Moderna Inc (MRNA)

[mick]

The results for the CMV vaccine mRNA-1647 in the Phase 2 trial seem better than in Phase 1 data vis-à-vis immunogenicity, tolerability and a commercial (lyophilized) formulation, the analyst said.

Moderna sees opportunities for combination vaccines in older and younger populations, she said.

"Systemic mRNA re-dosing appears feasible from a safety standpoint and novel, iterative, trial designs may help select optimal dose levels and schedules."

Intratumoral delivery induces expression of the encoded proteins and appears to trigger immunological changes, though whether these translate to responses remains to be seen, according to Chardan.

Related Link: The Week Ahead In Biotech: Decision Day For Bausch Health, IPO Flow Resumes, Oncology Conference

SVB Leerink Sticks To Moderna Model: Moderna mostly covered its early stage pipeline at the event, even as the investor focus remains on the company's COVID-19 vaccine program, Foroohar said in a note.

The November readout from the late-stage study is the earliest possible trigger for emergency use authorization filing, the analyst said.

The protocol suggested two interim analysis points, at 53 and 106 events, or 35% and 70%, respectively, of the primary analysis event number of 151 across active and placebo groups, he said.

The event rate for each analysis could be delayed due to fluctuating COVID-19 case rates across the country, potentially pushing back an EUA filing to December, Foroohar said.

"As such, an efficacy read out could be delayed by several weeks to a couple months."

With investors focused on any safety signals from the 600-patient-strong Phase 2 results, which are imminent, the analyst said these results could largely be confirmatory and in line with previously presented Phase 1 results.

Moderna also presented positive interim Phase 2 CMV data, and announced a new program in seasonal flu vaccines, along with two early stage collaborations in cystic fibrosis and pulmonary arterial hypertension, he said.

Moderna's pivot to a novel construct for their methymalonic acidemia Phase 1 program is less encouraging, Foroohar said.

"While we praise the company's transparency in releasing the Phase 3 COVE protocol, we do not make changes to our model at this time," the analyst said.