Moderna Inc. is broadening its testing of a vaccine for a leading infectious cause of birth defects after early-stage clinical results showed it induced immune responses in patients.
A larger, mid-stage study will begin soon and could produce interim results three months later, the biotech firm said before a research and development presentation Thursday in New York. Moderna is also preparing for a late-stage trial that could pave the way for an application to U.S. regulators.
The shot, known as mRNA-1647, has “blockbuster” potential, according to Chief Executive Officer Stephane Bancel. There is currently no vaccine approved for cytomegalovirus (CMV), a common infection that can lead to birth defects especially if caught while a woman is pregnant.
Moderna shares rose as much as 12% on Thursday to the highest since early June.
The company plans to test the vaccine in adolescents and infants in the future, Bancel said. He draws a parallel to rubella, which can cause a miscarriage or serious birth defects but is now preventable by vaccine.
“We have eradicated rubella,” Bancel said in a telephone interview. “We think we can do the same with CMV.”
This is the sixth study of Moderna’s messenger-RNA vaccines, which have so far been well tolerated, according to management. It’s also the second vaccine that the firm is advancing into Phase 2 testing, after its Merck & Co.-partnered
Separately, the Cambridge, Massachusetts-based biotech company reported that its experimental chikungunya treatment induced detectable levels of an antibody that fights the virus in healthy adults in an early-stage trial.
The data show “for the first time the ability to generate therapeutic levels of a complex protein in humans through systemic administration of an mRNA, essentially instructing the body to make its own medicines,” chief medical officer Tal Zaks said in a statement.
Shares of Moderna have fallen more than 45% from their peak in May, leaving their year-to-date gain at 4.3%. The biotech stock has traded only briefly
above $23, its initial public offering price last December.
Just the Data
- CMV vaccine:
- In both patients who did and didn’t have the CMV virus, mRNA-1647 triggered a dose-related increase in the levels of antibodies that typically block infections
- In CMV-negative patients’ epithelial cells, antibody levels after the second vaccination were 3 to 5 times higher than those patients who had the virus
- In CMV-positive patients’ epithelial cells, the second vaccination boosted antibody levels to a level of 10-fold to 19-fold the baseline in all dose groups
- Common side effects included muscle aches, headache, fatigue, chills and fever; there was one serious episode in blood tests measuring the blood’s coagulation, which resolved shortly after
- Administration of mRNA-1944 resulted in dose-related increases in CHKV-24 antibody levels at all doses
- All patients exceeded the levels of antibody expected to be protective against chikungunya infection following a single dose, with the middle and high doses projected to maintain antibody levels above protective levels for at least 16 weeks
- Three of the four participants on the high dose experienced side effects, including one person with severe tachycardia and elevated white blood cell count, as well as moderate nausea, fever and inverted T waves on a routine EKG, which resolved without treatment
(Updates with shares in fourth paragraph.)