Curevac AG, convinced it needs to grow its pipeline and work force, has raised about $110 million from new investors drawn to the ambitious company's mission of expanding its RNA-based technology platforms beyond their current applications in prostate cancer and non-small-cell lung cancer to include further programs in cancer immunotherapy, vaccines and molecular therapy.
Despite having secured substantial investments from the Bill & Melinda Gates Foundation and longstanding investor Dievini Hopp Biotech Holding GmbH & Co. KG in March to back development of vaccines for viral, bacterial and parasitic infectious diseases, "we need to do more," Franz Haas, Curevac's chief corporate officer, told BioWorld Today. "We need to have more products in the pipeline, and that's what we're going to spend the money on." (See BioWorld Today, March 9, 2015.)
Proceeds from the financing will help the company hire additional staff to help it optimize and formulate new messenger RNA therapies, add equipment to its labs and help it run new clinical trials. The money will also support the German company's efforts to further build out its new Cambridge, Mass., office, a critical piece in its effort to secure new expertise in prophylactic vaccines and other areas of interest under the leadership of the former head of the maternal immunization franchise at Novartis Vaccines, Karen Slobod. The company has already added 70 new employees this year, Haas said.
The new financing round led by Baillie Gifford was carefully conceived on the advice of Gates and Hopp to keep the company away from capital market pressures, said Haas. "On this advice, we had different parties in the process." That meant the company looked to family offices, such as Chartwave Ltd., Coppel Family and Sigma Group, all of which participated in the round, and Northview, another long-term investor.
Further tuning the company for growth, Curevac GmbH became Curevac Aktiengesellschaft, or AG, as the company transitioned into a joint German stock company, giving it a corporate structure to facilitate not just the new investors, who herald from various quarters outside Germany, but also setting the stage for further international growth and investments.
Work on another critical aspect of the company's strategy, its new manufacturing facility, is ongoing. The facility, intended to help it to vastly scale up its capacity to produce commercial quantities of new RNA-based therapeutics, will be critical to not only generating clinical trial supplies, but also to meeting Curevac's commitments to produce all the commercial supply of its medicines — the first of which, in partnership with Boehringer Ingelheim GmbH is expected to hit the market in the early 2020s — and doing so at a scale and price that will allow it to meet the Gates Foundation's expectations. Curevac is targeting approval of the plant in 2018. (See BioWorld Today, Sept. 19, 2014.)
Curevac has treated more than 350 people with its mRNA technology in seven clinical trials since 2008, testing mRNA-based cancer immunotherapies and prophylactic vaccines against infectious diseases built from its RNActive platform; molecular therapies designed to trigger patients' production of therapeutic proteins, in its RNArt program; and RNA encoded antibodies.
The company's most advanced candidate, CV9104, is being developed in an ongoing phase IIb trial for the treatment of prostate cancer. Data from a phase I/IIa study in prostate cancer was recently published in the Journal for Immunotherapy of Cancer and indicated that Curevac's mRNA cancer immunotherapy was well tolerated and immunogenic. Its pipeline also includes clinical programs in non-small-cell lung cancer, partnered with Boehringer Ingelheim, and rabies, as well as numerous development programs against infectious diseases, including HIV, rotavirus, respiratory syncytial virus and tuberculosis. (See BioWorld Today, June 24, 2015.)
With the flurry of activity and infrastructure building, an IPO would be of little surprise. Indeed, the company is prepared for one, said Haas, but not planning it. With the approach of the International mRNA Health Conference in Berlin later this month, he said he expects discussions among the leaders in the space, Curevac, Biontech AG and Moderna Therapeutics Inc. included, to be focused more than ever before on products, especially the "low-hanging fruit."