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Coronavirus Update: Gilead's Veklury Gets Full FDA Approval, Roche Partners With Atea

Coronavirus Update: Gilead's Veklury Gets Full FDA Approval, Roche Partners With Atea

Source : 'Scrip Intelligence'

Gilead's Veklury (remdesivir) is the first and only drug approved by the US Food and Drug Administration for the treatment of COVID-19, although it is already widely used for treating the infection in hospitalized patients. Veklury was granted an emergency use authorization in May for the treatment of patients with COVID-19 requiring hospitalization. ()

The antiviral was one of the first options to become available to patients hospitalized with COVID-19, along with the steroid dexamethasone. While supply was constrained initially, Gilead has ramped up the manufacturing capacity for Veklury. ( The product is expected to be a financial windfall for Gilead, which investors expect to hear more about during the company's third quarter earnings call on 28 October.

The approval comes just days after a large-scale open label study by the World Health Organization of repurposed drugs for COVID-19 found remdesivir did not improve survival in patients. () Some medical experts are also frustrated that Gilead has not run a randomized controlled trial study testing remdesivir in combination with dexamethasone as it is commonly used.

The approval was based on the Phase III ACTT-1 trial conducted by the US National Institute of Allergy and Infectious Disease, which showed treatment with Veklury resulted in faster time to recovery compared to placebo. Veklury also reduced disease progression in patients needing oxygen, resulting in a lower incidence of new mechanical ventilation.

Roche Holding AG and Atea Pharmaceuticals, Inc. are collaborating on the development, manufacture and distribution of a novel direct-acting antiviral (DDA), named AT-527, against SARS-CoV-2.

The orally administered product, which blocks viral RNA polymerase, entered a Phase II clinical trial for hospitalized patients with moderate COVID-19 in May, when it was already in Phase II for hepatitis C.

A Phase III COVID-19 study is due to start in the first quarter of 2021 to test its potential in patients outside of the hospital setting. AT-527 may also be developed for post-exposure prophylactic settings, the companies said.

No financial details of the deal were given.

The purine nucleotide prodrug has demonstrated antiviral activity in vitro and in vivo against several enveloped single-stranded RNA viruses, including human flaviviruses and coronaviruses. The highly selective prodrug was designed to uniquely inhibit viral RNA dependent RNA polymerase, which is essential for the replication of RNA viruses.

If successful, Atea will be responsible for US distribution, with the option to request Genentech’s support, and Roche will be responsible for distribution outside the US.

The companies note that the manufacturing process of small-molecule DAAs allows their production in large quantities, which could mean that AT-527 will be able to treat patients early, reduce the progression of the infection, and contribute to decreasing the overall burden on health systems.

Roche has had mixed success with other therapies it is testing for COVID-19. In September, the EMPACT study of its interleukin-6 inhibitor Actemra (tocilizumab) hit its primary endpoint in a pivotal trial of patients with severe COVID-19 associated pneumonia, but failed to reduce the risk of death compared with placebo. ()

That was the first Phase III success for the immunosuppressive therapy in COVID-19 after several earlier trials failed, including Roche’s own COVACTA study in July. ()

The Swiss major is also working with Regeneron Pharmaceuticals, Inc. to develop, manufacture and increase global supply of the investigational antibody combination for COVID-19, REGN-COV2, if successful in trials and at the regulators. ()

Merck KGaA and Serum Institute of India Pvt. Ltd. have agreed to commercialize investigational monoclonal antibodies (mAbs) against SARS-CoV-2 developed by International AIDS Vaccine Initiative (IAVI) and Scripps Research if results from clinical trials are satisfactory.

“If the highly potent and broadly cross-reactive SARS-CoV-2 neutralizing antibody candidates.....are shown to be efficacious in clinical trials, either as a single antibody or a potential combination of both candidates, Merck KGaA..will lead commercialization in developed countries”, a joint press release by IAVI and Serum Institute said.

Serum Institute will lead global manufacturing as well as commercialization in low- and middle-low-income countries, including India. However, commercial details of the deal were not disclosed.

Monoclonal antibodies are the new kid on the block, garnering a lot of attention after Regeneron’s antibody cocktail received a personal endorsement from US President Trump. AstraZeneca and Eli Lilly are the other biggies in the race to develop monoclonal antibodies as treatments or prophylactics against COVID-19 and, as in the case of vaccines, the US government has been entering supply arrangements with such companies.

Roche has high hopes for the investigational COVID-19 antibody cocktail from Regeneron it is helping to develop but Bill Anderson, head of pharma at the Swiss major, has warned that even if REGN-COV2 gets approval, demand will far outstrip supply. ()

Large-scale trials of AZ's long-acting monoclonal antibody product, AZD7442, were about to begin when the company signed a $486m deal with the US government for its development and supply. The company intends testing it both for prevention and treatment. ([A #SC143112])

Meanwhile, a hold has been placed on the study of Lilly’s monoclonal antibody Ly-CoV555 in combination with Gilead's Veklury (remdesivir) due to safety concerns. The US National Institute of Allergy and Infectious Disease is studying the benefits of the two therapies in combination, and comparing them with remdesivir and placebo treatment. ()

Under IAVI’s agreement with Merck and Serum Institute, the partners will conduct an accelerated, integrated program of preclinical and clinical research to evaluate the antibodies for treatment of COVID-19 with phase I clinical trials expected to start early 2021.

