CAMBRIDGE, Mass., January 11, 2016 — Moderna Therapeutics, a pioneer in the development of messenger RNA (mRNA) Therapeutics™, today announced it is now a clinical stage company with its first Phase I study for mRNA 1440 currently underway in Europe. Moderna also announced it has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for mRNA 1851, its second clinical program, with a Phase I study anticipated to begin in Q1 2016. mRNA 1440 and mRNA 1851 are infectious disease vaccines for undisclosed targets and indications. Moderna’s Chief Executive Officer, Stéphane Bancel, made the announcement during a presentation today at the J.P. Morgan 34th Annual Healthcare Conference in San Francisco, Calif. Mr. Bancel highlighted the company’s broad accomplishments in 2015 and outlined key focus areas for 2016.
“2015 was a year of tremendous growth and progress for Moderna. 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,” said Stéphane Bancel, CEO of Moderna. “Advancing to the clinic certainly was the most gratifying milestone. We are now a major step closer to delivering on the promise of transformative mRNA science to bring breakthrough medicines to patients across a vast array of diseases, including infectious diseases, rare diseases, cancer and cardiovascular diseases, among others. I am deeply grateful to our wonderful team who has made all of these successes happen.”
2015 and Recent Highlights
Expansion of the Moderna Ecosystem
In 2015, Moderna executed on its strategic plan to rapidly expand its ecosystem, which allows for simultaneous progression of both internal development programs as well as programs through key external partnerships. Highlights included:
Moderna announced today a new collaboration with AstraZeneca to discover, co-develop and co-commercialize immuno-oncology mRNA therapeutic candidates. The collaboration is in addition to the exclusive agreement announced by the companies in 2013 to develop mRNA Therapeutics for the treatment of cardiovascular, metabolic and renal diseases as well as selected targets in oncology.
Moderna also announced today that Merck has licensed a vaccine program against an undisclosed viral target, including mRNA 1566 and a set of related novel vaccine candidates, as part of the ongoing collaboration between the companies. The inclusion of this new program, which was not part of the original collaboration agreement, follows the rapid progress made in the first year of the collaboration.
Becoming a Clinical Stage Company
In 2015, Moderna became a clinical stage company with the initiation of its first Phase I study for mRNA 1440 and submission of a regulatory filing for a second clinical program, mRNA 1851. Highlights included:
To support its evolution as a clinical stage company, in January 2016, Moderna announced a strategic collaboration with Pharmaceutical Products Development, LLC (PPD). PPD’s support will include investigational new drug (IND) strategic planning, as well as clinical trial design and execution.
Rapid Pipeline Advancement
Across its ecosystem of ventures and partner collaborators, Moderna continued to accelerate its pipeline, with multiple research programs rapidly advancing across modalities and therapeutic areas.
Robust Financial Position Enabled by Landmark Funding
In 2015, Moderna announced $500 million in new equity financing to support the expansion of its platform and pipeline. Since the company’s founding in 2011 by Flagship VentureLabs™, Moderna has secured $1.2 billion in funding through financing activities and commercial partnerships. Additional highlights included:
Growth of Internal Expertise and Infrastructure
To help guide its rapid evolution as a clinical stage company, Moderna made key additions to its senior leadership team and Board of Directors, significantly grew its employee base and enhanced its infrastructure and capabilities in 2015. Highlights included:
2016 Business Objectives: Sustained, Cross-Ecosystem Growth Trajectory
“It’s remarkable to consider all that we have been able to accomplish since the company’s inception just over four years ago,” said Mr. Bancel. “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 and for many years to come.”
About Moderna Therapeutics
Moderna is pioneering messenger RNA Therapeutics™, an entirely new in vivo drug technology that produces human proteins, antibodies and entirely novel protein constructs inside patient cells, which are in turn secreted or active intracellularly. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of disease conditions. The company currently plans to develop and commercialize its innovative mRNA drugs through a combination of strategic relationships as well as newly formed ventures, including Onkaido LLC, focused on oncology drug development, Valera LLC, focused on infectious diseases, Elpidera LLC, focused on rare diseases, and Caperna LLC, focused on personalized cancer vaccines. Founded by Flagship VentureLabs®, Cambridge-based Moderna is privately held and currently has strategic agreements with AstraZeneca, Alexion Pharmaceuticals and Merck. www.modernatx.com.