CytoDyn announces first site in the southeastern USA to enroll patients in Phase 2 coronavirus trial

Proactive Investors | April 08, 2020

The Novant Health network cares for around 5 million patients a year at nearly 700 locations, including 15 hospitals and hundreds of outpatient facilities and physician clinics. CytoDyn Inc (OTCQB:CYDY), the late stage biotech, said partner Novant Health has started enrolling patients in the company's Phase 2 randomized clinical trial using leronlimab for coronavirus (COVID-19) patients with mild-to-moderate symptoms. Novant Health is the second trial site in the USA and the first site in the southeastern US to initiate this Phase 2 trial. Earlier on Wednesday, it was reported that the death toll from the virus in the US now stands at nearly 13,000 and there were nearly 2,000 deaths between Tuesday and Wednesday. New York state alone recorded 731 deaths on Tuesday.

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Cortexyme Successfully Completes Acquisition of Novosteo

Cortexyme | May 21, 2022

Cortexyme, Inc. (Nasdaq: CRTX), a clinical-stage biopharmaceutical company developing therapeutic approaches to improve the lives of patients diagnosed with degenerative diseases, today announced the completion of its acquisition of Novosteo, a privately-held biotech company focused on targeted therapeutics to treat rare skeletal diseases, bone cancer and injury. Novosteo stockholders now own approximately 15.5% of the combined company. With the completion of the acquisition, Cortexyme appointed former Novosteo executives Dr. Dirk Thye as Chief Executive Officer, and Dr. Karen Smith as Chief Medical Officer of Cortexyme. Dr. Thye and Dr. Philip Low have been appointed to the Cortexyme’s Board of Directors. Cortexyme plans to change its name to Quince Therapeutics, Inc. in the coming months to reflect the broadening pipeline of the company. Inducement Grant Under Nasdaq Listing Rule 5635(C)(4) In conjunction with the close of the Novosteo acquisition, Cortexyme reported that the Compensation Committee of the company’s Board of Directors approved grants of stock options to purchase an aggregate of 3,744,255 shares of Cortexyme’s common stock, which includes options to purchase (i) 1,979,650 shares to Dr. Dirk Thye, (ii) 1,365,449 shares to Dr. Karen Smith, (iii) 353,656 shares to Brendan Hannah, and (iv) an aggregate of 45,500 shares to six additional newly hired employees. The stock options will be issued under the Cortexyme, Inc. 2022 Inducement Plan with a grant date of May 23, 2022 and an exercise price equal to the closing price of a share of Cortexyme common stock on the grant date. The stock options are being issued as an inducement material to each new employee entering into employment with Cortexyme, in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options vest over four years, with 25% vesting on the first anniversary of the vesting commencement date for each employee and the remainder vesting in 36 installments over the following three years, subject to each employee being continuously employed by Cortexyme as of such vesting dates. About Cortexyme Cortexyme, Inc. (Nasdaq: CRTX) is a clinical stage biopharmaceutical company dedicated to improving the lives of patients diagnosed with degenerative diseases. The company’s innovative pipeline includes a precision bone growth molecule and drug-targeting platform to treat rare skeletal diseases, bone cancer and injury, in addition to small molecule therapeutics targeting the infectious pathogen P. gingivalis’ role in degenerative disease progression, including for indications such as periodontal disease, oral potentially malignant disorders, and Alzheimer’s disease, among others.

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INDUSTRIAL IMPACT

Agilent and A*STAR’s SIFBI Sign Research Collaboration Agreement to Advance Singapore Agri-Food Industry

