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Tagrisso Phase III ADAURA trial will be unblinded early after overwhelming efficiency in the adjuvant treatment of the patients with EGFR-mutated lung cancer

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Tagrisso Phase III ADAURA trial will be unblinded early after overwhelming efficiency in the adjuvant treatment of the patients with EGFR-mutated lung cancer

10 April 2020: “The ADAURA Phase III trial for Tagrisso (osimertinib) in the adjuvant treatment of patients with Stage IB, II and IIIA epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with complete tumour resection will be unblinded early following a recommendation from an Independent Data Monitoring Committee (IDMC) based on its determination of overwhelming efficacy.”

José Baselga, Executive Vice President, Oncology R&D, said: “We are thrilled by the recommendation to unblind the Phase III ADAURA trial much earlier than expected and are incredibly excited with these unprecedented results in patients with early-stage EGFR-mutated non-small cell lung cancer. Lung cancer is a devastating diagnosis and for the first time an EGFR-targeted medicine can now provide the hope of cure.”

The primary endpoint of the ADAURA Phase III trial is illness-free survival (DFS). Tagrisso was tested against placebo for up to three years of diagnosis. The experiment will move on testing the secondary outcome of overall survival. The IDMC did not pose any new health issues in its correspondence to AstraZeneca. The data will be discussed at a scientific meeting to be held next.

 “Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths, more than breast, prostate and colorectal cancers combined.Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.  Around 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.These patients are particularly sensitive to treatment with EGFR-tyrosine kinase inhibitors (TKIs) which block the cell-signalling pathways that drive the growth of tumour cells. Based on AstraZeneca estimates, just over 60% of NSCLC patients are diagnosed with early-stage (Stage I-III) disease.”

“ADAURA  is a randomised, double-blinded, global, placebo-controlled Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II, IIIA EGFRm NSCLC with complete tumour resection and optional, standard post-operative adjuvant chemotherapy. In the experimental arm, patients were treated with Tagrisso 80mg once-daily oral tablets for three years or until disease recurrence. The trial enrolled in more than 200 centres across more than 20 countries, including the US, in Europe, South America, Asia and the Middle East. The primary endpoint is DFS; data readout was originally anticipated in 2022.”

“Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against CNS metastases. Tagrisso 40mg and 80mg once-daily oral tablets have now received approval in 80 countries, including the US, Japan, China and the EU, for 1st-line EGFRm advanced NSCLC, and in 87 countries, including the US, Japan, China and the EU, for 2nd-line use in patients with EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being developed in the locally advanced unresectable setting (LAURA), in combination with chemotherapy (FLAURA2) in the metastatic setting, and with potential new medicines to address resistance to EGFR-TKIs (SAVANNAH, ORCHARD).”

“AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, several stages of disease, lines of therapy and modes of action. AstraZeneca’s aim to address the unmet needs of patients with EGFRm tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with the approved medicines Iressa (gefitinib) and Tagrisso, and its ongoing Phase III trials ADAURA, LAURA, and FLAURA2.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/tagrisso-phase-iii-adaura-trial-will-be-unblinded-early-after-overwhelming-efficacy-in-the-adjuvant-treatment-of-patients-with-egfr-mutated-lung-cancer.html

Coronavirus (COVID-19) Update: FDA Authorizes Blood Purification Device to Treat COVID-19

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Coronavirus (COVID-19) Update: FDA Authorizes Blood Purification Device to Treat COVID-19

April 10, 2020: The U.S. FDA issued an emergency use authorization for a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

The approved product works by reducing the number of cytokines and other inflammatory mediators, i.e. small active proteins in the bloodstream which control the immune response of a cell by filtering the blood and returning the filtered blood to the patient.

The proteins that are removed are usually elevated during infections and may be associated with a “cytokine storm” occurring in some COVID-19 patients, resulting in extreme inflammation, rapidly progressive shock, respiratory failure, organ failure and death.

“We continue to work across all sectors to expedite the development of numerous innovative potential preventive and treatment approaches by both facilitating emergency access for patients, to the extent we can, and supporting the evaluation of potential therapies,” said FDA Commissioner Stephen M. Hahn, M.D. “With today’s authorization of a blood purification device, we are expediting the availability of a treatment option for patients in the ICU to help reduce the severity of the disease. Our staff will continue our around the clock review of all medical products to expedite the availability of treatments to help fight this devastating disease.”

“The FDA issued this emergency use authorization to Terumo BCT Inc. and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices.”

