Roche’s ‘breakthrough’ immunotherapy fails phase 3 trial; FDA okays second booster for those over 50

By PharmaCompass

2022-03-31

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In this week’s Phispers, we bring you news that Roche’s ‘breakthrough’ cancer immunotherapy candidate tiragolumab has failed a late-stage trial. It was touted as one of the brightest candidates amongst next-gen checkpoint drugs.

The US Food and Drug Administration has approved a second Covid-19 booster shot for people aged 50 and above as the BA.2 sub-variant of Omicron spreads across the US, emerging as the dominant coronavirus strain.

Merck has decided to shut its Cherokee plant in 2024. The drugmaker will also be laying off 170 staffers who worked at Acceleron, a company it acquired last year. Pfizer’s partner Sobi has also announced plans to lay off staff at its Stockholm manufacturing facility.

In legal news, a federal judge in New Jersey has sided with Merck, tossing out over 500 lawsuits that allege it failed to warn users of its osteoporosis drug — Fosamax — and the risk of thigh bone fractures associated with it.

Late-stage trials of Eli Lilly’s atopic dermatitis drug — lebrikizumab — have shown improvement in patients suffering from the chronic skin condition. Once approved, Lilly’s drug will challenge market leader Sanofi and Regeneron’s blockbuster drug Dupixent, which generated sales of about US$ 5.8 billion last year. Dupixent is expected to clock over US$ 14 billion in peak sales.

Sanofi has entered into a potential US$ 6 billion partnership with US-based IGM Biosciences to co-develop three cancer targets and three inflammation targets. The French drugmaker has also bagged an approval in Japan for its rare disease drug, Xenpozyme, making it the world’s first therapy to treat symptoms of acid sphingomyelinase deficiency (ASMD).

And as expected, the FDA has rejected Eli Lilly and its Chinese partner Innovent Biologics’ cancer immunotherapy treatment – Tyvyt (sintilimab). The other drug to get the thumbs down was Akebia’s anemia drug Vadadustat.

Roche’s ‘breakthrough’ cancer immunotherapy drug fails in late-stage trial

In a disappointing setback for Roche, its ‘breakthrough’ cancer immunotherapy candidate — tiragolumab — has failed a late-stage trial.

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Touted as one of the brightest candidates in the next-gen checkpoint race, the drug failed to slow the progression of an aggressive form of lung cancer in the trial. The Swiss drugmaker said tiragolumab, when combined with its established cancer drug Tecentriq and chemotherapy, failed to reduce the rate of disease progression and death among a group of patients with extensive-stage small cell lung cancer (ES-SCLC), when compared to patients on Tecentriq and chemotherapy only.

The trial was one of the first in a class of drugs known as anti-TIGIT to produce results in the final stage of clinical testing. TIGIT is a receptor found on immune system cells that normally serves to prevent an immune attack against healthy cells.

Roche, which has developed the drug along with its US unit Genentech, said it will continue the trial against various other cancer types.

Several drugmakers are trying to use anti-TIGITs in combination with other cancer drugs, Gilead-Arcus’ Domvanalimab, Merck’s vibostolimab and Novartis-BeiGene’s ociperlimab are some of the drug candidates undergoing phase 3 trials.

Merck to shutter Pennsylvania antibiotics plant; to lay off 170 Acceleron staffers

Merck has announced plans to down the shutters on its Cherokee Plant in 2024, affecting around 300 full-time employees. “We will start discontinuation of active pharmaceutical ingredient (API) manufacturing in 2024, which will lead to the ultimate closure of the Cherokee manufacturing site,” the drugmaker said.

The facility manufactures non-sterile imipenem and cilastatin for the antibiotics Primaxin/Tienam and Recarbrio as well as ertapenem sodium for Invanz. Merck plans to continue manufacturing the drugs from its existing API production network after the shutdown.

To lay off 170 Acceleron staffers: Just four months after completing its acquisition of Acceleron for US$ 11.5 billion, Merck says it will lay off 170 staffers from Acceleron’s unit in Cambridge, Massachusetts. According to a Worker Adjustment and Retraining (WARN) notice, the job cuts will occur between May 31 and November 18.

