Durham’s Mycovia Pharma extends clinical trial of anti-fungal drug for yeast infections

WRAL TechWire | February 11, 2020

Durham’s Mycovia Pharma extends clinical trial of anti-fungal drug for yeast infections
Mycovia Pharmaceuticals, a developer of drugs in women’s health, has initiated “extension studies” as part of its ongoing Phase 3 global clinical trial of its lead drug candidate for treating recurrent yeast infections in women. The Durham-based firm is developing oteseconazole (VT-1161), an oral antifungal product candidate, for the treatment of Recurrent Vulvovaginal Candidiasis (RVVC), a debilitating, chronic infectious condition that affects nearly 138 million women worldwide each year and for which there is currently no approved treatment in the United States. “We are delighted by the progress we’re making with our oteseconazole clinical program, including the VIOLET trials,” said Stephen Brand, PhD, senior vice president of Clinical Development at Mycovia, in a statement. “The addition of an extension component to these studies will enable us to further evaluate the long-term effectiveness of oteseconazole in preventing recurrent episodes of vulvovaginal candidiasis in women who remain disease-free at their last scheduled study visit at Week 48.”

Spotlight

Sleep loss increases the experience of pain. However, the brain mechanisms underlying altered pain processing following sleep deprivation are unknown. Moreover, it remains unclear whether ecologically modest night-to-night changes in sleep, within an individual, confer consequential day-to-day changes in experienced pain. Here, we demonstrate that acute sleep-deprivation amplifies pain reactivity within human (male and female) primary somatosensory cortex yet blunts pain-reactivity in higher-order valuation and decision-making regions of the striatum and insula cortex. Consistent with this altered neural signature, we further show that sleep deprivation expands the temperature range for classifying a stimulus as painful, specifically through a lowering of pain thresholds.

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AstraZeneca spinoff Viela Bio scored its first FDA nod. Can it face down heavyweight rivals?

Fiercepharma | June 16, 2020

Two years after launching, AstraZeneca spinoff Viela Bio has its first FDA approval in Uplinza following Friday's nod to treat certain patients with neuromyelitis optica spectrum disorder. Analysts expect that the medicine, which won approval to treat patients who are anti-AQP4 antibody positive, can generate $586 million by 2026, according to Evaluate. But the competitive landscape could pose a challenge for the biotech's first launch. Doctors could prescribe Roche’s Rituxan or its biosimilars off label before trying Uplinza, Evaluate Vantage reports, or payers could require them to try the cheaper options first. Uplinza is a B cell depleter like Rituxan, so if those older options don’t work, docs might go another route and try Alexion’s Soliris rather than move on to Uplinza, Vantage said.

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BUSINESS INSIGHTS

Cyclenium Pharma and Vuja De Sciences Announce Oncology Drug Discovery Collaboration

