Moderna said today it received FDA clearance to advance its COVID-19 vaccine candidate mRNA-1273 into a Phase II trial—and laid out a timeframe for launching a pivotal study this summer and positioning the company for approval of its BLA for the vaccine next year.

“The imminent Phase II study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273,” Moderna CEO Stéphane Bancel said in a statement accompanying the company’s release of earnings for the first quarter.

Moderna said the FDA allowed mRNA-1273 to proceed to Phase II study—which is expected to begin “shortly,” according to the company—after completing its review of the company’s IND application for the vaccine candidate. The company submitted that application April 27, and said last week it expected to begin the Phase II study in the second quarter.

Moderna has said the Phase II trial will be designed to assess the safety, reactogenicity, and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. Each subject will be assigned to receive placebo, a 50 μg or a 250 μg dose at both vaccinations. Moderna intends to enroll 600 healthy participants across two cohorts of adults ages 18–55 years (n=300) and older adults ages 55 years and above (n=300). Participants will be followed through 12 months after the second vaccination.

The FDA is also finalizing protocol for a Phase III study of mRNA-1273, which Moderna said is expected to begin in the early summer of 2020.

Moderna is developing mRNA-1273 with a commitment of up to $483 million received last month from the Biomedical Advanced Research and Development Authority (BARDA), intended to fund development of mRNA-1273 to FDA licensure.

“Front runner” candidate

mRNA-1273 is among 18 candidates designated as “Front Runners” among 160+ COVID-19 therapeutics under study in GEN’s updated A-List published April 13, “Vanquishing the Virus: 160+ COVID-19 Drug and Vaccine Candidates in Development.”

mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA vaccine encoding for a prefusion stabilized form of the Spike (S) protein. The vaccine candidate is under study in a Phase I open-label, dose-ranging trial of mRNA-1273 (NCT04283461) in males and non-pregnant females, 18 to 55 years old, occurring at three sites: Kaiser Permanente Washington Health Research Institute in Seattle,WA; the NIH Clinical Center—Vaccine Research Center Clinical Trials Program in Bethesda, MD; and Emory Vaccine Center—The Hope Clinic in Decatur, GA.

The 45-patient study is designed to assess the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 3 dosages in healthy adults. The first patient was dosed in March.

Moderna’s update on the timing of mRNA-1273 clinical studies comes a week after the company signed a 10-year manufacturing agreement with Lonza that allowed it to establish manufacturing suites for producing the vaccine at Lonza’s facilities in the U.S. and Switzerland. The companies also agreed to establish additional production suites across Lonza’s worldwide facilities, ultimately allowing for the manufacture of material equivalent to up to 1 billion doses of mRNA-1273 per year for use worldwide, based on the currently expected dose of 50 mcg.

Technology transfer is expected to begin in June, with the first batches of mRNA-1273 set to be manufactured at Lonza’s U.S. site in July, Moderna and Lonza said May 1.

Moderna finished the first quarter with a net loss of $124.2 million, compared to $132.6 million for the three months ended March 31, 2019. Total revenue was $8.4 million for Q1 2020, compared to $16.0 million a year ago.

The company said the year-over-year decrease in revenue was mainly due to cumulative catch-up adjustments in revenue because of changes in estimated costs for future performance obligations under collaborations with Merck & Co. and AstraZeneca—as well as a decrease in revenue from Merck, primarily driven by the timing of amortization of deferred revenue due to the satisfaction of the Company’s performance obligation.

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