Aziyo Submits 510(k) for Biomaterial Envelope Enhanced with Antibiotics

  Aziyo Biologics, Inc. (Nasdaq: AZYO), today announced the Company has filed a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for CanGaroo® RM Antibacterial Envelope, its next-generation biomaterial envelope for use with implantable electronic devices (IED). Aziyo Biologics is a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improving outcomes in patients undergoing surgery.

With this 510(k) submission, the Company intends to bring to the U.S. market a version of its existing FDA-approved CanGaroo envelope enhanced with the antibiotics Rifampin and Minocycline in dissolvable polymer rings. The addition of antibiotics to the biomaterial envelope is designed to reduce the risk of bacterial colonization.

https://finance.yahoo.com/news/aziyo-announces-fda-510-k-120000076.html

Athira Starts Phase 1 for Small Molecule for Neuropsychiatric Conditions

 Preclinical data show ATH-1020 both mitigated depression-like behaviors and normalized sensory processing deficits in schizophrenia

https://finance.yahoo.com/news/athira-pharma-doses-first-subject-110000307.html

Baxter cut to Sell from Neutral by Goldman

 Target to $77 from $88

https://finviz.com/quote.ashx?t=BAX&ty=c&ta=1&p=d

Invitae: 1st Comprehensive Genetic Test Suite for Neurodevelopmental Disorders

 Invitae (NYSE: NVTA), a leading medical genetics company, today announced the full commercial launch of its Neurodevelopmental Disorders (NDD) package to deliver a robust testing suite that can deliver actionable genetic insights to inform treatment plans for children with developmental disabilities. Invitae is the first to offer this particular suite of tests to clinicians and patients in an easily accessible format.

The package includes chromosomal microarray analysis, analysis for fragile X-related disorders, and a next-generation-sequencing panel of 200+ genes in which variants are associated with neurodevelopmental disorders. The gene panel can detect sequence variants as well as full or partial gene deletions and duplications (i.e. intragenic copy number variants) that a chromosomal microarray analysis (CMA) alone may not detect. The comprehensive package provides reports for all three tests and can help provide clarity on the genetic etiology and root cause of these complex and sometimes overlapping conditions. The package is accessible, affordable, and fast, with test results delivered in 10-21 days.

One in six children between the ages of 3 and 17 years old has a developmental disability, yet two out of three children do not receive the recommended genetic testing. The NDD package is supported by guidelines from the American Academy of Pediatrics that recommend CMA and fragile X syndrome testing for children with intellectual disability, global developmental delay, or autism spectrum disorder. They also recommend further testing that may include gene panels and whole exome sequencing.

https://finance.yahoo.com/news/invitae-introduces-first-comprehensive-genetic-103000712.html

Bioventus Exercises Call Option to Acquire CartiHeal

  Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, today announced that it has exercised its call option to acquire CartiHeal Ltd., excluding the ownership interest already owned by Bioventus, for approximately $315 million, with an additional approximately $135 million payable contingent upon the achievement of $100 million in trailing twelve month sales. Bioventus plans to finance the acquisition with additional debt. The Company’s decision to exercise this option follows the U.S. Food and Drug Administration’s (FDA) March 29, 2022, premarket approval (PMA) of CartiHeal’s Agili-C™ implant.

https://finance.yahoo.com/news/bioventus-exercises-call-option-acquire-110000749.html

DNA vaccines join the fight against COVID-19

 

• Anna K Blakney
• Linda-Gail Bekker

DOI:https://doi.org/10.1016/S0140-6736(22)00524-4

PDF: https://www.thelancet.com/action/showPdf?pii=S0140-6736%2822%2900524-4

As of March, 2022, just over 1 year has passed since the authorisation of first-generation vaccines against COVID-19. Since then, almost 10 billion doses of COVID-19 vaccines have been administered globally.

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 Although the delivery of this number of vaccines is a remarkable achievement, there is still a disparity in vaccine equity, access, and affordability between high-income and low-income countries. According to the Global Dashboard for Vaccine Equity (established by the UN Development Programme, WHO, and the University of Oxford), as of Jan 18, 2022, approximately 67·6% of people in high-income countries have had at least one dose, compared with only approximately 11·36% of people in low-income countries.

