BioNTech to Report Third Quarter 2020 Financial Results and Operational Update on November 10, 2020
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BioNTech to Report Third Quarter 2020 Financial Results and Operational Update on November 10, 2020
First members include industry veterans with backgrounds at Merck, Pfizer, Novartis, and more First members include industry veterans with backgrounds at Merck, Pfizer, Novartis, and more
Nes Ziona, Israel, Nov. 03, 2020 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage immunotherapy company, today reported that the Israeli Ministry of Health authorized the initiation of a proposed Company-sponsored Phase IIb clinical trial evaluating Allocetra™, in sepsis patients.
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Enlivex: Israeli Ministry of Health Authorizes Initiation of Phase IIb Clinical Trial Evaluating Safety and Efficacy of Allocetra in Sepsis Patients
HANOVER, Md., Nov. 03, 2020 (GLOBE NEWSWIRE) -- via InvestorWire -- Processa Pharmaceuticals, Inc. (NASDAQ: PCSA) (“Processa” or the “Company”), a clinical-stage biopharmaceutical company developing products to improve survival and/or quality of life for patients who have high unmet medical need conditions, today announces it will host a conference call and live webcast on Nov. 12, 2020, at 5:30 p.m. Eastern time to discuss its third quarter 2020 results and provide an update on the Company’s clinical pipeline. The update will include a discussion of the Company’s three clinical-stage drugs (each of which addresses potential billion-dollar markets):
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Processa Pharmaceuticals Schedules Conference Call to Discuss Third Quarter Results and Provide Drug Development Update on Nov. 12 at 5:30 p.m. ET
NEW YORK, NY, Nov. 03, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire -- Tauriga Sciences, Inc. (OTCQB: TAUG) (“Tauriga” or the “Company”), a revenue generating, diversified life sciences company, with a proprietary line of functional “supplement” chewing gums (Flavors: Pomegranate, Blood Orange, Peach-Lemon, Pear Bellini, Mint, Black Currant) as well as two ongoing Biotechnology initiatives, today announced that during October 2020, the Company reported continued growth in its highest margin E-Commerce business segment. Additionally, there was a sharp increase (more than 25%) in the average order size – with respect to each individual On-Line E-Commerce transaction. The Company’s E-Commerce business is its highest margin segment and there are a number of potential future catalysts that the Company believes can fuel future growth.
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Tauriga Sciences Inc. Reports Continued Growth in its E-Commerce Business With a 25.8% Increase in Average Order Size
MIRAMAR, Fla., Nov. 03, 2020 (GLOBE NEWSWIRE) -- NuGenerex Immuno-Oncology (NGIO), a subsidiary of Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) is pleased to announce that the company has launched its new corporate website to provide investors with information on the NGIO mission, management, and pipeline for the Ii-Key vaccine platform for cancer and infectious disease. You can also learn about the company’s ongoing SARS-CoV-2 vaccine development program and collaborations. You can visit the site at https://www.nugenerexio.com/.
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NuGenerex Immuno-Oncology Announces the Launch of a New Corporate Website
Novo Nordisk A/S purchases B shares worth DKK 2,913 million from Novo Holdings A/S under the 2020 share repurchase programme
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While much of the attention on the November election is focused on the race for President, Californians are going to have a lot of other decisions to make. One (or 12) of the biggest: the statewide ballot measures.
Aired: November 2, 2020 | Transcript
While much of the attention on the November election is focused on the race for President, Californians are going to have a lot of other decisions to make. One (or 12) of the biggest: the statewide ballot measures.
Yes, there will be a dozen different propositions for California voters this year Prop. 14 through Prop. 25 on everything from expanding rent control to ending the ban on affirmative action. While we at CapRadio will be reporting on these more up until Nov. 3, we wanted to give you a quick overview now on what each measure covers and what a "yes" or "no" vote will mean.
Here are the basics of what you need to know about each proposition (including videos from our colleagues at CalMatters and more reporting from CapRadio):
Proposition 14: Stem cell research
A yes vote on this measure would authorize the state to purchase these bonds, increasing funding for stem cell research on treatments for cancer, Alzheimers and dozens of other diseases.
