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University of Aberdeen study finds diabetes almost doubles risk of COVID-19 death

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University of Aberdeen study finds diabetes almost doubles risk of COVID-19 death

May 09, 2022: “People with diabetes were almost twice as likely to die with Covid and almost three times as likely to be critically or severely ill compared to those without diabetes.

However, the study conducted by researchers from the University of Aberdeen which reviewed data from hundreds of thousands of people from all over the world, also found that good management of the condition can mitigate against the risks. 

Specifically, the collaboration with King’s College, London, found that while diabetes presents a significant risk of severe illness and death with Covid, good control of blood sugar in these patients can significantly reduce this risk.  

The researchers reviewed findings from 158 studies that included more that 270,000 participants from all over the world to determine how Covid affects people living with diabetes.  

The pooled results showed that people with diabetes were 1.87 times more likely to die with Covid, 1.59 times more likely to be admitted to ICU, 1.44 times more likely to require ventilation, and 2.88 times more likely to be classed as severe or critical, when compared to patients without diabetes.  

This is the first time a study, which has been published in Endocrinology, Diabetes and Metabolism looked at the risks of Covid in patients with diabetes while factoring in the patients’ location and thereby highlighting potential healthcare resources available as well as possible ethnic differences and other societal factors. 

Data was gathered from all over the world including China, Korea, USA, Europe and the Middle East.  

The researchers found that patients in China, Korea and the Middle East were at higher risk of death than those from EU countries or the USA. 

The researchers suggest this may be due to differences in healthcare systems and affordability of healthcare which may explain the finding that maintaining optimal glycaemic control, significantly reduces adverse outcomes in patients with diabetes and Covid. 

Stavroula Kastora who worked on the study alongside Professor Mirela Delibegovic and Professor Phyo Myint explains: “We found that following a Covid-19 infection, the risk of death for patients with diabetes was significantly increased in comparison to patients without diabetes. 

“Equally, collective data from studies around the globe suggested that patients with diabetes had a significantly higher risk of requiring an intensive care admission and supplementary oxygen or being admitted in a critical condition in comparison to patients without diabetes.  

“However, we found that the studies that reported patient data from the EU or USA displayed less extreme differences between the patient groups.  

“Ultimately, we have identified a disparity in Covid outcomes between the eastern and western world.  

“We also show that good glycaemic control may be a protective factor in view of Covid-19 related deaths. 

 “In light of the ongoing pandemic, strengthening outpatient diabetes clinics, ensuring consistent follow up of patients with diabetes and optimising their glycaemic control could significantly increase the chances of survival following a Covid infection.” 

https://www.abdn.ac.uk/news/15987/

Sanofi’s nirsevimab data analyses reinforce efficacy against RSV

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Sanofi’s nirsevimab data analyses reinforce efficacy against RSV

May 11, 2022. “Results from a prespecified pooled analysis of the pivotal Phase 3 MELODY and Phase 2b nirsevimab trials demonstrated an efficacy (relative risk reduction versus placebo) of 79.5% (95% CI 65.9 to 87.7; P<0.0001) against medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV in infants born at term or preterm entering their first RSV season.

In a separate pooled post-hoc analysis of the trials, blood samples taken from infants dosed with nirsevimab exhibited RSV neutralizing antibodies that were approximately 50-fold higher than baseline at Day 151 post-dose.

RSV neutralizing antibody levels remained greater than 19-fold higher than placebo recipients with no known RSV infection through Day 361, suggesting protection may extend beyond Day 151.

The safety profile across the nirsevimab and placebo groups, as reported in previous trials, remains similar.

These findings contribute to the growing body of evidence suggesting that nirsevimab can protect all infants through their first RSV season with a single dose.”

https://www.sanofi.com/en/media-room/press-releases/2022/2022-05-11-08-00-00-2440425

FDA Takes Important Steps to Improve Supply of Infant and Specialty Formula Products

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FDA Takes Important Steps to Improve Supply of Infant and Specialty Formula Products

May 10, 2022: “The U.S. Food and Drug Administration is providing an update on its work to increase the availability of infant and specialty formula products.

On Feb. 17, the agency warned consumers not to use certain powdered infant formula products from Abbott Nutrition’s Sturgis, Michigan facility, and Abbott initiated a voluntary recall of certain products.

Since that time, the agency has been working with Abbott and other manufacturers to bring safe products to the U.S. market.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so.

We are doing everything in our power to ensure there is adequate product available where and when they need it,” said FDA Commissioner Robert M. Califf, M.D.

