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Pharma News

Sanofi, GSK get approval for Phase 3 COVID-19 vaccine trial in India

by Vaishali Sharma
written by Vaishali Sharma

Sanofi and GSK received approval for their Phase 3 clinical study in India, to assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global, randomised, double-blind Phase 3 study will include over 35,000 volunteers aged 18 and older across sites in the US, Asia, Africa, and Latin America.

As COVID-19 vaccination becomes available, study participants are encouraged to receive an approved COVID-19 vaccine during the study, if they wish to do so. As part of the study design, all participants including the control group will be offered the study vaccine as soon as it is determined to be safe and effective.

“India is participating in Sanofi Pasteur’s pivotal Phase 3 study, and subject to subsequent approvals, we should soon begin enrollment of study participants in the country,” said Annapurna Das, Country Head, Sanofi Pasteur India.

“As the virus continues to evolve, we are anticipating what will be needed in the coming months and years, and accordingly, have adapted our vaccine development program. We believe our COVID-19 adjuvanted, recombinant vaccine can make a significant contribution to the ongoing fight against COVID-19 and are committed to initiating our clinical program in India, at the earliest,” she added.

The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection.

In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original virus strain (D.614), while a second stage will evaluate a second formulation targeting the Beta variant (B.1.351). Recent scientific evidence shows that antibodies created against the Beta variant may provide broad cross-protection against other more transmissible variants.

A statement informed, “The design of the Phase 3 study, conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the candidate against a variety of circulating variants. Sanofi and GSK will also run clinical studies to assess the ability of the adjuvanted recombinant-protein COVID-19 vaccine candidate to generate a strong booster response regardless of the type of vaccine initially received.”

It added, “The Phase 3 study initiation follows the global interim Phase 2 results which showed that the adjuvanted recombinant COVID-19 vaccine candidate achieved high rates of neutralising antibody responses in all adult age groups, with 95 to 100 per cent sero conversion rates. After a single injection, high neutralising antibody levels were also generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.”

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Pharma News

NICE turns down GSK’s IV Benlysta for systemic lupus

by Vaishali Sharma
written by Vaishali Sharma

The National Institute for Health and Care Excellence (NICE) has rejected NHS funding for an intravenous formulation of GlaxoSmithKline’s Benlysta (belimumab) as an add-on therapy for certain patients with active autoantibody-positive systemic lupus.

The preliminary decision, outlined in an appraisal consultation document, relates to use of the drug in people aged five years and older when there is a high degree of disease activity (for example, positive anti-double-stranded DNA, low complement) and despite standard therapy, as per its marketing authorisation.

According to NICE, while clinical trial evidence suggests that after a year of treatment Benlysta plus standard therapy reduces disease activity more than standard therapy alone, “the results are uncertain because the trials were short”.

Also, it noted that the long-term benefit of Benlysta compared with standard therapy or rituximab is unknown, as long-term extension studies did not have comparator arms.

Cost-effectiveness estimates are also uncertain, and are most likely higher than what is normally considers an acceptable use of NHS resources, the Institute said.

The consultation is open until June 25 for comments.

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Gynecology News

Sanofi partners with BIG, EORTC, AFT to study amcenestrant for ER+ breast cancer treatment

by Vaishali Sharma
written by Vaishali Sharma

Sanofi is partnering with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and the Alliance Foundation Trials (AFT), to initiate a pivotal trial of an oral selective estrogen receptor degrader (SERD) in the adjuvant setting. The Phase 3 AMEERA-6 study will evaluate the efficacy and safety of Sanofi’s amcenestrant vs tamoxifen for women with estrogen receptor-positive (ER+) breast cancer who were unable to continue their adjuvant aromatase inhibitor (AI) therapy.

“Together with our research partners, BIG conducts landmark, practice-changing trials that can have a significant impact on the lives of women with breast cancer,” said David Cameron, Chair of the BIG Executive Board. “Adjuvant therapy helps prevent and delay the progression of disease into the later setting. However, current adjuvant therapies, like AIs, can have side effects for some women, which may cause them to discontinue the medication prematurely. Amcenestrant may be a potential option for women in this setting and we look forward to working with Sanofi, EORTC and AFT to investigate this further. We look forward to collaborating with these leading academic networks to investigate amcenestrant in the adjuvant setting through AMEERA-6. Based on encouraging data emerging from our ongoing clinical program, we believe that amcenestrant, an investigational oral SERD, has the potential to become a best-in-class oral endocrine backbone therapy,” said Peter Adamson, Global Development Head, Oncology at Sanofi. 

Amcenestrant is an oral SERD that antagonises and degrades the estrogen receptor (ER), resulting in inhibition of the ER signaling pathway. Amcenestrant is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority.

As per the terms of the Pre-Study Agreement, Sanofi will be the sponsor and will provide funding and investigational drug product for the global study. BIG will conduct the study within the BIG network, EORTC will oversee study management and data analysis, as well as the medical management, and AFT will conduct the US portion of the study. Sanofi will conduct this global study in selected countries outside the geographical scope of the academic networks, as further described in a follow-on agreement under negotiation among the four parties. The protocol is being developed in collaboration with all four parties, including AFT, BIG, EORTC and Sanofi.

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Pharma News

After setback, Sanofi-GSK reports success in COVID-19 vaccine

by Vaishali Sharma
written by Vaishali Sharma

Sanofi and GlaxoSmithKline’s potential COVID-19 vaccine triggered strong immune responses in all adult age groups in preliminary trials after an earlier setback, boosting optimism that the shot may join the fight against the pandemic this year. After two doses of the vaccine candidate, participants showed neutralising antibodies in line with those found in people who had recovered from the disease, according to results of the phase-II trial released on Monday.

The drugmakers said they plan to begin late-stage trials and production in the coming weeks and hope to win regulatory approval for the vaccine before the end of 2021.

Regulators have already authorised a number of COVID-19 vaccines, though experts say more are needed as public health authorities around the world race to vaccinate their residents amid a pandemic that has already killed more than 3.3 million people and caused economic havoc.

The Sanofi-GSK vaccine was an important part of the European Union’s vaccination strategy and had notably been championed by French President Emmanuel Macron’s government.

However, researchers had to reformulate it after early testing produced an inadequate immune response in older people.

The Sanofi-GSK candidate joins about a dozen vaccines now undergoing late-stage trials.

The companies plan to produce up to one billion doses annually, and they have signed agreements to supply the US, Canada and developing countries, too. Public health experts say several vaccines will be needed to end the pandemic, because of the challenges in rapidly producing and distributing enough doses to vaccinate billions of people.

“We know multiple vaccines will be needed, especially as variants continue to emerge and the need for effective and booster vaccines which can be stored at normal temperatures increases,” said Thomas Triomphe, Head – Vaccine Unit, Sanofi.

The results released on Monday were from a phase-II trial involving 722 volunteers aged 18 to 95 who were recruited in the US and Honduras.

The vaccine showed even stronger antibody results in people who had already recovered from the virus. Sanofi said that makes it a potentially strong candidate as a booster shot in the future for those who have already been vaccinated with rival products.

The late-stage trial will involve about 37,000 participants from countries around the world, the companies said. They plan to study its efficacy against the virus variant first identified in South Africa, and potentially others as well.

After the initial setback, Sanofi struck agreements to help bottle or produce rival vaccines designed by Pfizer, Moderna and Johnson&Johnson. The progress in the Sanofi-GSK vaccine will not disrupt those production plans, Triomphe said.

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