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 This inequity has major negative implications for global pandemic control; thus, there is an imperative to develop more affordable, scalable, and easily distributable vaccines.

In the current landscape of mRNA, viral vector, and inactivated COVID-19 vaccines, one modality that has been largely under-represented is DNA vaccines. In The Lancet, Akash Khobragade and colleagues

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 report an interim analysis of a phase 3, randomised, double-blind, placebo-controlled study of a DNA vaccine, ZyCoV-D, against COVID-19. The vaccine contains a 2 mg dose of a DNA plasmid (pVAX-1) expressing the Wuhan Hu-1 spike antigen of SARS-CoV-2 and an IgE signal peptide, which is delivered intradermally using a needle-free injection system. Participants received three doses of vaccine or placebo at 28-day intervals. The primary outcome of this study was the number of participants with first occurrence of symptomatic COVID-19, as determined by a symptomatic RT-PCR test 28 days after the third dose, until the targeted number of 158 cases was achieved. Between Jan 16 and June 23, 2021, 27 703 participants (aged >12 years) were randomly assigned (1:1) to receive ZyCoV-D (n=13 851) or placebo (n=13 852), and 81 cases were eligible for the interim primary efficacy endpoint as per protocol, which yielded a vaccine efficacy of 66·6% (20 cases in the ZyCoV-D group and 61 in the placebo group). There was full protection against more severe disease and death. It is important to keep in mind that this study was done during a surge of the B.1.617.2 (delta) variant in India, and the study population was predominantly male (18 592 [67·11%] male and 9111 [32·89%] female), with no ethnicity data reported. Furthermore, the efficacy analysis was not stratified for age. Age is a known determinant of both COVID-19 outcomes and vaccine effectiveness. Finally, the efficacy analysis was only performed after the third dose, limiting insight into the effect of the first and second doses—this is useful information where incomplete vaccination could occur.

The vaccine was found to be safe, with approximately equivalent prevalence of solicited adverse events between the ZyCoV-D (n=623) and placebo (n=620) groups. The authors state that the safety profile of ZyCoV-D is comparable to another DNA-based vaccine in development.

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 Notably, ZyCoV-D was found to be stable at room temperature (25°C) for 2 months in initial studies, although it was stored at 2–8°C for this study. Based on the safety, immunogenicity, and efficacy findings from the phase 3 trial, ZyCoV-D has been granted Emergency Use Authorisation in India: a landmark milestone for DNA vaccines with potential to further contribute to the COVID-19 vaccine diversity and worldwide supply.

Despite decades of research and development of DNA vaccines, including at least eight candidates currently in clinical trials for COVID-19,

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 they have had limited success. One of the main challenges for DNA vaccines is the delivery: mRNA vaccines need to cross only one membrane to reach their site of action (cytoplasm), whereas DNA vaccines need to cross the cytoplasm and the nuclear membrane. Because of this difference, the lipid nanoparticles that effectively deliver mRNA do not work as well for DNA. Historically, DNA vaccines have required a physical method of delivery such as electroporation, or the needle-free injection system used in this study.

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 Although these physical devices appear to be effective—as shown in this study—they pose a potential challenge for widespread use and scale-up. The device used in Khobragade and colleagues’ study

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 is small and portable (<50 g) and consists of an injector, syringe, and filling adapter. However, widespread administration of ZyCoV-D will be limited not only by production and availability of the DNA, but also the injection device, which is vulnerable to global manufacturing disruptions. If these delivery system challenges can be overcome then the amenable storage conditions, efficacy against COVID-19 (including the delta strain), and low cost (<US$10) have poised ZyCoV-D to be another global solution in our fight against SARS-CoV-2, and might act as a catalyst for DNA-based vaccines against other diseases, such as tuberculosis and HIV-1, especially in areas that have restricted access and affordability.

AKB is a co-founder and reports holding shares in VaxEquity, a for-profit company that aims to develop self-amplifying RNA vaccines for infectious diseases, but is not currently actively involved in the company. VaxEquity does not produce DNA vaccines. L-GB has received honoraria from Gilead Sciences and Merck for advisory work in HIV prevention.

