Fighting Superbugs: The “Working to Fight AMR” Campaign

Biospace | September 04, 2019

Antimicrobial resistance (AMR) is increasingly becoming a global problem. According to the U.S. Centers for Disease Control and Prevention (CDC), about 2 million people each year are infected with antibiotic-resistant bacteria and 23,000 people die as a result. A recent study by the UK government estimated that by 2050, as many as 10 million people could die worldwide from antibiotic-resistant infections. “Working to Fight AMR” is an initiative by the Biotechnology Innovation Organization (BIO) to support efforts to increase development of new antibiotics to treat emerging AMR infections. Greg Frank, director of the campaign and director of Infectious Disease Policy at BIO, spoke withBioSpace about the campaign and its goals. Noting that fighting bacterial infections has been a major underpinning of modern medicine, and that so many procedures in cancer, chemotherapy, organ transplants, complex surgery and Caesarian sections have been made possible through these innovations, Frank says, “we’ve lost a few steps in the fight against the rise of drug resistance. We are behind in terms of developing the pipeline of new medicines to stay ahead of resistance.”

Spotlight

Over the course of the past seven years, SGB has succeeded in developing hybrids of Jatropha that are delivering per acre production in excess of 300 gallons of oil, 20 MT of green biomass and 0.6 MT of high quality protein per yeari . This document outlines the path leading to that success, and the reasons for Jatropha’s past failures.

Spotlight

Over the course of the past seven years, SGB has succeeded in developing hybrids of Jatropha that are delivering per acre production in excess of 300 gallons of oil, 20 MT of green biomass and 0.6 MT of high quality protein per yeari . This document outlines the path leading to that success, and the reasons for Jatropha’s past failures.

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Micreos Human Health Enrolles World's First Endolysin-drug as a Therapy for Atopic Dermatitis

Micreos | September 22, 2020

Dutch biotech company Micreos Human Health has enrolled the first patients in a Phase I/IIa, randomized, double-blind, placebo-controlled, parallel treated dose-ranging study to assess the safety and efficacy of XZ.700 in patients with mild to moderate atopic dermatitis. The study marks the world's first evaluation of a pharmaceutical endolysin for topical use in humans. Endolysins are highly specific enzymes that cut the bacterial cell wall, rapidly killing only the target bacteria, regardless of antibiotic resistance, while preserving the skin microbiome. XZ.700 specifically targets Staphylococcus aureus (S. aureus), a bacterium that is considered to be a causative and aggravating trigger for atopic dermatitis, and viewed as an independent cause of itch, irritation and infection. "The targeted removal of one particular bacterial species, S. aureus, from the skin microbiome, while preserving the beneficial ones is a fundamental new way to treat atopic dermatitis," says dermatologist Dr. Peter Lio, Scientific Advisor for Micreos and Scientific Advisory Board member for the National Eczema Association. XZ.700 is one of several endolysins Micreos has in its portfolio. A structurally similar endolysin, SA.100, is used in the company's over the counter (OTC) products for inflammatory skin disorders (e.g. acne and rosacea), found in the Gladskin range, which have been on the market since 2013. Data obtained in earlier Gladskin studies and feedback from doctors and thousands of customers support the pharmaceutical development program: "I am very encouraged by my experience with Gladskin and I am awaiting the findings with great anticipation." In this study, conducted in The Netherlands, XZ.700 will be tested for its safety as well as pharmacodynamics and efficacy in 48 patients with atopic dermatitis. They will be treated for 14 days with a cream containing XZ.700 at three different concentrations or placebo. Micreos expects to finish the study and report the results towards the end of 2021.

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INDUSTRIAL IMPACT

Navrogen Inc. and Tavotek Biotherapeutics Announce Strategic Collaboration to Improve Therapeutic Efficacy of Antibody Pipeline Agents

Navrogen Inc. | August 18, 2021

Navrogen Inc. a biopharmaceutical company specialized in developing therapies for cancer and immune-related disorders, and Tavotek Biotherapeutics, a biotech company focusing on novel multi-specific antibodies in immuno-oncology and autoimmune diseases, announced today that they have entered into a strategic collaboration to identify and develop experimental monoclonal antibodies (mAbs) for the treatment of various cancer indications. Under the agreement, Navrogen and Tavotek will collaborate on the development of future Tavotek oncology assets while utilizing Navrogen's proprietary screening technology to identify mAb leads that are susceptible to Humoral Immuno-Oncology (HIO) factors. HIO is a process by which tumors produce factors that suppress a patient's humoral immune response against malignant tissues as well as diminish therapeutic response of immune-mediated anti-cancer therapies. Working with Navrogen's HIO platform technologies and its expertise in patient tumor screening methods, the teams will identify and/or engineer HIO-refractory antibodies that are effective across a wide range of HIO-positive cancers leading to innovative treatment options for patients with limited therapeutic options. About Navrogen™ Inc Navrogen is a biopharmaceutical company focused on the discovery of tumor-produced Humoral Immuno-Oncology (HIO) factors that are associated with suppressed humoral immunity, poor prognosis and limited therapeutic response of immune-mediated anti-cancer therapies. The company's mission is to develop first-in-class agents that can overcome the immunosuppressive effects of HIO factors by employing its proprietary screening and engineering technologies as well as diagnostic assays that can identify patients whose tumors produce HIO factors to advise physicians on therapeutic options. About Tavotek Biotherapeutics Tavotek is a biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical needs. Tavotek has a rich pipeline of product candidates at various stages of development for cancer, autoimmune conditions, and inflammatory diseases.

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CELL AND GENE THERAPY

Tevogen Bio™ Further Strengthens IP Portfolio With Additional Patent for Method of Preparing Its Investigational SARS-CoV-2 Specific T cell Therapy

Tevogen Bio | January 13, 2022

Tevogen Bio, a clinical stage biotechnology company specializing in cell and gene therapies in oncology and viral infections, announced that the U.S. Patent and Trademark Office has granted a new patent for the method of preparing COVID-19 peptide specific cytotoxic T cells for the treatment of COVID-19 infection. The patent further reinforces the biotech pioneer’s expanding IP portfolio. “Omicron’s extensive mutations and its subsequent ability to evade antibodies highlights the importance of Killer T cells, which can still recognize and eliminate virus-infected cells. Millions among us suffer from inadequate T cell response for various reasons. After two years of the pandemic and witnessing the challenges posed by the ever-evolving virus, we must explore scientific options beyond our current approaches. CTL therapeutics for large patient populations is not an easy undertaking, but Tevogen’s ability to manufacture hundreds of doses from a single donor gives me hope,” Tevogen CEO Ryan Saadi, M.D., M.P.H The granted patent covers Tevogen’s investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T Lymphocytes therapy, TVGN-489, for high-risk COVID-19 patients. The product is currently undergoing a proof of concept clinical trial at Jefferson University Hospitals in Philadelphia. Trial details are available at Clinical Trials - Tevogen. About TVGN-489 TVGN-489 is a highly purified, SARS-CoV-2-specific cytotoxic CD8+ T lymphocyte product, which detects targets spread across the entire viral genome. These targeted CTLs are expected to recognize and kill off virally infected cells, allowing the body to replace them with healthy, uninfected cells. TVGN-489 demonstrated strong antiviral activity toward SARS-CoV-2 targets in preclinical studies. About Tevogen Bio Tevogen Bio is driven by a team of distinguished scientists and highly experienced biopharmaceutical leaders who have successfully developed and commercialized multiple franchises. Tevogen’s leadership believes that accessible personalized immunotherapies are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation in the post-pandemic world.

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