“Ensuring the availability of safe, sole-source nutrition products like infant formula is of the utmost importance to the FDA.

Our teams have been working tirelessly to address and alleviate supply issues and will continue doing everything within our authority to ensure the production of safe infant formula products.”

Prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition facility, the FDA was working to address supply chain issues associated with the pandemic including those impacting the infant formula industry.

The FDA continues to take several significant actions to help increase the current supply of infant formula in the U.S.

In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand. Notably, more infant formula was purchased in the month of April than in the month prior to the recall. 

Leveraging all of the tools at its disposal to support the supply of infant formula products, the FDA is:

  • Meeting regularly with major infant formula manufacturers to better understand their capacity to increase production of various types of infant formulas and medical foods.

    The infant formula industry is already working to maximize their production to meet new demands.

    Efforts already underway by several infant formula manufacturers include optimizing processes and production schedules to increase product output, as well as prioritizing product lines that are of greatest need, particularly the specialty formulas. 
  • Helping manufacturers bring safe product to the market by expediting review of notifications of manufacturing changes that will help increase supply, particularly in the case of the specialized formulas for medical needs. 
  • Monitoring the status of the infant formula supply by using the agency’s 21 Forward food supply chain continuity system, combined with external data.

    21 Forward was developed during the pandemic to provide a comprehensive, data-backed understanding of how COVID-19 is currently impacting food supply chains. 
  • Compiling data on trends for in-stock rates at both national and regional levels to help understand whether the right amount of infant formula is available in the right locations, and if not, where it should go. 
  • Expediting the necessary certificates to allow for flexibility in the movement of already permitted products from abroad into the U.S
  • Offering a streamlined import entry review process for certain products coming from foreign facilities with favorable inspection records. 
  • Exercising enforcement discretion on minor labeling issues for both domestic and imported products to help increase volume of product available as quickly as possible.

    Reaching out to retailer stakeholder groups to request that their members consider placing purchase limits on some products in order to protect infant formula inventories for all consumers.
  • Not objecting to Abbott Nutrition releasing product to individuals needing urgent, life-sustaining supplies of certain specialty and metabolic formulas on a case-by-case basis that have been on hold at its Sturgis facility.

    In these circumstances, the benefit of allowing caregivers, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection.

    The FDA is working to ensure health care provider associations and stakeholders understand information about the risks and benefits of pursuing this product.

It’s important to understand that only facilities experienced in and already making essentially complete nutrition products are in the position to produce infant formula product that would not pose significant health risks to consumers.

The FDA established an Incident Management Group to continue coordinating longer-term activities, which is focused on working with other major infant formula manufacturers to increase supply and helping to ensure that production of infant formula products can safely resume at Abbott Nutrition’s Sturgis facility, among other activities. 

The agency continues to advise against making infant formulas at home 

and encourages caregivers to work with their child’s health care provider for recommendations on changing feeding practices, if needed. 

The FDA will continue to dedicate all available resources to help ensure that infant formula products remain available for use in the U.S. and will keep the public informed of progress updates.

https://www.fda.gov/news-events/press-announcements/fda-takes-important-steps-improve-supply-infant-and-specialty-formula-products

Evonetix granted patents for novel gene assembly method

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Evonetix granted patents for novel gene assembly method

MAY 8, 2022: “EVONETIX LTD (‘Evonetix’), the synthetic biology company bringing semiconductor technology to DNA synthesis announced it has been granted a European patent covering its unique Binary Assembly method for gene synthesis.

The patent (EP 3688189 B1) further strengthens Evonetix’s IP portfolio and is a key milestone in the Company’s strategy to simplify gene synthesis for users and enable a new generation of in-lab DNA synthesis platforms.

Evonetix’s novel semiconductor-based synthesis chip uses precise temperature control to manage the DNA synthesis cycle at thousands of individually addressable sites across the surface of the chip.

The patented method allows for the assembly of long DNA molecules “on-chip” while also removing synthesis errors during the assembly process.

The combination of error removal and assembly processes results in a far greater proportion of accurate gene sequences than through conventional assembly methods, greatly simplifying downstream processing.

Binary assembly utilises the charged nature of DNA molecules, combined with precision liquid flow, to move DNA between synthesis and assembly sites on the surface of a semiconductor chip, bringing together complementary sequences.

Thermal control separates error containing sequences from those with correct homology based on changes in melting temperatures.

Thousands of sites can be arrayed across a single chip surface, enabling large scale parallel synthesis and assembly.

