AstraZeneca’s long-acting antibody combo advances into Phase III clinical trials

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AstraZeneca’s long-acting antibody (LAAB) combination, AZD7442, will advance into two Phase III clinical trials in more than 6,000 participants at sites in and outside the US that are due to begin in the next weeks.

The LAABs have been engineered with AstraZeneca’s proprietary half-life extension technology to increase the durability of the therapy for six to 12 months following a single administration.

The combination of two LAABs is also designed to reduce the risk of resistance developed by the SARS-CoV-2 virus.

The Company has received support of around $486 million from the US Government for the development and supply of AZD7442 under an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.

One trial will evaluate the safety and efficacy of AZD7442 to prevent infection for up to 12 months, in approximately 5,000 participants. The second trial will evaluate post-exposure prophylaxis and pre-emptive treatment in approximately 1,100 participants.

AstraZeneca is planning additional trials to evaluate AZD7442 in approximately 4,000 patients for the treatment of COVID-19.

The company also plans to supply up to 100,000 doses starting towards the end of 2020 and the US Government can acquire up to an additional one million doses in 2021 under a separate agreement.

“This agreement with the US Government will help accelerate the development of our long-acting antibody combination which has the potential to provide immediate and long-lasting effect in both preventing and treating COVID-19 infections,” said CEO Pascal Soriot.

“We will be evaluating the LAAB combination in different settings from prophylaxis, to outpatient treatment to hospitalisation, with a focus on helping the most vulnerable people.”

EMA starts first rolling review of COVID-19 vaccine

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The European Medicines Agency’s (EMA) human medicines committee (CHMP) has started the first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford.

The start of the rolling review means that the committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies (non-clinical data).

This does not mean that a conclusion can be reached yet on the vaccine’s safety and effectiveness, as much of the evidence is still to be submitted to the committee.

A rolling review is one of the regulatory tools that the Agency uses to speed up the assessment of a promising medicine or vaccine during a public health emergency.

Normally, all data on a medicine’s effectiveness, safety and quality and all required documents must be submitted at the start of the evaluation in a formal application for marketing authorisation.

In the case of a rolling review, the CHMP reviews data as they become available from ongoing studies, before deciding that sufficient data are available and that a formal application should be submitted by the company.

The CHMP’s decision to start the rolling review of the vaccine is based on preliminary results from non-clinical and early clinical studies suggesting that the vaccine triggers the production of antibodies and T cells (cells of the immune system, the body’s natural defences) that target the virus.

Large-scale clinical trials involving several thousands of people are ongoing, and results will become available over the coming weeks and months.

These results will provide information on how effective the vaccine is in protecting people against COVID-19 and will be assessed in later rolling review cycles.

All the available data on the safety of the vaccine emerging from these studies, as well as data on its quality (such as its ingredients and the way it is produced), will also be reviewed.

The rolling review will continue until enough evidence is available to support a formal marketing authorisation application.

EMA will complete its assessment according to its usual standards for quality, safety and effectiveness. While the overall review timeline cannot be forecast yet, the process should be shorter than a regular evaluation due to the time gained during the rolling review.

The rolling review process has been used previously in the assessment of the COVID-19 medicine, Veklury (remdesivir).

Pfizer & CStone address oncological needs in China

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Pfizer has formed a strategic collaboration with CStone Pharmaceuticals to address oncological needs in China.

As part of the collaboration, Pfizer Hong Kong will make a $200 million equity investment in CStone.

The collaboration provides financing to support CStone’s development of sugemalimab, a potential best-in-class PD-L1 antibody that is being developed for high-incidence cancer indications in China, including lung, gastric and esophageal cancers, among others.

Pfizer will in-license and exclusively lead commercialization of sugemalimab in China, harnessing its industry-leading capabilities to help doctors and patients across a far wider range of regions gain greater access to this treatment.

The collaboration positions CStone and Pfizer to develop and commercialize additional oncology assets for the Greater China market.

Pfizer’s investment in CStone is a statement of its confidence in the potential of our anti-PD-L1 treatment and recognition of our research and development capabilities,” said Frank Jiang, Chairman and CEO of CStone.

“By joining forces with Pfizer and leveraging its commercialisation infrastructure, we will ensure that patients across a vastly expanded number of markets in China have quicker access to our highly differentiated PD-L1 treatment.

In addition, we have advanced our transformation into a full-fledged biopharmaceutical company by forging a collaboration that will enable us to accelerate development and commercialization of globally innovative therapies for Chinese patients.”

Pierre Gaudreault, Acting President of Pfizer Biopharmaceuticals Group China, said: “This collaboration with CStone builds on that history by helping to develop a potential best-in-class PD-L1 treatment that we can commercialize upon approval.

“It also fosters our collaboration with a partner that has exceptional clinical development capabilities that can help us meet the clear need for novel oncology treatments in China.”