Daily Archives: September 25, 2020

UN, Britain to Co-host Climate Summit on December 12

UNITED NATIONS – The United Nations and Britain will co-host a global climate summit on December 12, the fifth anniversary of the landmark Paris Agreement, the world body said Wednesday.

The announcement came days after Chinese President Xi Jinping told the U.N. that the world’s largest greenhouse gas polluter would peak emissions in 2030 and attempt to go carbon neutral by 2060, a move hailed by environmentalists.

“We have champions and solutions all around us, in every city, corporation and country,” U.N. Secretary-General Antonio Guterres said.

“But the climate emergency is fully upon us, and we have no time to waste. The answer to our existential crisis is swift, decisive, scaled-up action and solidarity among nations.”

The world remains off-track to limit global temperature rise to 1.5 degrees Celsius by the end of the century, which scientists say is crucial to prevent runaway warming that would leave vast swaths of the planet inhospitable to life.

“In light of this urgency, Secretary-General Antonio Guterres and U.K. Prime Minister Boris Johnson will co-host a landmark global event convening global leaders … to rally much greater climate action and ambition,” the statement said.

Session on Thursday

The two were to address the issue at a climate round-table meeting hosted by Guterres on Thursday.

National governments will be invited to present more ambitious and high-quality climate plans at the summit, which would involve government leaders, as well as the private sector and civil society.

According to the U.N., the December 12 summit is intended to increase momentum ahead of the U.N. Climate Change Conference (COP 26) to be held in Glasgow in November 2021.

Recent data show greenhouse gas concentrations reaching record levels, worsening extreme events such as unprecedented wildfires, hurricanes, droughts and floods.

Source: Voice of America

Automakers Sue US Government Over Tariffs on Chinese Imports

NEW YORK – Automakers Tesla, Volvo, Ford and Mercedes-Benz have sued the U.S. government over tariffs on Chinese goods, demanding customs duties paid on imports be returned, with interest.

The lawsuits were filed over the past days in the New York-based Court of International Trade and concern tariffs imposed by the U.S. Trade Representative on imports from China, which Tesla in its filing called “arbitrary, capricious, and an abuse of discretion.”

The duties came amid a wider trade dispute between Washington and Beijing, and the automakers are asking for the tariffs to be revoked and any money paid to import parts returned.

Mercedes in its filing accused Washington of “prosecution of an unprecedented, unbounded and unlimited trade war impacting over $500 billion in imports from the People’s Republic of China,” and argued U.S. law “did not confer authority on defendants to litigate a vast trade war for however long, and by whatever means, they choose.”

U.S. President Donald Trump’s administration engaged in months of trade conflicts with China and imposed the levies as part of an effort to wean American manufacturers off Chinese technology.

China and the U.S. signed their “phase one” trade deal earlier this year that partially ended the dispute, under which China promised to buy $200 billion in U.S. goods and Washington backed down on tariffs on $160 billion in Chinese goods, particularly consumer electronics.

The U.S. also slashed by half 15% tariffs on $120 billion in goods but kept in place 25% duties on $250 billion in imports, which some of the automakers cited in their lawsuits.

Beijing has retaliated for these levies, while Washington is aiming both to reduce its trade deficit and reform Chinese business practices it considers “unfair.”

The Commerce Department reported the U.S. trade deficit in July surged nearly 11% to $63.6 billion, with the deficit with China climbing to $28.3 billion.

Source: Voice of America

AKWEL: NET EARNINGS OF €20.2 MILLION IN THE FIRST HALF OF 2020

Thursday 24 September 2020

NET EARNINGS OF €20.2 MILLION
IN THE FIRST HALF OF 2020

AKWEL (FR0000053027, AKW, PEA-eligible), the automotive and HGV equipment and systems manufacturer specialising in fluid management and mechanisms, published its 2020 half-yearly results.