In April 2022 Evonetix was granted patent EP3551331B1 in Europe for its proprietary thermal control technology for DNA synthesis.

Matthe

w Hayes, Chief Technology Officer at Evonetix, commented: “Our Binary Assembly method is at the core of Evonetix technology.

By completing full gene synthesis on one of our semiconductor chips, we can bring the prospect of a desktop DNA printer to thousands of labs.

Securing this foundational IP across Europe is both a validation of the novel nature of this approach and confirms a key part of the value of the Company.”

https://www.evonetix.com/gene-assembly-patent/

FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

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FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

May 05, 2022: “The U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.

Key Points:

  • After conducting an updated analysis, evaluation and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine.
  • The FDA has determined that the known and potential benefits of the vaccine for the prevention of COVID-19 outweigh the known and potential risks for individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and for individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
  • The Fact Sheet for Healthcare Providers Administering Vaccine  now reflects the revision of the authorized use of the Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS.

    Additionally, information on the revision to the authorized use of the vaccine and updated information on this risk of blood clots with low levels of blood platelets has been added to the Fact Sheet for Recipients and Caregivers. 

“We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community.

Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions.

We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA.

The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-janssen-covid-19-vaccine-certain-individuals

Novartis provides update on production of radioligand therapy medicines

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Novartis provides update on production of radioligand therapy medicines

May 5, 2022: “Novartis announced a temporary, voluntary suspension of production at its radioligand therapy production sites in Ivrea, Italy and Millburn, New Jersey.

The company has taken this action out of an abundance of caution as it addresses potential quality issues identified in its manufacturing processes.

Novartis is conducting a thorough review of the situation and currently expects to resolve the issues and resume some supply in the next six weeks.

As a result, the company is temporarily suspending delivery of Lutathera® (USAN: lutetium Lu 177 dotatate; INN: lutetium (177Lu) oxodotreotide) in the US and Canada, and 177Lu-PSMA-617 (INN: lutetium (177Lu) vipivotide tetraxetan), marketed as Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) in the US.

Some doses of Lutathera® (lutetium (177Lu) oxodotreotide) will be available in Europe and Asia from Novartis radioligand therapy production site in Zaragoza, Spain, although there may be some delays in supply.

In addition, Novartis is putting a temporary hold on screening and enrollment for 177Lu-PSMA-617 clinical trials globally, and Lutathera clinical trials in the US and Canada.

Quality and patient safety are our top priorities.

There is currently no indication of any risk to patients from doses previously produced at these sites. Novartis has notified treatment sites to closely monitor patients who have recently been injected and asked them to report any adverse events to Novartis patient safety.

We recognize that this situation affects patients, their families and care teams. Novartis takes this very seriously and the company is doing everything it can to resolve this issue and resume patient doses as quickly as possible.

Health authorities have been informed and will receive additional updates as they are available.

https://www.novartis.com/news/media-releases/novartis-provides-update-production-radioligand-therapy-medicines

FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease

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FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease

May 04, 2022: “The U.S. Food and Drug Administration permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease.

The Lumipulse G β-Amyloid Ratio (1-42/1-40) test is intended to be used in adult patients, aged 55 years and older, presenting with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. 
 
“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive PET scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

“With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease.” 

According to the National Institutes of Health, more than six million Americans, most age 65 or older, may have dementia caused by Alzheimer’s disease, a brain disorder known to slowly destroy memory and thinking skills, and, eventually, the ability to carry out the simplest tasks.

In most people with Alzheimer’s disease, clinical symptoms first appear later in life.  
 
Alzheimer’s disease is progressive, meaning that the disease gets worse over time.  Early and accurate diagnosis is important to help patients and caregivers with planning and early treatment options.

There is an unmet need for a reliable and safe test that can accurately identify patients with amyloid plaques consistent with Alzheimer’s disease.

While amyloid plaques can occur in other diseases, being able to detect the presence of plaque, along with other evaluations, helps the doctor determine the probable cause of the patient’s symptoms and findings.

Prior to today’s authorization, doctors used positron emission tomography (PET) scans, a potentially costly and cumbersome option, to detect/visualize amyloid plaques in a patient’s brain, often years before clinical symptom onset, to aid in diagnosing Alzheimer’s disease. 
 
The Lumipulse test is intended to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40 (specific proteins that can accumulate and form plaques) concentrations found in human cerebral spinal fluid (CSF), which can help physicians determine whether a patient is likely to have amyloid plaques, a hallmark sign of Alzheimer’s disease. Results must be interpreted in conjunction with other patient clinical information. 
 