The FDA, a United States department Health and Human Services Agency, protects public health by ensuring the quality, effectiveness, and protection of human and veterinary medicines, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the health and protection of the food supply, cosmetics, dietary supplements, products that give off electronic radiation, and to regulate tobacco products in our country.
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-blood-purification-device-treat-covid-19

COVID-19: Sanofi to donate 100 million doses of hydroxychloroquine across 50 countries

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COVID-19: Sanofi to donate 100 million doses of hydroxychloroquine across 50 countries

April 10, 2020: “As of today, Sanofi has committed to donating 100 million doses of hydroxychloroquine to 50 countries around the world, and has begun to progressively deliver the medicine to authorities that have requested it.

Hydroxychloroquine donation

In this global health emergency, Sanofi stands ready to assist as many countries as possible, starting with countries where its medicine is registered for current approved indications as well as countries where there are no hydroxychloroquine suppliers or countries with underserved populations.

Since the beginning of the COVID-19 crisis, Sanofi has received a growing number of requests from local governments around the world. The company is regularly evaluating its increasing supply capacity and re-assessing how best to help those countries in the most ethical way. Sanofi’s priority is to ensure supply continuity for patients treated under the current approved indications of the medicine, notably including lupus and rheumatoid arthritis, while working hard to supply governments wishing to increase stocks in the hope that it may be an effective treatment of COVID-19.

Sanofi will continue to donate the medicine to governments and hospital institutions if ongoing clinical studies demonstrate its efficacy and safety in COVID-19 patients.”

Production capacity ramp up

“Sanofi has already doubled its incremental production capacity (on top of the usual production for current indications) across its eight hydroxychloroquine manufacturing sites worldwide and is on track to quadruple it by the summer.

Call for greater international cooperation

Sanofi is calling for coordination among the entire hydroxychloroquine chain worldwide to ensure the continued supply of the medicine if proven to be a well-tolerated and effective treatment in COVID-19 patients.”

“The COVID-19 pandemic is an unprecedented health and economic crisis which is shaking some of the very fundamentals of international solidarity and cooperation among countries”, says Paul Hudson, Chief Executive Officer at Sanofi. “This virus does not care about the concept of borders, so we shouldn’t either. It is critical that international authorities, local governments, manufacturers, and all the other players involved in the hydroxychloroquine chain work together in a coordinated manner to ensure all patients who may benefit from this potential treatment can access it. If the trials prove positive, we hope our donation will play a critical role for patients.”

“The company is already actively working with different stakeholders at local and international levels, and is ready to play its part in contributing to a more coordinated global initiative.

Ensure patient safety

At this point, the interpretations of the available preliminary data on hydroxychloroquine in the management of COVID-19 differ widely. In this context, patient safety must always be the guiding principle.

Hydroxychloroquine has several serious known side effects and should be used with caution.  Not everyone can take this medicine.”

“To date, there is insufficient clinical evidence to draw any conclusion over the safety and efficacy of hydroxychloroquine in the management of COVID-19 patients. It is one of several medicines being investigated by the World Health Organization (WHO) in its international clinical trial seeking a treatment solution for COVID-19. Sanofi is supporting ongoing trials by providing the medicine to some participating investigator sites and other independent research centers.

While hydroxychloroquine is generating a lot of hope for patients around the world, it should be remembered that there are no results from ongoing studies, and the results may be positive or negative.”

Sanofi’s efforts in the fight against COVID-19

“Sanofi remains at the forefront of initiatives to fight the coronavirus, while also carrying on the daily business of making and delivering important medicines for patients. The company is also exploring alternative treatment options such as Kevzara® (sarilumab) for severe COVID-19 patients, and leveraging its expertise to develop a new vaccine. Both measures could have an immediate and a lasting impact. Dealing with a pandemic as daunting as COVID-19 requires collaboration to create as many paths forward as possible, and Sanofi is helping lead the way, playing its part.”
https://www.sanofi.com/en/media-room/press-releases/2020/2020-04-10-07-55-20

Pfizer clinches coronavirus vaccine deal, sees potential in antiviral treatment

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Pfizer clinches coronavirus vaccine deal, sees potential in antiviral treatment

April 09, 2020: “BioNTech SE  and Pfizer disclosed additional details of their collaboration to advance candidates from BioNTech’s mRNA vaccine program, previously announced on March 17, 2020.

The collaboration aims to rapidly advance multiple COVID-19 vaccine candidates into human clinical testing based on BioNTech’s proprietary mRNA vaccine platforms, with the objective of ensuring rapid worldwide access to the vaccine, if approved. The collaboration will leverage Pfizer’s broad expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network.”

“The two companies plan to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in the United States and Europe across multiple sites. BioNTech and Pfizer intend to initiate the first clinical trials as early as the end of April 2020, assuming regulatory clearance.

