The two companies that currently market CAR-T cells for cancers are participating in a funding round for a company that makes software for cell and gene therapy firms.
San Francisco-based Vineti said Wednesday that it closed a Series C funding round in which it had raised $35 million. Cardinal Health, one of the three largest pharmaceutical distributors in the country, led the round, while a division of Swiss drugmaker Novartis and Foster City, California-based Gilead Sciences’ Kite Pharma participated. Existing investors in Vineti took part as well, including Canaan Partners, Threshold Ventures, Section 32, LifeForce Capital, Casdin Capital and Hive Ventures, among others that were not disclosed.
The company said the funding would allow it to develop new software products and enhance the ones it already has, which are used for automation, analytics and ensuring chain of identity and custody for cell therapies, which have highly complex logistical and manufacturing requirements beyond those of ordinary pharmaceuticals and biologics. It also plans to expand into new supply chains for other advanced therapeutics and further expand its geographic footprint, in the European and Asia-Pacific markets.
“We have entered the critical window as an industry to define the standards that will ensure continued growth,” Vineti CEO Amy DuRoss said in a statement. “Vineti was built for purpose to serve pioneers in personalized medicine who share this same commitment to industrialization and to redefining what is possible in the next wave of therapeutics.”
The company’s last major fund raise happened in April 2018, when it raised a $33.5 million Series B round led by Canaan and Threshold, known at the time as DFJ.
“Cell and gene therapies are critical pieces in our continued drive to advance cancer care, yet these approaches require technologies which fall well outside of the scientific and medical expertise of pharma and biotech companies,” wrote Mike Pellini, managing partner of Section 32, in an emailed statement. “Vineti has built a software based which can serve as the logistics platform for the entire industry, from patient to pharma manufacturer and back.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Novartis markets the CAR-T therapy Kymriah (tisagenlecleucel) for pediatric acute lymphoblastic leukemia and diffuse large B-cell lymphoma, while Gilead – through Kite – markets Yescarta (axicabtagene ciloleucel) for DLBCL. Vineti’s announcement cited data from the Alliance for Regenerative Medicine showing that more than 1,050 clinical trials of advanced therapies are underway, while the Food and Drug Administration anticipates approving 10-20 such therapies annually starting in 2025.
CAR-Ts that may win FDA approval this year include Bristol-Myers Squibb and bluebird bio’s idecabtagene vicleucel, for multiple myeloma, and BMS’ lisocabtagene maraleucel, for DLBCL. Other cell therapy modalities include CAR-NK, which relies on natural killer cells rather than T cells, T-cell receptor (TCR) therapy and tumor-infiltrating lymphocytes (TILs). The aforementioned approved CAR-Ts and the ones up for approval this year are made using patients’ own cells, but CAR-Ts can also be made from donor cells.
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