A positive Lumipulse G β-amyloid Ratio (1-42/1-40) test result is consistent with the presence of amyloid plaques, similar to what would be seen in a PET scan. A negative result is consistent with a negative amyloid PET scan result.

A negative test result reduces the likelihood that a patient’s cognitive impairment is due to Alzheimer’s disease, enabling physicians to pursue other causes of cognitive decline and dementia.

The test is not intended as a screening or stand-alone diagnostic assay.

There is also the possibility that a positive test result could be seen in patients with other types of neurologic conditions, as well as in older cognitively healthy people, which underscores the importance of using this test in conjunction with other clinical evaluations.  
 
The FDA evaluated the safety and effectiveness of this test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank. The samples were tested by the Lumipulse G β-amyloid Ratio (1-42/1-40) and compared with amyloid PET scan results.

In this clinical study, 97% of individuals with Lumipulse G β-amyloid Ratio (1-42/1-40) positive results had the presence of amyloid plaques by PET scan and 84% of individuals with negative results had a negative amyloid PET scan.
 
The risks associated with the Lumipulse G β-amyloid Ratio (1-42/1-40) test are mainly the possibility of false positive and false negative test results.

False positive results, in conjunction with other clinical information, could lead to an inappropriate diagnosis of, and unnecessary treatment for, Alzheimer’s disease.

This could lead to psychological distress, delay in receiving a correct diagnosis as well as expense and the risk for side effects from unnecessary treatment.

False negative test results could result in additional unnecessary diagnostic tests and potential delay in effective treatment.

Importantly, the Lumipulse G β-amyloid Ratio (1-42/1-40) is not a stand-alone test and other clinical evaluations or additional tests should be used for determining treatment options.  
  
The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device. 
 
The Lumipulse G β-amyloid Ratio (1-42/1-40) was granted Breakthrough Device designation, a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. 
 
The FDA permitted marketing of the Lumipulse G ß-Amyloid Ratio (1-42/1-40) to Fujirebio Diagnostics, Inc.”

https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-new-test-improve-diagnosis-alzheimers-disease

Idorsia’s Quviviq (daridorexant) approved for adults with chronic insomnia disorder

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Idorsia’s Quviviq (daridorexant) approved for adults with chronic insomnia disorder

May 3, 2022: “Idorsia Ltd announced the EC has granted marketing authorization for QUVIVIQ™▼ (daridorexant) for the treatment of adult patients with insomnia characterized by symptoms present for at least three months and considerable impact on daytime functioning.

Chronic insomnia disorder is one of the most prevalent sleep disorders in Europe, affecting between 6%-12% of the adult population, and impacting both physical and mental health.

With this approval, QUVIVIQ becomes the first dual orexin receptor antagonist (DORA) in the European Union (EU) for the treatment of insomnia. Rather than inducing sleep through broad inhibition of brain activity, QUVIVIQ blocks only the activation of orexin receptors.

Consequently, QUVIVIQ decreases the wake drive, allowing sleep to occur, without altering the proportion of sleep stages.

The recommended dose of QUVIVIQ is one tablet of 50 mg once per night, taken orally in the evening within 30 minutes before going to bed.

In certain circumstances, such as patients with moderate hepatic impairment or who are taking moderate CYP3A4 inhibitors, the recommended dose is 25 mg once per night.

Jean-Paul Clozel, MD and Chief Executive Officer of Idorsia, commented:
“As our first treatment authorized in the EU, the approval of QUVIVIQ marks a significant medical advancement in the management of insomnia and a big milestone for Idorsia.

I am delighted to see the comprehensive long-term safety and efficacy data we have generated with QUVIVIQ included in an outstanding label.

In particular, I’m pleased with the description of the unique daytime functioning improvement data, which I believe will revolutionize the way insomnia is treated in the EU.

We are incredibly proud to bring the therapeutic benefits of QUVIVIQ, the first dual orexin receptor antagonist in Europe, to clinicians and patients. We expect to make it available in the first countries before the end of the year.”

The EC decision is supported by robust Phase 3 results – recently published in The Lancet Neurology – which demonstrated that at the recommended dose, QUVIVIQ improved sleep onset, sleep maintenance and self-reported total sleep time in adults with chronic insomnia disorder.

A major focus of the trials was to evaluate the impact of QUVIVIQ on daytime functioning in patients with insomnia disorder, as assessed by IDSIQ, a patient-reported outcomes instrument specifically developed and validated according to FDA guidelines, to measure daytime functioning in patients with insomnia.