Meanwhile, Sobi said it plans to lay off about 80 employees working at its Stockholm manufacturing facility over the next two years. The move comes after Pfizer decided to shift production of its hemophilia drug ReFacto to its own facility in Ireland. The downsizing will begin later this year.

At least 23 companies have announced layoffs this year, with four of them in just the last two weeks. Last week, Athenex had announced job cuts as part of its cost-cutting measures.

Gilead’s NJ hub to employ up to 500 employees: Earlier this month, Gilead had said it will lay off 114 staffers based out of Immunomedics’ headquarters in Morris Plains, New Jersey. But now, the drugmaker says it plans to establish a hub in northern New Jersey that will employ up to 500 employees. There will be no manufacturing at the new hub, the company said.

Lilly’s atopic dermatitis drug shows promise in phase 3 trials

Back in 2020, Eli Lilly had secured the rights to atopic dermatitis drug lebrikizumab through the acquisition of Dermira (a biopharmaceutical firm) for US$ 1.1 billion. This week, the drugmaker announced that the phase 3 trial results of the drug have shown significant improvement in patients suffering from the chronic skin condition.

Over 50 percent of the patients suffering from moderate-to-severe atopic dermatitis showed at least 75 percent reduction in the disease at 16 weeks. The monoclonal antibody also helped reduce itching while reporting less adverse effects. Lilly plans to share the detailed results in the coming months.

If approved, Lilly’s atopic dermatitis drug could challenge market leader Sanofi and Regeneron’s blockbuster drug Dupixent. Lilly’s lebrikizumab will have a strong advantage over Dupixent — while the former will need to be administered once a month, Dupixent has to be given every other week. Lilly plans to submit filings to regulatory authorities by the end of 2022.

Dupixent sales to cross US$ 14 billion: Sanofi expects Dupixent's peak sales to grow beyond US$ 14.44 billion (€13 billion). A potential add-on approval in chronic obstructive pulmonary disease next year could help raise the peak sales estimate even further, the company said. The drug generated about US$ 5.8 billion (€5.25 billion) in sales last year, a 53 percent increase from 2020.

FDA approves second Covid-19 booster shot for those above 50

With the BA.2 sub-variant of Omicron becoming the dominant coronavirus strain in the US, the FDA has approved a second Covid-19 booster shot for people aged 50 and above. The FDA said the Pfizer-BioNTech and Moderna booster shots should be administered at least four months after the first booster dose.

The FDA also authorized a second booster dose for younger people with compromised immune systems. Those aged 12 and older with underlying medical conditions can now go in for a second booster of the Pfizer-BioNTech vaccine; and those 18 and older for Moderna’s.

According to a Reuters news report, Covid infections in Asia crossed 100 million on Wednesday, as the region recorded a resurgence in cases, dominated by the BA.2 Omicron sub-variant. The region is reporting over 1 million new Covid-19 cases about every two days.

Revises EUA for GSK-Vir Biotech’s Covid drug: GlaxoSmithKline and its partner Vir Biotechnology have said the FDA has revised the emergency use authorization (EUA) granted to their monoclonal antibody, sotrovimab, for the treatment of Covid-19 infection.

The revised EUA restricts the use of sotrovimab in certain regions of the US where Covid-19 infection is likely to have been caused by BA.2 sub variant of Covid-19. The restriction is currently limited to the states of Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont. The therapy is also no longer authorized for use in New Jersey, New York, Puerto Rico and the Virgin Islands.

Lockdown in Shanghai: China – the world’s largest exporter of API – has imposed a lockdown in various areas of Shanghai due to a surge in Covid-19 cases that have increased by a third, despite stringent measures. The lockdown may pose a risk to the global supply chains for drugs and APIs.

Sanofi’s rare disease drug bags ‘world’s first’ status through approval in Japan

Japan has granted marketing authorization to Xenpozyme (olipudase alfa), Sanofi’s drug for the treatment of adult and pediatric patients with non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) – a rare, progressive and potentially life-threatening genetic disease. This makes Xenpozyme the only approved treatment for ASMD.

This first therapy from Sanofi was approved under the Sakigake (or “pioneer”) designation, which is the Japanese government’s regulatory fast-track pathway to promote research and development of innovative new medical products addressing urgent unmet medical needs.