Consolidated data – in € millions 30.06.2020 30.06.2019 Var. in %
Revenue 387.0 566.5 -31.7%
EBITDA 60.0 66.6 -9.9%
Current operating income 24.3 46.9 -48.2%
Current operating margin 6.3 % 8.3 % -2.0 pts
Operating income 25.2 46.7 -45.9%
Financial income (1.0) (1.1) -10.1%
Net result (group share) 20.2 35.5 -43.0%
Net margin 5.2 % 6.3 % -1.1 pt

In the first half of 2020, AKWEL posted a consolidated turnover of €387.0 million, down by 31.7% when comparing published figures and by 31.0% when taking exchange rates and scope as constants.

The current operating income was down by 48.2% in the first half year, at €24.3 million. Against this backdrop of an exceptional crisis in the world automotive market and with only limited provision of public aid, the robustness of AKWEL’S business model and speed at which it is able to adapt enabled it to achieve positive results.

The reduction in working capital requirements in addition to the adaptation of the investment margins made it possible to generate a free cash flow of €51.5 million in the first half of 2020. On 30 June, the Group had a positive net cash position of €7.7 million, with €157.8 of available cash.

The upturn in activity seen at the start of the year has continued for AKWEL, with a cumulative turnover achieved in July and August of €153.5 million, with the fall being limited to 4.6% compared to the comparable months of 2019.

The Group is continuing to invest in order to meet new market requirements as a priority, particularly in clean vehicles and new hybrid, electrical or hydrogen engine systems, or in the innovative partnership developed with Tallano to reduce microparticle emissions when braking. AKWEL is also ready to take up any external growth opportunities, enabling it to extend its geographical reach or to speed up the development of new product lines An independent, family-owned group listed on the Euronext Paris Stock Exchange, AKWEL is an automotive and HGV equipment and systems manufacturer specialising in fluid management and mechanisms, offering first-rate industrial and technological expertise in applying and processing materials (plastics, rubber, metal) and mechatronic integration.

Operating in 20 countries across every continent, AKWEL employs more than 10,500 people worldwide.

 

Euronext Paris – Compartment B – ISIN: FR0000053027 – Reuters: AKW.PA – Bloomberg: AKW:FP

Attachment

Kinesio Tape for dogs?

You betcha!

Albuquerque, New Mexico, USA, Sept. 24, 2020 (GLOBE NEWSWIRE) — You may have heard about Kinesio Taping on people, from elite athletes to medical patients. Maybe you know about someone who uses Kinesio Equine Taping on a horse.

Now there is a Kinesio Tape specially designed and formulated for your furry friend.

Kinesio Tape for Canine is designed to produce its therapeutic benefit through the dog’s hair follicles, without the need for shaving. To achieve this Kinesio designed a unique tape.  The canine-specific attributes of this tape and taping patterns address a dog’s physiology. Kinesio Tape for Canine can be used on its own or with complimentary therapies to assist in rehabilitation or to address postural changes or musculoskeletal issues.

The process and application of tape on dogs involves no discomfort and has no inhibiting effect on movement or natural exuberance, as can be seen on a video “commercial” posted on YouTube (see referenced link).

The pioneering inventor and innovator of the practice of elastic therapeutic taping Dr. Kenzo Kase® invented the tape more than 40 years ago and continues to find more frontiers of healing – canine taping is just the latest.  “Most of us at Kinesio are dog owners or dog lovers.” said Kinesio Vice President Elisa Kase, “As users and beneficiaries of taping on ourselves, we wondered how this might also benefit our canine friends and have been thrilled to discover and develop an entire methodology that can produce sometimes dramatically positive outcomes.”

As with all Kinesio tapes, the material is breathable, contains no medicine, and uses only hypoallergenic dyes.  Kinesio Tape for Canine uses 100% cotton fabric and 100% medical grade adhesive.  Once applied the tape can remain on the dogs 24 hours a day from 2-5 days.