The recommended dose of QUVIVIQ demonstrated highly statistically significant improvement in the daytime sleepiness domain of IDSIQ, which means patients reported feeling less mentally and physically tired, less sleepy and more energetic during the day, at months one and three compared to placebo, with a favorable safety profile.

In clinical trials, the most frequently reported adverse reactions were headache and somnolence.

The majority of adverse reactions were mild to moderate in intensity.

No evidence of a dose-relationship for the frequency or severity of adverse reactions was observed.

The adverse reaction profile in elderly patients was consistent with younger patients.

Somnolence was reported in 3% and 2% of patients treated with QUVIVIQ 25 mg and 50 mg, respectively, compared to 2% of subjects on placebo.

The marketing authorization was also supported by a long-term follow-up extension study, which together with the pivotal trials, provides clinical data for up to 12 months of continuous treatment.

For more information on the marketing authorization of QUVIVIQ in the European Union, please review the Summary of Product Characteristics (SmPC).

Professor Damien Léger, Université Paris Cité, France, commented:
“Sleep is an essential pillar for good physical and mental health to ensure optimal functioning throughout the day.

Chronic insomnia disorder is persistent in many patients and has direct consequences, such as impaired daytime function, decreased workplace productivity, injuries and accidents, making insomnia not only a disease of the night, but one that also markedly affects the day and a patient’s well-being.

QUVIVIQ, which can be used long-term, effectively improves sleep parameters and people’s ability to function better during the day, while avoiding major safety concerns, fulfilling the major medical requirements for insomnia management.

This is great news for the millions of adults and elderly people across the EU living with chronic insomnia.”

About QUVIVIQ (daridorexant) in insomnia disorder
Studies over the past decades have shown that hyperarousal processes in the brain play a key role in the pathology of insomnia.

Chronic insomnia disorder is the result of continued brain hyperarousal that requires sustained management with therapy suitable for daily use over months.

Orexin is a neuropeptide, a small protein-like molecule, produced by the brain that promotes wakefulness.

QUVIVIQ reduces nocturnal hyperarousal to improve sleep (onset and maintenance) without next-morning residual effects in insomnia patients, and thus improve daytime functioning.

Regulatory status of daridorexant
Marketing authorization of QUVIVIQ in Europe follows a positive opinion issued on 24 February by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

The approval is valid in all European Union Member States, as well as the European Economic Area countries Iceland, Liechtenstein and Norway, and Northern Ireland under the Northern Ireland Protocol.

In Great Britain, a separate application for the use of daridorexant for the same indication has been submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) via the European Commission Decision Reliance Procedure.

Daridorexant is currently under review with Swissmedic and Health Canada.

In January 2022, QUVIVIQ (daridorexant) was approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.”

https://www.idorsia.com/media/news-details?newsId=2743349

Byondis and medac Collaborates to commercialise Trastuzumab Duocarmazine

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Byondis and medac Collaborates to commercialise Trastuzumab Duocarmazine

May 03, 2022: “Byondis B.V., an independent, Dutch clinical stage biopharmaceutical company creating precision medicines, has entered into a License and Collaboration Agreement and a Supply Agreement with medac GmbH, a privately owned pharmaceutical company based in Germany.

Byondis and medac will partner to commercialize Byondis’ lead program, anti-HER2 antibody-drug conjugate (ADC) trastuzumab duocarmazine (SYD985), pending approval by the EMA and the UK Medicines and Healthcare products Regulatory Agency (MHRA), as well as other regulatory authorities in Europe.

Under the terms of the agreement, medac receives an exclusive license to commercialize SYD985 in the EU, the UK and further European countries, in all approved indications.

Byondis will receive an undisclosed upfront payment and sales royalties. Byondis will also be eligible for payments upon achievement of certain development and sales milestones.

“This collaboration with medac on SYD985 is a crucial step in ensuring that the therapy, once approved, is available to patients, who desperately need other treatment options,” said Byondis Founder and Chairman Jacques Lemmens, Ph.D.

“Like Byondis, medac is committed to developing novel therapies, especially in areas of unmet medical need. We believe in the potential of Byondis and SYD985 and look forward to bringing this next generation ADC to patients who need it,” said medac Managing Director, CEO Jörg Hans.

Byondis CEO Marco Timmers, Ph.D. added: “We are pleased to have found in medac a true partner who shares our passion for innovation and making a difference in the lives of patients.”

SYD985 targets a range of HER2-expressing cancers such as metastatic breast and endometrial (uterine) tumors.