The FDA has accepted olipudase alfa’s biologics license application (BLA) for priority review and a decision is expected during the third quarter of this year. The European Medicines Agency (EMA) has also awarded the drug with the PRIority MEdicines (PRIME) designation, and a decision is expected in the second half of 2022.

According to Sanofi’s estimates, the disease affects around 2,000 people in the US, Europe and Japan and around three percent of the patients die annually because of respiratory or liver failure.

Signs potential US$ 6 billion deal with IGM: Sanofi, which was one of the most active dealmakers of 2021 in the biotech industry, signed its first deal of 2022 — it is tying up with US-based IGM Biosciences to bolster its cancer and inflammatory disease drugs pipeline.

Sanofi will pay IGM US$ 150 million upfront to co-develop three cancer targets and three inflammation targets. IGM will be eligible to receive up to US$ 6 billion – US$ 1 billion per program – in payments tied to clinical, regulatory and commercial milestones.

IGM will lead research and phase 1 trials of the inflammation targets. For the oncology candidates, it will assume responsibility from research until the approvals of the drugs. It will also receive royalties and share in profits.

UCB’s seizure drug gets add-on approval: Belgian biotech UCB’s drug to treat seizures – Fintepla – has received an add-on approval to treat a rare form of childhood epilepsy, known as Lennox-Gastaut Syndrome (LGS). The drug is already approved in the US to treat another form of epilepsy – Davet Syndrome (DS) – in children aged two years and older.

As per UCB’s estimates, around 30,000 to 50,000 people in the US are suffering from LGS. Fintepla was developed by California-based Zogenix, which was acquired by UCB earlier this year for US$ 1.9 billion. The drug is pitted against Jazz Pharmaceuticals’ cannabis-based drug, Epidiolex.

FDA rejects Lilly-Innovent’s lung cancer drug; recommends new, multi-regional trial

In February, an FDA committee had voted 14-1 against approving a lung cancer immunotherapy treatment – Tyvyt (sintilimab) – developed by Eli Lilly and its Chinese partner Innovent Biologics. Lack of population diversity (the drug’s phase 3 trial was entirely carried out in China) was a key reason behind the unfavorable vote, along with the fact that the study’s main goal was the use of progression-free survival instead of overall survival.

Now, the FDA has made its reservation official through an imminent complete response letter (CRL). The agency has recommended a multi-regional clinical trial that shows the Tyvyt-chemotherapy combo works as well as standard of care at extending patients’ lives. Lilly and its partner Innovent said they were assessing the next steps for the sintilimab program in the US.

The agency’s decision has dashed the hopes of several other Chinese drugmakers planning to sell their products in the US market at lower costs by conducting a single-country clinical trial. According to the FDA, there are at least 25 applications with China-only data either under review, or in the process of being submitted or currently under development.

FDA panel votes against Amylyx’s ALS drug: A panel of external advisers to the FDA has voted six to four against Amylyx Pharmaceutical’s drug for amyotrophic lateral sclerosis (ALS), a neurodegenerative disease. Amylyx’s FDA submission was based on a 24-week placebo-controlled study of 137 participants with ALS. The panel said the study data failed to establish it was effective against the disease. The agency’s decision on the drug is expected by June 29.

Akebia’s anemia drug rejected: FDA has declined to approve Akebia Therapeutics’ drug — Vadadustat — to treat anemia caused by chronic kidney disease on safety concerns in non-dialysis patients. The drug was found to be inferior in its safety profile when compared with the current standard of care for patients not dependent on dialysis, the FDA said.

Court dismisses age-old lawsuits against Merck over its osteoporosis drug

For over 14 years, Merck has been defending itself against hundreds of lawsuits that allege it failed to warn users about the risks of thigh bone fractures associated with its osteoporosis drug Fosamax. The drugmaker argued that it tried to add the fracture warning to Fosamax’s label, but the FDA had rejected the addition.

Last week, a federal judge in New Jersey sided with Merck, tossing out more than 500 lawsuits. The judge ruled that since FDA labels amount to federal law, the company shouldn’t be held liable under state laws for failing to warn of the drug’s risks.

This is the second time Merck has won the dismissal of the cases on pre-emption grounds after another district judge ruled in its favor in 2013. Fosamax won its original FDA approval in 1995.

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