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Through the acquisition, Merck will gain access to VelosBio’s lead investigational candidate, VLS-101, an antibody-drug conjugate that targets receptor tyrosine kinase-like orphan receptor 1.

 

A new tube-pouch made with paper has been developed which could reduce the use of plastic in pharmaceutical packaging. 

Developed by Toppan Printing, the producer says that due to the use of thinner film material, the conventional tube-pouch is easier to squeeze and uses 30 percent less plastic than the type of laminated tube widely used for toothpaste.

According to the company, the tube-pouch maintains its functionality while demonstrating an improved environmental performance by employing a paper-based material for the body, making possible a 50 percent reduction in plastic volume. Coupled with a redesign of the plastic parts of the head section, this enables plastic to be reduced by a total of 65 percent. Although plastic has been replaced with paper, the tube-pouch still maintains its shape even when the volume of content inside decreases, and the use of a film on the inner surface ensures a barrier to protect contents. 

The body of the paper tube-pouch has a thickness of 0.1mm and a special folded structure. Combined with a horizontal design for the plastic spout, the company says this makes it easier to squeeze out the contents.

“The paper tube-pouch represents a new solution that can meet the needs of manufacturers, consumers and society as a whole by reducing impact on the environment, enhancing user-friendliness and also offering new possibilities for design,” said Shingo Wada, general manager of business strategy in Toppan’s western Japan division. “It is another example of Toppan’s efforts to tackle such issues as marine plastic and the need for efficient circulation of resources by developing eco-friendly packaging and containers that sacrifice nothing in terms of functionality while making use of more sustainable materials, such as recycled and biomass plastics, monomaterials and paper.”

Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers and infectious diseases, announced the dosing of the first COVID-19 patient with agenT-797, an allogeneic cell therapy, through its subsidiary, AgenTus Therapeutics. The trial is being led by Dr. Koen van Besien at Weill Cornell Medical College/New York Presbyterian Hospital. Separately, the FDA has also cleared agenT-797 to treat patients with cancer. Cancer trials are expected to commence shortly.

“We are pleased to advance our proprietary iNKT cell therapy in our efforts to address the COVID-19 pandemic,” said Dr. Walter Flamenbaum, CEO of AgenTus Therapeutics. “Our trial is designed to treat patients with moderate to severe symptoms of COVID-19, where these cells have the potential to clear SARS-CoV-2 virus, dampen harmful inflammation, and prevent reinfection.”

“iNKT cell therapy offers new promise for the fight against solid tumor cancers as well as COVID-19,” said Dr. Garo Armen, Chairman and CEO of Agenus. “iNKTs can penetrate tissues, giving them a critical advantage in targeting solid tumors not currently served by approved cell therapies. iNKTs have also demonstrated curative potential in preclinical cancer models that are refractory to available therapies. Our product is designed to treat patients affordably and accessibly.”

As a subsidiary of Agenus, AgenTus currently has unique access to Agenus’s portfolio of checkpoint antibodies and cancer vaccines which allows for optimal combinations with its cell therapies. This gives the company enormous flexibility to develop effective combinations with curative potential for patients with cancer and infectious disease at a significant cost advantage.

About AgenTus Therapeutics, Inc.
AgenTus Therapeutics is a biopharmaceutical company focused on the discovery, development, and commercialization of breakthrough unmodified and modified allogeneic iNKT cells with engineered receptors, such as T cell receptors (TCRs) and Chimeric Antigen Receptors (CARs), designed to supercharge the human immune system cells to seek and destroy cancer. AgenTus also aims to advance adoptive cell therapy formats which would enable off-the-shelf living drugs. AgenTus has locations in Lexington, MA and Cambridge, UK. For more information, please visit www.agentustherapeutics.com.

About Agenus
Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body’s immune system to fight cancer. The Company’s vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its AgenTus Therapeutics subsidiary), and proprietary cancer vaccine platforms. The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our Twitter handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter.

Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the anticipated commencement of cell therapy clinical trials for cancer and COVID-19 and the expected benefits to be observed in these trials and with these cell therapy treatments generally. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Danish pharmaceutical company Novo Nordisk AS said Friday that it has agreed to buy Emisphere Technologies Inc. and the royalty stream obligations of its Eligen oral drug-delivery platform for a total of $1.8 billion.

Emisphere Technologies is a drug-delivery company with proprietary technologies, such as Eligen SNAC, that enable drug therapies to be provided in a tablet formulation.

Researchers from the University of California San Francisco (San Francisco, CA, USA) are studying whether cells drawn from deep inside the bones can hold hope for the sickest of COVID-19 patients who have severe lung injury called acute respiratory distress syndrome, or ARDS.

There is currently no drug to treat ARDS, which has a mortality rate of 27% for mild cases and 45% for the most severe cases. An early study on COVID-19 patients with ARDS found that only about 25% survive, though that percentage may be as high as 40%. The clinical trial is testing the effects of infusions of stem cells drawn from bone marrow in the hopes of finding a therapy for the deadly syndrome. Patients in a randomized double blind clinical trial are being given mesenchymal stem cells (MSCs) or placebo to test the effectiveness of the therapy. The trial hopes to repair the severe and often fatal lung damage in people suffering from ARDS.