A no vote would prevent the state from issuing these bonds.
Learn More About Prop. 14
Proposition 15: 'Split roll'
Known as the "split roll" measure, Proposition 15 would increase taxes on factories, stores and other commercial and industrial real estate worth $3 million or more. It would do this by requiring owners pay property tax based on market value, rather than what is often a much lower tax rate based on the original purchase price.
The measure is considered one of the largest revisions of Proposition 13, the landmark 1978 initiative that slashed property taxes and limited how much they could go up. Residential and agricultural properties would be exempt from the changes. The split roll measure would raise an estimated $6.5 billion to $11.5 billion annually, according to an analysis by the nonpartisan Legislative Analysts Office. The money would be distributed to K-12 public schools, community colleges and local governments.
A yes vote on this measure would revise Proposition 13, increasing taxes on factories, stores and other commercial and industrial real estate by requiring owners to pay property tax based on its market value, rather than based on what they bought the property for.
A no vote on this measure would allow owners of these properties to continue to pay what is often a much lower tax rate based on the original purchase price.
Learn More About Prop. 15
Proposition 16: End ban on affirmative action
If passed by voters, this state constitutional amendment would end Californias ban on affirmative action. It would allow schools and public agencies to take race, ethnicity and sex into account when making admission, hiring or contracting decisions. It would repeal portions of Proposition 209, the constitutional amendment California voters passed in 1996 prohibiting affirmative action at state institutions.
A yes vote on this measure would allow government agencies to set goals for recruiting diverse employees and granting contracts to women and minority-owned businesses. These considerations are meant to give a leg up to historically disadvantaged communities.
A no vote would continue the ban on these affirmative action practices created by Proposition 209.
Learn More About Prop. 16
Proposition 17: Voting rights for previously incarcerated people
This constitutional amendment would allow people on parole for felony convictions to vote after their state or federal prison term ends. The states constitution prohibits people with felony convictions from voting until both their incarceration and parole are finished. The change, proposed by state lawmakers, would affect approximately 40,000 Californians, according to a state Senate analysis.
A yes vote on this proposition would allow people on parole for felony convictions to vote.
A no vote on this proposition would continue to prohibit people with felony convictions from voting until both their prison term and their parole are over.
Proposition 18: 17-year-olds voting in primaries
If passed, this constitutional amendment would expand voting rights for certain 17-year-olds in California. Citizens who are 17, residents of the state and will be at least 18 years old at the time of the next general election, would be allowed to vote in any primary or special election that occurs before the next general election. State lawmakers placed this measure on the November ballot.
A yes vote on this proposition would allow these qualifying 17-year-olds to vote in primaries or special elections if they will be 18 by the general election.
A no vote on this would not expand voting rights to these 17-year-olds.
Proposition 19: Transfer of property tax breaks
This would allow homeowners who are over 55, disabled or victims of natural disasters to transfer part of their property tax base with them when they sell their home and purchase a new one. The constitutional amendment would also prevent people who inherit family properties from keeping the low property tax base unless they use the home as their primary residence and the market value is less than $1 million. Most of the revenue from the measure would fund wildfire agencies.
A yes vote on this measure would allow these homeowners who are seniors, disabled or have been victims of a natural disaster to keep a lower property tax rate when they buy a new home.
A no vote on this measure would not allow these qualifying homeowners to keep their lower property tax base when they sell their home and purchase a new one.
Proposition 20: Criminal sentencing
This measure would roll back some changes to Californias criminal sentencing laws approved over the past decade. It would authorize judges to impose felony charges on certain theft or fraud crimes currently chargeable only as misdemeanors. It would also restrict the number of inmates eligible for parole by adding drug, theft and other crimes to the list of violent crimes or sentence enhancements excluded from parole review. Lastly, the measure would require people convicted of drug, theft or domestic violence misdemeanors to submit to DNA collection for the state database.
A yes vote on this measure would allow judges to charge more crimes as felonies, restrict the number of inmates eligible for parole and increase the number of people who will submit their DNA to the states criminal database.
A no vote on this measure would not enact the changes listed.
