Akston and LakePharma to manufacture second-gen COVID-19 vaccine

Akston Biosciences and LakePharma have established a strategic partnership under which the latter will manufacture the former’s adjuvated COVID-19 vaccine candidate (AKS-452), which is scheduled to begin Phase 1/2 clinical testing later this month.

AKS-452 is the most advanced COVID-19-specific Fc fusion protein vaccine in commercial development and is engineered to induce or boost a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain (RBD) of the novel SARS-CoV-2 coronavirus spike protein.

The inherent nature of this construct provides a unique combination of benefits compared to nucleic acid, viral-vectored, and inactivated virus vaccines.

Unlike other vaccines that must be kept refrigerated or even deep-frozen for transport and storage, AKS-452 has been shown to be shelf-stable for weeks at up to 37 degrees Celsius (95°F). This greatly simplifies distribution and is critically important for vaccinating the billions of people not served by sophisticated and costly cold-chain transportation.

Akston has engineered AKS-452 to use conventional antibody manufacturing techniques, such that with multiple batches over one year, a single 2,000-liter production train would be capable of producing over one billion doses.

“Our objective is to provide a practical solution to the problem of vaccinating and, if need be, boosting the immunity of people all over the world against the SARS-CoV-2 virus,” said Todd Zion, President & CEO of Akston Biosciences.

“Our team realised early on that our fusion protein platform could be used to design a vaccine that checked all the boxes – transportable at ambient temperatures, produced at very low cost, and suitable for repeated dosing if immunity wanes.

“Partnering with LakePharma gives us great confidence that we can ramp up quickly to deliver large quantities of AKS-452 on a commercial basis.”

Hua Tu, President and CEO of LakePharma, said: “We bring three critical components to this partnership: our experience in making SARS-CoV-2 proteins, our stable CHO-GSN technology, and most importantly, the use of the cGMP manufacturing suite in our Hopkinton, MA facility.

“We have worked with Akston and its fusion protein therapeutics since 2015, and this experience means we can transition AKS-452 into large-scale production very rapidly.”

First COVID patients enrolled in AM-Pharma’s Phase III trial

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The first patients with COVID-19 infection and sepsis-associated acute kidney injury (SA-AKI) have been enrolled in AM-Pharma’s Phase III REVIVAL pivotal trial in an exploratory cohort to assess the safety, tolerability and clinical benefit of recombinant alkaline phosphatase.

Patients with severe COVID-19 infection often present with acute severe inflammation and organ failure. Recent studies conducted in the US demonstrated that up to 90% of the COVID-19 patients that received mechanical ventilation also suffered from AKI and that the development of AKI in these patients is associated with poor prognosis.

AM-Pharma, a Dutch company focused on the treatment of kidney disease, sepsis and organ injury, received an innovation credit of up to EUR 5 million from the Netherlands Enterprise Agency (RVO.nl), which has been established by the Dutch Ministry of Economic Affairs and Climate Policy to support the development of innovative programs with promising market potential.

Erik van den Berg, CEO of AM-Pharma, said: “The prevalence of COVID-19 infections and the high AKI comorbidity support our decision to include this additional cohort into our Phase III REVIVAL pivotal study.

“By providing our proprietary recombinant alkaline phosphatase to clinicians for evaluation in severe COVID-19 cases, we aim to make our novel treatment option available for these patients.”

The REVIVAL Phase III pivotal trial is a randomised, double-blind, placebo-controlled, two-arm, parallel-group, multi-centre trial to evaluate the efficacy and safety of AM-Pharma’s proprietary human recombinant alkaline phosphatase for the treatment of patients with SA-AKI.

The study will enrol approximately 1400 patients with SA-AKI in the main study population. In two exploratory cohorts, up to 100 patients with moderate Chronic Kidney Disease (CKD) and up to 100 patients with COVID-19 will be enrolled.

The primary aim of the study is to confirm the improvement on the primary endpoint of 28-day all-cause mortality, as observed in the Phase II STOP-AKI study.

Secondary endpoints include the treatment effect on long-term Major Adverse Kidney Events (MAKE), on the use of organ support, length of stay in the ICU and on 90-day all-cause mortality.

COVID-19 Vaccine Moderna authorised in Europe

The European Commission has granted a conditional marketing authorisation (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union.

The authorisation is based upon the recommendation of the European Medicines Agency (EMA) for use of the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older.

Stéphane Bancel, CEO of Moderna, said: “The EMA and the Committee for Medicinal Products for Human Use reviewers, working over the holidays, provided a thorough review and comprehensive guidance as we worked together to achieve this authorization.

“I am proud of the role Moderna has been able to play globally in helping to address this pandemic.”

The European Union is the fourth jurisdiction to authorize Moderna’s COVID-19 vaccine, following the United States on December 18, 2020, Canada on December 23, 2020 and Israel on January 4, 2021.

Additional authorisations are currently under review in Singapore, Switzerland and the United Kingdom.