Agilent Technologies Inc. | January 27, 2022

Agilent Technologies Inc. recently signed a Research Collaboration Agreement with the Singapore Institute of Food and Biotechnology Innovation outlining their collaboration on developing food research knowledge advancement over the next two years. SIFBI is a research institute under the Agency for Science, Technology, and Research in Singapore. This collaboration aims to bring state-of-the-art science and technology to drive innovation in food, nutrition, ingredients, industrial biotechnology, and related applications. In Singapore, Agilent has been actively contributing to research development over the last two years in food sustainability, security, and innovation to enhance the quality of life. This work supports the Singapore Government’s ambitious plan of producing 30% of the nation’s nutritional needs by 2030. "SIFBI's end-to-end capabilities in the food innovation value chain aim to support Singapore's food resilience and security through advancements in science and technology. Collaborating with industry in public-private partnerships is essential to not only achieve this but also level up together with our partners. This collaboration with Agilent aims to develop enhanced, more efficient methods of biochemical analysis that are crucial to accelerating our common drive towards innovative, nutritious future foods," Dr. Hazel Khoo, executive director of SIFBI “At Agilent, we are committed to accelerating knowledge transfer and investing in the communities where we operate. This latest agreement reflects the benefit we can bring to human health and the environment through translating research findings into healthy food. We believe this initiative will drive science advancement in support of Singapore’s growing food innovation ecosystem—ultimately satisfying the demand for safer, healthier, and more sustainable food, both regionally and globally,” said Chow Woai Sheng, vice president and general manager for Agilent’s global instrument manufacturing and Singapore country general manager. Agilent will supply the mechanical elements for early food research into target compounds and high-value ingredients in this collaborative effort. Agilent brings innovative thinking, multidisciplinary technology expertise, and training on world-class analytical development to help improve agri-food systems in Singapore. Through this agreement, Agilent’s goal is to re-imagine data optimization and analytics to drive prioritization on the population’s health sustainably. Since establishing its Singapore site in 1999, Agilent has grown its local team to over 800 scientists, skilled engineers, and employees—delivering trusted answers for Singapore, Asia Pacific, and globally. Its Singapore hub hosts a Global Solutions Development Center to advance integrated methodologies and novel applications working for projects worldwide. Agilent is also committed to the development of Singapore’s future talent. Agilent has launched an Agilent University offering more than 200 courses to build local capabilities, as well as a translational R&D facility to boost clinical diagnostics through biochemical innovation. These efforts support Agilent’s vision of growing strong local roots in key growth markets. About Agilent Technologies Agilent Technologies Inc. is a global leader in the life sciences, diagnostics, and applied chemical markets, delivering insight and innovation toward advancing the quality of life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.32 billion in fiscal 2021 and employs 17,000 people worldwide.

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INDUSTRIAL IMPACT

BeiGene Announces Approval for BRUKINSA (zanubrutinib) by Swissmedic for Treatment of Adult Patients with Waldenströms Macroglobulinemia

BeiGene | February 18, 2022

BeiGene a global, science-driven biotechnology company focused on developing innovative and affordable medicines, today announced that BeiGene’s BTK inhibitor BRUKINSA received approval from Swissmedic for the treatment of adult patients with Waldenström’s macroglobulinemia who have received at least one prior line of therapy, or for treatment-naïve patients who are not suited for standard chemo-immunotherapy. BRUKINSA had previously been granted orphan drug status. “The authorization of BRUKINSA will bring a new option and an innovative medicine that has potential to offer deep and durable response for eligible patients with WM in Switzerland. BRUKINSA is a next-generation BTK inhibitor which has also provided meaningful improvements in tolerability for some patients with WM compared to ibrutinib, as treatment discontinuation remains a concern.” Pr. Davide Rossi, Deputy Head of the Division of Hematology of the Oncology Institute of Southern Switzerland IOSI Reto Kessler, Country Manager, Switzerland at BeiGene added, “This approval is a significant development for people living with WM in Switzerland and for BeiGene’s expansion in Europe. Our teams are committed to collaborating with the Federal Office of Public Health and healthcare professionals to ensure access to BRUKINSA for patients in Switzerland.” The Marketing Authorization Application (MAA) is supported by data from the global Phase 3 ASPEN clinical trial, a Phase 3 randomized, open-label, multicenter trial (NCT03053440) that evaluated BRUKINSA compared to ibrutinib in patients with relapsed/refractory (R/R) or treatment-naïve (TN) WM who harbor a MYD88 mutation (MYD88MUT). In the ASPEN trial, BRUKINSA demonstrated a numerically higher very good partial response (VGPR) rate and a favorable safety profile over ibrutinib, although the primary endpoint of statistical superiority related to deep response (VGPR or better) was not met. As assessed by independent review committee (IRC) per adaptation of the response criteria updated at the Sixth International Workshop on Waldenström’s Macroglobulinemia (IWWM), the combined complete response (CR) + VGPR rate in the overall intention-to-treat (ITT) population was 29% with BRUKINSA (95% CI: 20, 40), compared to 19% with ibrutinib (95% CI: 12, 30). In the ASPEN trial, of the 101 patients with WM randomized and treated with BRUKINSA, four percent of patients discontinued due to adverse events, including cardiomegaly, neutropenia, plasma cell myeloma, and subdural hemorrhage. Adverse events leading to dose reduction occurred in 14% of patients, with the most common being neutropenia (3%) and diarrhea (2%). The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions. About Waldenström’s Macroglobulinemia WM is a rare B-cell lymphoma that occurs in less than two percent of patients with non-Hodgkin lymphomas.2 The disease usually affects older adults and is primarily found in bone marrow, although lymph nodes and the spleen may be involved.1 Throughout Europe, the estimated incidence rate of WM is approximately seven for every one million men and four for every one million women.2 About BRUKINSA BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues. BRUKINSA is supported by a broad clinical program which includes more than 3,900 subjects in 35 trials across 28 markets. To date, BRUKINSA has received more than 20 approvals covering more than 40 countries and regions, including the U.S., European Union, China, Australia, Great Britain and Switzerland. Currently, more than 40 additional regulatory submissions are in review around the world. BeiGene Oncology BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU and U.K., Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China. BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks. In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under FDA review, BeiGene and Novartis announced an option, collaboration and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China. About BeiGene BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 8,000 colleagues across five continents.