Learn More About Prop 20
Proposition 21: Rent control
Prop 21 would allow cities and counties to implement rent control for certain residential properties over 15 years old. The initiative's official summary says it would grant exemptions from new rent control policies for individuals who own no more than two homes. The measure is meant to replace the Costa-Hawkins Rental Housing Act, which prohibited rent control for housing that was built after 1995 as well as for units such as single-family homes, townhomes and condos.
A yes vote on this measure would allow cities and counties to put rent control policies into place on these properties.
A no vote on this measure would continue the provisions of Costa-Hawkins.
Learn More About Prop. 21
Proposition 22: Rules for app-based drivers
This would exempt certain gig workers from AB5, Californias contentious new labor law, by reclassifying app-based delivery and rideshare drivers as independent contractors. Funded by companies including Uber, Lyft and DoorDash, Prop 22 would require companies with independent contract drivers to provide their drivers with benefits like minimum compensation and health care subsidies based on driving time, vehicle insurance and sexual harassment training rather than regular employee benefits like a minimum wage, workers compensation or overtime pay.
A yes vote on this measure would allow companies not to classify drivers as regular employees, but would require them to provide them with the benefits listed above.
A no vote on this measure would continue AB5s requirement that these drivers be classified as employees and be provided minimum wage, workers compensation and overtime pay.
Learn More About Prop. 22
Proposition 23: Dialysis clinic rules
If approved, Proposition 23 would require dialysis clinics to have a licensed physician, nurse or physician assistant on site during kidney dialysis treatment. It would require outpatient clinics to report data on dialysis-related infections, ban them from discriminating against patients based on their source of payment or care, and require state approval to shut down a dialysis clinic.
A yes vote on this measure would add these new requirements on dialysis clinics.
A no vote on this measure would allow dialysis clinics to continue operating as they have been.
Proposition 24: Consumer privacy
Proposition 24 would allow Californians to block companies from sharing personal information and limit businesses use of sensitive personal information including geolocation, private communications, race or ethnicity, religion, union membership and health or biometric data. It raises maximum penalties for violations involving consumers under the age of 16. The measure would also create a new state agency to enforce consumer privacy regulations, which is estimated to cost about $10 million per year.
A yes vote on this measure would enact these new privacy protections and create a new state agency to enforce the regulations.
A no vote on this measure would not change California's data privacy law.
Its Election Day. It's the last day to cast your ballot in person, or to post mark your mail in ballot. KPBS will have coverage throughout today to bring you the election latest. Also, the tensions around Election Day have hospitals on high alert, even though those institutions are always planning ahead for disasters that could send a wave of ... Read more
Aired: November 3, 2020 | Transcript
Some people in San Diego and Tijuana can vote on both sides of the U.S.-Mexico border.
In a new episode of Port of Entry," we profile three of these binational citizens who can vote in elections in the U.S. and Mexico. And while you might think these folks all fall on the same side of the political fence when ... Read more
Aired: October 23, 2020 | Transcript
KPBS Midday Edition is a daily radio news magazine keeping San Diego in the know on everything from politics to the arts.
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What's On The Ballot? Here's A Look At California's 2020 Propositions - KPBS
KING OF PRUSSIA, Pa., Nov. 2, 2020 /PRNewswire/ --Global biotherapeutics leader CSL Behring announced today that its investigational, plasma-derived hemopexin therapy (CSL889) received orphan drug designation from both the European Commission and the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development for the treatment of sickle cell disease (SCD). These designations grant special status to drugs and biological products intended to treat a rare disease, affecting less than 200,000 patients in the US or affecting not more than five in 10,000 people in the European Union.
CSL889 is a form of plasma-derived hemopexin, an important, naturally occurring protein produced in the body whose levels are decreased in patients with SCD. Low levels of hemopexin have been associated with increased symptoms in SCD, particularly acute vaso-occlusive crises (VOC). VOC, the most common manifestation in SCD, are severe, debilitating episodes characterized by severe pain. There is no approved treatment for acute VOC, so episodes can only be managed with supportive measures such as fluids and pain killers.
