Sinovac coronavirus vaccine 78% effective in Brazil trial, details sparse

 A coronavirus vaccine developed by China’s Sinovac Biotech was 78% effective in a late-stage Brazilian trial and entirely prevented severe COVID-19 cases, researchers said on Thursday, although a lack of data details stirred calls for more transparency.

The announced efficacy, closely watched by developing countries counting on the vaccine to begin mass inoculations to help end a raging pandemic, was below preliminary findings from Turkish researchers and lacked detailed data provided on U.S. and European vaccines.

The director of Brazilian biomedical center Butantan, Sinovac’s research and production partner, said detailed results were being submitted to health regulator Anvisa as part of a request for emergency use of the vaccine.

“One thing is a presentation at a news conference. It’s something else to get the data and analyze it, which is what Anvisa will do,” said Cristina Bonorino, who sits on the scientific committee of the Brazilian Immunology Society. “If it’s what they say, that’s an excellent result,” she added.

Brazil and Indonesia, which have the most COVID-19 cases in Latin America and Southeast Asia, respectively, are preparing to roll out the vaccine, called CoronaVac, this month. Turkey, Chile, Singapore, Ukraine and Thailand have also struck supply deals with Sinovac.

Although CoronaVac’s efficacy falls short of the 95% success rate of vaccines from Moderna Inc or Pfizer Inc with partner BioNTech SE, it is easier to transport and can be stored at normal refrigerator temperatures.

The 78% efficacy rate is also well above the 50% to 60% benchmark set by global health authorities for vaccines in development early in the pandemic, given the urgent need.

Moderna and Pfizer/BioNTech released detailed results of late-stage trials last year, before receiving emergency use authorizations in the United States and elsewhere.

Butantan Director Dimas Covas told a news conference that full CoronaVac data would be released in an unspecified scientific publication but did not provide a timeline.

Pressed by journalists, Covas said there had been 218 COVID-19 cases in the trial of 13,000 volunteers. Just over 160 of those cases occurred among participants who received a placebo and the rest were in vaccinated volunteers, he said.

Brazil’s CoronaVac trial included elderly volunteers, unlike other studies of the vaccine.

Covas said CoronaVac had entirely prevented severe COVID-19 cases among the vaccinated group, including the elderly. None of those who received the vaccine become ill enough to require hospitalization, he added.

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Piecemeal disclosure of results from global CoronaVac studies have led to concerns about transparency of the trials.

Dr. Gregory Poland, a virologist and vaccine researcher with the Mayo Clinic in Rochester, Minnesota, complained that Thursday’s news from Brazil was “bereft of any real detail.”

“I want to see the data. I want to understand the methods and what was done. And I want to see an actual peer-reviewed publication, not a press release,” he said.

The partial disclosure by Butantan, which had delayed its announcement three times, citing obligations to Sinovac, added to skepticism about the Chinese vaccine in Brazil. Nearly half of Brazilians said they would not take a COVID-19 vaccine developed by China, according to a December poll.

Brazilian President Jair Bolsonaro has expressed disdain for the Sinovac vaccine, citing doubts about its “origin.” He has traded barbs with political rival João Doria, the governor of Sao Paulo, which is funding trials and production of the shot.

Brazil has the world’s second-deadliest outbreak after the United States with nearly 200,000 coronavirus-related fatalities, and aims to vaccinate 51 million people, or about one-fourth of its population, in the first half of 2021, although immunizations have not yet begun.

Doria reiterated that Sao Paulo, the country’s most affluent and populous state, expected to start vaccinations on Jan. 25.

Based on traditional vaccine technology using inactivated coronavirus to trigger an immune response, CoronaVac can be stored temperatures of 2-8 degrees Celsius (36°-46°F) and may remain stable for up to three years.

Vaccines offered by Pfizer/BioNTech and Moderna use a novel synthetic messenger RNA (mRNA) technology, requiring far colder temperatures for shipping and storage. The Pfizer/BioNTech vaccine must be kept at a sub-Arctic temperature, making it an ineffective option for poor nations and areas without the required cold storage equipment.

https://www.reuters.com/article/us-health-coronavirus-brazil-sinovac/sinovac-coronavirus-vaccine-78-effective-in-brazil-trial-details-sparse-idUSKBN29C1VZ

Meridian Bioscience Preliminary Fiscal 2021 Q1 Revenues Up 94%

 Meridian Bioscience announced Thursday its preliminary revenues for the first quarter of fiscal year 2021 were up 94 percent compared to the previous year, driven largely by an increase in the firm's life science segment. 