Data from the SYD985 pivotal Phase III TULIP® study (SYD985.002) in HER2-positive unresectable locally advanced or metastatic breast cancer showed statistically significant progression-free survival (PFS) results compared to physician’s choice (PC) treatment.

TULIP continues to study overall survival and a Marketing Authorization Application (MAA) for this initial clinical indication will soon be submitted to the EMA.

The ADC is also in a Phase II multiregional clinical trial to evaluate its safety and efficacy in patients with HER2-expressing recurrent, advanced or metastatic endometrial cancer (SYD985.003).

ABOUT MEDAC GMBH

medac GmbH is a privately held, global pharmaceutical company with a growing pharmaceutical and diagnostics business.

Since its foundation in Germany in 1970, medac has been specializing in the treatment of diseases within the indication areas oncology, hematology, urology and autoimmune disorders.

medac is committed to the refinement of existing and the development of new therapeutic products – always with the focus on improving patients’ quality of life. medac has become known for developing innovative products also in less common indications.

This dedication has resulted in a comprehensive portfolio of pharmaceutical products that help make a difference in the lives of patients.

medac continually invests in its product development and manufacturing as well as logistic capacities to meet both patients’ needs and the demands of healthcare professionals.”

https://www.byondis.com/media/press-releases/byondis-and-medac-enter-into-license-and-collaboration-and-supply-agreements-for-anti-her2-adc-trastuzumab-duocarmazine

Imfinzi plus chemotherapy granted Priority Review in for biliary tract cancer

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Imfinzi plus chemotherapy granted Priority Review in for biliary tract cancer

May 04, 2022: “AstraZeneca’s BLA for Imfinzi (durvalumab), in combination with standard-of-care chemotherapy, has been accepted and granted Priority Review in the US for patients with locally advanced or metastatic biliary tract cancer (BTC).

The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.

The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the third quarter of 2022.

BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder. 

Approximately 23,000 people in the US are diagnosed with BTC each year.

These patients have a poor prognosis, with approximately 5% to 15% of patients with BTC surviving five years.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “People with advanced biliary tract cancer have faced poor outcomes and limited treatment options for too long, and today’s news for the TOPAZ-1 trial underscores the urgency to deliver new, effective therapies in this setting.

We are working closely with the FDA to bring the first immunotherapy-based option to patients with this devastating cancer and potentially set a new standard of care with Imfinzi plus chemotherapy.”

The sBLA was based on results from an interim analysis of the TOPAZ-1 Phase III trial presented during the 2022 American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium.

The data showed Imfinzi plus chemotherapy (gemcitabine plus cisplatin) reduced the risk of death by 20% versus chemotherapy alone (based on a hazard ratio [HR] of 0.80; 95% confidence interval [CI], 0.66-0.97; 2-sided p=0.021).

An estimated one in four (25%) patients treated with Imfinzi plus chemotherapy were alive at two years compared to one in 10 (10%) treated with chemotherapy alone.

Results also showed a statistically significant 25% reduction in the risk of disease progression or death with Imfinzi plus chemotherapy (HR, 0.75; 95% CI, 0.64-0.89; 2-sided p=0.001).

The Imfinzi combination was generally well tolerated and did not increase the discontinuation rate due to adverse events compared to chemotherapy alone.

In December 2020, Imfinzi was granted Orphan Drug Designation in the US for the treatment of BTC.

Notes

Biliary tract cancer
Biliary tract cancer (BTC) is a group of rare and aggressive gastrointestinal (GI) cancers that form in the cells of the bile ducts (cholangiocarcinoma), gallbladder or ampulla of Vater (where the bile duct and pancreatic duct connect to the small intestine).

Cholangiocarcinoma is more common in China and South-East Asia and is on the rise in Western countries.

Gallbladder cancer is more common in certain regions of South America, India and Japan.

Early-stage BTC affecting the bile ducts and gallbladder often presents without clear symptoms and most new cases of BTC are therefore diagnosed at an advanced stage, when treatment options are limited and the prognosis is poor.

TOPAZ-1
TOPAZ-1 is a randomised, double-blind, placebo controlled, multicentre, global Phase III trial of Imfinzi in combination with chemotherapy (gemcitabine plus cisplatin) versus placebo in combination with chemotherapy as a 1st-line treatment in 685 patients with unresectable advanced or metastatic BTC including intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer. Patients with ampullary carcinoma were excluded.

The primary endpoint is overall survival and key secondary endpoints included progression-free survival, objective response rate and safety.

