has successfully discovered a novel genetic biomarker associated with DB104 response to treat depression using its proprietary biomarker discovery platform. DB104 was licensed from Albany Molecular Research, Inc. following its return from Bristol-Myers Squibb, who had conducted two phase 2b clinical trials in treatment-resistant depression with this first-in-class triple reuptake inhibitor targeting transporters for dopamine, serotonin, and norepinephrine.

Spotlight

December 1st marks the 30th anniversary of World AIDS Day. Acquired immunodeficiency syndrome (AIDS) is a chronic, potentially life-threatening condition caused by the human immunodeficiency virus (HIV). In 2017, worldwide approximately 36.9 million people were living with HIV, an estimated 940,000 people died from AIDS-related illnesses. Antiretroviral therapy has transformed HIV from a nearly always fatal infection into a manageable chronic condition, however, HIV remains a global health threat. In honor of the world’s AIDS day, we created this infographic that summarizes important facts and timelines about the disease. Education is key in prevention and management of the AIDS.

Spotlight

December 1st marks the 30th anniversary of World AIDS Day. Acquired immunodeficiency syndrome (AIDS) is a chronic, potentially life-threatening condition caused by the human immunodeficiency virus (HIV). In 2017, worldwide approximately 36.9 million people were living with HIV, an estimated 940,000 people died from AIDS-related illnesses. Antiretroviral therapy has transformed HIV from a nearly always fatal infection into a manageable chronic condition, however, HIV remains a global health threat. In honor of the world’s AIDS day, we created this infographic that summarizes important facts and timelines about the disease. Education is key in prevention and management of the AIDS.

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RESEARCH

Bio-Techne And Carterra Initiate A Clinical Research Collaboration For COVID-19 Variant Analysis

Bio-Techne Corporation | September 08, 2021

Bio-Techne, a leading supplier of high-quality and innovative tools for life science research, therapeutic manufacturing and clinical diagnostics and Carterra Inc., the world leader in high-throughput antibody screening and characterization, today announced a clinical research collaboration studying COVID-19 variants. New variants, such as Delta, can be more easily transmitted and more likely to evade the immune response of vaccinated or previously infected people. To assess immune responses to new variants and to plan for intervention mechanisms that avoid vaccine escape, scientists and epidemiologists need a fast and effective assay. The partnership leverages Carterra's flagship analytical platform - the LSA® - to characterize panels of SARS-CoV-2 spike and receptor-binding domain (RBD) variants in an information-rich assay. The SARS-CoV-2 variants were developed by Bio-Techne and used to fast-track the new, scalable assay for measuring the potential risks that new variants may evade the ability of the immune system to block the virus. Bio-Techne has been leading the way in COVID-19 research reagent and immunoassay development enabling scientists to make discoveries leading to effective diagnoses, therapies and vaccines. The company was first to market with COVID-19 research protein variants and has significant expertise with SARS-CoV-2 antibody quantitation. Bio-Techne and Carterra will focus this collaboration on more than 40 variants, including the Delta variant that is prevalent today, and emerging variants as they are discovered. The Carterra LSA will be used to generate high-definition insights with over 120 data points from patient serum samples, including a variant profile, ACE-2 blocking potential, and isotyping profiles of immunoglobin response. The LSA's hands-free, high-throughput setup requires only 2 µL of patient serum and provides for the analysis of new and emerging variants in the ever-evolving field of COVID-19 research. Carterra's LSA instrument is the fastest, most sensitive and flexible biosensor platform on the market. Combining proprietary flow printing microfluidics with High Throughput Surface Plasmon Resonance (HT-SPR) technology, the LSA enables detailed screening and characterization of vast antibody or variant libraries, including full kinetic profiles. With the ability to generate real-time binding data for 384 proteins on one chip and assay up to 1152 patient samples in a single unattended run, the LSA significantly improves efficiency and speed in both drug discovery and clinical research. About Bio-Techne Bio-Techne Corporation is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated approximately $931 million in net sales in fiscal 2021 and has approximately 2,700 employees worldwide. About Carterra, Inc. Carterra® is the leading provider of high throughput technologies designed to accelerate and improve the discovery of novel therapeutic candidates. Carterra's LSA™ instrument, software, and consumables for monoclonal antibody (mAb) characterization deliver up to 100 times the throughput of existing platforms in 10% of the time while using only 1% of the sample required by other systems. The LSA combines patented microfluidics technology with real-time high throughput Surface Plasmon Resonance (HT-SPR) and industry-leading data analysis and visualization software to revolutionize mAb screening. Carterra, Inc. is based in Salt Lake City, Utah, and has Customer Experience Centers in San Francisco, Salt Lake City, Boston, and Munich, Germany.