The company said it expects revenues to be approximately $92 million, up from $47.4 million in the year-ago quarter. Life science revenues are expected to be $62 million, up nearly 400 percent from $12.6 million in Q1 2020. Diagnostic revenues are expected to be $30 million, down 14 percent from $34.8 million in the first quarter of 2020. 

The increase in life science revenues was driven by high demand for COVID-19 products and Meridian said it expects the high levels of revenues to continue through the second quarter of FY2021. The firm has provided reagents and consumables for many SARS-CoV-2 tests throughout the pandemic, including qPCR chemistries and enzyme master mixes. 

Meanwhile, the diagnostics segment saw improvement at the beginning of the quarter but experienced headwinds as COVID-19 cases surged globally and lockdowns were put back in place. Meridian has developed a molecular test for SARS-CoV-2 to run on its Revogene platform, the company said on its most recent earnings call. Last month, it received $1 million from the National Institute of Health to speed up the launch of the test.

The firm isn't updating its FY2021 guidance at this time, and full financial results are scheduled to be released on Feb. 5. 

“Demand for our Life Science reagents continues to exceed expectations and while the Diagnostics segment saw a setback in its recovery during the quarter, its own contribution to the fight begins in the coming week with initial shipments of the Revogene SARS-CoV-2 assay to select customers expected,” CEO Jack Kenny said in a statement.

https://www.genomeweb.com/business-news/meridian-bioscience-preliminary-fiscal-2021-q1-revenues-94-percent

BioNTech CEO applies COVID-19 vaccine's mRNA tech to multiple sclerosis

 The new vaccine technology mRNA is making waves these days as COVID-19 shots based on it deliver efficacy that’s unrivaled by other platforms. One of the successful shots, Comirnaty (BNT162b2), was developed with BioNTech’s technology and is being rolled out in the U.S. and EU.

Now BioNTech's CEO, Ugur Sahin, M.D., Ph.D., has led new research showing that an mRNA vaccine might also work in multiple sclerosis (MS).

In several mouse models of MS, Sahin's team showed that an mRNA vaccine encoding a disease-related autoantigen successfully ameliorated MS symptoms in sick animals and prevented disease progression in rodents showing early signs of MS. The results were published in Science.

MS occurs when the immune system mistakenly attacks the protective myelin sheath that covers nerve cells in the brain and spinal cord. Existing treatments work by systemically suppressing the immune system. That can control MS, but it also leaves patients vulnerable to infections.

Sahin, together with colleagues at BioNTech and scientists at the Johannes Gutenberg University, hypothesized that an mRNA vaccine could work in a targeted fashion to help the immune system tolerate specific MS-related proteins without compromising normal immune function.

The team came up with an mRNA candidate that wrapped the genetic information coding for MS-causing self-antigens in fatty substances. A similar lipid nanoparticle is used in Comirnaty to protect the COVID-19 mRNA material until it reaches target cells, where it produces the antigen protein.

In mice with autoimmune encephalomyelitis, a model for human MS, the team found that the vaccine was processed by lymphoid antigen-presenting cells without triggering a systemic inflammatory immune response, even when delivered at very high antigen concentrations. It did not impair the animals' ability to launch a protective immune response.

The vaccine blocked all clinical signs of MS in mice, while control animals experienced the typical symptoms of the disease. In mice that started on the mRNA vaccine when small signs of disease such as paralysis of the tail were noted, the treatment prevented further disease progression and restored motor functions, the team reported.

In treated mice, the researchers observed lower levels of infiltrating and antigen-specific CD4+ T cells in the brain and spinal cord, and the T cells in the spleen showed low expression of certain markers that are critical for the immune cells to be able to enter the central nervous system.

What’s more, the treatment led to the expansion of regulatory T cells, or Treg cells. This is important because MS is a complex disease in which the specific self-antigens may differ from one patient to the next. But Treg cells offer a more general “bystander tolerance,” which suppresses T cells against other antigens in the inflamed tissue, the researchers explained in the paper.

The mRNA technology is being hailed as a revolution in the vaccine space. BioNTech’s Pfizer-partnered Comirnaty demonstrated 95% efficacy in preventing COVID-19 in its phase 3 trial, leading to one industry watcher to predict the success will “open the floodgates” of mRNA application especially in infectious disease.

Sahin originally founded BioNTech to translate the mRNA idea to cancer immunotherapy, but the firm rose to the challenge of COVID-19 amid the pandemic. Now, Sahin and colleagues believe their research shows mRNA vaccines also hold promise in treating MS.

