Briefs

EMA Recommends Eli Lilly’s COVID-19 Antibody and Combo Therapy

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Eli Lilly’s monoclonal antibody bamlanivimab as a COVID-19 treatment, as well as in combination with etesevimab.

The committee found that bamlanivimab alone and bamlanivimab with etesevimab can be used for treating COVID-19 in patients age 12 and up who are at high risk of progressing to severe illness but don’t require supplemental oxygen. With the CHMP’s positive opinion, the European Commission is likely to authorize use of the monoclonal antibodies as a new weapon against the virus.

In forming its opinion on the treatments, the EMA assessed results from phase 2 and 3 trials that showed bamlanivimab alone reduced viral load and symptoms and reduced COVID-19 hospitalizations by approximately 70 percent. The combination therapy also performed well, reducing the risk of COVID-19 hospitalizations and death by 70 percent in mild-to-moderate, high-risk COVID-19 patients.

Health Canada Clears Johnson & Johnson’s COVID-19 Vaccine

Canada has issued an interim authorization for Johnson & Johnson’s (J&J) single-shot COVID-19 vaccine, allowing its use for preventing COVID-19 infections in patients age 18 and older.

Health Canada made the decision based on data from a phase 3 trial. The trial, which enrolled 43,783 participants, found the vaccine was 85 percent effective in preventing severe COVID-19 and protected against hospitalization and death starting 28 days after vaccination.

The single-dose vaccine offers advantages in that it can be shipped in common refrigerator temperatures and stored at the same temperatures for up to three months. Kept at -4 degrees Fahrenheit, it can be stored for up to two years.

J&J said that it expects to fulfill the 10 million doses it’s committed to supplying Canada by the end of the third quarter.

Sinovac’s CoronaVac Vaccine May Not Be Effective Against Brazilian Variant, Study Finds

A small study of Sinovac’s CoronaVac vaccine has found that it doesn’t appear to protect against a newly identified coronavirus variant in Brazil.

Researchers from Brazilian, U.S. and UK universities took blood plasma samples from eight vaccinated participants in Sinovac’s Brazilian phase 3 study and evaluated how well they held up against the new Brazilian strain.

They found that the new variant may evade the protection afforded by CoronaVac. Specifically, the plasma samples had six times less neutralizing capacity against the Brazilian strain than against the UK and South African strains. Additionally, five months after being given a booster shot of CoronaVac, plasma from vaccinated patients still failed to effectively neutralize the Brazilian variant.

NIH Ends Enrollment in Brii Biosciences’ COVID-19 Antibody Trial

Brii Biosciences announced that its investigational monoclonal antibodies BRII-196 and BRII-198 failed to reach the minimum required efficacy rate for hospitalized patients and will not move on to the late stage of the National Institutes of Health’s (NIH) ACTIV-3 trial.

The NIH evaluated the safety and efficacy of the antibodies as a combination treatment in approximately 150 hospitalized patients, but the trial’s data and safety monitoring board determined the pre-specified efficacy criteria for the hospitalized population was not met, so the study will not be expanded to enroll more participants.

“While we are disappointed that BRII-196 and BRII-198 have not shown clear benefits during the interim analysis against COVID-19 in hospitalized patients receiving the current standard of care, we remain committed to investigating this antibody combination in ambulatory COVID-19 patients through the ongoing ACTIV-2 trial,” said Brii Biosciences CEO Zhi Hong.

Baxter Will Help Manufacture 60-90 Million Moderna Vaccine Doses

Moderna has struck a deal with Baxter International to perform fill and finish work for an estimated 60 to 90 million doses of Moderna’s COVID-19 vaccine in 2021 at its plant in Bloomington, Indiana.

 “This additional production will help us continue to scale up our manufacturing capacity in the United States.” said Juan Andres, Moderna’s chief technical operations and quality officer.

Last month, the U.S. government purchased 100 million more doses of Moderna’s messenger RNA-based vaccine, and the company plans to deliver its second batch of 100 million doses by the end of May.

FDA Approves First Generic of Symbicort Inhalation Aerosol

The FDA has granted tentative approval for the first generic version of AstraZeneca’s Symbicort (budesonide/formoterol) indicated for asthma or chronic obstructive pulmonary disease.

The agency gave only tentative approval to Viatris and Kindeva Drug Delivery because the drug is at the center of ongoing patent litigation involving the generics makers and AstraZeneca.

“Kindeva looks forward to providing Viatris with reliable, quality supply from our state-of-the-art commercial filling and packaging lines in our Northridge, Calif., facility,” said Aaron Mann, Kindeva’s CEO.

Symbicort earned AstraZeneca $2.7 billion in 2020 global sales.

Roche Pulls Bladder Cancer Indication for Tecentriq

Roche is withdrawing its U.S. indication for immunotherapy Tecentriq (atezolizumab) used to address prior platinum-based chemotherapy treated urothelial carcinoma, a type of bladder cancer.

The drug received accelerated approval in 2016 for the indication but failed to meet its primary endpoint of overall survival in a follow-up study.

While the withdrawal is disappointing, Tecentriq “continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients,” said Levi Garraway, Roche’s chief medical officer and head of global product development.

UK’s NICE Approves Novartis’ Zolgensma for Spinal Muscular Atrophy

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Novartis’ Zolgensma (onasemnogene abeparvovec) for babies up to 12 months with type 1 spinal muscular atrophy, a rare genetic disorder with a life expectancy of less than two years.

The gene therapy is the most expensive treatment NICE has ever recommended for National Health Service use, potentially costing £1.79 million per treatment.

NICE said the therapy should be administered to infants with spinal muscular atrophy “before they develop symptoms as part of a managed access arrangement while further data is collected.”

