Moderna CEO Stéphane Bancel again updated investors on the company's pipeline at the J.P. Morgan Healthcare Conference, including strides it is making in infectious diseases.
Bancel offered the first glimpse into the mRNA biotech’s pipeline at 2016’s J.P. Morgan Healthcare Conference, and now it has 19 mRNA drug candidates spanning infectious diseases, immuno-oncology, rare diseases and cardiovascular disorders, according to the company.
The company has initiated phase 1 study of mRNA-1647, a cytomegalovirus (CMV) vaccine, in November, and in December began dosing phase 1 subjects with mRNA-1653, a combination vaccine against human metapneumovirus (HMPV) and parainfluenza virus type 3 (PIV).
The CMV candidate consists of six mRNAs that direct cells to express antigenic proteins gB, gL, UL128, UL130 and UL131A. CMV is one of the most common cause of newborn disability and is also a frequent infection in organ transplant recipients, yet no approved vaccine is currently available against it. But a few programs are in clinical studies.
Astellas is developing DNA vaccine ASP0113 with partner Vical. The shot, which encodes CMV pp65 and gB antigens, previously failed to best placebo in kidney transplant patients in a phase 2. In October, the pair announced a phase 3 registration trial of the shot in 515 hematopoietic cell transplant recipients has finished last-patient assessment for the one-year follow-up, with top-line data expected the first quarter of 2018. Besides that, Helocyte—who licensed from the City of Hope—and VBI Vaccines also have vectored candidates in human testing.
There’s no approved vaccine for HMPV or PIV3, either, but the two viruses are the second- and third-most common causes of lower respiratory hospitalization in children, behind RSV, Moderna said.
The updates came a quarter after Moderna provided new information about its Chikungunya and Zika programs. It now has also unveiled an antibody candidate designed to neutralize Chikungunya in the blood. The program, dubbed mRNA-1944, and the phase 1 Chikungunya prophylactic candidate mRNA-1388, are supported by the U.S. Department of Defense’s Defense Advanced Research Projects Agency.
Moderna has doubled its clinical programs from five at last year’s JPM to 10 this year. Bancel said he’s proud of the progress over the past year and will forge ahead in 2018 with emphasis on the discovery of new rare disease candidates and prophylactic vaccines.
Most of the candidates in Moderna’s pipeline lie in infectious diseases, but more eyes are pivoting on its AstraZeneca-partnered lead candidate AZD-8601 for cardiovascular diseases and potentially higher-margin candidates in immuno-oncology. Despite some big-name tie-ups, before any later-stage data are presented, some industry watchers might remain suspicious of the company’s real worth.
Editor's Note: The story was updated to clarify that the CMV vaccine candidates developed at the City of Hope had been licensed to Helocyte.