As COVID-19 has shown, mRNA vaccines can be designed quickly and mRNA can code for virtually any autoantigen. “Thus, tailoring the treatment for the disease-causing antigens of individual patients is conceivable, similar to that which has been successfully executed in the setting of personalized cancer vaccines,” the researchers wrote in the study. The combination of mRNAs may enable control of even more complex autoimmune diseases, they suggested.

https://www.fiercebiotech.com/research/biontech-ceo-turns-covid-19-vaccine-s-mrna-tech-against-multiple-sclerosis

High hopes as Inventiva takes NASH contender into phase 3

 Analysts are continuing to back Inventiva’s lanifibranor as a potential “best-in-class” drug for the fatty liver disease NASH, as the company prepares for the launch of a phase 3 trial in spring.

A team of analysts from Jefferies led by Lucy Codrington noted the design of the trial, which will have a dual goal measuring both liver inflammation and scarring could give an edge over potential competitors.

There are no approved drugs for NASH – full name non-alcoholic steatohepatitis – after the FDA rejected Intercept’s obeticholic acid last year.

The regulator said it wanted more long-term safety and efficacy data from the REGENERATE study before making a final decision on the drug, which had been expected to be the first entrant into a likely multi-billion dollar market niche.

According to the latest analysis from Jefferies the design for the phase 3 NATIVE3 study from Inventiva has been okayed by regulators and the case for lanifribanor has already been boosted by “stellar” results in phase 2.

The decision to include two endpoints of inflammation and scarring is important because improvements in both these measures are likely to lead to an improved prognosis.

Lanifibranor is also taken orally, making it convenient for patients and Inventiva is hoping to offer a choice of two doses offering doctors the ability lower the strength of the medication to control side-effects such as oedema.

The trial will take a while however, with results not due until the second half of 2023, with sales forecast to peak at around $2.6 billion annually if approved.

The Jefferies team also noted that the French biotech is also partnered with AbbVie to develop an oral successor to its inflammatory diseases blockbuster Humira (adalimumab).

Proof-of-concept phase 1b data is due from the drug codenamed ABBV-157 is due this quarter, which will help AbbVie decide on whether to continue development.

A host of other pharma companies including Gilead, Novo Nordisk, Merck & Co are also developing potential NASH drugs.

Only this morning, Novo Nordisk selected the first candidate from a project with Dicerna to find new gene-silencing drugs to treat liver-related diseases including NASH.

https://pharmaphorum.com/news/high-hopes-as-inventiva-takes-nash-contender-into-phase-3/

Oxford BioTherapeutics to research cell therapies for Gilead’s Kite

 Gilead Sciences’ Kite unit has teamed up with the UK’s Oxford BioTherapeutics (OBT) to develop a new clutch of cell therapy products for solid tumours and blood cancers.

The partnership covers up to five oncology targets identified by OBT using its discovery platform, and the UK firm will try to develop antibodies against them. Kite and Gilead will then develop and commercialise therapies based on these targets or antibodies.

“Selecting the right target is fundamental for the successful development of first-in-class cell therapies,” said OBT chief executive Dr Christian Rohlff.

“We are delighted that Kite, the global leader in cell therapy, has recognised the potential of OBT’s OGAP discovery platform and antibody capabilities through this partnership.”

Under the agreement, OBT will receive an undisclosed upfront payment and may receive receive additional payments based on the achievement of discovery, clinical, and regulatory milestones, as well as royalties on any sales coming down the line.

Gilead acquired Kite in 2017 for almost $12 billion, at a time when enthusiasm for cell therapies for cancer, and particularly CAR-T, was riding high on the back of unprecedented, life-saving efficacy in trials involving patients with few treatment options left.

The commercial reality for CAR-Ts has been more challenging, and as the pipeline has become more crowded Gilead has cut the value of the experimental assets it acquired along with Kite on more than one occasion to the tune of around $1.6 billion.

The main draw for the Kite takeover for Gilead was lead CAR-T Yescarta (axicabtagene ciloleucel), approved for large B-cell lymphoma shortly after the company made its move, which was joined by Tecartus (brexucabtagene autoleucel) for mantle cell lymphoma last July.

Problems with tolerability, reimbursement and a complex manufacturing process has pegged back sales of CAR-Ts from earlier expectations, but Yescarta reached $450 million in 2019, and nearly matched figure that in the first nine months of 2020, with Tecartus adding a modest $9 million to the pot.