During the clinical development stage, BioNTech and its partners will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe. BioNTech and Pfizer will work together to scale-up manufacturing capacity at risk to provide worldwide supply in response to the pandemic. BioNTech and Pfizer will also work jointly to commercialize the vaccine worldwide (excluding China, which is already covered by BioNTech’s collaboration with Fosun Pharma) upon regulatory approval.”

“Combatting the COVID-19 pandemic will require unprecedented collaboration across the innovation ecosystem, with companies coming together to unite capabilities like never before,” said Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development & Medical, Pfizer. “I am proud of Pfizer’s collaboration with BioNTech and have every confidence in our ability to harness the power of science – together – to bring forth a potential vaccine that the world needs as quickly as possible.”

“We have already started working with Pfizer on our COVID-19 vaccine and are pleased to announce these further details of our ongoing collaboration, which reflects both companies’ strong commitment to move quickly to bring a safe and efficacious vaccine to patients worldwide,” says Co-Founder and CEO of BioNTech, Ugur Sahin, M.D.

“Under the terms of the agreement, Pfizer will pay BioNTech $185 million in upfront payments, including a cash payment of $72 million and an equity investment of $113 million. BioNTech is eligible to receive future milestone payments of up to $563 million for a potential total consideration of $748 million. Pfizer and BioNTech will share development costs equally. Initially, Pfizer will fund 100 percent of the development costs, and BioNTech will repay Pfizer its 50 percent share of these costs during the commercialization of the vaccine.”
https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_biontech_announce_further_details_on_collaboration_to_accelerate_global_covid_19_vaccine_development

How AI will Affect the Healthcare-Jobs Published on October 13, 2019

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What is artificial intelligence? “Psychologists generally do not characterize human intelligence by just one trait but by the combination of many diverse abilities. Research in AI has focused chiefly on the following components of intelligence: learning, reasoning, problem solving, perception, and using language.

Artificial intelligence (AI) can be defined as the ability of a digital computer or computer-controlled robot to perform tasks commonly associated with intelligent beings. The term is frequently applied to the project of developing systems endowed with the intellectual processes characteristic of humans, such as the ability to reason, discover meaning, generalize, or learn from past experience” as per Encyclopedia Britannica.

Facts and Figure: These figures are based on report titled Automation and Artificial Intelligence: How machines are affecting people and places. It analyses the long period and look at how automation impacted the workforce from the 1980s to 2016 and offers projections on how new automation and artificial intelligence (AI) tools will affect the economy by 2030.

Almost all jobs will be affected by AI but few segments are more vulnerable, for example office administration, production, transportation, and food preparation. In case of healthcare, it will not be among most affected (Medium to low exposure) area despite the increased use of artificial intelligence to replace some tasks.

As per the report “Over the next few decades, approximately 25% of U.S. employment (36 million jobs in 2016) will have experienced high exposure to automation (with greater than 70 % of current task content at risk of substitution). At the same time, the data suggest that another 36 % of U.S. employment (52 million jobs in 2016) will experience medium exposure to automation by 2030, while another 39 % (57 million jobs) will experience low exposure”.  

Management analyst job carries the least potential of automation (4%). Healthcare practitioners and technical occupations have 33% task- automation potential. Whereas healthcare support-occupations have a 49 % potential for automation. Medical Assistant jobs and registered nurses have 54 and 29 % -automation potential respectively. “The manufacturing and transportation and storage sectors could see a reduction in employment levels” PwC (PricewaterhouseCoopers) estimates.

Impact on healthcare: “As per the new report from world economic forum, overall, Machines and algorithms in the workplace are expected to create 133 million new roles, but cause 75 million jobs to be displaced by 2022. It means that the growth of artificial intelligence could create 58 million net new jobs in the next few years. By 2025, machine will share 52 % of total tasks.”

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 AI, robotics and smart automation technology could contribute up to $15 trillion to global GDP by 2030. About half of the core jobs will remain stable till the 2022. “While the overall net effect of AI on UK jobs may be broadly neutral, this varies significantly across industry sectors. The most positive effect of AI is seen in the health and social work sector, where that employment could increase by nearly 1 million, equivalent to around 20% of existing jobs in the sector: PwC (PricewaterhouseCoopers) estimates.

“Accenture Research recently concluded a study of future workforce trends, including in health care, and the data point to significant growth for the industry, both in terms of jobs and revenues, as AI moves beyond rudimentary automation and enables greater collaboration between humans and machines. The data predict that, from 2018 to 2022, employment in health care will increase by 15% while revenues will surge by 49%.”

