News
DCPrime brings cell-based vaccines to broad markets
This article is published in partneringNEWS, an online journal for executives in the life sciences, an initiative of the BIO-Europe Spring in Milan from March 14 till March 16.
DCPrime is entering a Phase I clinical trial with a novel approach to dendritic cell-based cancer vaccines. Rather than use the patient’s own dendritic cells, it has developed a dendritic cell-based platform that promises the efficacy of an autologous approach with the cost-effectiveness and broad market of a universal delivery technology.
Cancer vaccines based on dendritic cells are among the most promising of vaccine therapies. But, Ada Kruisbeek, CEO and CSO, cautions, there are many competing vaccine therapies. “It’s too early to know which will be the best,” she said, but suggested that several effective approaches will emerge, tailored to specific types of cancers and conditions. “There’s been great interest in dendritic cell vaccines. They have been in studies for the past 20 years in thousands of patients, with very powerful clinical effects in some patients, and no toxicity.” Those therapies, however, have required the use of each patient’s own cells, thereby limiting their utility.
Dendritic cell-based vaccines got a huge boost last year when the FDA approved a first-in-class vaccine using a dendritic cell-based approach. That therapy, like the vast majority of those currently in development, takes an autologous approach and uses each patient’s own cells to create an individualized vaccine. The resulting vaccine cannot be warehoused or used for other patients.
“Autologous therapies, no matter how valuable, do not offer a business model that can be cost-effectively applied to thousands or ten of thousands of patients,” Kruisbeek explained. DCPrime’s vaccine platform eliminates that challenge, as it is designed to be effective throughout the population. ”We can make huge quantities,” she stressed. When commercialized, this product “can be taken from the pharmacist’s shelf and injected directly into the patient.”
Called DCOne™, this delivery platform is based upon the immortalized equivalents of dendritic precursor cells prepared from blood. Once stimulated using DCPrime’s proprietary process, they mature into fully functional dendritic cells that can induce specific T-cell and antibody responses.
The DCOne cell line is derived from a patient with acute myeloid leukemia (AML) and, therefore, expresses multiple AML-specific antigens. DCOne also can be loaded with many other genes, proteins or peptides from multiple antigens—singly or in combinations—to create an immune response against a wide variety of targets.
“We’re entering the clinic with our first cancer vaccine,” Kruisbeek said. That vaccine targets acute myeloid leukemia. A trial targeting a solid tissue cancer is being designed. The immediate challenge, she said, is to show it works “as well as or better than other therapeutic vaccines,” which is true for every new therapy.
She already knows the product is stable, with a long shelf life. DCPrime’s stock cells have been frozen for three years now. When thawed and processed, they are identical to the starter cells, Kruisbeek observed. Therefore, “with our stock of vaccines, we won’t have the variability that occurs naturally in autologous vaccines.”
Another benefit to the DCOne platform, Kruisbeek notes, is the cell line’s consistency. “Ours is composed of just one cell type,” she pointed out. “The benefits of our approach will have to be shown,” she admitted, but it does ensure greater purity than many other therapeutic dendritic cell-based approaches.
Financing
DCPrime received its first venture financing last autumn from Thuja Capital for an undisclosed amount. In addition to funding, “Thuja also brings expertise in developing a growth strategy for an early stage company,” said Kruisbeek. One of the key uses of that expertise, she explained, is to ensure that additional financing is acquired to maximize the potential of DCPrime’s platform technology. Thuja, as a dedicated healthcare venture capital fund focused on early-stage life science companies is well positioned to do that.
Since its founding in 2005, DCPrime has successfully raised funds through multiple grants and subsidies, including EUR 0.74 million from EUROTRANS-BIO last August, and earlier, the Senter International Collaboration grant and the Senter SI2 grant from the Dutch Ministry of Economic Affairs. “It hasn’t been hard for me to raise money from various subsidy programs designed to support innovation,” Kruisbeek confided. Now that it is beginning its first clinical trial, however, larger sums are required. “The company has reached the point that we are ready to look to the market for partners and additional financing,” she said.
Collaborations
Kruisbeek has assembled an experienced team of collaborating companies and academic researchers. Galapagos, for example, is working closely with DCPrime to develop the DCOne platform to identify targets for inflammatory diseases. SMS-oncology, which specializes in oncology drug development, helps design DCPrime’s clinical studies, and Signifx shares its expertise in regulatory matters. Peptide specialist Orpechem Peptide Chemicals is working with DCPrime to improve the peptide loading approach. For manufacturing, “PharmaCell has been our partner for production of our vaccine,” Kruisbeek said.
Kruisbeek also has recruited university researchers throughout Europe to work on this delivery system. “DCPrime is a small company. We can’t have a huge research department,” she said. So, like many savvy companies today, a virtual research department helps the company leverage novel insights from a variety of researchers throughout the world. Academic partners include the Ludwig Institute for Cancer Research, as well as the University of Gent, the University of Antwerp, the Twincore Center in Berlin, the Providence Cancer Center in Portland, the Academic Medical Center in Amsterdam and her home institution, the VU Medical Center.
Insights from such collaborations will contribute to a small, but growing, patent portfolio. “Currently, DCPrime holds one patent, and another is in development. From our research program, we’re developing data to build a broader portfolio of patents.”
Development team
The company has taken care to assemble an experienced business team as well as scientific expertise. Chief Operating Officer Sandra van Wetering, PhD, for example, most recently was part of the Pharming project team where she was responsible for assay development, and a member of the group responsible for EMA/FDA filings. Regulatory Manager Eliane Schutte has more than a decade of experience with regulatory filings throughout Europe, the USA, the Middle East and Asia. Kruisbeek herself has some 30 years experience in scientific management and at the bench. Before co-founding DCPrime, Ada Kruisbeek was Senior VP of Research at Crucell, where she was responsible for expanding its cancer antibody pipeline. Prior to that, she was Head of Immunology at the Netherlands Cancer Institute in Amsterdam, and before that, she led a large research group at the NIH-NCI in Bethesda.
Staff expertise is augmented by a seasoned Supervisory Board of the Directors. Michel Briejer, Partner at Thuja Capital, is one of its members. He gained his practical and strategic experience from positions at Janssen Pharmaceuticals, Yamanouchi (now Astellas Pharma), and at Crucell. The additional directors are Herbert Heyneker who worked with Genencor (a spin-off from Genentech) and several other companies, and Leon Hooftman, who held senior positions at F. Hoffman-La Roche, Celltech and Chroma Therapeutics. Its newest member is Onno van de Stolpe, CEO of Galapagos, a company which is exploiting its target discovery platform and strategic partnering approach with great success.
The Scientific Advisory Board includes Viggo Van Tendeloo, PhD, an internationally recognized expert in autologous dendritic cell vaccines and their application in the treatment of AML. Another member, Walter Urba, MD, PhD, is a former chair of the FDA Cellular, Tissue and Gene Therapy Advisory Committee. He currently serves on the National Cancer Institute’s Board of Scientific Counselors for Clinical Services and Epidemiology, and is Director of the Providence Cancer Center. Pedro Romero, MD, another member of the Scientific Advisory Board, is head of clinical immunology at the Ludwig Institute for Cancer Research.
DCPrime’s extended team of experts and board members have brought many innovative products to the clinic and through commercialization, Kruisbeek noted. As well, DCPrime is gearing up for its first clinical trial. Her current focus is more immediate. “Right now,” she said, “my goals are to acquire additional funding, and to identify partners who want to combine their antigens with our platform.”
