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Agnes Shanley is senior editor of Pharmaceutical Technology.
New funding brings competitors, and a leading healthcare products distributor, into the standardization effort.
Vineti received an infusion of new investment on February 5, 2020. The company, a spinoff of GE Ventures, focuses exclusively on the supply chain and data management challenges of autologous and allogeneic cell and gene therapies and personalized cancer vaccines. Led by the distributor Cardinal Health, as well as Novartis Pharma AG and Kite, a division of Gilead Sciences, Inc., the funding, $35 million in Series C investments, will be used to improve and expand Vineti’s technology platform, and to aid its global expansion into Europe and the Asia Pacific region, according to a company press release (1).
The investment comes in response to rapid growth and the need for a strong technology infrastructure and standardization in the cell and gene therapy space. FDA expects to approve 10-20 cell and gene therapies each year starting in 2025, and to receive up to 200 clinical trial applications for cell and gene therapies per year starting in 2020. Currently, more than 1050 advanced therapy clinical trials are underway that could involve nearly 60,000 patients, according to data from the Alliance for Regenerative Medicine that were quoted in the press release.
Novartis and Kite, both customers of Vineti’s, each offer their own CAR-T (chimeric antigen receptor T cell) therapies, and compete in the nascent cell and gene therapy business. Their investment collaboration in Vineti suggests recognition of the need for standardization across the industry. At the same time, the participation of Cardinal Health, a distributor that works with 90% of the hospitals in the US, suggests that the infrastructure required for cell and gene therapies will need to go far beyond the laboratory, facility, and clinic. Under terms of the funding agreement, a Cardinal Health executive will join the company’s board of directors.
According to Vineti’s management team, the funding will enable a number of enhancements that will improve the configurability of its software, making it easier to add new or updated features or adjust them, allowing for significant savings and faster time to market. The platform will also be improved to facilitate global expansion, including more languages and support for more regional regulations and standards around the world.
Of paramount importance will be the inclusion of the standards and integrations needed to scale up and industrialize more therapies. “Even though it’s still early days in cell and gene therapy, some standard approaches are emerging as pre-built integrations that connect critical technology stacks,” CEO Amy DuRoss told Pharmaceutical Technology.
So far, the company offers the only independent data management platform that supports commercialized cell and gene therapies in the US and EU. Vineti’s technology has been used in successful regulatory filings, as well as to support early phase clinical programs. The cloud-based platform features Chain of Identity and Chain of Custody capabilities within what are shaping up to be the most complex supply chain, logistics, reimbursement, and patient-monitoring workflows in the history of biologics. The platform currently supports more than 200 leading medical centers around the world, says DuRoss.
Vineti’s platform is designed to support a wide range of therapies from clinical to commercial phase, including autologous, allogeneic, and personalized cancer vaccines. In the future, the company plans to expand efforts to support other high-value therapeutics that require precise supply chain coordination, DuRoss says.
1. Vineti Press Release, February 5, 2020, http://www.globenewswire.com/news-release/2020/02/05/1980163/0/en/Vineti-Completes-35-Million-in-Series-C-Financing-to-Industrialize-Personalized-and-High-Value-Therapeutics.html