How Artificial intelligence improves the life of people through healthcare transformation: The Artificial intelligence increases the accuracy and precision of diagnosis. The Harvard-based team of pathologists recently developed an AI-based technique to identify breast cancer cells with greater precision. It has increased their accuracy from 96% to 99.5% and this improvement translates to 68,000 to 130,000 more women receiving accurate diagnoses.

 AI based Chatbot can help mental health professional serve many more patient a day. Philips has developed an AI-based tool Illumeo for radiologist. It can record and reproduce user’s hanging protocol in consistent manner. It provide the contextual relevant information. It  standardize workflow and ultimately supports reducing variability throughout the institution. A well known advancement of AI is robot assisted surgery i.e. overgrown retina membrane correction. AI can be used for target identification, in-silico drug design, Prediction of study risk and designing of statistical model. There are many areas to be touched by AI for the betterment of human life. Every change comes with an opportunity and one needs to upgrade himself by learning new skill to meet that golden opportunity. 
https://www.brookings.edu/research/automation-and-artificial-intelligence-how-machines-affect-people-and-places/ 
https://revcycleintelligence.com/news/how-will-automation-ai-impact-healthcare-employment 
https://www.forbes.com/sites/amitchowdhry/2018/09/18/artificial-intelligence-to-create-58-million-new-jobs-by-2022-says-report/#55a6052e4d4b 

http://reports.weforum.org/future-of-jobs-2018/http://reports.weforum.org/future-of-jobs-2018/key-findings/ 
https://www.forbes.com/sites/amitchowdhry/2018/09/18/artificial-intelligence-to-create-58-million-new-jobs-by-2022-says-report/#55a6052e4d4b http://reports.weforum.org/future-of-jobs-2018/key-findings/ //www.brookings.edu/research/automation-and-artificial-intelligence-how-machines-affect-people-and-places/ https://www.networkerstechnology.com/ai-jobs-in-healthcare https://hbr.org/2018/03/ai-will-change-health-care-jobs-for-the-better

FDA Warns Seller of Fraudulent COVID-19 Products

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FDA Warns Seller of Fraudulent COVID-19 Products

April 09, 2020: “The U.S. FDA has issued warning letters to three sellers of fraudulent COVID-19 products. There are currently no approved preventatives or treatments for COVID-19, the FDA said in a statement.


According to the FDA, the Genesis II Church of Health and Healing sold fraudulent and dangerous chlorine dioxide products known as “Miracle Mineral Solution” to prevent and treat COVID-19. But, the FDA said it is not aware of any scientific evidence supporting their safety or effectiveness and they pose significant risks to patient health.”

“Similarly, Savvy Holistic Health dba Holistic Healthy Pet sold fraudulent products with misleading claims about the prevention or treatment of COVID-19 in people and pets. The FDA alleged that CBD Online Store also offered unapproved and misbranded CBD products with misleading claims that the products are safe and/or effective for the treatment or prevention of Coronavirus.
As of Thursday, Over 1.5 million novel coronavirus cases have been reported all over the world, with 88,500 reported death. The United States has more than 435,000 confirmed coronavirus cases, and more than 14,700 people died.”
https://fda.einnews.com/article/514189726?lcf=8DWPqPuUsDVNDakfEIxsCA%3D%3D

Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy in First-Line Lung Cancer

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Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy in First-Line Lung Cancer

April 08, 2020 : “Bristol Myers Squibb announced that the U.S. FDA has accepted its supplemental Biologics License Application (sBLA) for Opdivo(nivolumab)plus Yervoy(ipilimumab), administered concomitantly with a limited course of chemotherapy, for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

The FDA granted this application Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of August 6, 2020, in addition to granting Fast Track designation.”

“Additionally, the European Medicines Agency (EMA) validated a type II variation application for Opdivo plus Yervoy, combined with limited chemotherapy, for the same indication. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process. This follows an announcement on March 26, 2020 that Ono Pharmaceutical Co., in partnership with Bristol Myers Squibb, submitted a supplemental application for Opdivo plus Yervoy combined with limited chemotherapy for consideration of manufacturing and marketing approval in Japan. The applications were based on results from the Phase 3 CheckMate -9LA trial. In October 2019, the company announced the trial met its primary endpoint of superior overall survival (OS) at a pre-specified interim analysis.”

“Despite treatment advances, there remains a serious unmet need for additional innovative treatment options for lung cancer patients globally,” said Sabine Maier, M.D., development lead, thoracic cancers, Bristol Myers Squibb. “The FDA’s acceptance and EMA’s validation of our applications represent important milestones for patients with lung cancer, and we look forward to working with regulatory authorities to bring the first and only dual immunotherapy plus limited chemotherapy regimen to patients as soon as possible.”

