Regeneron, Sanofi arthritis drug fails late-stage study in COVID-19 patients

Regeneron Pharmaceuticals Inc and Sanofi said on Thursday their rheumatoid arthritis drug Kevzara failed to meet the main goals of a late-stage study testing it in COVID-19 patients.

A separate Sanofi-led trial outside of the United States in hospitalized patients with severe and critical COVID-19 using a different dosing regimen is ongoing, the companies said.

The trial results come after a study in April showed that Kevzara may only help the sickest coronavirus patients.

https://www.reuters.com/article/us-health-coronavirus-regeneron-pharms/regeneron-sanofi-arthritis-drug-fails-late-stage-study-in-covid-19-patients-idUSKBN24337U

NIH Director Collins optimistic on COVID-19 vaccine by year end

The U.S. National Institutes of Health’s director said on Thursday that he was optimistic that the Trump administration’s vaccine-acceleration program, Operation Warp Speed, will generate a safe and effective vaccine for COVID-19 by year end and can meet a target of making 300 million doses by early 2021.

“That’s really a stretch goal, but it’s the right goal for the American people,” Dr. Francis Collins said at a hearing held by a subcommittee of the Senate Committee on Appropriations to discuss the program.

Dr. Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority (BARDA), said that the U.S. government was trying to negotiate the lowest possible price for a vaccine. Still, he said that the country would likely have to pay more for any vaccine not developed with government funding.

BARDA has provided funds for three vaccine candidates being developed under Operation Warp Speed by Moderna Inc, Johnson & Johnson and AstraZeneca Plc.

NIH’s Collins also said in his testimony that the United States is targeting having 1 million rapid, on-site tests per day some time around September to enable schools to reopen and sports events.

https://www.reuters.com/article/us-health-coronavirus-usa-nih/nih-director-collins-optimistic-on-covid-19-vaccine-by-year-end-idUSKBN2432FZ

Trump upbeat on three coronavirus vaccine candidates

U.S. President Donald Trump on Thursday voiced optimism the United States would soon come up with a vaccine for the novel coronavirus, saying three vaccine candidates were looking especially good.

“Three are really, really looking good,” Trump said at an event at the White House, without providing details. “We think we’re going to have it soon.”

U.S. National Institutes of Health Director Dr. Francis Collins said earlier on Thursday that he was optimistic the Trump administration’s vaccine-acceleration program “Operation Warp Speed” will generate a safe and effective vaccine for COVID-19 by year-end and can meet a target of making 300 million doses by early 2021. [nL1N2E91B7]

Speaking at a U.S. Senate hearing, Collins said the United States aimed to have the ability to conduct a million rapid, on-site COVID-19 tests per day some time around September to enable the reopening of schools and resumption of sports events.

The U.S. Department of Health and Human Services said last month that the administration aimed to narrow its financial support to about seven experimental coronavirus vaccines from the previous 14. [nL4N2DT3KH]

The number of U.S. COVID-19 infections has surged over the past week, with daily figures setting new records several times fueled by outbreaks in Texas, California, Florida and Arizona.

https://www.reuters.com/article/us-health-coronavirus-usa-vaccines/trump-upbeat-on-three-coronavirus-vaccine-candidates-idUSKBN2432LQ

Glaxo says it is within weeks of resubmitting HIV injection Cabenuva

GlaxoSmithKline’s HIV business ViiV is within weeks of resubmitting its request for approval of its long-acting injection Cabenuva to U.S. drug regulators, ViiV’s head of research said on Thursday.

ViiV executive Kimberly Smith told a media briefing that the company would stick to its previous guidance of refiling the request around mid-year and that this would happen “within weeks”.

The U.S. Food and Drug Administration in December declined to approve the long acting injection, designed as an alternative to the standard daily pills for people infected with the virus that causes AIDS.