"Having treated hundreds of adults and children living with sickle cell disease over 30 years, I'm intensely aware of the need for novel and effective therapies, especially to relieve the tremendous pain from VOC," said Professor Greg Kato, who is leading the clinical development of CSL 889 at CSL Behring. "This newly granted orphan status recognizes the urgency for progressing new treatment options into the clinic."
CSL Behring has two Phase I SCD programs poised to evolve the treatment paradigm for patients: CSL889 hemopexin therapy for the treatment of VOC and CSL200 lentiviral stem cell gene therapy for long-term disease management.
About Sickle Cell Disease
Sickle Cell Disease is a hereditary blood disorder in which red blood cells contain an abnormal type of hemoglobin, causing some of the cells to become distorted into a crescent, or sickle-shape. These misshapen red blood cells have difficulty passing through small blood vessels, slowing and blocking blood flow to areas of the body, damaging tissue that isn't receiving a normal flow of blood. Sickle Cell Disease can lead to episodes of severe pain, strokes, kidney, lung and heart problems, slow growth, vision problems and infection vulnerability. While frequency of Sickle Cell Disease varies globally, it is estimated to impact 100,000 people in the US and 1 in 10,000 persons in the European Union.
About CSL Behring
CSL Behringis a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 27,000 people, anddelivers its life-saving therapies to people in more than 100 countries. For inspiring stories about the promise of biotechnology, visit Vita CSLBehring.com/vita and follow us on Twitter.com/CSLBehring.
SOURCE CSL Behring
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Orphan Drug Designation Granted for CSL Behring's Investigational Plasma-Derived Hemopexin Therapy for Sickle Cell Disease - PRNewswire
AgenTus Immune Cell Therapy in Patients with COVID-19
Excessive inflammatory response in the most serious cases of COVID-19, along with surges in infection rates, has caused a healthcare crisis in many countries around the world.
Could cell therapy be the answer?
The public health crisis of COVID-19 has propelled and catalyzed investigations of therapies known to have potential in related disease states for their suitability in combating COVID-19. One such area is immune cell therapy.
To that end, AgenTus Therapeutics, the cell therapy subsidiary of Agenus, an immuno-oncology company advancing immune therapies for patients with cancer, announced the start of a clinical trial with its proprietary allogeneic iNKT cell therapy. iNKT cell therapy has the potential to eliminate the COVID-19 virus, dampen harmful inflammation, and promote protection from reinfection all particularly critical in combating COVID-19. The first patient was treated at Weill Cornell Medical Center and New York Presbyterian Hospital, and early trial results are expected later this year.
Most people who become infected with COVID-19 experience symptoms such as a dry cough and mild fever and recover without medical care, but around 15% develop more serious symptoms including pneumonia and shortness of breath. Approximately 5% of patients with more severe disease experience acute respiratory distress syndrome (ARDS). When this syndrome occurs, the patients lungs become severely inflamed and fluid seeps into the lung tissue from nearby blood vessels, making breathing increasingly difficult. Some of these patients can go on to develop septic shock and multi-organ failure, with more than half dying after reaching this stage.
Respiratory failure from COVID-19 is linked to excessive immune activation that causes a cytokine storm, in which the inflammatory immune protein in the lungs increase to dangerously high levels. This hyper-reaction of the immune system has been observed with other coronaviruses, like SARS and MERS. Cell therapy has previously shown promise for treating respiratory distress for the nearly 500,000 who are affected globally every year even without the COVID-19 pandemic.
Agenus, a US-based biotechnology company headquartered in Lexington, MA with the goal of advancing immune therapies for patients with cancer, recently announced that its proprietary allogeneic iNKT cell therapy will be evaluated for its potential to treat COVID-19 and cancer through its cell therapy subsidiary, AgenTus.
Invariant natural killer T cells (iNKT cells) are a unique cell type that combine features of two critical arms of the immune system, T cells (adaptive immunity) and NK cells (innate immunity), making them invaluable in combatting diseases like cancer and COVID-19. In the case of cancer, they travel to tumor tissue by detecting a protein known as CD1d. They also express a protein known as NKG2D, which recognizes tumor stress ligands. Importantly, these proteins are expressed in both solid and liquid tumors, making iNKT cells broadly applicable to all cancer patients. In preclinical models, iNKT cells have been shown to work alone and have also demonstrated curative potential when activated and combined with Agenus pipeline of immuno-oncology drug candidates.
