AstraZeneca will oversee global development, manufacturing, and distribution of the COVID-19 vaccine candidate that was created by researchers at University of Oxford, and is now being studied in a human clinical trial launched last week, the partners said today.

AstraZeneca, the University, and its spinout company Vaccitech—which has joint rights to the platform technology behind the vaccine candidate, ChAdOx1 nCoV-19—said they will start work immediately while hammering out final terms of their collaboration agreement. The partnership is designed to enable rapid production and distribution of the vaccine should it prove effective in clinical studies.

“Our hope is that, by joining forces, we can accelerate the globalization of a vaccine to combat the virus and protect people from the deadliest pandemic in a generation,” AstraZeneca CEO Pascal Soriot said in a statement. “As COVID-19 continues its grip on the world, the need for a vaccine to defeat the virus is urgent. This collaboration brings together the University of Oxford’s world-class expertise in vaccinology and AstraZeneca’s global development, manufacturing and distribution capabilities.”

ChAdOx1 nCoV-19 has been developed by the University’s Jenner Institute, whose researchers last week partnered with colleague from the University’s jointly with the University’s Oxford Vaccine Group to launch the COV001 Phase I/II trial (NCT04324606.)

The single-blinded, randomized, multi-center study is designed to determine the efficacy, safety and immunogenicity of the vaccine candidate in healthy adult volunteers aged 18–55 years across five trial centers in Southern England. Data from the Phase I trial could be available next month, AstraZeneca predicted, with advancement to late-stage trials expected to occur by the middle of this year.

“By June, July we will already have a very good idea of the direction of travel in terms of its potential efficacy,” Soriot told BBC Radio 4.

The vaccine has shown positive results in six rhesus macaque monkeys inoculated with single doses, all of which remained healthy 28 days following treatment, followed by exposure to SARS-CoV-2, Vincent J. Munster, PhD, Chief, Virus Ecology Unit at the NIH’s National Institute of Allergy and Infectious Disease, told The New York Times this week.

The trial began recruiting patients on April 23, after U.K. Health Secretary Matt Hancock pledged £20 million ($25 million) in government funding to support ChAdOx1 nCoV-19 development.

“Our best hope”

“In the long run, a vaccine remains our best hope of defeating this virus for good,” Hancock stated. “I am determined to do everything in my power to develop an effective vaccine and get it to the people of the U.K. as soon as possible. I want the U.K. to lead the world in developing a coronavirus vaccine—and I will back our scientists to the hilt in doing so.”

ChAdOx1 nCoV-19 uses a viral vector based on a weakened version of the adenovirus containing the genetic material of SARS-CoV-2 spike protein. After vaccination, the surface spike protein is produced, which primes the immune system to attack COVID-19 if it later infects the body. The recombinant adenovirus vector (ChAdOx1) is designed to generate a strong immune response from a single dose and to not replicate, in order to preclude causing an ongoing infection in the vaccinated individual.

According to AstraZeneca, vaccines made from the ChAdOx1 virus have been given to more than 320 people to date and have been shown to be safe and well tolerated—although they can cause temporary side effects such as a temperature, flu-like symptoms, headache or sore arm, the company acknowledged.

Under its agreement with the University, AstraZeneca agreed to provide the U.K. with access to the vaccine as soon as possible should it succeed in clinical trials. AstraZeneca also agreed to work with global partners on the international distribution of the vaccine, with emphasis on making it available and accessible for low- and medium-income countries.

“The University of Oxford and AstraZeneca have a longstanding relationship to advance basic research and we are hugely excited to be working with them on advancing a vaccine to prevent COVID-19 around the world,” added Mene Pangalos, AstraZeneca executive vice president, BioPharmaceuticals R&D.

Calquence® and antibodies

By partnering with Oxford, AstraZeneca signaled its intent to accelerate efforts to bring a COVID-19 treatment to market.

On April 14, AstraZeneca announced plans for a randomized, global clinical trial to assess Calquence® (acalabrutinib) as a treatment for cytokine storm associated with COVID-19 infection in severely ill patients. The Phase II CALAVI trial (NCT04346199) is based on early clinical data with Calquence, which according to the company showed that a decrease in inflammation caused by BTK inhibition appeared to reduce the severity of COVID-19-induced respiratory distress in a small number of patients at Walter Reed Army Medical Center.

“We are encouraged by anecdotal suggestions that BTK inhibitors could be effective in COVID,” Andrew Berens, MD, a Senior Research Analyst at SVB Leerink covering “targeted oncology” drug developers, and colleagues wrote this morning in an investor note.

The CALAVI trial—two arms totaling 428 patients—aims to evaluate the efficacy and safety of adding Calquence to best supportive care (BSC); the primary endpoint measures the use of assisted ventilation or death.

Calquence is a next-generation, highly selective Bruton’s tyrosine kinase (BTK) inhibitor indicated for Mantle cell lymphoma patients who have received at least one prior therapy, and chronic lymphocytic leukemia or small lymphocytic leukemia. Calquence generated $88 million in product sales during the first quarter, more than triple the $29 million generated in Q1 2019. The drug generated $164 million last year, its first full year on the market.

On April 8, AstraZeneca said it was working to develop coronavirus-neutralizing monoclonal antibodies through the Defense Advances Research Project Agency’s Pandemic Prevention Platform (P3). AstraZeneca said it was exploring three potential sources for antibodies: Patients who have recovered from COVID-19, immunized humanized mice, and lab techniques such as phage display: “AstraZeneca is aiming for clinical evaluation in the next 3 to 5 months.”

AstraZeneca also disclosed antibody collaborations with external partners, saying that The Chinese Academy of Sciences, and Vanderbilt University Medical Center had provided genetic sequences for antibodies they have discovered against SARS2-CoV-2 for further in silico and in vitro assessment, while the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and the University of Maryland School of Medicine were conducting preclinical safety and efficacy assessments of antibody candidates discovered by AstraZeneca through internal research.

AstraZeneca prevailed over several other pharmaceutical giants—many of them U.S.-based—also seeking to partner with Oxford in the global manufacturing and distribution of its vaccine, the Financial Times reported, citing an unnamed source.

Not-for-profit basis

In its latest partnership, AstraZeneca said it had agreed with the University of Oxford to operate on a not-for-profit basis for the duration of the COVID-19 pandemic, with only the costs of production and distribution being covered. The University and its spinout Vaccitech have agreed to receive no royalties from the vaccine during the pandemic.

“We believe this vaccine candidate provides significant validation for our ChAdOx platform, which is one of the few to have already induced neutralizing antibodies against coronavirus spike proteins in human studies for MERS,” asserted Vaccitech CEO Bill Enright. “We are committed to doing all we can to support our scientific founders at the Jenner Institute in order to overcome this unprecedented global crisis.”

Oxford also committed to reinvesting any royalties it receives from the vaccine once the pandemic ends directly back into medical research—including through the creation of a Pandemic Preparedness and Vaccine Research Centre to be developed in collaboration with AstraZeneca.

“Sadly, the risk of new pandemics will always be with us, and the new research center will enhance the world’s preparedness and our speed of reaction the next time we face such a challenge,” said Professor Sir John Bell, Regius Professor of Medicine at Oxford University. “Our partnership with AstraZeneca will be a major force in the struggle against pandemics for many years to come. We believe that together we will be in a strong position to start immunizing against coronavirus once we have an effective approved vaccine.”

AstraZeneca’s partnership with the University and Vaccitech is the first partnership formed since the U.K. government launched its dedicated Vaccines Taskforce two weeks ago, with the aim of helping find, test and deliver a new COVID-19 vaccine.

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