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CELL AND GENE THERAPY

Shoreline Biosciences Announces $140M Financing To Advance Pipeline Of Next Generation Cell Immunotherapies

Shoreline Biosciences | November 02, 2021

Shoreline Biosciences, Inc. (Shoreline), a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized, and targeted induced pluripotent stem cells (iPSC) derived natural killer (NK) and macrophage cellular immunotherapies, today announced the completion of a $140M financing, led by Ally Bridge Group, with participation from new investors Eventide Asset Management, BeiGene, Irving Investors, Kingdon, NS Investment, Piper Heartland Healthcare Capital, and Superstring. Existing investors Boxer Capital, BVF Partners, L.P., Commodore Capital, Cormorant Asset Management, Janus Henderson Investors, Kite, a Gilead Company, Stork Capital, Wedbush Healthcare Partners and an undisclosed leading global investment firm, also participated. In connection with the financing, Frank Yu, Founder, CEO and CIO of Ally Bridge Group, joined the Shoreline Board of Directors. "We are proud of Shoreline's tremendous progress over the past year, including next generation, more persistent and more effective iPSC-derived NK cells, enhancing our core technologies, advancing our preclinical programs, establishing transformative and validating partnerships with Kite and BeiGene, creating smart manufacturing methods, and attracting exceptional talent to support our next phase of development and growthWith this financing and our corporate partnerships, Shoreline has now more than $300 million to continue building our pipeline of safe, effective and affordable cellular immunotherapies for both solid tumors and hematologic malignancies." Kleanthis G. Xanthopoulos, Ph.D., Shoreline's co-founder, Chairman and Chief Executive Officer "Having invested in – and followed closely for several years -- the iPSC-derived NK cells-based therapeutics field which has made highly encouraging progress in the clinic, we are convinced of the true differentiation demonstrated by the Shoreline technology platform. Ally Bridge Group, a leading investor in best-in-class cell therapy companies from oncology to autoimmune diseases, expects Shoreline to be a new category leader," said Frank Yu, Founder, CEO and CIO of Ally Bridge Group. The proceeds from the financing will allow Shoreline to continue the advancement of its proprietary iPSC platform focused on developing next generation natural killer (NK) cell and macrophage-cell therapies, create potent and persistent NK cell-specific Chimeric Antigen Receptors (CARs) as well as switchable CAR-NK cell engagers and macrophage-specific CARs to treat blood cancers, solid tumors, and other health conditions. With the close of this financing, Shoreline is well-capitalized with greater than $300 million, including committed partnership R&D funding, to execute on its goals and advance its pipeline. About Shoreline Biosciences Shoreline is dedicated to creating next-generation cellular immunotherapies for cancer that overcome the current limitations of first-generation cell therapy products. Shoreline is building a pipeline of natural killer cell and macrophage-cell therapy candidates derived from its deep expertise in iPSC differentiation methods and genetic reprogramming of disease relevant pathways. Shoreline has strategic partnerships with Kite, a Gilead Company, and BeiGene, a global biotechnology company, Contract Development and Manufacturing Organization partnerships with well-established organizations, and is supported by high-quality investors. Shoreline Biosciences is headquartered in San Diego, CA.

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RESEARCH

Kineta and Samsung Biologics Announce Anti-VISTA Antibody Immunotherapy Development and Manufacturing Agreement

Samsung Biologics | July 21, 2021

Kineta, Inc., a clinical-stage biotech firm developing novel immunotherapies in oncology, has signed a strategic partnership agreement with Samsung Biologics, one of the world's top contract development and manufacturing companies (CDMO). To support the IND filing for KVA12.1, Kineta's new anti-VISTA antibody under development to treat solid tumors, Samsung Biologics will offer end-through-end CDMO services ranging from cell line development to cell line development clinical drug substance and drug product manufacturing. VISTA, which is overexpressed on myeloid-derived suppressor cells (MDSC) and regulatory T cells, is a major driver of the immunosuppressive tumor microenvironment (TME) (Tregs). It is an important immune checkpoint in myeloid cells, and VISTA blockade can reprogram suppressive myeloid cells and restore anti-tumor immune function. Preclinical studies show that KVA12.1 has anti-tumor activity as a single agent and that targeting VISTA in combination with PD-1, PD-L1, or CTLA-4 can substantially enhance the anti-tumor efficacy of those checkpoint inhibitors. Thus, Kineta's KVA12.1 is intended to reprogram the TME in hard solid tumors. The manufacturing cell line will be created with assistance from Samsung Biologics' R&D Center in San Francisco. The clinical trial materials will be manufactured in Samsung Biologics' headquarters in Incheon, South Korea. Samsung Biologics provides one-stop CDMO research and development services from its headquarters in Incheon, South Korea, and its newly built R&D Center in San Francisco. Providing quality-driven development services at a faster pace, the company delivers cell line development to drug substance manufacturing in six months and drug product manufacturing in seven months, the industry's fastest pace. Samsung Biologics is currently building its fourth and largest facility in Incheon, Korea, which will have a biomanufacturing capacity of 620,000 liters upon completion in 2023. About Kineta, Inc. Kineta, Inc. is a clinical-stage biotechnology company dedicated to developing game-changing life science technologies that address unmet patient needs. We have used our immunology expertise to advance a focused pipeline of oncology investigational drugs. To develop our innovative products, we actively work with a diverse range of private, government, and industry partners. About Samsung Biologics Co., Ltd. Samsung Biologics is a fully integrated CDMO that provides state-of-the-art contract development, manufacturing, and laboratory testing. Samsung Biologics is an award-winning partner of choice, with proven regulatory approvals, the largest capacity, and the fastest throughput. As a result, it is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide.

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