Yiviva Announces Dosing of First Patient in Phase 2b Study of First-Line YIV-906 Plus Sorafenib Combination Therapy in the Treatment of Hepatocellular…

- First-in-class oncology therapeutic candidate YIV-906 applies an integrative systems biology approach -- Global study to evaluate efficacy, safety, and quality of life in patients with hepatitis B-positive hepatocellular carcinoma -

NEW YORK and SHANGHAI, China, April 06, 2020 (GLOBE NEWSWIRE) -- Yiviva today announced that the first patient has been dosed in a Phase 2b study of YIV-906 in combination with sorafenib in the treatment of patients with hepatitis B-positive hepatocellular carcinoma (HCC). YIV-906 is a novel, proprietary therapeutic candidate based on molecular profiling of extracts identified from use in traditional botanical medicine. YIV-906 has demonstrated that it can potentiate the anti-tumor activity of sorafenib, enhance innate and adaptive immune function in the tumor microenvironment, protect cells of the gastrointestinal tract by reducing inflammation mediated by IL-6, NF-kappaB, COX2, iNOS, and accelerate regeneration of damaged gastrointestinal tissue by promoting progenitor and stem cell growth via the Wnt signaling pathway.

Patients and providers are eager to have evidence-based systemic treatment options for cancer, such as YIV-906, commented Edward Chu, M.D., Chief of the Division of Hematology and Oncology, Deputy Director at the UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine and senior advisor to Yiviva. YIV-906 applies a novel systems biology approach that has been shown in preclinical and preliminary clinical studies to enhance immune function in the tumor microenvironment and protect gastrointestinal tissue. Observations of the effects of YIV-906 in proof of concept clinical studies provide a compelling rationale for conducting this large global study in the first-line treatment setting. In addition, patients with hepatitis B-positive HCC represent a population with particularly limited treatment options where the YIV-906 approach could have a particularly significant impact on care.

The development of YIV-906 is a state-of-the-art approach using modern science, bioinformatics, and current GMP manufacturing to develop a precisely engineered botanical medicine, commented Yun Yen, M.D., Ph.D., Co-Global PI Coordinator of the YIV-906 study and former President of Taipei Medical University. The components of YIV-906 have been selected for their expected effects across multiple targets when administered as a complex mixture in combination. Given the major need for better treatments for patients with liver cancer, and the safety and efficacy profile of YIV-906 as seen to date, we look forward to the results of this global study. This could lead to new therapeutic strategies to treat cancer patients holistically.

The randomized, placebo-controlled Phase 2b study of YIV-906 is evaluating efficacy, safety, and quality of life in patients with hepatitis B-positive HCC. The clinical study is designed to enroll approximately 125 patients at 20 sites in the U.S., mainland China, Hong Kong, and Taiwan, including Memorial Sloan Kettering Cancer Center, Taipei Medical University, Queen Mary Hospital in Hong Kong and the China National Cancer Center in Beijing. Patients will be randomized 2:1 to either the study arm (YIV-906 plus sorafenib) or control arm (placebo plus sorafenib). The primary endpoint of the study is an evaluation of progression free survival. Secondary endpoints include safety and quality of life assessments and additional measures of clinical efficacy, including time to progression, overall survival, objective response rate and disease control rate. Change of quality of life will be assessed according to HCC18 and EORTC QLQ-C30 assessments. Additional information is available at https://clinicaltrials.gov/ct2/show/NCT04000737.

About YIV-906

YIV-906 (also PHY906 or KD018) is a therapeutic candidate comprised of a proprietary cGMP botanical extract of four herbs inspired by a traditional Chinese medicine formulation used for over a millennium. YIV-906 has the potential to be developed as a platform oncology therapeutic when administered in combination with chemotherapy, immunotherapy and radiation therapies, in multiple cancer indications. YIV-906 has been shown to enhance immune function in the tumor microenvironment (by polarizing M1 macrophages and activating T cells), protect the gastrointestinal tract (by inhibiting inflammation via IL-6, NF-kappa-B, COX2, and iNOS pathways) and promote intestinal tissue repair (by increasing activity and expression of components of the Wnt signaling pathway). YIV-906 has been observed to enhance the anti-tumor activity of sorafenib in preclinical models of hepatocellular carcinoma and has shown promise in preliminary clinical studies in liver, pancreatic, colorectal and rectal cancers. YIV-906 has been granted Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for development of YIV-906 in the treatment of hepatocellular carcinoma and pancreatic cancer. Yiviva holds worldwide intellectual property for YIV-906 including 32 patents related to methods of use, manufacturing and quality control. YIV-906 is being developed for approval under the U.S. FDA Botanical Drug regulatory pathway.

