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Moderna Announces Pipeline And Corporate Update

9/14/2017 6:25:12 AM

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--Phase 1 studies underway for seven mRNA medicines--

--Moderna achieves key milestones advancing mRNA therapeutics for cardiovascular diseases, cancer and rare liver diseases--

--Pipeline comprises 16 development candidates, including first therapeutic for rare liver disease methylmalonic acidemia (MMA)--

Clinical Study Highlights:

  • Successful completion of AstraZeneca’s Phase 1 study of first mRNA therapeutic, mRNA AZD-8601 (VEGF-A); Phase 2a study preparations underway
  • Initiation of Phase 1 study of mRNA-2416, Moderna’s first immuno-oncology therapeutic, targeting intratumoral expression of membrane-bound OX40L
  • Initiation of DARPA-supported Phase 1 study of mRNA-1388, a Chikungunya vaccine; fifth prophylactic vaccine to enter clinical study

New Preclinical Development Candidate Nominations:

  • mRNA-3704, first therapeutic for severe, life-threatening rare liver disease, methylmalonic acidemia (MMA)
  • mRNA-5671, a cancer vaccine for the treatment of KRAS-mutated cancers of the lung, colorectum and pancreas
  • mRNA-2752, an intratumoral immuno-oncology triple combination mRNA encoding for OX40L+IL23+IL36?
  • mRNA MRK-1278, second prophylactic vaccine under Merck collaboration
  • mRNA-1893 replaces mRNA-1706 as backup Zika vaccine

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Moderna Therapeutics, a clinical stage biotechnology company that is pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, provided an update today, noting continued progress of clinical programs and the introduction of several new development candidates (DCs) across its broad, diverse development pipeline. Moderna announced the update in conjunction with an Investor R&D Day hosted by its management team this morning in New York.

A Phase 1 study of mRNA AZD-8601, the first-ever mRNA therapeutic to be evaluated in a clinical study, has been successfully completed. mRNA AZD-8601 is anticipated to move into Phase 2 development. mRNA AZD-8601 is being developed by Moderna’s partner AstraZeneca to express a local and transient surge of vascular endothelial growth factor-A (VEGF-A) as a potential treatment for cardiovascular diseases. The Phase 1 randomized, double-blind, placebo-controlled, single ascending dose study, which assessed the safety, tolerability and pharmacokinetics (PK) of mRNA-AZD-8601 after single dose administration in male patients with Type 2 diabetes mellitus was successfully completed. The study met its primary endpoint of safety and tolerability and also demonstrated proof of mechanism as measured by expression of VEGF-A protein in the skin (protein PK).

AstraZeneca has submitted a Clinical Trial Application (CTA) in Europe to initiate a Phase 2a study of mRNA AZD-8601 in heart failure patients undergoing coronary artery bypass grafting (CABG) surgery.

Moderna initiated a Phase 1 study of mRNA-2416, an intratumoral (iTu) immuno-oncology (I-O) therapeutic that encodes for the membrane expression of the co-stimulatory protein OX40 Ligand, or OX40L, to potentially enhance T-cell attack against tumors. This is Moderna’s first I-O therapeutic to enter clinical study.

Moderna also unveiled its first clinical development candidate (DC) that utilizes a novel modality, liver expression of therapeutic proteins. Utilizing this modality, the company will advance toward the clinic an mRNA DC, mRNA-3704, for methylmalonic acidemia (MMA), a serious and often life-threatening rare liver disease for which there are no approved therapies.

In total, Moderna announced the addition of four new DCs to its development pipeline today. The company also announced that it has replaced its preclinical stage Zika vaccine DC, mRNA-1706, with mRNA-1893, a Zika vaccine with an enhanced mRNA construct anticipated to augment immunogenicity. Moderna’s development pipeline now comprises 16 mRNA therapeutics and vaccines spanning infectious diseases, cancer (I-O), cardiovascular diseases and rare liver diseases. Approximately 460 subjects have been dosed to date across clinical studies for seven mRNA vaccines and therapeutics.

“2017 is a major inflection point for Moderna, as we’ve made significant progress advancing mRNA therapeutics for unmet needs across several disease areas,” said Stéphane Bancel, Chief Executive Officer of Moderna. “In the cardiovascular space, our partner AstraZeneca successfully completed a Phase 1 study for mRNA-AZD-8601, a VEGF-A therapeutic, and planning is underway for a Phase 2a study. In addition, we have initiated first-in-human dosing in a Phase 1 study of mRNA-2416, our first immuno-oncology candidate, encoding OX40 ligand. We also have progressed the expression of therapeutic proteins in the liver as a development stage modality. As such, we are now able to advance chronically dosed mRNA therapeutics to development for rare liver diseases. I’m very thankful to the Moderna team for their commitment, dedication and continued progress to deliver on our mission.”

Mr. Bancel added, “This past May we experienced the extremely sad, untimely loss of Henri Termeer, a Moderna board member, and a dear friend and mentor to so many of us at Moderna and across our industry. Henri was tirelessly dedicated to helping patients, particularly those impacted by rare diseases. We hope to honor his remarkable legacy by delivering on the promise of mRNA science for patients.”

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