The FDA at the time questioned the treatment’s manufacturing process, but not its safety.

https://www.reuters.com/article/us-gsk-viiv-fda-resubmission/gsk-says-it-is-within-weeks-of-resubmitting-hiv-injection-cabenuva-idUSKBN24326Q

Tesla to make molecule printers for German Covid vaccine developer CureVac

Tesla Inc is building mobile molecule printers to help make the potential COVID-19 vaccine being developed by CureVac in Germany, the electric-car maker’s Chief Executive Officer, Elon Musk, tweeted on Wednesday.

CureVac, an unlisted German company, has said it is developing portable, automated mRNA production units that it calls printers and which Musk described as “RNA microfactories”.

They are being designed to be shipped to remote locations, where they can churn out its vaccine candidate and other mRNA-based therapies depending on the recipe fed into the machine.

But for the immediate pandemic use – should its vaccine candidate win market approval – it has production sites with regulatory approval in Germany with a capacity to produce hundreds of millions of doses.

The company, based in Tuebingen and backed by the Bill & Melinda Gates Foundation, is a pioneer of the so-called messenger RNA approach, which is also pursued by BioNTech and its partner Pfizer as well as Moderna.

RNA molecules are single-stranded, and thanks to their recurring molecular pattern, they can be produced in a relatively simple biochemical process that do not require genetically modified living cells, which are needed to produce most other biotech drugs.

CureVac is also building a new stationary site that could increase its output tenfold to billions of doses.

The “microfactories” would be built at Tesla Grohmann Automation in Germany, Musk said in a Twitter thread late on Wednesday night.

Tesla acquired the company that develops automated manufacturing systems for batteries and fuel cells in 2016 to expand its production.

CureVac has been working with Tesla Grohmann to develop the mobile printer technology, a person familiar with CureVac said.

Musk did not elaborate on his plans. Tesla and CureVac were not immediately available to comment.

Musk, who is known to make impromptu announcements on Twitter, had in March said that Tesla has extra FDA-approved ventilators that can be shipped free of cost to hospitals within regions where the electric-car maker delivers.

https://www.reuters.com/article/us-health-coronavirus-tesla/tesla-to-make-molecule-printers-for-german-covid-19-vaccine-developer-curevac-idUSKBN243168

Ipsen, Exelixis, Roche team for combo study in lung, prostate cancer

Ipsen (OTCPK:IPSEY) will join the Exelixis (NASDAQ:EXEL) and Roche (OTCQX:RHHBY) clinical collaboration and participate in the funding of the recently initiated CONTACT-01 and CONTACT-02 global Phase III trials.

CONTACT-01 is evaluating the safety and efficacy of Exelixis’ cabozantinib (cabometyx) in combination with Roche’s atezolizumab (tecentriq) in patients with metastatic non-small cell lung cancer.

CONTACT-02 is evaluating the safety and efficacy of cabozantinib in combination with atezolizumab versus a second novel hormonal therapy in men with metastatic castration-resistant prostate cancer.

Under this agreement, following its decision to opt-in to pivotal studies exploring cabozantinib in new potential indications, Ipsen gains access to the results of those studies, which if positive, may support potential future regulatory submissions in its territory.

Ipsen has an exclusive agreement with Exelixis for the further development and commercialization of cabozantinib outside U.S. and Japan.

https://seekingalpha.com/news/3588183-ipsen-teams-up-for-cabozantinib-combo-study-in-lung-and-prostate-cancer

Sarepta in deal for imlifidase for use in muscular dystrophies

Sarepta Therapeutics (NASDAQ:SRPT) signs an agreement with Hansa Biopharma (OTC:HNSBF) for imlifidase, for rare Immunoglobulin G (IgG) mediated diseases.

Under the terms of agreement, Sarepta obtains an exclusive, worldwide license to develop and promote imlifidase as a pre-treatment to enable gene therapy administration in Duchenne muscular dystrophy and Limb-girdle muscular dystrophy, for patients who may otherwise not be eligible for treatment.

Hansa will receive an upfront payment of $10M, additional milestone payments potentially totaling up to $397.5M and tiered royalties up to the mid-teens.

https://seekingalpha.com/news/3588201-sarepta-therapeutics-inks-deal-for-imlifidase-for-use-in-muscular-dystrophies