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About Yiviva

Yiviva is a clinical stage biotechnology company developing multi-target botanical therapeutics using a systems biology approach, focused on cancer, inflammatory and chronic diseases. The Yiviva STAR (signal transduction, activity and response) discovery platform accelerates the identification of botanical therapeutics that influence immune function, inflammatory responses, cell growth and metabolic functions and hormone activity. Yiviva applies patented, mechanism-based quality control linked to biological activity to satisfy established regulatory requirements for complex products. The company was launched with Yale University as a co-founder and co-founders include Yung-Chi Cheng, Ph.D., with teams in New York, New Haven, Connecticut and Shanghai. For further information, please visit https://yiviva.com.

Contact:Tel: +1 646-883-3906Email: hello@yiviva.com

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Yiviva Announces Dosing of First Patient in Phase 2b Study of First-Line YIV-906 Plus Sorafenib Combination Therapy in the Treatment of Hepatocellular...

Coronavirus Business Tracker: How The Private Sector Is Fighting The COVID-19 Pandemic – Forbes

Alain Mrieux, founder of BioMrieux.

Latest update: April 6, 2020, at 5:46 pm ET.

Businesses around the world are shifting into overdrive to help battle the coronavirus, providing everything from rubber gloves and ventilators to diagnostic tools and, hopefully soon, vaccines. While the pandemic continues to wreak havoc, large corporations and small businesses are developing creative solutions to halt the spread of the virus.

Just as automakers famously shifted to make tanks and planes during World War II, todays global giants LVMH, Ford and GE to name a few are retooling their production lines to help make everything from hand sanitizers to respirators. On the medical front, there are more than three dozen COVID-19 vaccines under development, a smart move considering that two out of every three vaccines for infectious diseases fail, according to a study by the Massachusetts Institute of Technology.

Forbes will continue to update this list of private companies and how they are stepping up to fight the COVID-19 pandemic:

Testing:

Abbott Laboratories: Abbott Park, Illinois healthcare firm obtained emergency FDA authorization for its 5-minute coronavirus testing kit on March 27, with plans to start manufacturing 50,000 kits a day.

Alphabet: Through its healthcare arm Verily, Googles parent company launched a website where users can find nearby testing sites in four California counties.

Jeff Bezos.

Amazon: Jeff Bezos retail behemoth invested $20 million in the Amazon Web Services Diagnostic Initiative, which aims to speed up delivery of COVID-19 tests to the market.

BioMrieux: French biotech company, founded by billionaire Alain Mrieux,received emergency FDA approval for its subsidiarys new testing kit, which cuts testing times for the virus down to 45 minutes.

Carbon: California-based 3D printing unicorn backed by Russian tech investor Yuri Milner will soon be distributing testing swabs and face shields to hospitals in the Bay Area.

Cellex: North Carolina biopharma firms antibody-based test for COVID-19 received emergency approval from the FDA.

Cepheid: Sunnyvale, California molecular diagnostics company gained emergency FDA authorization for its new 45-minute COVID-19 testing kit.

Copan Diagnostics: Family-owned company located at the heart of Italys hard-hit Lombardy region makes diagnostic swabs for testing, airlifting 500,000 swabs to the U.S.

DiaSorin: Italian biotech company owned by billionaire Gustavo Denegri obtained emergency authorization from the FDA for its new 60-minute testing kit for COVID-19.

Ipsum Diagnostics: Sandy Springs, Georgia diagnostic company gained emergency FDA authorization for its COVID-19 testing kit.

Mammoth Biosciences: South San Francisco-based biotech startup, founded by three 30 Under 30 alums, prototyped a rapid test by using the gene-editing tool Crispr to detect the disease.

Mesa Biotech: San Diego biotech business obtained FDA approval for its new 30-minute testing kit for COVID-19.

Puritan Medical Products: Maine-based diagnostic maker, one of the worlds largest makers of diagnostic swabs along with Italys Copan Diagnostics, is reportedly increasing production to make one million COVID-19 testing swabs a week.

QIAGEN: Hilden, Germany-based molecular diagnostics firm received emergency approval from the FDA for its new COVID-19 testing kit.

Siemens Healthineers: The German conglomerates healthcare unit received FDA clearance for its blood gas analyzer, which helps doctors monitor the conditions of critical COVID-19 patients in ICUs.

Treatments:

AbbVie: North Chicago-based, publicly traded pharma firm is collaborating with authorities in the EU, the U.S. and China on experimental use of its HIV drug lopinavir/ritonavir to treat COVID-19.

AIM Immunotech: Florida-based pharmaceutical company announced on March 9 it would begin experimental testing of its chronic fatigue syndrome drug rintatolimod as a treatment for COVID-19 in Japan, at the National Institute of Infectious Diseases and the University of Tokyo.

