Moderna to pause certain clinical development activities amid Covid-19

Biotechnology firm Moderna has provided an update on the impact of the Covid-19 pandemic on its clinical development activities and business operations.

The company is set to pause recruitment of new participants for its Phase I trials of mRNA-3704 and mRNA-3927 in rare diseases methylmalonic acidemia and propionic acidemi, respectively.

Moderna’s decision comes from a risk-based analysis used to review new participant enrolment and site initiation for its ongoing clinical trials.

The company also decided to temporarily halt its age de-escalation trial of pediatric respiratory vaccine.

The ongoing Phase II CMV trial of mRNA-1647 and Phase I Zika trial mRNA-1893 are fully enrolled but some participants may not receive scheduled vaccines doses due to the pandemic.

Moderna is assessing the impact of these disruptions on the trials’ integrity.

Furthermore, the company will pause enrolment of new participants for the hMPV/PIV3 study of mRNA-1653 in seropositive paediatric participants aged 12-36 months.

Discussions will be held with relevant medical and site personnel on resuming recruitment.

Enrolment for chikungunya virus antibody trial of mRNA-1944 has also been temporarily suspended by the site due to Covid-19.

Treatment of existing participants, as well as enrolment, is ongoing in the company’s oncology trials, including mRNA-4157, mRNA-2752 and OX40L / mRNA-2416 programmes.

However, the pandemic is said to cause enrolment delays for these cancer trials and the company is considering the initiation of new sites based on a risk-based framework.

Moderna CEO Stéphane Bancel said: "The Covid-19 pandemic has created unprecedented challenges and we are committed to ensuring the health and safety of all participants in our and our partners’ clinical trials, our clinical trial site teams, vendors and our employees.

"Moderna’s primary focus is on the safety of all involved and the continued conduct of our clinical programs as we navigate the pandemic together."

Meanwhile, the company established an internal, cross-functional response team on 2 March to track the Covid-19 pandemic situation and advise on its response.

As of 12 March, Moderna switched to a remote work plan for several employees while certain in-person laboratory, manufacturing and related activities take place on-site.

To help fight Covid-19, the company is developing a vaccine candidate, mRNA-1273, which could be available for emergency use by autumn.

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