COVAX Delivers 20 Million COVID-19 Vaccine Doses in First Week of Distribution

During its first week of shipments, the COVAX global vaccine-sharing scheme distributed 20 million vaccine doses to 20 countries, World Health Organization Director-General Tedros Adhanom Ghebreyesus said. Vaccine distributions began in late February starting with India, Ghana and Cote d’Ivoire.

This week, COVAX will distribute an additional 14.4 million doses to 31 more countries, and it aims to deliver 2 billion doses globally by the end of this year.

COVAX is operated by Gavi, the Vaccine Alliance, the WHO and the Coalition for Epidemic Preparedness Innovations.

India’s COVID-19 Vaccine Covaxin Shows High Levels of Antibody Response

Bharat Biotech’s Covaxin (BBV152), the first successful COVID-19 vaccine developed in India, showed high levels of antibody response and no serious side effects in a phase 2 study, researchers reported in The Lancet.

Last week, the company reported that the vaccine demonstrated an 81 percent efficacy in preventing symptomatic COVID-19 in an interim analysis from a 25,800-participant phase 3 trial.

The two-dose vaccine can be stored at standard refrigeration temperatures of 35.6 to 46.4 degrees Fahrenheit, so it presents fewer logistical hurdles than messenger RNA-based vaccines that must be stored ultra-cold.

NICE Turns Down AstraZeneca’s Prostate Cancer Drug Lynparza

In a draft guidance, AstraZeneca’s drug Lynparza was rejected for the treatment of prostate cancer by the UK’s National Institute for Health and Care Excellence’s (NICE) appraisal committee, which makes decisions about drugs used by the National Health Service.

Lynparza is aimed at adults whose BRCA-positive disease has progressed after use of the hormone-based chemotherapy drug abiraterone or the treatment with the nonsteroidal antiandrogen enzalutamide.

Though clinical trial evidence showed that study subjects taking Lynparza had improved progression-free survival and overall survival, NICE said that there is no direct comparison of Lynparza to the current standard of care for metastatic prostate cancer, which includes chemotherapy drugs docetaxel, cabazitaxel, or radiation drug radium-223.

Lynparza is also used for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.

The draft guidance is open for comment until March 26, after which NICE will make its final recommendations.

Natural COVID-19 Antibodies Plus One Dose of Pfizer–BioNTech’s Vaccine May Be All One Needs

A single dose of Pfizer/BioNTech’s vaccine after prior COVID-19 infection may generate the same or higher levels of antibodies as having had two doses of the vaccine, according to a small study led by researchers from NYU Grossman School of Medicine’s Vaccine Center.

Te study also suggests that the immune responses in most patients previously infected with the virus did not improve further after a second dose of vaccine.

“Our results would need to be borne out by larger studies before they influenced current policy, which is that patients receive the evidence-based, two-shot regimen,” said Mark Mulligan, director of the division of infectious diseases and immunology and director of the NYU vaccine center.

Should the final data support it, Mulligan said, the goal would be to make more doses available more quickly if a subset of patients didn’t need a second shot.

Patients known to be previously infected were excluded from Pfizer/BioNTech's original trial, as their immune response to the actual infection would have confused the measurement of their response to the vaccine, researchers say.

ViiV Healthcare’s HIV Prevention Drug Hid Infection in Rare Cases, Study Finds

A re-examination of blood samples taken during a clinical trial found that ViiV Healthcare’s investigational HIV prevention drug cabotegravir actually cloaked infections and fueled infection resistance in rare cases, according to a study published in Nature.

While the bi-monthly injection kept nearly all participants in the 4,570-person clinical trial free of the infection, four people contracted HIV.

Researchers believe the drug suppressed the virus enough to prevent HIV tests from detecting it during early stages of infection. Sensitive tests that measure RNA from HIV later showed that the participants had been infected for six to 16 weeks before regular, monthly HIV diagnostics identified the infection. Additionally, the four patients developed resistance to cabotegravir and similar therapies.

The news comes just as several other potent HIV preventative drugs — called pre-exposure prophylaxis or PrEP drugs — are entering clinical trials.

Novartis’ Ilaris Fails in Late-Stage Lung Cancer Trial

Novartis’s inflammation therapy Ilaris (canakinumab) didn’t meet its primary endpoint of survival in a phase 3 trial evaluating its use, along with chemotherapy agent docetaxel, in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed after chemotherapy.

Novartis said it will continue other phase 3 studies evaluating Ilaris, a monoclonal antibody that blocks certain proteins in the body that can affect inflammation and other immune responses, in NSCLC in earlier treatment settings.

The company said it launched its late-stage trials after seeing significantly lower-than-expected rates of lung cancer mortality among patients in another phase 3 trial evaluating Ilaris as a secondary prevention measure for cardiovascular events in patients following a heart attack.

Ilaris, approved to treat periodic fever syndromes and arthritis in kids, also recently struck out as a COVID-19 treatment and a heart disease therapy.

Bluebird Bio: ‘Very Unlikely’ its Gene Therapy Caused Leukemia During Phase 1/2 Trial

Bluebird bio said its investigations have shown that it’s “very unlikely” that LentiGlobin, the company’s investigational gene therapy for sickle cell disease, caused the case of acute myeloid leukemia (AML) reported recently during LentiGlobin’s phase 1/2 trial.

The suspected serious adverse reaction resulted in the FDA instructing the company to halt its trial in late February.

Given the results of its analysis in addition to findings from independent analyses, the company says it’s talking with regulators to begin the process of resuming clinical studies on LentiGlobin for sickle cell disease.

Bluebird is continuing to investigate a possible second adverse reaction of what appears to be myelodysplastic syndrome in a study participant.