AlloVir: Houston-based cell and gene therapy company is collaborating with Baylor College of Medicine to discover and develop T-cell therapies to fight COVID-19.

Amgen: Thousand Oaks, California biotech outfit is working with Seattle-based Adaptive Technologies to develop antibody-based treatments for COVID-19.

Apeiron Biologics: Vienna-based biotech firm announced it would begin a trial of its immunotherapy treatment on 200 COVID-19 patients in Austria, Germany and Denmark.

Applied Therapeutics: New York-based biopharma outfit is conducting trials of its lung inflammation and cardiomyopathy drug, AT-001, on COVID-19 patients at several hospitals in New York City, including Mount Sinai.

Ascletis: Hangzhou, China pharmaceutical company announced results of clinical trials of its antiviral drug danoprevir on COVID-19 patients in China; the small-scale study found that danoprevir combined with ritonavir is safe and well tolerated in all patients.

Celltrion: South Korean healthcare firm is developing an antiviral treatment for COVID-19, with plans to start human trials in July; the company is also developing rapid self-testing kits that would provide results within fifteen to twenty minutes, expected by the summer.

Celularity: New Jersey-based therapeutics startup obtained FDA clearance to begin trials of a potential stem cell treatment against COVID-19.

Cocrystal Pharma: Bothell, Washington pharma outfit is developing antivirals to treat COVID-19 using patents it recently acquired from the Kansas State University Research Foundation.

CytoDyn: Vancouver, Washington biotech firm announced preliminary results from three days of testing its antiviral drug leronlimab on COVID-19 patients in New York; the company stated in a press release that test results from the first four patients suggests immunological benefit within three days following treatment with leronlimab.

Eli Lilly: Indianapolis pharma company is partnering with Vancouver-based biotech outfit AbCellera to develop antibody-based treatments for COVID-19.

Emergent BioSolutions: Maryland drugmaker is developing treatments derived from the antibodies found in the blood of people who tested positive for the disease.

EUSA Pharma: British pharmaceutical firm initiated trials of its siltuximab antibody treatment on COVID-19 patients at the Papa Giovanni XXIII hospital in Bergamo, Italy; the company released initial data on April 1 showing that one third of patients experienced clinical improvement with reduced need for oxygen support and a further 43% saw their disease stabilise.

Fujifilm: Tokyo-based conglomerates pharmaceutical arm, Fujifilm Toyama Chemical, recently started phase 3 clinical trials of its flu drug favipiravir on COVID-19 patients in Japan and is accelerating production.

Gilead: The Californian biotech giant initiated clinical trials in March for its antiviral drug remdesivir on patients in the U.S.

Grifols: Spanish pharmaceutical company is working with the FDA and the U.S. Department of Health and Human Services to develop a COVID-19 treatment using the blood plasma of former patients.

Harbour BioMed: Cambridge, Massachusetts biomedical firm announced a collaboration with New Yorks Mount Sinai Health System to develop new human antibodies to treat COVID-19.

Humanigen: Burlingame, California pharma company received emergency FDA approval for compassionate use of its antibody lenzilumab in COVID-19 patients.

I-Mab Biopharma: Shanghai-based biopharma outfit announced it would begin clinical trials of its TJM2 antibody treatment on COVID-19 patients in the United States, with plans to expand to other countries affected by the pandemic.

Innovation Pharmaceuticals: Wakefield, Massachusetts biopharma firm is researching the use of its drug brilacidin part of a category of investigational new drugs called defensin mimetics, which could have antimicrobial effects as both a treatment and a vaccine for COVID-19, in separate efforts with a major U.S. university and with the Department of Health and Human Services.

ISR Immune System Regulation: Swedish immunotherapy firms subsidiary, ISR HBV, is conducting toxicological studies to determine whether its Immunolid ISR50 treatment could be used against COVID-19.

Kamada: Israeli pharmaceutical company is working on an antibody-based treatment for COVID-19 using the blood plasma of patients who recovered from the disease.

Merck KGaA: Darmstadt, Germany-based pharma multinational donated a supply of its multiple sclerosis drug interferon beta-1a to the French National Institute of Health and Medical Research in Paris for clinical trials on COVID-19 patients. The companys North American life sciences arm, MilliporeSigma, is supplying several vaccine efforts with reagents and other essential raw products for vaccine development.

Mesoblast: Australian medical firm is working with authorities in the U.S., Australia, China and Europe to evaluate the use of its remestemcel-L drug to treat COVID-19.

Mylan: Pennsylvania-based pharmaceutical firm restarted production of hydroxychloroquine, a drug used to fight lupus, malaria and arthritis, at its West Virginia factory; the drug is being tested as a treatment for COVID-19 in human trials in New York.

