- Company expects to initiate clinical testing of four new mRNA product candidates in 2018
- Expanded mRNA manufacturing capacity and leading IP position will drive product development across a wide range of diseases and therapies
TÜBINGEN, Germany, BOSTON, MA and SAN FRANCISCO, CA, January 10, 2018 - CureVac AG, a clinical-stage biopharmaceutical company pioneering mRNA-based drugs, today outlined key 2018 milestones in conjunction with its presentation at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco. The Company highlighted its clinical development milestones and strategy for the year, including plans to initiate clinical testing of four new mRNA product candidates targeting infectious diseases and cancers.
“CureVac has made significant technological and clinical achievements over the past several years that position us to realize the full potential of mRNA therapies to improve the lives of people globally,” said Ingmar Hoerr, Ph.D., co-founder and CEO of CureVac. “We expect to have six product candidates in clinical trials in 2018 with potential for interim clinical results late in the year. We believe the strategic approach to securing IP around mRNA that we began early in CureVac’s history positions us well for creating first-in-class, high-value novel products across a broad range of therapeutic modalities and diseases. We’re also continuing to enhance our industry-leading mRNA platform with new delivery technologies and scalable GMP manufacturing capabilities. Together these milestones will enable us to achieve our vision of bringing an entirely new approach to the creation of valuable medicines for serious conditions throughout the world.”
CureVac has achieved important corporate, clinical and manufacturing milestones that have laid the foundation for accelerating product development efforts across multiple modalities and diseases in 2018. The Company mainly expects to:
- Initiate phase I trial of an RNActive® rabies vaccine with improved formulation: CureVac will initiate a phase I clinical trial of its reformulated RNActive® prophylactic vaccine candidate for rabies in 2018. The Company published animal data in npj Vaccines on the product candidate in October 2017 that demonstrated greater potency and superiority over the commercially available vaccine.
- Launch phase I trial for RNActive® prophylactic vaccine targeting seasonal influenza: An RNActive® prophylactic vaccine for seasonal influenza will be evaluated in a phase I clinical trial in 2018.
- Begin clinical testing of CureVac’s RNArt® technology to encode immunostimulating proteins in tumors
- Begin clinical testing of CureVac’s RNAntibody® technology to encode antibodies in tumors
- Further advance the ongoing phase I study of the RNA-based TLR and RIG I agonist RNAdjuvant® as an intratumoral therapy: Initiated in late 2017, the therapy will be evaluated with and without systemic checkpoint inhibitors for the treatment of solid tumors.
- Expand delivery formulations and identify targets for proprietary CureVac Carrier Molecule (CVCM): CureVac recently entered a collaboration with Arcturus Therapeutics to advance a pipeline of mRNA therapeutic candidates utilizing best-in-class, lipid-based delivery systems for mRNA therapies. In 2018, CureVac will continue to expand its product-specific delivery formulations by identifying targets for CureVac Carrier Molecule, the Company’s proprietary, advanced mRNA delivery technology.
- Continue to scale up in commercial-scale GMP manufacturing: The first mid-scale batches of mRNA from GMP III, CureVac’s third and most technologically advanced manufacturing facility that can generate up to 10 million doses per year of GMP-grade mRNA, will be produced in 2018. Construction on the commercial-scale GMP IV manufacturing facility, capable of manufacturing up to 30 million mRNA doses per year for initial market needs, began in early 2017.
- Advance three new collaborations: CureVac successfully initiated three new collaborations with: Eli Lilly & Co. to develop up to five cancer neoantigen vaccines, CRISPR Therapeutics to develop up to three in vivo gene editing programs in liver diseases and Arcturus Therapeutics to co-develop up to four mRNA therapeutics for enzyme replacement and antibody generation.
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