Moderna Therapeutics, a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create transformative medicines for patients, today provided updates on its portfolio of development candidates and progress on its 2018 priorities.
Moderna now has 21 mRNA development candidates in its pipeline with 10 in clinical development, including one program in Phase 2 and nine programs in Phase 1.
The Company remains focused on executing against its pre-clinical and clinical development pipeline; introducing new rare disease and prophylactic vaccine candidates in areas of unmet need; continuing investment in its mRNA development platform; and opening the company’s new GMP clinical development manufacturing plant.
Key updates from the first half of the year include:
“The first half of this year has been about execution on our strategic priorities including progressing pre-clinical and clinical programs across our portfolio, generating new rare disease development candidates, advancing our mRNA platform technology and delivery science, and completing construction of our new manufacturing facility,” said Moderna CEO Stephane Bancel. “Our strategic partnerships continue to be productive, and we were pleased to recently add a fourth collaboration with Merck, focusing on mRNA cancer vaccines, to our ongoing joint development efforts. Lastly, we closed an important funding round earlier this year, with those proceeds enabling us to further invest in research, our platform, and the acceleration of our programs as we work to bring new medicines to patients.”
As of today, more than 700 subjects have been dosed in Moderna’s internally developed and collaboration programs. Moderna's full pipeline can be found here.
Clinical and Development Pipeline Updates
Moderna’s pipeline of development candidates are in the following modalities: prophylactic vaccines, cancer vaccines, intra-tumoral immuno-oncology, local regenerative therapeutics, and systemic therapeutics. Following is a full summary of program updates from the first half of 2018 by modality.
Moderna has nine infectious disease vaccine programs, with seven completed or in ongoing Phase 1 trials. Four of these vaccines have met their primary safety and secondary immunogenicity endpoints in Phase 1 studies. The Company is developing commercial vaccines – including increasingly complex vaccines with multiple antigens – and public health vaccines aimed at helping prevent future epidemics and pandemics.
Public Health Vaccines
Moderna is collaborating with Merck on two cancer vaccine programs, one of which is in Phase 1 while an IND was authorized by the U.S. Food and Drug Administration (FDA) for the second. In addition, Moderna is also supplying an mRNA personalized cancer vaccine for an NCI investigator-initiated Phase 1 trial. This modality leverages the potential of cells to use mRNA for making antigens from mutated proteins that are specific to tumors that are presented and recognized by T cells, thus immunizing or vaccinating a patient against their cancer.
Intra-Tumoral Immuno-Oncology (I/O)
Moderna currently has three intra-tumoral immuno-oncology (I/O) programs. One is in Phase 1 and two have completed IND-enabling toxicology studies and are advancing toward clinical studies. These programs are focused on driving anti-cancer T cell responses with mRNA therapies injected directly into tumors.
Local Regenerative Therapeutics
Localized production of proteins has the potential to be used as a regenerative medicine for damaged tissues. Moderna’s most advanced program is exploring this application in cardiology in collaboration with AstraZeneca.
Moderna has six programs in its systemic therapeutics modality, with one having completed and a second having started IND-enabling toxicology studies. In this modality, mRNA is either delivered systemically to create proteins that are secreted outside the cell with the aim of producing pharmaceutically active therapeutic proteins with effects across the human body – or intracellularly within target organs as a therapeutic approach for diseases caused by a missing or defective protein.
Systemic Therapeutics (Secreted)
Systemic Therapeutics (Intracellular)
Q4 2017 and Recent Business/Financial Updates
Board of Directors and Management Updates
About Moderna Therapeutics
Moderna pioneers the discovery and development of messenger RNA (mRNA) therapeutics and vaccines, an entirely new class of medicines that directs the body’s cells to produce intracellular or secreted proteins that can have a therapeutic or preventive benefit for both patients and healthy individuals. With its breakthrough platform, Moderna is creating mRNA medicines for a wide range of diseases and conditions, in many cases by addressing currently undruggable targets or underserved areas of medical need. Moderna is developing its innovative mRNA medicines for infectious diseases, immuno-oncology, rare diseases, and cardiovascular diseases, through solely controlled programs and collaborations with strategic partners.
Headquartered in Cambridge, Mass., privately held Moderna currently has strategic relationships with AstraZeneca, Plc. (AZ), Merck & Co., Inc. (MRK) and Vertex Pharmaceuticals (VRTX), as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS); and the Bill & Melinda Gates Foundation. In 2017, Moderna was ranked a top biopharma industry employer by Science Magazine and a Top Places to Work by the Boston Globe. To learn more, visit www.modernatx.com.
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