Partner Therapeutics: Lexington, Massachusetts biotech startup began clinical trials of its bone marrow stimulant drug sargramostim on COVID-19 patients at University Hospital Ghent in Belgium.

PharmaMar: Spanish drugmaker is preparing to start clinical trials of its multiple myeloma drug plitidepsin to treat COVID-19 patients at several hospitals in Spain.

Pluristem Therapeutics: Haifa, Israel-based medical company is developing a cell-based therapy to treat COVID-19, announcing on March 30 it had dosed three Israeli patients under a compassionate use program, with plans to enroll more.

Leonard Schleifer.

Regeneron Pharmaceuticals: Westchester, New York biotech outfit, run by billionaires Leonard Schleifer and George Yancopoulos, is conducting clinical trials of its rheumatoid arthritis drug sarilumab, developed with French firm Sanofi, on patients in New York.

Roche: Swiss pharma titan, part-owned by billionaire Maja Oeri, is testing its arthritis drug tocilizumab to treat patients in China and received FDA approval to begin U.S. trials.

Roivant Sciences: Swiss pharma company is working with U.S. authorities to begin trials of its antibody treatment, gimsilumab, on COVID-19 patients.

Synairgen: Southampton, UK-based drugmaker began clinical trials of its SNG001 treatment on COVID-19 patients on March 31.

Takeda: Japanese medical firm is working on hyperimmune therapy using blood plasma from previously infected patients.

Teva Pharmaceuticals: Pharma multinational is ramping up production of hydroxychloroquine, which is being tested as a treatment for COVID-19 in human trials in New York.

Vir Biotechnology: The San Francisco-based firm is collaborating with Biogen and Chinese medical firm WuXi Biologics to manufacture antibodies that could treat the virus; on April 6, British pharma giant GlaxoSmithKline purchased a stake in the company for $250 million, with the goal of collaborating on treatments for COVID-19.

Vaccines:

AJ Vaccines: Danish vaccine developer is working on a COVID-19 vaccine that could hit the market in 2021.

Altimmune: The company is developing a novel intranasal vaccine for the coronavirus, making it one of three firms based in Gaithersburg, Maryland along with Emergent Biosolutions and Novavax thats working on treatments and vaccines for COVID-19.

Arcturus Therapeutics: San Diego-based vaccine maker is developing a COVID-19 vaccine with researchers at the Duke-National University of Singapore medical school in Singapore.

Biocad: Russian drug developer is researching a COVID-19 vaccine, with animal trials scheduled for late April.

Thomas and Andreas Struengmann.

BioNTech: German biotech firm backed by billionaire twins Thomas and Andreas Struengmann is working to develop a coronavirus vaccine in partnership with Pfizer and Fosun Pharma, chaired by billionaire Guo Guangchang.

CanSino Biologics: Tianjin, China-based pharma company isstarting clinical trials for its COVID-19 vaccine, using the vaccine technology deployed to develop the Ebola vaccine.

Codagenix: Melville, New York biotech firm is teaming up with the Serum Institute of India to develop a live-attenuated COVID-19 vaccine, which uses a live but weakened form of the virus.

Dietmar Hopp.

CureVac: German firm, funded by billionaire Dietmar Hopp and the Bill and Melinda Gates Foundation, received $87 million from the European Commission to scale up development of its coronavirus vaccine.

Dyadic: Jupiter, Florida company is collaborating with the Israel Institute for Biological Research on both treatment and a vaccine against COVID-19, using the firms gene expression platform.

Dynavax: Emeryville, California vaccine maker is working with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Queensland to develop a COVID-19 vaccine.

EpiVax: Providence-based immunology firm is working with the University of Georgia and Miramar, Florida biotech outfit Generex on separate COVID-19 vaccine efforts.

ExpreS2ion: Danish biotech company received a grant of nearly $1 million from the European Union to develop a vaccine for COVID-19.

GeoVax: Atlanta-based medical company is collaborating with Wuhan-based BioVax to jointly produce a COVID-19 vaccine.

GlaxoSmithKline: British pharma titan is partnering with CEPI and Chengdu, China-based Clover Pharmaceuticals to use its pandemic vaccine adjuvant platform which boosts the immune response in patients receiving a shot to speed up development of COVID-19 vaccines; on April 6, the company purchased a stake in San Francisco-based Vir Biotechnology for $250 million, with the goal of collaborating on treatments for COVID-19.

Greffex: Houston-based genetic engineering firm is preparing to begin animal trials for its COVID-19 vaccine.

Heat Biologics: North Carolina biopharma company is developing a COVID-19 vaccine with the University of Miami.

iBio: Newark, Delaware biotech upstart is collaborating with Beijing-based CC-Pharming on the rapid development of a COVID-19 vaccine.