Bangalore-based Syngene and ATUM, a California-based bioengineering company, will collaborate with IAVI on research for the development and conduct of assays to support clinical development of the SARS-CoV-2 mAb candidates.

Recently, the Indian Council of Medical Research (ICMR), India’s research body, also entered the race, partnering with Biological E Limited. to develop antiserum containing monoclonal or polyclonal antibodies for COVID-19 treatment. ()

As the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on 21 October to discuss COVID-19 vaccine development, Moderna, Inc. announced it had completed enrolment of 30,000 participants in its Phase III COVE study of its frontrunner vaccine candidate, mRNA-1273. To date, more than 25,650 participants have also received their second vaccination, Moderna added.

The company is still being outpaced, however, by Pfizer Inc./BioNTech SE’s mRNA vaccine candidate BNT162b2 in terms of both first and second injections. ()

Moderna’s randomized, placebo-controlled trial is studying 100μg doses of mRNA-1273 in 30,000 US participants with a primary endpoint of the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2.

Moderna said it would determine whether file for Emergency Use Authorization once two months of median safety follow-up have accrued. The target vaccine efficacy against symptomatic COVID-19 disease is 60% (95% confidence interval to exclude a lower bound >30%). Formal study efficacy analysis will be triggered at 151 cases, with two earlier, interim analyses after 53 and 106 cases.

The COVE study was designed to evaluate Americans at the highest risk of severe COVID-19 disease. It includes more than 7,000 participants over the age of 65, and more than 5,000 who are under 65 but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease.

These medically high-risk groups represent 42% of the total participants in COVE. The study includes more than 11,000 participants from minority communities, or 37% of the study population, similar to the diversity of the US overall.

Biopharma industry leaders issued a statement of support for federal scientists and other institutions and organizations handling the COVID-19 pandemic amid growing politically motivated attacks. In a letter to the editor published in Nature Research Bioengineering Community 22 October, CEOs of nine biotechnology companies and the CEO of the Biotechnology Innovation Organization expressed support in particular for National Institute of Allergy and Infectious Diseases director Anthony Fauci, as well as other institutions and organizations working to combat the COVID-19 pandemic.

“This year, our industry has risen to the challenge of overcoming the deadly pandemic that has gripped the world, putting that engine to work at miraculous speed to develop therapies and vaccines,” wrote the signatories, led by Ovid Therapeutics, Inc. CEO Jeremy Levin. They added that effectively combatting the pandemic requires close collaboration among biopharma, US government agencies and other scientific institutions.

The letter did not single out any individual or group that has attacked Fauci, but did note concern that “various parties” have faced politically motivated attacks, including the Centers for Disease Control and Prevention, the FDA and Fauci himself requires a security detail.

“Not only are these attacks completely unjustified, they risk intimidating and demoralizing the very people we all are relying on to help end the COVID-19 nightmare. As such, they are irresponsible and ... pose [a] danger to us all.”

On 19 October, it was reported that during a campaign call, President Donald Trump called Fauci a “disaster” and claimed that the COVID-19 death toll would be 500,000 or even as high as 800,000 if he had listened to the NIAID director.

The letter quotes a statement of support for Fauci from Republican senator Lamar Alexander of Tennessee, while several other Senate Republicans - John Thune of South Dakota, Lindsey Graham of South Carolina, Mitt Romney of Utah and Thom Tillis of North Carolina - have expressed support for the NIAID director as well.

In addition to Levin, who also serves as BIO’s chairman, other CEO signatories included BIO’s Michelle McMurry-Heath; Ron Cohen, Acorda Therapeutics, Inc.; Cedric Francois, Apellis Pharmaceuticals, Inc.; John Crowley, Amicus Therapeutics, Inc.; Paul Hastings, Nkarta, Inc.; Rachel King, GlycoMimetics, Inc.; Ted Love, Global Blood Therapeutics, Inc.; and John Maraganore, Alnylam Pharmaceuticals Inc.

The state-run Korea Drug Development Fund has selected Genexine Inc.’s prophylactic DNA vaccine for COVID-19, GX-19, as a project eligible for financial support.

KRW9.3bn ($8.2m) will be provided to help progress the vaccine’s ongoing Phase I/IIa trial and secure an IND approval for a Phase IIb/iII trial. A total of KRW12.4bn in R&D funds, including an investment from the company, will be used for these stages of development.

Genexine, which is leading a local development consortium, plans to confirm safety and immune response through the studies and to obtain dosing data for a planned Phase IIb/III program. The consortium comprises Genexine, Binex Co. Ltd., the Seoul-based International Vaccine Institute, GenNBio, the Korea Advanced Institute of Science and Technology and Postech.

Genexine also aims to progress Phase II trials in multiple countries through overseas partners, including in Indonesia and Turkey.




By Scrip Team