Cyclenium Pharma | January 06, 2022

Cyclenium Pharma, Inc. an emerging pharmaceutical company specializing in the discovery and development of novel therapeutic agents based on their proprietary macrocyclic chemistry, and Vuja De Sciences, Inc. a biotechnology startup dedicated to discovering therapies that target the unique vulnerability of undetected disseminated tumor cells before they can cause deadly metastatic cancer recurrence, have announced today the signing of a drug discovery collaboration agreement. The companies will screen and optimize lead candidates to advance treatments uniquely suited for preventing cancer metastatic recurrence, the biggest unmet need in oncology. The collaboration will exploit Vuja De’s proprietary anti-metastatic progression in vitro and ex vivo drug discovery screening platform and Cyclenium’s proprietary QUEST™ Library of next generation synthetic small-molecule macrocycles and associated optimization expertise to identify clinical candidates effective against dormant disseminated tumor cells for the prevention of metastatic cancer recurrence. Vuja De will be responsible for all screening efforts, while Cyclenium will be responsible for all medicinal chemistry efforts to generate new optimized macrocyclic compounds by employing its unique CMRT™ Technology. “We are very excited about entering this collaboration with Vuja De. We are confident that our CMRT™ Technology and proven success in the macrocycle area combined with the innovative anti-metastatic progression platform and excellent research team at Vuja De will enable the discovery and development of novel macrocyclic therapeutic agents to effectively control metastatic progression.” Helmut Thomas, Ph.D., President, Chief Executive Officer & Chief Scientific Officer of Cyclenium “We highly appreciate Cyclenium’s expertise in the macrocycle area and their technology platform that is based on over 20 years of pioneering experience in small molecule macrocyclic chemistry,” said David Warshawsky, Ph.D., Chief Executive Officer of Vuja De. “We are very pleased to work with Cyclenium on identifying and developing novel game-changing drug candidates that prevent metastatic recurrence, the most urgent need of most cancer patients,” he added. About Cyclenium Pharma Cyclenium Pharma is an emerging, privately held pharmaceutical research and development company exploiting its proprietary next generation CMRT™ macrocyclic drug discovery technology for the discovery and development of novel small molecule therapeutic agents to address areas of unsatisfied medical need. Cyclenium is creating value through progression of internal programs in oncology, infectious diseases and inflammation/pain. In addition, Cyclenium is providing its extensive experience and exploring its CMRT-based QUEST™ screening library in risk-sharing partnerships with leading academic and research driven non-profit organizations, as well as collaborations with innovative pharmaceutical and biotechnology companies world-wide seeking to modulate unique and difficult disease targets in diverse therapeutic areas. About Vuja De Sciences Vuja De is a biotechnology startup company dedicated to discovering and developing therapies that target the unique vulnerability of undetected disseminated tumor cells before they can cause deadly metastatic cancer recurrence. This vulnerability of DTCs stems from their dependence on a unique phenotype that includes stress adaptation, survival & dormancy, which we have coined “Metastatic Endurance”. ME enables DTCs to persist undetected at secondary sites like “ticking time-bombs” and eventually start to rapidly divide and form overt deadly tumors. We successfully created the first-ever cell-based and ex vivo drug screening platform that finds drugs that target ME. We are using the largely adolescent, orphan disease, osteosarcoma, as the best proof of concept model for developing anti metastatic progression drugs for many cancers such as breast, melanoma and kidney. We are testing repurposed drugs that have previously been in clinical trials, as well as novel preclinical drugs. About Osteosarcoma Osteosarcoma is an aggressive cancer of the bone and is the most common type of bone cancer in children and teens. Since metastatic recurrence has shared biological mechanism in many other cancer types, therapies that show promise in osteosarcoma can be developed in parallel for many other cancer types, such as breast, kidney and melanoma. Despite successful control of the primary osteosarcoma tumors and follow-up chemotherapy, metastasis continues to be the most common cause of mortality. The last 30 years have brought little improvement in survival outcomes for children with osteosarcoma, despite intensification of therapy. Due to lack of improved outcomes, new approaches to therapy are highly needed. Furthermore, if targeted therapeutics are found to prevent metastasis in this cancer, a strong biological rationale would exist for the evaluation of such a therapy in other human cancers.

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PHARMA TECH

PathAI Announces Strategic Partnership with Roche to Enable Development and Distribution of Digital Pathology Diagnostics

Roche | October 15, 2021

PathAI, a global leader in artificial intelligence (AI)-powered technology for pathology, and Roche, a global pioneer in pharmaceuticals and diagnostics, announced a strategic partnership to develop and distribute PathAI's AI-powered technology through Roche's uPath enterprise software, enabling broad access to digital pathology diagnostics to support clinical research and companion diagnostic (CDx) programs globally. AI-powered pathology has the potential to inform biomarker development, better identify and treat patients, and enable personalized medicine. However, the digital pathology industry is largely fragmented across various software, hardware and algorithm providers, which has prevented effective implementation of AI platforms in labs. The collaboration between PathAI and Roche now provides a comprehensive menu of AI-powered digital pathology solutions in diagnostics. "This collaboration brings together all of the components required to deliver and commercialize a differentiated AI-based digital pathology medical device including assay, scanner, image management system, and image analysis algorithms. We believe this collaboration will unlock the potential for digital pathology in the CDx setting, offering a differentiated service to biopharma sponsors and ultimately new opportunities to improve patient outcomes," - Dr. Andy Beck, CEO of PathAI. The collaboration will initially involve distribution of PathAI-developed research-use-only (RUO) algorithms through NAVIFY Digital Pathology, the cloud version of Roche's uPath enterprise software, focusing on immuno-oncology in multiple cancer types. The collaboration will also support biopharmaceutical partners with an end-to-end solution for CDx development, leveraging Roche's diagnostic assays and pathology lab solutions with new and expanded innovative imaging tools from PathAI, in addition to the AI tools already provided by Roche. About PathAI PathAI is a leading provider of AI-powered research tools and services for pathology. PathAI's platform promises substantial improvements to the accuracy of diagnosis and the efficacy of treatment of diseases like cancer, leveraging modern approaches in machine and deep learning. Based in Boston, PathAI works with leading life sciences companies and researchers to advance precision medicine. To learn more, visit pathai.com. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognized as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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Spotlight

Sleep loss increases the experience of pain. However, the brain mechanisms underlying altered pain processing following sleep deprivation are unknown. Moreover, it remains unclear whether ecologically modest night-to-night changes in sleep, within an individual, confer consequential day-to-day changes in experienced pain. Here, we demonstrate that acute sleep-deprivation amplifies pain reactivity within human (male and female) primary somatosensory cortex yet blunts pain-reactivity in higher-order valuation and decision-making regions of the striatum and insula cortex. Consistent with this altered neural signature, we further show that sleep deprivation expands the temperature range for classifying a stimulus as painful, specifically through a lowering of pain thresholds.