Study finds HIV+ cancer patients benefit from immunotherapy

Medical Xpress | February 07, 2019

The immunotherapy that has revolutionized the treatment of many cancers appears to offer a similar benefit to cancer patients living with HIV, say researchers at Georgetown Lombardi Comprehensive Cancer Center. Their study, published in JAMA Oncology, focused on whether a relatively new class of drugs called checkpoint inhibitors is both safe and effective in patients with advanced cancer who also live with HIV. Because checkpoint inhibitors manipulate the immune system, the concern has been that these therapies might have adverse effects such as virus reactivation in patients with HIV infection. Investigators searched the medical literature to find 73 HIV patients whose cancer had been treated with checkpoint inhibitors. Only a fraction of patients came from a clinical trial; the rest were mostly cased reports and case series from oncologists who chose to treat their patients with cancer and HIV infection with the new cancer drugs.

Spotlight

Some Microorganisms live in very acidic or alkaline, or even radioactive environments. There is a study to find ways to use microorganism's abilities for environmental conservation. A new field of study. It's Metal Biotechnology.

Spotlight

Some Microorganisms live in very acidic or alkaline, or even radioactive environments. There is a study to find ways to use microorganism's abilities for environmental conservation. A new field of study. It's Metal Biotechnology.

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DIAGNOSTICS

GRAIL Announces Strategic Collaboration With AstraZeneca to Develop Companion Diagnostic Tests to Enable the Treatment of Early-Stage Cancer

GRAIL | June 06, 2022

GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced a broad strategic collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) to develop and commercialize companion diagnostic (CDx) assays for use with AstraZeneca’s therapies. The collaboration will initially focus on developing companion diagnostic tests to identify patients with high-risk, early-stage disease, with plans to embark on numerous studies across multiple indications over the next several years. The parties are additionally planning to use GRAIL’s technology to enable recruitment of patients with early-stage cancer for AstraZeneca’s clinical studies. GRAIL has developed a novel approach to detect cancer signals in blood, regardless of whether or not the patient has clinical symptoms. We are excited to embark on this work with AstraZeneca to transform cancer outcomes through a broad, strategic collaboration, Through our collaboration, we hope to provide critical information to improve the identification of patients who may be eligible for clinical trials and change clinical paradigms for the treatment of early-stage cancers." Sir Harpal Kumar, President, Biopharma Business and Europe at GRAIL. Across the projects within this collaboration, GRAIL will use its methylation platform to perform testing for patients enrolled in AstraZeneca’s clinical trials. GRAIL will seek regulatory approval in key markets for the liquid biopsy companion diagnostics. Identifying and treating cancer early is at the heart of this strategic collaboration. Combining GRAIL’s innovative blood-based methylation profiling platform with AstraZeneca’s leadership in Oncology, we hope to accelerate the adoption of circulating tumor DNA across clinical trials and make our cancer medicines available at an earlier stage of disease when there is greater potential to transform patient outcomes, and even cure.” Susan Galbraith, Executive Vice President of Oncology R&D, AstraZeneca. GRAIL is developing its proprietary methylation platform for use in multiple post-diagnostic settings to identify patients at high risk of future cancer recurrence, detect the presence or absence of residual disease, and to inform treatment decisions, including identifying patients with cancer who may be eligible for neoadjuvant or adjuvant therapy. GRAIL’s technology platform is designed to optimize circulating tumor DNA testing to enable detection of early stage disease and minimal residual disease (MRD). About GRAIL GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021.

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INDUSTRIAL IMPACT

Ecological Laboratories, Inc. announces acquisition of TOMCO Chemical to Bolster Reach into Hog Farming Waste Management.

Ecological Laboratories, Inc. | July 08, 2022

Ecological Laboratories, Inc. a Biotechnology company that develops and manufactures novel, proprietary, liquid microbial formulations capable of solving many of the most challenging environmental problems, announced that it has acquired TOMCO Chemical. TOMCO Chemical has provided bacterial products specifically to breakdown solids and reduce odors for Hog Farms in the United States. "We are thrilled to bring together the TOMCO team with Ecological, which gives us critical mass to research, support and deliver against producer's farm waste challenges today and tomorrow." Ecological's CEO Nick Favret Ecological Laboratories, Inc. has been servicing the Hog Farming Waste Management Industry for more than forty years. By acquiring TOMCO, Ecological will be able to reach more farming leaders looking to use Biologically friendly solutions moving forward. TOMCO's premier product Pit-Perfect, a component of their In-Gest-O-Bac product series has been a tool used by farmers with great success. As Bio-Gas and Sustainable Agriculture continue to scale globally, Ecological recognizes the further demand of their microbial solutions. Ecological's Farm Waste Management solutions under the brand MICROBE-LIFT is the most effective way to improve farm waste processes. With unmatched capabilities to breakdown waste, and reduce toxic gases. MICROBE-LIFT technology drives down costs, increases operation efficiency, provides return on investment and supports regulatory compliance. "I am proud to announce the merger of TOMCO Chemical and Ecological Laboratories, Inc. By joining forces with Ecological we have the capacity to bring the best solution in waste management to a level that has not been seen before", said Tom Elsner President & CEO of TOMCO Chemical. Ecological Laboratories, Inc. continues to innovate with our propriety microbial formulations focusing on solutions for the Commercial Waste Water, Farm Waste, Aquaculture, Composting, Eco-System Restoration and Bio Gas Industries as well as the Retail Water Garden, Lawn and Garden, Aquarium, Pet, Hydroponic and Septic markets.