Inovio: Plymouth Meeting, Pennsylvania biotech business is the second company to start human trials of a COVID-19 vaccine, announcing on April 6 it would begin testing in Philadelphia and Kansas City; the company also received $11.9 million in funding from the Department of Defense to rapidly produce the vaccine.

Johnson & Johnson: The companys pharma unit, Janssen, will start manufacturing its vaccine developed with the Department of Health and Human Services this month, with human trials set to begin by September and a public rollout hoped for early 2021. The company and the federal government are investing more than $1 billion in the vaccine effort.

Medicago: Quebec City-based biotech company received more than $7 million from the Canadian and Quebec governments to fund development of its COVID-19 vaccine.

Moderna: Massachusetts biotech company, led by billionaire CEO Stphane Bancel, was the first tobegin human trials of its vaccine on March 16 in Seattle and could deploy it to health workers for emergency use by the fall.

Novavax: Maryland-based vaccine maker received $4 million in funding from CEPI to accelerate development of its vaccine candidates, with clinical trials expected in the late spring.

Sanofi: French medical firm is working with the federal government and Massachusetts-based Translate Bio to expedite its coronavirus vaccine, using technology previously used to develop one for SARS.

SK Group: South Korean conglomerates pharmaceutical arm, SK Bioscience, is conducting animal trials of its COVID-19 vaccine.

Sorrento Therapeutics: San Diego-based biotech firm is teaming up with Cambridge, MA gene therapy company SmartPharm Therapeutics to develop a gene-encoded COVID-19 vaccine; its also working with Chinese drugmaker Mabpharm on a fusion protein treatment for the disease.

Takis Biotech: Italian startup with just 25 employees is developing a vaccine with Stony Brook-based Applied DNA Sciences, with plans to begin human trials before the end of the year.

Themis Bioscience: Austrian biotech firm is part of a group, with the Institut Pasteur and the University of Pittsburgh, which received $4.9 million in initial funding from CEPI to build a COVID-19 vaccine modeled on the vaccine for measles.

Tonix Pharmaceuticals: New York-based pharma outfit is researching a potential COVID-19 vaccine based on the virus that causes horsepox.

Vaxart: San Francisco vaccine manufacturer Vaxart is working with Emergent Biosolutions to develop and manufacture an oral vaccine that can be taken as a tablet.

Vaxil: Israeli biotech startup began preclinical trials for its COVID-19 vaccine candidate.

VBI Vaccines: Massachusetts-based vaccine developer is collaborating with the National Research Council of Canada on a pan-coronavirus vaccine, which would target COVID-19 as well as SARS and Middle East respiratory syndrome, or MERS.

Protective Equipment And Sanitizer:

Anheuser-Busch InBev: The worlds largest beer company is making more than one million bottles of hand sanitizer from surplus alcohol at its breweries around the world.

Aria Designs: North Carolina furniture manufacturer received financing from CIT Group to procure millions of N95 surgical masks with its international suppliers.

Giorgio Armani.

Armani: Billionaire Giorgio Armanis luxury fashion brand converted all production at its Italian factories to manufacture single-use medical overalls on March 26.

Bacardi: The Bermuda-based spirits giant converted production at nine production facilities in Mexico, France, England, Italy, Scotland, Puerto Rico and the continental U.S. to make hand sanitizer.

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Coronavirus Business Tracker: How The Private Sector Is Fighting The COVID-19 Pandemic - Forbes

Treatment with CytoDyn’s Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients – Associated Press

VANCOUVER, Washington, April 02, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the three-day effect of leronlimab in eight severely ill COVID-19 patients demonstrated a significant improvement in several important immunologic bio-markers. Patient test data reveals improvement in cytokines, IL-6, and a trend toward the normalization of the CD4/CD8 ratio.

The Companys investigational new drug, leronlimab, has been administered to 10 severely ill patients with COVID-19 at a leading medical center in the New York City area under an emergency IND recently granted by the FDA. The Company recently initiated enrollment in a Phase 2 trial for leronlimab treatment of COVID-19 patients with mild-to-moderate indications and under the same IND, is now proceeding with its second COVID-19 clinical, a Phase 2b/3 trial for the treatment of critically ill patients.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, We are very pleased with our most recent laboratory data for patients treated with leronlimab for COVID-19 infection. We continue to see increases in the profoundly decreased CD8 T-lymphocyte percentages by Day 3, normalization of CD4/CD8 ratios, and resolving cytokine production including reduced IL-6 correlating with patient improvement. The current data suggests a trend toward the restoration of immune function and mitigation of the cytokine storm. This is consistent with prior laboratory results in the first four patients treated for COVID-19 with leronlimab.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, said, As leronlimab continues to provide hope for many patients, our management team is focused to ensure we can distribute the drug across the country in a timely fashion. These results, although anecdotal, appear to be very promising. We are now initiating enrollment for two clinical trials, first trial is a Phase 2 for mild-to-moderate and second trial is a Phase 2b/3 for a severely ill population.