MSCs are stromal cells found in bone marrow, play a key role in how human bodies make and repair skeletal tissues – things like bone and cartilage and support the cells in the bone marrow that produce red and white blood cells. Once researchers discovered that MSCs could modulate inflammation when transplanted into other people, they began exploring them as potential therapies for a range of diseases and traumas.

ARDS can be caused by trauma, bacterial infection, or a viral infection like COVID-19. In an earlier trial, the team had showed that MSCs are safe to use, and that they have promising benefits in treating patients with ARDS. In the current Phase 2 double blind clinical trial, the researchers are enrolling 120 ARDS patients who are adult ICU patients on ventilators with excess fluid in their lungs, and no sign of heart failure as a primary cause of the respiratory failure. Based on these outcomes and further studies on MSCs, the researchers view them as a possible route for cell-based therapy. Much like cancer treatment is not a single approach but instead different therapies tailored to the type of cancer cells, the use of something like MSCs could be perhaps tailored exactly to whatever specific kind of syndrome of respiratory failure.

“It’s a very interesting possible therapy,” said Michael Matthay, MD, professor of medicine at the UCSF School of Medicine. “We’re really in the early phases of understanding these cell-based therapies.”

Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM™ adjuvant.

“The FDA’s decision to grant Fast Track Designation for NVX-CoV2373 reflects the urgent need for a safe and effective vaccine to prevent COVID-19, and we look forward to working closely with the agency to accelerate access to this vaccine,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. and globally.”

Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. Data from the event-driven trial could support global authorization and approval, including in the U.S. The Company’s ongoing Phase 3 clinical trial in the UK to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 is expected to be fully enrolled by the end of November. Depending on the overall COVID-19 attack rate, interim data in the UK trial, which is also event-driven, are expected as soon as early first quarter 2021.

About NVX-CoV2373

NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 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 antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 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 a Phase 3 trial in the UK and two ongoing Phase 2 studies that 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 $399 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and almost $1.7 billion from the U.S. government.

About Fast Track Designation

Fast Track Designation by the U.S. FDA is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, with the intent of getting important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. Specifically, Fast Track Designation facilitates meetings with FDA to discuss all aspects of development to support licensure and provides the opportunity to submit sections of a BLA on a rolling basis as data become available.

AlpVision has announced it is launching the “AlpVision COVID-19 Initiative”, a programme aimed to help pharmaceutical companies protect their medicines relevant to COVID-19 against counterfeiting. The initiative involves using a crytoglyph on the packaging of the medicinal products.

According to the company, COVID-19 has caused not only the pandemic, but has also created unprecedented economic challenges. In response, AlpVision has launched its initiative to support pharmaceutical companies by providing them with the necessary tools to protect COVID-19 relevant medicines and vaccines against counterfeiting for free.

To do so, AlpVision will provide pharma companies and their suppliers with all necessary tools to deploy a cryptoglyph on their packaging. The AlpVision Cryptoglyph is a digital security feature which can be implemented and deployed within just a few weeks. The company says it is invisible to the human eye and authentication of a product protected with a cryptoglyph can be completed using a regular smartphone. The company says that the smartphone applications connect to AlpVision’s Brand Monitoring System (BMS), a centralised server platform through which pharmaceutical companies are able to monitor in real-time product authentication activities and gain important insight into counterfeiting activities.

Furthermore, securing of packaging with a cryptoglyph is very easy as it neither changes the standard production process, nor requires additional consumables.

The AlpVision COVID-19 Initiative will start today, on 13 November 2020, and subscription will run for an initial period of three months. Participating companies will be able to protect their COVID-19 relevant products with no additional cost for the authentication feature. AlpVision says that it will provide this service gratuitously until the pandemic is officially declared as ended by the World Health Organization (WHO).

The US Food and Drug Administration (FDA) has approved an emergency use authorisation for Eli Lilly’s monoclonal antibody bamlanivimab in high-risk COVID-19 patients.

Bamlanivimab is now available under emergency use for the treatment of mild to moderate COVID-19 in adults and paediatric patients 12 years and older who are at high risk of progressing to severe COVID-19 and/or hospitalisation.

In a statement, Lilly said that bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within ten days of symptom onset.

The emergency approval is supported by data from Lilly’s BLAZE-1 study – a phase II study in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting.

In this study, patients treated with bamlanivimab showed a reduced viral load and rates of symptoms and hospitalisation.

In addition, the frequency and types of adverse events were similar between bamlanivimab and placebo in the BLAZE-1 study, with the majority being mild to moderate in severity.

Despite the EUA, bamlanivimab remains an investigational drug and has not been approved under a Biologics Licence Application (BLA). Further evaluation of its safety and efficacy is ongoing across a number of patient populations impacted by COVID-19.