The trial was conducted in 105 centres across 17 countries including in the US, Europe, South America and several countries in Asia including South Korea, Thailand, Japan and China.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is the only approved immunotherapy in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy, and is the global standard of care in this setting based on the PACIFIC Phase III trial.

Imfinzi is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage small cell lung cancer (ES-SCLC) based on the CASPIAN Phase III trial.

In 2021, updated results from the CASPIAN trial showed Imfinzi plus chemotherapy tripled patient survival at three years versus chemotherapy alone.

Imfinzi is also approved for previously treated patients with advanced bladder cancer in several countries.

Since the first approval in May 2017, more than 100,000 patients have been treated with Imfinzi.

As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with small cell lung cancer (SCLC), NSCLC, bladder cancer, several GI cancers, ovarian cancer, endometrial cancer, and other solid tumours.

In the past year, Imfinzi combinations have demonstrated clinical benefit in multiple additional cancer settings with positive Phase III trials in unresectable advanced liver cancer (HIMALAYA) and metastatic NSCLC (POSEIDON). 

AstraZeneca in GI cancers
AstraZeneca has a broad development programme for the treatment of GI cancers across several medicines and a variety of tumour types and stages of disease.

In 2020, GI cancers collectively represented approximately 5.1 million new cancer cases leading to approximately 3.6 million deaths.

Within this programme, the Company is committed to improving outcomes in gastric, liver, BTC, oesophageal, pancreatic, and colorectal cancers.

Imfinzi is being assessed in combinations in liver, BTC, oesophageal and gastric cancers in an extensive development programme spanning early to late-stage disease.

The Company aims to understand the potential of Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate, in the two most common GI cancers, colorectal and gastric cancers. Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Lynparza (olaparib) is a first-in-class PARP inhibitor with a broad and advanced clinical trial programme across multiple GI tumour types including pancreatic and colorectal cancers. 

Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada).

AstraZeneca in immunotherapy
Immunotherapy is a therapeutic approach designed to stimulate the body’s immune system to attack tumours.

The Company’s Immuno-Oncology (IO) portfolio is anchored in immunotherapies that have been designed to overcome evasion of the anti-tumour immune response.

AstraZeneca is invested in using IO approaches that deliver long-term survival for new groups of patients across tumour types.

The Company is pursuing a comprehensive clinical-trial programme that includes Imfinzi as a single treatment and in combination with tremelimumab and other novel antibodies in multiple tumour types, stages of disease, and lines of treatment, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient.

In addition, the ability to combine the IO portfolio with radiation, chemotherapy, and targeted small molecules from across AstraZeneca’s oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers.

It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/imfinzi-combo-granted-priority-review-for-btc.html

SK bioscience and GSK’s adjuvanted COVID-19 vaccine candidate meets coprimary objectives in phase III study

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SK bioscience and GSK’s adjuvanted COVID-19 vaccine candidate meets coprimary objectives in phase III study

April 29, 2022: “SK bioscience and GSK announced submission of a biologics license application for SKYCovione™ a recombinant protein-based COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, to the Korean Ministry of Food and Drug Safety (KMFDS) following positive Phase III clinical data.

SK bioscience conducted a Phase III clinical trial in 4,037 adults over 18-year-old across 6 countries (Thailand, Vietnam, New Zealand, Ukraine, the Philippines and South Korea).

The vaccine candidate demonstrated superior neutralizing antibody titres over AstraZeneca’s Vaxzevria™ (control vaccine), a currently authorized COVID-19 vaccine. SKYCovione™ vaccine candidate showed a clinically favorable safety profile.

The clinical trial was conducted in cooperation with 16 institutions, including Korea University Guro Hospital and IVI (International Vaccine Institute), a non-profit international organization.

The results of the Phase III clinical trial show a superior neutralizing antibody response of SKYCovione™ against SARS-CoV-2 parental strain, 2.93 times that of a control vaccine 2 weeks after the second dose.

In addition, the proportion of participants who seroconverted, (with a greater than four-fold increase in neutralizing antibody titres compared to baseline), was 98.06% in the SKYCovione™ group and 87.30% in the control group.

Both immunological superiority and non-inferiority of SKYCovione™ was demonstrated compared to Vaxzevria™ (control vaccine).

Even in subjects aged 65 or older, the antibody conversion rate of those vaccinated with SKYCovione™ was over 95%, when compared to the control vaccine (about 79% for the same age group).

In terms of safety, overall, SKYCovione™ showed a clinically acceptable safety profile​. Most of the adverse reactions that occurred after injection were mild or moderate.