Agenus has observed that the number of iNKT cells in the body is reduced in people with cancer and infectious diseases like COVID-19, and this reduction is associated with poorer response to disease. In preclinical models that bear similarities to SARS-COV-2, increasing the number or frequency of iNKT cells reduced viral shedding and prevented inflammation-driven lung injury. These specific attributes are of paramount importance in any therapy attempting to overcome COVID-19.
As a result of this research, AgenTus is advancing an iNKT cell therapy program towards clinical trials in both cancer and COVID-19. Beyond the curative potential of iNKT cells as addressed above, AgenTus cell therapy program has the potential to be more practical and more beneficial than currently approved cell therapies. Currently approved cell therapies require genetic manipulation, which increases their cost, manufacturing time and complexity. On the other hand, iNKT cells may be effective even without genetic manipulation and have the potential to be manufactured to treat large numbers of patients from a single batch, presenting the opportunity for lower costs. Further, iNKT cells have been tested in clinical trials and have been well-tolerated, thus decreasing the risk of serious side effects.
Encouraged by these compelling properties of this cell therapy, AgenTus announced today the start of a clinical trial to test iNKT cells in patients with moderate to severe symptoms of COVID-19. The study is being led by Dr. Koen van Besien, M.D., Ph.D., Professor of Medicine and Director of the Stem Cell Transplant program at Weill Cornell Medical Center and New York Presbyterian Hospital. The trial is designed to evaluate the benefit of infusing iNKT cells in patients who have moderate to severe symptoms of COVID-19. The outcome of the trial will provide insight into whether administering iNKT cells will help to eliminate the virus, dampen harmful inflammation, and promote protection from reinfection.
As mentioned earlier, iNKT cell therapy offers promise for the fight against cancer as well as the fight against COVID-19. To that end, Agenus is also advancing iNKT cells into clinical trials for patients with cancer. Agenus recently presented data at two major cancer conferences, the Society of Immune Therapy for Cancer (SITC; #SITC19) and the American Association of Cancer Research (AACR; #AACR20), which revealed that in preclinical models AgenTus iNKTs can penetrate tissues, giving them a critical advantage in targeting solid tumors not currently served by approved cell therapies. These data also showed that the combination of checkpoint antibodies and iNKT cell triggering therapy shows curative potential in cancer models that are refractory to available therapies.
Agenus is the only company known to have a portfolio of checkpoint antibodies, cell therapy, and cancer vaccines. This gives the company enormous flexibility to develop novel combinations of agents with curative potential for patients with cancer and infectious disease at a significant cost advantage.
The potential benefits of iNKT cell therapy against both COVID-19 and cancer thus look very promising. Agenus is excited to investigate the possibilities of these treatments against these diseases that cause suffering and death for thousands of patients every year. By leveraging its unique capabilities and extensive pipeline against these diseases, Agenus hopes to provide significant benefit to these patients and a potential path to a cure.
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1) https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html
2) https://investor.agenusbio.com/2020-06-02-FDA-Clears-IND-for-iNKT-Cells-to-Treat-COVID-19-Patients
3) Exley et al., Clinical Cancer Research, 2017.
4) Tanne et al., American Association of Cancer Research, 2020.
5) Mavers et al., Frontiers in Immunology, 2017.
6) Nair and Dhodapkar, Frontiers in Immunology, 2017.
7) Wolf et al. Frontiers in Immunology, 2018.
8) Burcu et al., Society for Immunotherapy of Cancer, 2019.
_______________________________________________________________________________________________________________ Forward-Looking Statements: This article includes forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding Agenus and AgenTus abilities to produce effective allogeneic cell therapies to treat solid tumors, the anticipated clinical benefits and costs of such cell therapies, and future clinical development and regulatory plans. These statements are subject to risks and uncertainties, including those described in Agenus SEC filings.
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Could Cell Therapy Be The Answer To COVID-19? - CBS Boston