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00524-4/fulltext

China reports record-high infections with Shanghai worst hit, new variant found in Suzhou

 The Chinese mainland reported 13,146 local COVID-19 cases on Sunday, including 1,455 confirmed and 11,691 asymptomatic ones, the highest number of daily increase since the latest outbreak, which has already infected over 100,000 people. 

While one of the severest-hit regions in Northeast China's Jilin Province successfully curbed the epidemic, the infection curve has not seen signs of decline, and a new Omicron variant mutation was detected in East China's Jiangsu Province, neighboring Shanghai, where the mass majority of cases in China have been found in recent days. 

Shanghai in particular, reported 438 local confirmed and 7,788 asymptomatic cases on Sunday. Chinese Vice Premier, Sun Chunlan, on Saturday made an official visit to the city to help battle the virus.

Sun stressed that the dynamic zero-COVID strategy must be upheld with resolute and swift action, while recognizing the enormous challenges that the mega city of 25 million faces in both maintaining the normal operation of its core functions and battling the Omicron variant outbreak.

Even with the Omicron variant, as long as we take proactive measures, it still can be brought under control, said Zhang Boli, an academician from the Chinese Academy of Engineering and head of the Tianjin University of Traditional Chinese Medicine (TCM), adding that the high percentage of asymptomatic cases in the current epidemic outbreak is due to the characteristics of the variant itself, but is also tied to the speedy mass testing rollout. 

Zhang also noted that the increase in vaccination rates among residents has boosted herd immunity against the virus, and those who get infected will show lighter or no symptoms. As of Sunday, the Chinese mainland had administered a total of over 3.27 billion doses of COVID-19 vaccine, according to health officials. 

Wu Zunyou, chief epidemiologist of China's Center for Disease Control and Prevention, said on Friday that the reason that China reports more asymptomatic cases and fewer severe cases is not the result of the characteristics of Omicron, as foreign countries are reporting even more deaths caused by Omicron compared with that of Delta. 

"It is the result of our effective epidemic prevention work, namely the early identification of the epidemic, timely response, and the whole-process management for all infected people, including the asymptomatic cases, giving them traditional Chinese medicine to improve their immunity and prevent severe infection," Wu said. 

If more asymptomatic cases are to be discovered as the epidemic progresses, there is a possibility that the asymptomatic cases who meet the quarantine conditions can be quarantined at their own homes, Chen Erzhen, the deputy head of Ruijin Hospital in Shanghai, said in an interview with the People's Daily on Friday.

Wu said that epidemic control would be more challenging for a city when infections exceed 10,000 within a short period. For one thing, more patients need to be treated and greater quantities of close contacts need to be quarantined; for another thing, medical staff are put under increased pressure. However, he believed that the Chinese tradition of helping others in need will help regions win this hard battle eventually.

Community workers guide local residents to do nucleic acid test in Changning District of east China's Shanghai, April 1, 2022. Shanghai has launched a nucleic acid testing campaign in areas west of the Huangpu River from Friday amid the second phase of the city's closed-off management.Photo:Xinhua

With Shanghai's hospital system on the verge of being overwhelmed, medical teams and supplies from across the country are flooding in to help fight the outbreak, with thousands of medical workers coming from neighboring provinces of Jiangsu and Zhejiang to assist in nucleic acid testing and the building of makeshift hospitals among other epidemic prevention tasks.

Apart from medical supplies, food and other daily necessities are being sent to Shanghai to ensure local residents maintain a state of normalcy. A total of 10 regions from across China had come to the aid of Shanghai as of Sunday. 

Shanghai has distributed antigen self-testing kits to help with citywide screening. The renowned local infectious disease expert Zhang Wenhong said that through the antigen test, authorities can acquire the basic infection data and contain parts of the infection sources so that they can prevent the transmission in a timely manner. To conduct antigen tests aside from the nucleic acid test can also boost the efficiency, he said. 

Suzhou in East China's Jiangsu Province, which borders Shanghai, discovered a confirmed coronavirus disease patient infected with a mutation VOC/Omicron variant BA.1.1, unidentified in previously found strains worldwide, posing new threats to the already dangerous situation in the region.

Another hard-hit region by the epidemic, Jilin Province, has seen little sign of improvement, recording 4,455 cases on Sunday. Jilin city announced on Sunday that it had successfully curbed the virus. 

https://www.globaltimes.cn/page/202204/1257462.shtml