“CheckMate -9LA is an open-label, multi-center, randomized Phase 3 trial evaluating Opdivo (360 mg Q3W) plus Yervoy (1 mg/kg Q6W) combined with chemotherapy (two cycles) compared to chemotherapy alone (up to four cycles followed by optional pemetrexed maintenance therapy if eligible) as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and histology. Patients in the experimental arm were treated for up to two years or until disease progression or unacceptable toxicity. Patients in the control arm were treated with up to four cycles of chemotherapy and optional pemetrexed maintenance (if eligible) until disease progression or toxicity. The primary endpoint of the trial was overall survival (OS) in the intent-to-treat population. Secondary endpoints included progression-free survival (PFS), overall response rate (ORR) and efficacy measures according to biomarkers.

Lung cancer is the leading cause of cancer deaths globally. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer and accounts for up to 84% of diagnoses. Survival rates vary depending on the stage and type of the cancer when diagnosed. For patients diagnosed with metastatic lung cancer, the five-year survival rate is approximately 5%.”
https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-announces-acceptance-us-and-eu-regulatory

Tiziana Life Sciences Develops Novel Investigational Treatment For Patients Infected with COVID-19 Utilizing Direct Delivery of Anti-Interlukin-6-Receptor Monoclonal Antibodies

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Tiziana Life Sciences Develops Novel Investigational Treatment For Patients Infected with COVID-19 Utilizing Direct Delivery of Anti-Interlukin-6-Receptor Monoclonal Antibodies

April 09, 2020: “Tiziana Life Sciences (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for inflammatory and autoimmune diseases, announced that it has developed investigational new technology to treat COVID-19 infections, which consists of direct delivery of anti-IL-6 receptor (anti-IL-6R) monoclonal antibodies (mAbs) into the lungs using a handheld inhaler or nebulizer.

Development of this novel technology is a step forward toward expediting development of TZLS-501, a fully-human anti-interleukin-6 receptor (anti-IL6R) monoclonal antibody (mAb) for treatment of patients infected with COVID-19 (SARS-CoV-2) coronavirus.

The Company believes the technology could also be applicable for use with other FDA approved mAbs and drugs. The Company has submitted a provisional patent application for the delivery technology.”

“Direct delivery of anti-IL-6R mAb to the lungs using a portable handheld inhaler or nebulizer is a rapid and immediate therapy for children and adults infected with COVID-19.

Importantly, this treatment with our fully human anti-IL-6R mAb (TZLS-501) has the potential to be a long-term therapy to halt progression and reduce mortality in patients with COVID-19, as a portion of the population may not opt to utilize a vaccine,” said Gabriele Cerrone, Chairman of Tiziana Lifesciences.

“Patients infected with COVID-19 are known to develop an uncontrolled immune response (“cytokine storm”), which results in excessisive production of pro-inflammatory cytokines and other proteins such as interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-a) and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), which in turn causes severe damage to lung tissue resulting in respiratory failure and eventually death.

Among these cytokines, IL-6 seems to be one of the major culprits underlying coronavirus-mediated respiratory failure. Early clinical studies conducted by doctors in China suggest that anti-IL6R mAbs may be used in clinical practice for treatment of COVID-19.

Consequently, China’s National Health Commission has recommended the use of Roche’s blockbuster drug, Actemra® and Sanofi’s Kevzera® for treatment of patients infected with COVID-19.”

“Excessive production of IL-6 is regarded as a key driver of chronic inflammation and is believed to be associated with the severe lung damage commonly observed with COVID-19 infections and acute respiratory distress syndrome (ARDS). Tiziana believes TZLS-501 (anti-IL6R) combined with this newly introduced inhalation technology may rapidly inhibit inflammation in lungs and in combination with intravenous administration may deplete circulating levels of IL-6 and potentially halt progression of COVID-19-mediated lung damage and death.

“The filing of this comprehensive provisional patent application covering treatment with our anti-IL-6R mAb, as well as prophylactic intervention with a vaccine candidate, designed from Spike (S) protein of COVID-19, is an important step in finding a solution to the current pandemic. We look  forward to providing updates on the development of this product candidate and its introduction into clinical trials in a real-world setting,” said Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences. The person who arranged for the release of this information was Dr Kunwar Shailubhai, the Chief Executive Officer of the Company.”