Kinesio canine care is also integrated with a companion book and an innovative online workshop. This joins equine care and various specialties of human care.  The book and the Kinesio Canine Tape is now available globally through Kinesio’s network of International Distribution Partners in more than 40 countries.

About Kinesio Holding Corporation:  Kinesio Holding Corporation is a U.S. based manufacturer of unique therapeutic tapes that are sold all over the world. The Kinesio Taping® Method is designed to facilitate the body’s natural healing process while allowing support and stability to muscles and joints without restricting the body’s range of motion.  Course and training offerings have been extended in 2020 beyond published books and in person courses to include a new series of On Demand Classes and Webinars accessible from the kiniotaping.com webinar portal (see link).

Attachments

Mona Angel
Kinesio Holding Corporation
888-320-8273, ext. 104
mangel@kinesiotaping.com

Novavax Initiates Phase 3 Efficacy Trial of COVID-19 Vaccine in the United Kingdom

Clinical trial to enroll up to 10,000 volunteers across the UK to assess whether NVX-CoV2373 is effective in the prevention of COVID-19

GAITHERSBURG, Md., Sept. 24, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has initiated its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. The trial is being conducted in the United Kingdom (UK), in partnership with the UK Government’s Vaccines Taskforce, and is expected to enroll and immunize up to 10,000 individuals between 18-84 (inclusive) years of age, with and without relevant comorbidities, over the next four to six weeks.

“With a high level of SARS-CoV-2 transmission observed and expected to continue in the UK, we are optimistic that this pivotal Phase 3 clinical trial will enroll quickly and provide a near-term view of NVX-CoV2373’s efficacy,” said Gregory M. Glenn, M.D., President, Research and Development at Novavax. “The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries. We are grateful for the support of the UK Government, including from its Department of Health and Social Care and National Institute for Health Research, to advance this important research.”

NVX-CoV2373 is a stable, prefusion protein made using Novavax’ recombinant protein nanoparticle technology that includes Novavax’ proprietary MatrixM™ adjuvant. The vaccine has a favorable product profile that will allow handling in an unfrozen, liquid formulation that can be stored at 2°C to 8°C, allowing for distribution using standard vaccine channels.

Novavax has continued to scale-up its manufacturing capacity, currently at up to 2 billion annualized doses, once all capacity has been brought online by mid-2021.

About the Phase 3 Study

Consistent with its long-standing commitment to transparency and in order to enhance information-sharing during the worldwide pandemic, Novavax will be publishing its UK study protocol in the coming days.

The UK Phase 3 clinical trial is a randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 10,000 subjects aged 18 to 84 years. Half the participants will receive two intramuscular injections of vaccine comprising 5 µg of protein antigen with 50 µg Matrix‑M adjuvant, administered 21 days apart, while half of the trial participants will receive placebo.

The trial is designed to enroll at least 25 percent of participants over the age of 65 as well as to prioritize groups that are most affected by COVID-19, including racial and ethnic minorities. Additionally, up to 400 participants will also receive a licensed seasonal influenza vaccine as part of a co-administration sub-study.

The trial has two primary endpoints. The first primary endpoint is first occurrence of PCR-confirmed symptomatic COVID-19 with onset at least 7 days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2. The second primary endpoint is first occurrence of PCR-confirmed symptomatic moderate or severe COVID-19 with onset at least 7 days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2. The primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic or moderate/severe COVID-19 disease. An interim analysis will be performed when 67% of the desired number of these cases has been reached.

For further information, including media-ready images, b-roll, downloadable resources and more, click here.