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INDUSTRIAL IMPACT

Anthos Therapeutics Announces that Abelacimab has Received FDA Fast Track Designation for the Treatment of Thrombosis Associated with Cancer

Anthos Therapeutics | July 11, 2022

Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, announced that the U.S. Food and Drug Administration has granted Fast Track Designation to its investigational Factor XI inhibitor, abelacimab, for the treatment of thrombosis associated with cancer. The company will also be announcing this important milestone today at a session of the ongoing 2022 Congress of the International Society on Thrombosis and Haemostasis Congress in London, UK. The Fast Track Designation process is designed to facilitate the development and expedite the review of treatments for serious medical conditions, thereby, addressing unmet medical needs. Drugs that are included in this program may be eligible for more frequent interactions with the FDA to discuss the development path, and if the program criteria are met, eligibility for a potential Rolling Review, Accelerated Approval, and Priority Review. Venous Thromboembolism including both deep vein thrombosis and pulmonary embolism, is the second most prevalent cause of death in patients with cancer, second only to the disease itself.1 However, treatment of Cancer Associated Thrombosis (CAT) can be challenging because the currently available anticoagulants used to treat VTE can have an increased risk of bleeding.2,3 "We believe that abelacimab has the potential to provide patients with cancer associated thrombosis an enhanced safety profile and overall low risk of bleeding, without sacrificing any efficacy of currently available agents. This unmet need is particularly true in patients with gastrointestinal / genitourinary (GI/GU) cancers who are at an even higher risk of bleeding and can be further burdened by the inconvenience of daily injections. Fast track designation by the FDA is a significant milestone for abelacimab and Anthos Therapeutics, but more importantly represents another hopeful step forward for patients. We look forward to working closely with the FDA on our clinical trial program to bring once-monthly abelacimab to patients in need." Dan Bloomfield, Chief Medical Officer at Anthos Therapeutics "Caring for cancer patients is a delicate and complex process, requiring a fine balance between the risks and benefits of their anticoagulant treatments. Managing thrombosis episodes is of the utmost importance for physicians, patients, and their caregivers, as untreated blood clots or bleeding episodes associated with currently available anticoagulants, can have dire consequences," said Jean Marie Connors, M.D., Associate Professor of Hematology at Harvard Medical School. "The hemostasis sparing potential of FXI inhibitors, such as abelacimab, may represent an important treatment advance in how we manage patients moving forward." About the Abelacimab Phase 3 Program in Cancer Associated Thrombosis (CAT) The abelacimab phase 3 CAT program comprises two complementary studies targeting to enroll approximately 2700 patients across 220 sites in more than 20 countries -- the largest program of any anticoagulant performed in Cancer-Associated Thrombosis. ASTER is an international multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism recurrence and bleeding in patients with cancer associated VTE in whom DOAC treatment is recommended. Abelacimab 150 mg will be administered intravenously (IV) on Day 1 and subcutaneously (SC) monthly thereafter for up to 6 months; Apixaban 10 mg will be administered orally, twice daily (bid) for the first 7 days, followed by 5 mg bid up to 6 months. Enrollment in this trial began in May 2022. MAGNOLIA is an international multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study in patients with gastrointestinal (GI) / genitourinary (GU) cancer in whom DOAC treatment is not recommended. The study will compare the effect of abelacimab relative to dalteparin on VTE recurrence and bleeding in patients with cancer associated VTE who are at a high bleeding risk with non-resectable, locally or regionally invasive GI / GU tumors. Abelacimab 150 mg will be administered intravenously (IV) on Day 1 and subcutaneously (SC) monthly thereafter for up to 6 months; dalteparin administered subcutaneously will be given daily, 200 IU/kg/day for the first month, and then 150 IU/kg/day up to 6 months. About the AZALEA-TIMI 71 Phase 2 Trial The AZALEA-TIMI 71 trial is an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study to evaluate the effect of two blinded doses of abelacimab relative to open label rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke. The trial completed enrollment in December 2021, with 1287 patients across 95 global study sites including the U.S., Canada, as well as from parts of Europe, and Asia. About Abelacimab Abelacimab is a novel, highly selective, fully human monoclonal antibody designed to induce effective hemostasis-sparing anticoagulation through Factor XI inhibition. Abelacimab targets the active domain of Factor XI, demonstrating dual inhibitory activity against both Factor XI and its activated form, Factor XIa. Abelacimab can be administered intravenously (IV) to achieve rapid inhibition of Factor XI activity and then used subcutaneously (SC) monthly to maintain nearly complete inhibition in a chronic setting. In a PK/PD study, abelacimab administered IV provided profound suppression of Factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days. 4,5 In a Phase 2 study whose results were published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.4 Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.6 Abelacimab is an investigational agent and has not been approved for any indication. About Anthos Therapeutics Anthos Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of genetically and pharmacologically validated innovative therapies to advance care for people living with cardiovascular and metabolic diseases. Anthos Therapeutics aims to combine the agility of a biotech with the rigor of a large pharmaceutical company.

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