About Coronavirus Disease 2019SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in April of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking Statements This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Companys cash position, (ii) the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv) the Companys ability to enter into partnership or licensing arrangements with third parties, (v) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Companys ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Companys clinical trials, (viii) the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEO RedChip Companies Office: 1.800.RED.CHIP (733.2447) Cell: 407.491.4498 dave@redchip.com

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Treatment with CytoDyn's Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients - Associated Press

Coronavirus daily news update, April 6: What to know today about COVID-19 in the Seattle area, Washington state and the nation – Seattle Times

Washington state appears to be flattening its curve the impact on the hospital system at any one time according to the latest analysis from theUniversity of Washingtons Institute for Health Metrics and Evaluation(IHME). The IHME models suggest the state hit peak resource use on April 2 and project daily COVID-19 deaths will peak today, April 6, before dropping to 18 deaths per day during April 7-9 and declining slowly from there.

The model also revises its estimates of deaths in Washington sharply downward, to 632. Earlier model results had suggested about 1,400 people in the state were likely to die from the disease. IHME has been adjusting its model daily, and the latest results are based on a massive infusion of new data, institute director Christopher Murray said in a statement.

The estimated death toll nationwide remains at around 82,000, similar to earlier estimates. But the upper end of the uncertainly range has been lowered to about 136,400, from previous estimates of nearly 200,000.

Washington will return more than 400 of the 500 ventilators it recently received from the federal government, so they can go to New York and other states harder hit by the coronavirus crisis, Gov. Jay Inslee said Sunday.Vice President Mike Pence commended Inslee for returning the ventilators and said Washington and Oregon are two states leading by example in taking steps to slow the spread of the coronavirus that causes COVID-19.

The state Department of Health mirroring the Centers for Disease Control and Prevention recommends residents wear cloth face masks anytime they are in public and cant guarantee theyll be able to stay 6 feet away from another person.

The state health department on Sunday confirmed an additional 393 cases and 28 deaths from COVID-19 as of 11:59 p.m. Saturday, bringing the states totals to 7,984 cases and 338 fatalities.

Throughout today, on this page, well be posting updates from Seattle Times journalists and others on the outbreak and its effects on the Seattle area, the Pacific Northwest and the world. Updates from Sunday can be found here, and all our coronavirus coverage can be found here.

The following graphic includes the most recent numbers from the Washington State Department of Health, released Sunday.

President Trump and members of the Coronavirus Task Force have scheduled a press briefing for this afternoon.

Leticia Frutos never imagined shed spend weeks avoiding her month-old granddaughter because of her manufacturing job in Bothell.

The Mill Creek resident and material assistant for Ventec Life Systems is one of more than 1,000 workers nationwide on the front lines of Ventecs Project V venture with General Motors to make thousands of ventilators for the nations coronavirus fight.

Ventec, GM and the companies supplyingparts for them say worker safety is a prime concern. Its also a challenge, given the ramp-up inproduction means more workerson the production line, often for more hours per week, and at a hurried pacethat could lead to mistakes safeguarding against COVID-19, the illness caused by the novel coronavirus.

Read the full story here.

Geoff Baker

Thomas Lopez, who ran a fleet of Tacos El Tajin food trucks around Seattle, has died from COVID-19, the disease caused by the novel coronavirus, his family announced Monday afternoon.

After suffering flu-like symptoms, Lopez, 44, was hospitalized last week and put on a ventilator, but his condition got worse and he died on Thursday, his son Isaac Lopez said.

Lopez made national headlines in February 2017 for hawking tacos out of his food truck on Interstate 5 after a semitruck rolled over and brought traffic to a standstill. After realizing he would not make it to South Lake Union for the Amazon lunch rush and seeing how drivers around him were losing their patience, Lopez got out and started selling steak and chicken tacos to commuters as if he were parked in a food-truck pod.

Lopez, a Pacific resident, is survived by his wife Antonia Zamorano and their five children.

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Tan Vinh

BELLINGHAM Escalating a global spat over workplace safety and the rights ofhealth-care workers during the coronavirus crisis, a top official of PeaceHealth has now confirmed the company ousted emergency physician Ming Lin for allegedly inciting public fear by criticizing the hospitals emergency precautions.

In a lengthy interview on a YouTube video blog popular with medical professionals, Richard DeCarlo, chief operating officer of PeaceHealth, which operates Bellinghams St. Joseph Medical Center, likened Lins public warnings about workplace coronavirus concerns to yelling fire in a crowded theater. He said the hospital had no choice but to remove Lin from his post of 17 years.