Roger Connor, President of GSK Vaccines, said, “As the COVID-19 pandemic continues to evolve, a variety of vaccines will be needed to meet the health needs across the globe, including temperature stable vaccines like the SK/GSK vaccine candidate.

These immunogenicity and safety data confirm the important role that our adjuvant technologies play in vaccine development.”

Jae-Yong Ahn, CEO of SK bioscience said, “At this point in time, when countries around the world are developing strategies to respond to the endemic phase of the COVID-19 global health crisis, SK bioscience has reached the final stage of developing Korea’s first COVID-19 vaccine for the benefit of Korea and the world.

SK bioscience will not settle for the present but will do its best to become an innovative vaccine and biotechnology company in South Korea through continuous cooperation with global organizations and companies.”

SKYCovione™ is a self-assembled nanoparticle vaccine candidate targeting the receptor binding domain of the SARS-CoV-2 Spike protein for the parental SARS-Cov-2, jointly developed with the Institute for Protein Design (IPD) at the University of Washington School of Medicine with combination of GSK’s pandemic adjuvant.

The development of SKYCovione™ has been supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

The approval of SKYCovione™ is through a formal biologics license application procedure, not a conditional approval process.

In March, SK bioscience signed an advance purchase agreement with the Korea Centers for Disease Control and Prevention (KDCA) for a total of 10 million doses of SKYCovione™.

In addition, SK bioscience will apply for emergency use listing (EUL) to the World Health Organization (WHO) and authorizations at individual regulatory agencies around the world.

If authorized, GBP510 could be made available to the COVAX Facility for procurement and equitable allocation worldwide, if required.

SK bioscience is conducting a homologous booster clinical trial of SKYCovione™ in South Korea and a heterologous booster trial in both South Korea and abroad.

The Adolescents trial between 12 to 17-year-old is expected to enter a Phase III stage in the first half of 2022.

In addition, an extended clinical trial seeking to test the preventive effect of SKYCovione™ against COVID-19 variants such as Omicron is planned.”

https://www.gsk.com/en-gb/media/press-releases/sk-bioscience-and-gsk-s-adjuvanted-covid-19-vaccine-candidate-meets-coprimary-objectives-in-a-phase-iii-study/

FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines

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FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines

April 29, 2022: “The U.S. FDA is announcing its plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of emergency use authorization requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.

It is important to note that the dates below are tentative as none of the submissions are complete.

The agency understands the urgency to authorize a vaccine for age groups who are not currently eligible for vaccination and will work diligently to complete our evaluation of the data.

Should any of the submissions be completed in a timely manner and the data support a clear path forward following our evaluation, the FDA will act quickly and anticipates convening the following VRBPAC meetings: 

  • On June 7, FDA intends to convene VRBPAC to discuss an EUA request for a COVID-19 vaccine manufactured by Novavax to prevent COVID-19 in individuals 18 years of age and older.
  • On June 8, 21 and 22, the FDA has held dates for the VRBPAC to meet to discuss updates to the Moderna and Pfizer-BioNTech EUAs for their COVID-19 vaccines to include younger populations.

    As the sponsors complete their submissions and the FDA reviews that data and information, it will provide additional details on scheduling of the VRBPAC meetings to discuss each EUA request.
  • On June 28, the FDA plans to convene the VRBPAC to discuss whether the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified, and if so, which strain(s) should be selected for Fall 2022.

    This meeting is a follow-up to the April 6 VRBPAC meeting that discussed general considerations for future COVID-19 vaccine booster doses and the strain composition of COVID-19 vaccines to further meet public health needs. 

“As we continue to address the ongoing COVID-19 pandemic, there are a number of anticipated submissions and scientific questions that will benefit from discussion with our advisory committee members,” said Peter Marks, M.D., Ph.D., director of the Center for Biologics Evaluation and Research.

“We are providing a tentative schedule for discussion of these submissions, as these meetings will cover a number of topics that are of great interest to the general public.

The agency is committed to a thorough and transparent process that considers the input of our independent advisors and provides insight into our review of the COVID-19 vaccines.

We intend to move quickly with any authorizations that are appropriate once our work is completed.”

Once the meeting dates are finalized, the FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days before each meeting.

The agency is also prepared to schedule additional VRBPAC meetings as needed should additional complete EUA requests be submitted that warrant discussion with the FDA’s advisors.

In general, advisory committees include a Chair, members with scientific, medical and public health expertise and a consumer and industry representative.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-tentative-advisory-committee-meeting-schedule-regarding

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