Gilead and Kite remain convinced that cell therapy can become the cornerstone of cancer treatment, however, and the deal with OBT isn’t the first that has boosted Kite’s portfolio.

In April last year, for example, Kite licensed a suite of antibodies from Teneobio against BCMA – a key target for multiple myeloma therapy – that will be used to generate CAR-T treatments for the blood cancer.

Last September it forged a second alliance with HiFiBiO Therapeutics to find novel targets and antibodies for acute myeloid leukaemia (AML), adding to an earlier agreement focusing on T cell receptor (TCR) therapies for cancer.

In 2018 it also formed a partnership with Gadeta of the Netherlands to develop new forms of CAR-T with greater activity against solid tumours.

https://pharmaphorum.com/news/oxford-biotherapeutics-to-research-cell-therapies-for-gileads-kite/

Oxford Immunotec hits the spot for Perkinelmer

 As interesting as Oxford Immunotec’s T-cell test for Covid-19 immunity is, it was not the main motivation behind Perkinelmer’s takeover of the UK company today. Instead the $591m all-cash takeout is more to do with Oxford Immunotec’s established test, for latent tuberculosis. The immune response to tuberculosis infection involves T cells becoming sensitised to bacterial antigens. The T-Spot.TB test works by separating these T cells, stimulating them with tuberculosis bacterial antigens and detecting the quantity of interferon gamma they release as a result. It is approved for sale in over 50 countries, and will fit nicely into Perkinelmer’s existing immunodiagnostics offerings, which are largely made up of its Euroimmun and Tulip businesses. Oxford Immunotec’s third-quarter revenues were $19.4m, though it made a loss of $149,000 – still, Perkinelmer believes the acquisition will be accretive to non-GAAP earnings in the year following the deal’s close. It also believes that Oxford Immunotec’s sales growth will exceed that of its own diagnostics franchise for the foreseeable future, and Oxford Immunotec has said that the market for quantified TB testing is worth $1bn. Should the Covid-19 test prove a reliable way of assessing patients or vaccine recipients’ resistance to reinfection, Oxford Immunotec could grow even faster.

https://www.evaluate.com/vantage/articles/news/snippets/oxford-immunotec-hits-spot-perkinelmer

Quidel Announces Preliminary Revenue for Q4

 Quidel Corporation (NASDAQ: QDEL) ("Quidel"), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it expects revenues in the fourth quarter of 2020 to be in the range of $808 million to $810 million, up from $476 million in the prior quarter.

"The COVID-19 pandemic has presented challenges to all companies. At Quidel, our people have responded at every level and function -- from R&D and regulatory to supply chain and manufacturing. Due to the hard work and dedication of our people, we had another record quarter, and our best year yet," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "We continue to see strong demand for our COVID-19 diagnostic products; in fact, open orders at the end of 2020 were approximately 25% of what we shipped the entire year. We’ve increased the scale meaningfully of our QuickVue and Sofia tests, and expect to scale further from a current combined 13 million tests per month, to over 70 million tests per month by the end of 2021. In 2020, we shipped over 23,000 Sofia analyzers to new and existing customers, over 14,000 of which shipped in Q4 alone. Further, we expect another 20,000 Sofia analyzers will be shipped to new customers in the first quarter alone," added Mr. Bryant.

These preliminary results are based on management’s initial analysis of operations for the quarter ended December 31, 2020. The company expects to issue full financial results for the fourth quarter and fiscal year 2020 in February.

Quidel to Present at 39th Annual J.P. Morgan Healthcare Conference

Quidel will present at the 39th Annual J.P. Morgan Healthcare Conference to be held virtually on Wednesday, January 13, 2021.

Douglas Bryant will present that day at 2:00 p.m. Eastern time (11:00 a.m. Pacific time) with a question and answer session scheduled immediately following the presentation. During the presentation, the company will discuss business and financial developments and trends. The company's statements may contain or constitute material information that has not been previously disclosed.

A live webcast and audio archive of the presentation will be available via the Investor Relations section of the company’s Web site at https://ir.quidel.com, or by clicking on the link below:

https://jpmorgan.metameetings.net/events/healthcare21/sessions/35234-quidel-corporation/webcast?gpu_only=true&kiosk=true

Participants should allow approximately five to ten minutes prior to the presentation's start time to visit the site and download any streaming media software needed to listen to the Internet webcast. A replay of the webcast will also be available on the company’s Web site for 14 days.

https://finance.yahoo.com/news/quidel-announces-preliminary-revenue-fourth-191500143.html