Lin said Monday that he had seen the video and urged members of the public to view his Facebook postsand draw their own conclusions. Lin on March 16 accused PeaceHealth management of mishandling early COVID-19 testing; failing to conduct proper triage of patients and staff entering the hospital; and lagging in procedures for protective equipment and other emergency measures.

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Ron Judd

Boeing said Monday it will suspend its 787 production work in South Carolina until further notice, halting temporarily its last aircraft manufacturing center that was still operating.

The company closed its Seattle-area production facilities March 25, and announced Sunday it would keep them closed indefinitely as the coronavirus ravages airlines finances and the COVID-19 disease forces many factories to close.

Boeing said its suspension in North Charleston, S.C., affects its Airport Campus, Emergent Operations, Interiors Responsibility Center South Carolina and Propulsion South Carolina. Collectively these employ several thousand people in final assembly of the 787 and manufacturing some sections of the plane.

Read the full story here.

Seattle Times business staff

Employees at Valley Medical Center had a brush with COVID-19 even before the outbreak became publicly known in Western Washington after a man twice visited the Renton hospital in late February.

He came into the Emergency Department, got discharged, a few days later came in very sick and was admitted to the critical care unit, said Jamie Park, the hospitals chief medical officer.

In a March 1 conference call, hospital administrators told some clinicians as many as 350 staffers could have been exposed during the mans visits, according to two physicians who listened to the call.

Interviews with more than a dozen front-line Valley employees, including multiple physicians, and copies of emails and internal documents, underscore the concerns of many employees who said that COVID-19s sudden arrival left staff and administrators scrambling. Directives changed regularly and sometimes confusion reigned, fueling employees fears for their safety.

And since the outbreak began, a rift in understanding, amplified by stress, risk and fear, has grown between some Valley employees and management over access to personal protective equipment (PPE), testing availability and criteria and infection-control measures.

Read the full story here.

Evan Bush

Sound Transit will reduce Sounder South service by one round trip starting Wednesday because of reduced staffing availability,the agency said Monday.

A southbound train that departs from Seattle at 7:55 a.m. and a northbound train that departs from Lakewood at 10:16 a.m. will be removed from the schedule.

The reductions follow previous cuts to Sounder service because of concerns around the novel coronavirus pandemic.

Sounder ridership has declined by 92%, the agency said.

Sound Transit and King County Metro last monthbegan reducing service, eliminated fares and asked riders to board through rear doorson buses to reduce contact between drivers and riders.

Michelle Baruchman

The next time more than a million kids in Washington state attend classeswith their peers, it will be a new school year.

Washington schoolswill remain closed through the end of the academic year, Gov. Jay Inslee announced at a Monday news conference.Distance learning is expected to continue, and schools are expected to resume on a normal schedule this fall.

The announcement comes 20 days into a state-mandated closure of all public and private schools in an attempt to slow the spread of coronavirus. The closures werefirst supposed tolast until at least April 24, about six weeks, but state schools chief Chris Reykdal has repeatedly stressed the shutdown could last longer.

We simply cannot take the chance of reopening on site instruction in this calendar school year, Inslee said. We cannot risk losing the gains we have made after the peak of this pandemic presumably will have passed.

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The Seattle Times

A Kitsap County resident has died of COVID-19, the first person from the county todie from the disease caused by the novel coronavirus, the Kitsap Public Health District said.

The person, who had tested positive for the virus, was an "older adult" with underlying health conditions, the Health District said.

"We were saddened to learn of the death of this community member and our hearts go out to their family and loved ones during this difficult time, Dr. Susan Turner,the district's health officer said. As a community, we must do everything we can to slow the spread of this illness and protect our neighbors who are most at risk. Please continue to stay home, wash your hands, and clean your living spaces. These simple steps can save lives.

As of Monday, 111 Kitsap County residents had tested positive for the virus, out of more than 1,900 tested, the Health District said.

David Gutman

New York City officials are starting to lay chilling contingency plans if deaths from the coronavirus outbreak begin to overwhelm the capacity of morgues: temporarily burying the dead in one of the citys public parks.

Mark Levine, chairman of the City Council health committee, said Monday that the office of the chief medical examiner was looking into creating temporary mass graves in a public park as it confronts the possibility that deaths from the coronavirus outbreak may soon exceed the capacity of city and hospital morgues.

Levine declined to say which park was under consideration, noting only that it would likely have to be a large one out of the way of the public.

Mayor Bill de Blasio said Monday that no such plan had been put in place yet, although he acknowledged it was under consideration.

If we need to do temporary burials to be able to tide us over to pass the crisis, and then work with each family on their appropriate arrangements, we have the ability to do that, he said, adding, We may well be dealing with temporary burials so we can deal with each family later.