About NVX-CoV2373

NVXCoV2373 is a vaccine candidate engineered from the genetic sequence of SARSCoV2, the virus that causes COVID-19 disease. NVXCoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigens and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVXCoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its the Phase 1 portion of its Phase 1/2 clinical trial, NVXCoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in two ongoing Phase 2 studies, which began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

About Matrix-M™

Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Novavax Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

Novavax

Investors
Silvia Taylor and Erika Trahan
ir@novavax.com
240-268-2022

Media
Brandzone/KOGS Communication
Edna Kaplan
kaplan@kogspr.com
617-974-8659

Rhizen Pharmaceuticals S.A. Announces Publication of Clinical Data from the Phase I/Ib study of Tenalisib (RP6530) in Patients with Relapsed/Refractory T-Cell Lymphoma (TCL)

La Chaux-de-Fonds, Switzerland, Sept. 24, 2020 (GLOBE NEWSWIRE) — Rhizen Pharmaceuticals S.A. today announced the publication of the results from the Phase I/Ib study of Tenalisib (RP6530), the company’s novel next generation dual PI3K δ/γ inhibitor, in the journal Cancers.

— Single-agent Tenalisib was well tolerated with a good overall response rate (ORR) in both peripheral and cutaneous T-cell Lymphoma patients (PTCL and CTCL)

The results include safety and efficacy information from 58 heavily pre-treated patients with relapsed/refractory peripheral and cutaneous T-Cell Lymphoma treated with single-agent Tenalisib.   Tenalisib was well tolerated with favorable safety profile compared to prior generation dual PI3K δ/γ inhibitors.

Tenalisib showed promising activity with an overall response rate (ORR) of 45.7% (9%Complete Response and 37%Partial Response) and median duration of response (DoR) comparable to currently approved therapies for T-Cell Lymphoma’s. Unlike other PI3K inhibitors, late onset toxicities like colitis, pneumonitis were not seen with Tenalisib even in patients treated for more than six months. Five patients were on therapy for more than 18 months and did not report any late onset immune toxicities. This indicates an emerging differentiated safety profile for Tenalisib.

Dr. Swaminathan P. Iyer, Professor, T-Cell Lymphoma’s Director, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston, TX, and Principal Investigator of this study stated, “We are pleased to have been involved in the early clinical development phase of single-agent Tenalisib (RP6530) in patients with relapsed/refractory T-Cell Lymphoma and believe this oral targeted drug has an important place in the treatment landscape of these patients.  The outstanding safety profile of Tenalisib lends itself to be combined with other approved/standard of care drugs, and we are currently involved in the ongoing Phase I/II combination study of Tenalisib plus romidepsin in relapsed/refractory T-Cell Lymphoma.”  (ClinicalTrials.gov Identifier: NCT03770000).

Article: Phase I/Ib Study of Tenalisib (RP6530), a Dual PI3K delta/gamma inhibitor in Patients with Relapsed/Refractory T-Cell Lymphoma.   The online version of the published article can be accessed at

Cancers 202012(8), 2293; https://doi.org/10.3390/cancers12082293

About Tenalisib (RP6530):

Tenalisib (RP6530) is a highly selective next generation orally active dual PI3K δ/γ inhibitor, which is in Phase 2 clinical development for hematological malignancies and solid tumors.  Tenalisib has been granted US FDA Fast Track Designations for treatment of relapsed/refractory peripheral T-cell lymphoma and cutaneous T-cell lymphoma (R/R PTCL and R/R CTCL), in addition to Orphan-Drug Designations for treatment of peripheral and cutaneous T-cell lymphoma (PTCL and CTCL).

About T-Cell Lymphomas: 

T-Cell Lymphomas (TCL), are a group of cancers that originate in T-cells and develop in lymphoid tissues such as the lymph nodes and spleen, or outside of lymphoid tissues (i.e., gastrointestinal tract, liver, nasal cavity, skin, and others). TCL constitute ~7-15% of all NHL cases and can be generally classified on the basis of their presentation, as indolent or aggressive.

Peripheral T-Cell Lymphoma (PTCL), describes a heterogeneous group of lymphoproliferative disorders arising from mature T-Cells and accounts for ~10% of all NHL cases. PTCL is an aggressive disease that most commonly presents in patients over the age of 60 and usually has a worse prognosis than diffuse large B cell lymphoma.