“TZLS-501, a fully human mAb, was acquired from Novimmune, a Swiss biotechnology company, in 2017. The cytokine, IL-6, a major determinant in the priming of pathogenic T cells to produce an inflammatory response, binds to its receptor subunit IL-6Rα on the cell membrane. The receptor IL-6Rα can be shed as a soluble sIL6Rα, which binds to circulating IL-6 cytokine in the blood. The downstream signaling from which sIL-6R is implicated mediates pro-inflammatory effect underlying the inflammatory diseases such as rheumatoid arthritis (RA) and acute respiratory distress syndrome (ARDS). The Company believes that the novel features of TZLS-501 consisting of its dual mechanism of action to inhibit signaling by the membrane-bound and soluble IL-6 receptor and the rapid depletion of circulating IL-6 cytokines, which is the major cause of lung damage, provides this mAb with distinct advantages for treatment of COVD-19. The Company licensed TZLS-501 from Novimmune, a Swiss biotechnology company, in 2017.”
https://www.tizianalifesciences.com/news-item?s=2020-04-09-tiziana-life-sciences-develops-novel-investigational-treatment-for-patients-infected-with-covid-19-utilizing-direct-delivery-of-anti-interlukin-6-receptor-monoclonal-antibodies

Avacta and Cytiva collaborating on COVID-19 Rapid Test

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Avacta and Cytiva collaborating on COVID-19 Rapid Test

April 08,  2020: “Avacta Group plc the developer of Affimer® biotherapeutics and reagents, is pleased to announce that it has entered into a collaboration with Cytiva, formerly known as GE Healthcare Life Sciences. The companies will develop and manufacture an Affimer-based point-of-care rapid test intended for screening of large populations to diagnose the COVID-19 coronavirus infection.

The World Health Organisation recently highlighted the need for the development of rapid tests to quickly diagnose COVID-19 at point-of-care to assist in limiting and tracking infections.

Existing tests are not suitable for screening large numbers of people for the infection as they are laboratory based and it can take up to several days to get the results.”

“Avacta is already generating Affimer reagents that detect the COVID-19 virus and together with Cytiva will develop and manufacture a test capable of diagnosing the infection in minutes using a respiratory sample such as saliva.

Cytiva will transfer this diagnostic assay onto its proprietary point-of-care test strip platform and both companies will work together to complete analytical and clinical validation of the test as quickly as possible.
Avacta will own the intellectual property relating to the COVID-19 Affimer-reagents and will retain all the commercial rights to future products. Further commercial details have not been disclosed.”

Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: “I am delighted that we have established this collaboration with Cytiva to develop, manufacture and commercialise a rapid test for COVID-19 infection. Importantly the test will indicate if a person has the virus now, whether they are showing symptoms or not, and will do so in minutes, in-situ with no need f or laboratory equipment.

“Unfortunately, many millions of people around the world will ultimately become infected and it is likely to be an annual occurrence. There is a clear and urgent need for a test that can be carried out quickly in the community to limit the spread of the virus and track its progress.

We have demonstrated before in the case of the Zika virus that the Affimer platform can very quickly provide highly specific reagents in response to an outbreak of an infectious disease. Our partnership with Cytiva means that we now have a global technology partner for a COVID-19 diagnostic which is essential if a practical and commercial solution is to be provided to governments and healthcare providers around the world promptly.”

“Hundreds of millions of tests will be needed for population screening and we will be working hard to deliver an Affimer based solution on Cytiva’s platform, and potentially on the platforms of other partners with whom we are in active discussion, as soon as possible. We are aiming to have developed Affimer reagents for a COVID-19 test by the end of May that can be transferred to Cytiva and potentially to other global diagnostic manufacturers to implement in a test strip”.

Klaus Hochleitner, Global Lead, Technology Product Specialist at Cytiva, commented: “There is an urgent unmet need for rapid tests to screen large numbers of people for COVID-19. Affimers are tools that can be designed quickly and very specifically for specific epitopes. We will support Avacta with technology transfer and usability to ensure the test is ready at the earliest point for use in the field.”
https://avacta.com/avacta-and-cytiva-formerly-ge-healthcare-life-sciences-collaborating-on-covid-19-rapid-test/

Roche provides regulatory update on Risdiplam for the treatment of Spinal Muscular Atrophy (SMA)

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Roche provides regulatory update on Risdiplam for the treatment of Spinal Muscular Atrophy (SMA)

April 07, 2020: “Roche announced that the U.S.FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of risdiplam with a decision expected by August 24, 2020.

The extension is a result of the recent submission of additional data by Roche, including data from the pivotal SUNFISH Part 2 study, in close collaboration with the FDA. These data were recently presented at the 2nd International Scientific and Clinical Congress on Spinal Muscular Atrophy.

In November 2019, the FDA granted Priority Review for risdiplam with a decision for approval expected by May 24, 2020. In February 2020, based on discussions with the FDA, Roche submitted additional data which could help ensure access to risdiplam for a broad range of people living with the condition, if approved.