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RESEARCH

Institute for Bioscience and Biotechnology Research Receives $16.8 M Investment from the National Institute of Standards and Technology

Institute for Bioscience and Biotechnology Research | January 14, 2022

The Institute for Bioscience and Biotechnology Research announces a newly funded five-year cooperative agreement with the National Institute of Standards and Technology headed by the Co-Directors of IBBR, Dr. David J. Weber (PI) and Dr. John Marino This award provides more than $3.3 million each year to support groundbreaking research, including technology and standards development that will impact vaccine and therapeutic discovery and development, and to improve access to life-saving treatments for addressing other crucial health challenges. IBBR is a joint research enterprise of the University of Maryland, College Park, the University of Maryland, Baltimore and NIST. Research born out of this new cooperative agreement will be applied to accelerating the development and manufacturing of new pharmaceutical and vaccine approaches including cell and gene therapies and mRNA vaccines. This type of bioscience and bioengineering research will enable robust and rapid responses to pandemics and help remove obstacles to care and treatment related to rare childhood diseases and complex cancers. "Trusting in and funding research makes it possible to find solutions to address major health and scientific challenges, and to prepare for the unknown. UMB has invested heavily in operational support and high-end instruments for IBBR in support of the NIST relationship. I am very pleased to see that the long-standing NIST collaboration will continue." Bruce E. Jarrell, MD, FACS, President of the University of Maryland, Baltimore As part of the new agreement, NIST provided state-of-the-art equipment for the "IBBR Commons"—a highly sophisticated research space shared with researchers throughout Maryland and the nation. For example, NIST recently partnered with Maryland to establish the Maryland Center for Advanced Molecular Analysis (M-CAMA) that established new cryo-electron (cryoEM) instruments and facilities to be used by NIST and researchers in Maryland for the timely development of new therapies and vaccines. "IBBR has long provided the critical link necessary to bring together researchers across disciplines to address major health challenges and help strengthen the state's economic base in bioscience and biotechnology," said Darryll J. Pines, Ph.D., President of the University of Maryland, College Park. "I am so pleased this collaboration between NIST and the University of Maryland, Baltimore and the University of Maryland, College Park remains strong, and I look forward to seeing the innovations it will lead to in the future." IBBR was established by the University System of Maryland Board of Regents in 2010, building on and integrating previous partnerships between the University of Maryland and NIST that date back to 1984. The institute connects dozens of experts from interrelated fields of study with the common goal of accomplishing world-class interdisciplinary research that can lead to real-world advances like drug discovery, more effective vaccines, and disease prevention and treatment. "Achieving truly groundbreaking results in fields like bioscience and biotechnology requires a wide array of resources, perspectives and expertise—from pharmaceutical and biotech companies to academic and government institutions, to foundations and NGOs," said Jennifer King Rice, Ph.D., Senior Vice President and Provost of the University of Maryland, College Park. "What makes IBBR so unique and impactful is its ability to stand in the center of this circle of voices as the catalyst for collaborative and impactful work." "Having this important cooperative agreement with NIST enables us to develop and share the most sophisticated and advanced instrumentation for use in the discovery, development and manufacturing of safe and effective new medicines to treat human disease—including, most recently, for COVID19," said E. Albert Reece, MD, Ph.D., MBA, Executive Vice President for Medical Affairs at the University of Maryland, Baltimore and the John Z. and Akiko K. Bowers Distinguished Professor and Dean of the University of Maryland School of Medicine. About IBBR IBBR is a joint research enterprise of the University of Maryland, College Park, the University of Maryland, Baltimore, and the National Institute of Standards and Technology. IBBR brings together critical elements necessary to inspire transformative discoveries in the field of bioscience and biotechnology and provides innovative solutions to major scientific and engineering challenges important to society. IBBR researchers seek to advance the fields of biomedical research, therapeutic development, biomedical manufacturing, and state-of-the-art measurement technologies, to support accelerated delivery of safe and effective medicines to the public. IBBR is financially supported in part by the University of Maryland Strategic Partnership: MPowering the State, an initiative designed to achieve innovation and impact through collaboration.

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IPM is a holistic approach to sustainable agriculture that focuses on managing insects, weeds and diseases through a combination of cultural, biological and chemical measures that are cost effective, environmentally sound and socially acceptable.1 This includes the responsible use of crop protection and plant biotech products.

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