Read the full story here.

The New York Times

Major supermarket chains are beginning to report their first coronavirus-related employee deaths, leading to store closures and increasing anxiety among grocery workers as the pandemic intensifies across the country.

A Trader Joes worker in Scarsdale, New York, a greeter at a Giant store in Largo, Maryland, and two Walmart employees from the same Chicago-area store have died of COVID-19 in recent days, the companies confirmed Monday.

Though more than 40 states have ordered nonessential businesses to close and told residents to stay home to stem the spread of the virus, supermarkets are among the retailers that remain open.

Read the full story here.

The Washington Post

British Prime Minister Boris Johnson was moved to the intensive care unit of a London hospital after his coronavirus symptoms worsened Monday, just a day after he was admitted for what were said to be routine tests

Johnson was admitted to St. Thomas Hospital late Sunday, 10 days after he was diagnosed with COVID-19.

Over the course of this afternoon, the condition of the Prime Minister has worsened and, on the advice of his medical team, he has been moved to the Intensive Care Unit at the hospital, his office said in a statement.

Downing St. said Johnson was conscious and does not require ventilation at the moment, but was in the intensive care unit in case he needed it later.

Read the full story here.

The Associated Press

Seattle's Woodland Park Zoo has canceled ZooTunes, its popular summer concert series, as well as summer day camps and other special events.

The zoo has been closed since early March because of the coronavirus pandemic.

The zoo, in a social media post, said it decided to cancel the summer events to "put community safety first and focus our resources and staff on our animals."

It said it has lost millions of dollars in revenue since it closed, nearly a month ago.

David Gutman

Tim Eyman, the anti-tax advocate and Republican candidate for governor, is urging his supporters to come to Seattle City Hall Monday afternoon to protest a new tax proposal at the weekly City Council meeting.

But there will be no City Council meeting at Seattle City Hall.

The City Council has moved to all-remote meetings, by teleconference, to slow the spread of the novel coronavirus.

Eyman, in a letter to supporters Monday morning, seemed unaware.

"Would we have beaten the British in the Revolutionary War if George Washington and his patriots had stayed home?" Eyman wrote. "At 1 p.m., at the east entrance to City Hall (dress warm), we will stay 6 feet apart and walk in together. We'll have signs for you. We'll have gloves and hand-sanitizer for you."

They will be waving signs to no one. While City Hall, and the Council chambers, will be unlocked, there will be no one there, except a staff member to operate a conference call line. City Council members will be participating from their homes.

Eyman is aware of his mistake. Seattle City Clerk Monica Martinez Simmons said she sent him a note letting him know Council chambers are closed (even if the room is not locked).

He did the same thing at an Edmonds City Council meeting two weeks ago, My Edmonds News reported, showing up to a meeting that was being held remotely.

Democratic State Rep. Gerry Pollet, an instructor at the University of Washington's School of Public Health, said it was "unconscionable" to encourage a gathering, like Eyman is doing.

"Eyman is demonstrating absolute ignorance of our states measures to prevent the spread of COVID-19," Pollet said. "Its inexcusable for anyone seeking to be in a position of leadership to be unaware of those measures."

Council members Kshama Sawant and Tammy Morales have been proposing a tax on big businesses, like Amazon. To "attend" the council meeting, tune in to the Seattle Channel or call 206-684-8566.

Council President M. Lorena Gonzalez said Monday she hopes to develop a tool to accept public comments during remote council meetings, but that won't be operational for at least a couple weeks.

David Gutman

Deja Vu Showgirls, an adult entertainment club in downtown Seattle, appears to be closed or clothed until April 30, according to a banner announcement outside the venue.

The club, across the street from Pike Place Market, is generally open 2 p.m. to 2:30 a.m. daily.

The windows have been boarded up with plywood as many other shops downtown have emptied in response to Gov. Jay Inslees stay-at-home order.

Jon Talton and Michelle Baruchman

Alaska Air Group said Monday it is cutting capacity for April May further than announced just two weeks ago, as it continues to experience demand that is 80% or more below normal levels.

In a regulatory filing, the company said, Today we are updating our capacity reduction plans to reflect 80% cuts in both April and May.

The parent of Alaska Airlines and Horizon Air added that for June and beyond, given current trends and circumstances, it is our expectation that sizable cuts will be necessary for the coming months.

Read the full story.

Seattle Times business staff

Washington State Superintendent Chris Reykdal says school buildings may stay closed through the end of the school year. Since schoolsclosed in mid-March, Reykdal and Gov. Jay Inslee have said buildings would remain closed until at least April 24.

Read more from the original source:
Coronavirus daily news update, April 6: What to know today about COVID-19 in the Seattle area, Washington state and the nation - Seattle Times