This included 12-month efficacy and safety data from the pivotal SUNFISH Part 2 study (n=180), the only placebo-controlled study ever undertaken in people aged 2-25 years with Type 2 or 3 SMA. Given the volume of additional data submitted, the FDA requires more time for review.”
“We strongly believe in the potential of risdiplam as a new therapeutic option and recognize that unmet need remains in the treatment of SMA,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are working closely with the FDA to support the review of risdiplam. Our goal is to bring this therapy to infants, children and adults living with SMA as quickly as possible.”

“As part of our continued commitment to people living with SMA, Roche is pleased to announce that we have also submitted in Brazil, Chile, Indonesia, Russia, South Korea and Taiwan. Filing in China is imminent and we are currently on track to submit a Marketing Authorization Application (MAA) to the European Medicines Agency in mid-2020 as well as other international markets.

Roche leads the clinical development of risdiplam, an investigational, orally administered survival motor neuron-2 (SMN2) splicing modifier for SMA, as part of a collaboration with the SMA Foundation and PTC Therapeutics. Risdiplam is being studied in a broad clinical trial programme in SMA, with patients ranging from birth to 60 years old, and includes patients previously treated with other SMA-targeting therapies. The clinical trial population is designed to represent the broad, real-world spectrum of people living with this disease with the aim of ensuring access for all appropriate patients.”

“Spinal muscular atrophy (SMA) is a severe, inherited, progressive neuromuscular disease that causes devastating muscle atrophy and disease-related complications. It is the most common genetic cause of infant mortality and one of the most common rare diseases, affecting approximately one in 11,000 babies. SMA leads to the progressive loss of nerve cells in the spinal cord that control muscle movement. Depending on the type of SMA, an individual’s physical strength and their ability to walk, eat or breathe can be significantly diminished or lost.
SMA is caused by a mutation in the survival motor neuron 1 (SMN1) gene that results in a deficiency of SMN protein. SMN protein is found throughout the body and increasing evidence suggests SMA is a multi-system disorder and the loss of SMN protein may affect many tissues and cells, which can stop the body from functioning.”

“Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier for SMA and is an orally administered liquid. It is designed to durably increase and sustain SMN protein levels both throughout the central nervous system and in peripheral tissues of the body. It is being evaluated for its potential ability to help the SMN2 gene produce more functional SMN protein throughout the body.”
https://www.roche.com/media/releases/med-cor-2020-04-07.htm

Oxford Biomedica joins Consortium to rapidly develop a COVID-19 vaccine candidate

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Oxford Biomedica joins Consortium to rapidly develop a COVID-19 vaccine candidate

April 08, 2020: “As of this morning, the current recorded case count for COVID-19 (coronavirus) in the UK has hit 55,242 with 6,159 deaths.

Oxford Biomedica plc, a leading gene and cell therapy group, announced today it has joined a Consortium led by the Jenner Institute, Oxford University, to rapidly develop, scale-up and manufacture a potential vaccine candidate for COVID-19, called ChAdOx1 nCov-19.

This vaccine candidate is one of the leading vaccine candidates currently in development globally, and is expected to be the UK’s first COVID-19 vaccine in clinical trials later this month.

The Consortium is led by the Jenner Institute, University of Oxford and also includes the Vaccines Manufacturing and Innovation Centre (VMIC), Pall Life Sciences, Cobra Biologics and Halix BV.”

“The Jenner Institute and the Oxford Vaccine Group have recruited individuals aged 18-55 from the Thames Valley area in the UK to study the vaccine’s safety and efficacy (see https://www.covid19vaccinetrial.co.uk/). Oxford Biomedica will provide access to its large scale GMP manufacturing facilities for viral vectors, including its new Oxbox facility, to the Consortium as required, which, along with other Consortium manufacturing partners in the UK and internationally, would allow for scaled manufacturing capacity should the safety and efficacy of the vaccine candidate be confirmed in clinical trials.

The Oxford vaccine candidate relies on adenoviral vector technology, ChAdOx1, developed at the Jenner Institute, in Oxford. It is seen as one of the most promising vaccine technologies for COVID-19 as ChAdOx1 has been shown to generate a strong immune response from one dose and it has demonstrated a good safety profile in pre-clinical and clinical trials conducted to date. No financial terms were disclosed.”

John Dawson, Chief Executive Officer of Oxford Biomedica, said: “As an established clinical and commercial manufacturer of viral vectors, we are very pleased to be in a strong position in terms of capacity and capabilities to support the important and urgent efforts of the Consortium led by the Jenner Institute, University of Oxford, to develop and scale up manufacturing of this promising vaccine candidate for COVID-19.