“This emergency authorisation allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients – adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic,” said David A. Ricks, Lilly’s chairman and chief executive officer.

“The rapid development and availability of bamlanivimab could not have been achieved without the relentless work of our Lilly team, collaboration across the industry and the urgent work being done by the government to ensure appropriate allocation to patients who need it the most,” he added.

Before the onset of the coronavirus pandemic, leading organizations in clinical research had been gradually discovering, experimenting with, and implementing remote technology. The pandemic has catapulted their transformation agendas forward.

This acceleration challenges the industry by shortening often lengthy vendor evaluation processes, uprooting existing cross-departmental workflows, and requiring swift and meticulous compliance and regulatory rework. Yet there are opportunities for organizations that face this change head on: avoiding costly study delays, continuing patient participation in critical chronic disease studies, accessing higher levels of study oversight and compliance adherence, and more.

I offer a look at how the technology landscape for clinical research accelerated in 2020, raise some risks this rapid acceleration poses, and offer suggestions for how leaders in clinical research and operations can navigate these changes for successful outcomes.

The shifting landscape

Over the past decade, clinical operations executives have been slowly adopting new technologies to reduce their bottom lines and increase the efficiency of clinical research. Covid-19 has accelerated their transformation timelines for implementing new technologies and approaches. Former technology infrastructure estimates for sites, sponsors, and clinical research organizations (CROs) for 2025 have now been pulled forward to 2021.

Part of the dramatic industry shift can be attributed to protocols put in place by research sites to ensure the safety of both patients and research staff as the pandemic began expanding globally.

These protocols include:

• Offsite work for all nonessential staff work
• No outside visitors, monitors, or clinical research associates
• Only critical patient visits; most visits suspended or delayed
• Nearly two-thirds of active studies suspended or paused
• Routine inspections suspended by the FDA
• The rise of telehealth visits

Although these measures helped reduce the spread of Covid-19, they required sites, sponsors, and CROs to reimagine how to safely conduct clinical trials in remote, technology-based environments. This was no small task, as adopting new technology at any research organization requires administrative, regulatory, and process changes.

Standard operating procedures and protocols that formerly addressed manual and paper processes had to be adjusted to include remote, technology-based methods. This shift also required clinical research coordinators, clinical research associates, and other research staff to learn and integrate technology into their workflows.

As these changes take hold, the barrier to future technology adoption and an increase in technology-based skills among research staff continues to lower, further accelerating the shift to permanent remote-capable technology processes in clinical research.

Risks of rapid acceleration

Adapting quickly in order to continue vital clinical research on treatments for Covid-19 and other diseases means evaluating and adopting technology platforms to accommodate new remote needs and keep research moving forward. The vendor evaluation process has become shorter than ever, as have adoption timelines, leaving room for error.

Increased vendor selection hurdles. The market is being flooded with new technology platforms to meet remote research demands. This influx can overwhelm research teams and add complexity to vendor selection by increasing the platforms and capabilities to sift through. This complexity increases the risk that sites, sponsors, and CROs will select platforms that don’t appropriately address their needs.

Shortened evaluation timelines. Research organizations typically form vendor evaluation teams that include members from various departments that will be affected by the technology. Under normal circumstances, vendor evaluations can take anywhere from six to 18 months, which includes time for research teams to test a platform’s workflows in a live environment. Accelerated transformation timelines are shortening this evaluation period, which may cause temporary resource strain and intensified decision-making.

Increased risk of system integration failures. Verifying that a new technology can integrate with current systems is an essential step for building robust, remote-ready technology infrastructures for clinical research. Vendor evaluation teams typically complete thorough investigations of the existing technology infrastructures of all involved research partners — sites, sponsors, and CROs — to avoid adopting technology systems that are redundant or incompatible with existing platforms. Accelerated transformation timelines hurry this infrastructure investigation, increasing the risk of overlooking current systems, miscalculating integration capabilities, producing integration failures, and creating inefficient or redundant workflows.

Rushed system testing and validation. Many organizations, especially large sponsors and CROs, now require a security evaluation to assess a technology platform’s regulatory and compliance abilities. This is helpful and often recommended to mitigate any compliance risk and verify system security and privacy. Yet to be effective, these evaluations require vendor cooperation, resource allocation, and timely responses. As vendor evaluation timelines shorten, rapid system testing and validation by research organizations increase the potential to overlook security or compliance risks identified in the questionnaire.

On Wednesday, Russia’s National Research Centre for Epidemiology and Microbiology and the Russian Direct Investment Fund announced that the Sputnik V vaccine demonstrated high efficacy—92 per cent.

On September 4, The Lancet, one of the world’s leading medical journals, published a research paper on the results of Phase I and Phase II clinical trials of the vaccine that showed no serious adverse events and effective immune response of those vaccinated.

Requests for more than 1.2 billion doses of Sputnik V vaccine came from over 50 countries. The vaccine supplies for the global market will be produced by RDIF’s international partners in India, Brazil, China, South Korea and other countries