January 12, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Cambridge, Mass.-based Moderna Therapeutics had a big day yesterday at the J.P. Morgan 34th Annual Healthcare Conference in San Francisco, highlighting a range of new deals and advancing clinical trials.
Moderna announced that it has shifted from a preclinical company to a clinical stage company with its first Phase I clinical trial for mRNA 1440 now ongoing in Europe. In addition, it has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for mRNA 1851, and expects to start a Phase I trial in the first quarter of this year.
Both mRNA 1440 and mRNA 1851 are vaccines for yet unspecified targets.
“2015 was a year of tremendous growth and progress for Moderna,” said Stéphane Bancel, chief executive officer of Moderna, in a statement. “With the introduction of three new ventures and the advancement of key external collaborations, we have established a unique infrastructure that is enabling us to amass a pipeline that covers an unprecedented number of drug modalities and therapeutic targets.”
The collaborations include a three-year license and collaboration deal with Merck & Co. to develop messenger mRNA-based antiviral vaccines and passive immunity therapies for four viruses that have not been disclosed. Merck indicates it plans to start a clinical trial with its first mRNA Therapeutics program this year.
The second collaboration is accelerating current relationships with AstraZeneca and Alexion . They plan to push their mRNA research programs for cardiovascular and rare diseases, respectively. They also hope to push those programs into the clinic this year.
In addition, Moderna is extending an existing grant from the Defense Advanced Research Projects Agency (DARPA) for preclinical toxicology studies and a Phase I study of mRNA 1388 that is expected to start this year.
Moderna also announced two new programs with AstraZeneca and Merck. In the deal with AstraZeneca, they will work to discover, co-develop and co-commercialize immuno-oncology mRNA-based therapies. This is in addition to its 2013 deal. The new Merck agreement is to license a vaccine program for an undisclosed virus, and includes mRNA 1566 and a group of related new vaccine candidates.
The company also announced a strategic collaboration with Pharmaceutical Products Development, LLC (PPD), which will provide support for strategic planning for its IND, as well as clinical trial design and implementation.
Moderna’s financials are more than solid, having announced $500 million in new equity financing last year. It was founded in 2011 by Flagship VentureLabs, and has pulled in $1.2 billion in funding since.
Overall, Moderna expects six candidates to be in human trials by the end of 2016. It has two lead compounds, has a Merck-partnered vaccine (MRK 1777), a DARPA treatment (mRNA 1388), is working with Alexion on ALXN 1540 for Crigler-Najjar syndrome, and with AstraZeneca on AZD 8601 in the cardiovascular arena.
The company currently employs 192 people and has plans to hire 134 by the end of the year. It also has signed a lease at 500 Technology Square in Cambridge, which will bring the company’s Cambridge footprint to more than 170,000 square feet.
It is also adding people to its executive leadership team, appointing Elizabeth Nabel, president of Brigham and Women’s Health Care to its board of directors, bringing on Tal Zaks, former senior vice president and head of Sanofi Global Oncology, as the company’s chief medical officer, and appointing Marcello Damiami, previously from Motorola and bioMerieux, as chief digital officer. Jeff Hrkach, formerly chief technology officer of BIND Therapeutics , will become head of Delivery Innovation.
“It’s remarkable to consider all that we have been able to accomplish since the company’s inception just over four years ago,” said Bancel in a statement. “Our success to date speaks to the validity and superiority of our novel mRNA approach, the vision and dedication of our team and the continued support and commitment of our partners and investors. I believe this trajectory will define Moderna in 2016 for many years to come.”