 “While our current activities on this vaccine candidate are just initiating, should the Consortium confirm there is promise for this candidate in the clinical trial initiating this month, we will play our role within the Consortium to scale up manufacturing as fast as possible. This will help to provide significant access to the vaccine candidate for further clinical trials and potentially, if approved for use, for many people in the UK and beyond.”
https://www.oxfordbiomedica.co.uk/news-media/press-release/oxford-biomedica-joins-consortium-rapidly-develop-covid-19-vaccine

Lancaster University academic sees positive signs from first published clinical trial for treatment of COVID-19

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Lancaster University academic sees positive signs from first published clinical trial for treatment of COVID-19

April 06, 2020: “A Lancaster University statistician who worked on the first published large randomised clinical trial for a potential treatment for the COVID-19 virus said the scientific community was coming together to combat the coronavirus. There are currently no specific treatments for COVID-19. However, it is possible that some existing drugs, usually used for other conditions, may have some benefits.”

Professor Thomas Jaki, from the Medical and Pharmaceutical Statistics Research Unit in the Department of Mathematics and Statistics at Lancaster University, said the initial trial in Wuhan, China, investigated whether anti-viral drugs used to treat HIV would relieve the symptoms of COVID-19 – and started when there were less than 500 confirmed cases worldwide.

“The trial saw 199 COVID-19 patients at Jin Yin-Tan Hospital treated either using standard of care or being given lopinavir–ritonavir. The results were published recently and showed enough promise that further, larger trials of the lopinavir–ritonavir treatment have now been established.

Specifically, the trial showed that patients who were randomly chosen to receive lopinavir–ritonavir appeared to improve faster. Meanwhile, among those patients who actually received lopinavir–ritonavir, the time to clinical improvement was significantly shorter than in patients receiving standard of care alone. At the same time acceptable safety levels were observed.”

Professor Jaki said: “The results were quite encouraging, which has led to further studies taking place and I would expect to see these treatments to be introduced into routine care, in some cases, in the coming weeks.”

“The findings from this study will also be considered as part of the forthcoming Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial. This will provide a trial platform to evaluate some of the approximately 30 treatments which are currently believed to have potential for treatment of COVID-19. The chief investigator for that trial is Peter Horby, Professor of Emerging Infectious Diseases and Global Health in the Nuffield Department of Medicine at the University of Oxford – who was also part of the initial study in Wuhan.

Professor Jaki said the fact these studies were taking place during a medical emergency had seen a determination to move things forward at pace.”

He added: “The astonishing thing about the RECOVERY trial is the speed with which it got off the ground, from the initial agreement being received from the Department of Health and Social Care it was just nine days before the first patient was recruited. That process would usually take between six and nine months.

“We have benefitted by learning from trials in China – keep it simple. RECOVERY uses a very short protocol and attempts to minimise burden on staff in hospitals which are overwhelmed, so we have tried to ensure data collection is simple. It is an important study and one which needs to be done quickly.

“This is one of the largest trials into treatments for COVID-19. There is a second large trial that is currently recruiting in the UK – REMAP-CAP – which is looking at impacts of treatments on severely ill patients, but both teams have worked together to ensure they will be able to learn as much as they can from both trials.This is unusual but a lot of the competitive nature of these things isn’t there at the moment. We all have the same goal.”

“The RECOVERY trial has been classed as an Urgent Public Health Research Study. It is one of a round of projects to receive £10.5m as part of the £20m rapid research response funded by UK Research and Innovation, and by the Department of Health and Social Care through the National Institute for Health Research (NIHR).

Chief Medical Officer Professor Chris Whitty and NHS England Medical Director Professor Stephen Powis have written to NHS trusts in England asking them to fully support the new trial.

Professor Jaki is also one of the authors of an opinion piece published in the New England Medical Journal last week on an approach to clinical trials around large epidemics.

While the piece was predominantly written months before the coronavirus outbreak, it encourages greater collaboration between scientists and much of the advice is already being reflected in the World Health Organisation’s developing strategy.

Professor Jaki added: “This is the culmination of a conversation which started several years ago where the WHO recognised the necessity of pre-planning in the event of a disease outbreak.”

“While it may sometimes feel like we are unprepared for incidents like the COVID-19 outbreak there is actually a co-ordinated global effort among scientists, and Lancaster plays its part in that.”
https://www.lancaster.ac.uk/health-and-medicine/about-us/news/lancaster-university-academic-sees-positive-signs-from-first-published-clinical-trial-for-treatment-of-covid-19-1

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