Cutaneous T-Cell Lymphoma (CTCL) describes a group of typically indolent lymphomas that appear on, and are most often confined to, the skin and accounts for ~3% of all NHL cases and usually affects adults. CTCL subtypes include the more common and indolent Mycosis Fungoides (MF), which is largely confined to the skin, and the less common but more severe Sézary Syndrome (SS) that affects both the skin and blood and has poor prognosis.

About Rhizen Pharmaceuticals S.A.:

Rhizen Pharmaceuticals is an innovative, clinical-stage biopharmaceutical company focused on the discovery and development of novel therapeutics for the treatment of cancer and inflammatory diseases.  Since its establishment in 2008, Rhizen has created a diverse pipeline of proprietary drug candidates targeting several cancers and immune associated cellular pathways.  Rhizen is headquartered in La-Chaux-de-Fonds, Switzerland.  For additional information, please visit Rhizen’s website, www.rhizen.com.

Contact:         
Kumar V. Penmetsa, Ph.D.
Executive Vice President, Corporate Development
Rhizen Pharmaceuticals S.A.
Telephone:  +1-267-207-5707
Email:  kvp@rhizen.com

Phoenix Software International Delivers Optional Software Development Kit for its Data Entry Software Suite

EL SEGUNDO, Calif., Sept. 24, 2020 (GLOBE NEWSWIRE) — Tomorrow, Friday, September 25, 2020, Phoenix Software International, Inc., will release an update to its web- and desktop-based data entry software suite, Entrypoint. The new release, Entrypoint 16.1, includes an optional software development kit (SDK), which allows developers to extend the core functionality of Entrypoint using the Java platform to integrate new and existing applications with an Entrypoint Server through direct network client connections and plug-in extension components. Also new in this release is the ability to use re-key verify, a proven technique for improving data accuracy, through the web-based interface. This feature was previously only available in the desktop data entry client.

The Entrypoint SDK is an optional add-on to Entrypoint that enables the development of five basic project types:

  • Entrypoint Clients are Java applications that can connect to an Entrypoint Server through the network. These may be standalone applications or other Java programs and components.
  • Batch Exporters are extensions that plug into an Entrypoint Server and can be used to generate file output from one or more batches and a set of options selected by the user at runtime.
  • Report Generators are extensions that plug into an Entrypoint Server and can be used to generate reports given a set of parameters and options selected by the user at runtime.
  • WS-API Call Handlers are extensions that plug into an Entrypoint Server and expose new web-service calls through the Entrypoint WS-API interface.
  • EntrypointScript API Extension Objects are extensions that plug into Entrypoint to add new functions to EntrypointScript, Entrypoint’s scripting language based on JavaScript.

The SDK documentation contains step-by-step instructions for creating, deploying, and executing each type of project.

“Every customer’s application and integration needs are unique,” said Brien Wienke, Entrypoint Product Manager at Phoenix Software International. “While the built-in functionality of Entrypoint is extremely flexible and robust, putting development tools in the hands of our customers enables the software to be truly adaptable to, and tightly integrated with, existing processes and IT infrastructure.”

Re-key verification is a technology common to many professional data entry products in which certain critical fields are independently retyped by another user and the results are compared to improve accuracy. In previous releases of Entrypoint, the verification step could only be performed on the desktop data entry client. With the release of Entrypoint 16.1, verification can now be performed in the web-based interface as well. Entrypoint’s verification feature has options that allow you to fine tune your processes while improving speed and accuracy.

Please see https://phoenixsoftware.com/support.htm for more information about individual software products and releases.

About Phoenix Software International

Phoenix Software International, Inc., (https://www.phoenixsoftware.com) is a systems software development company providing advanced software applications to enterprises around the globe. The company offers a wide range of solutions to modern business challenges.

Press Contact:
(310) 338-0400
news@phoenixsoftware.com