BioPharma

GE Ventures spin-out Vineti raises $13.75M for complex biomanufacturing

For all the complexity of CAR-T autologous transplant technology, GE Ventures spin-out Vineti has a simple question to ask: What if the wrong cells are infused back into the patient?

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For all the complexity of CAR-T autologous transplant technology, Vineti has a simple question to ask: What if the wrong cells are infused back into the patient?

That scenario is not as far-fetched as it sounds and it’s just one of many logistical challenges that will plague every step of the transplant and engineering process.

It’s problems like those that led to the creation of Vineti, a cloud-based software platform for advanced cell and gene therapies.

On Tuesday, the second day of the BIO International Convention in San Diego, the San Francisco, California-based company officially launched with $13.75 million in funding from GE Ventures, Mayo Clinic, and Draper Fisher Jurvetson (DFJ).

In a phone interview, CEO Amy DuRoss and Chief Strategy Officer Heidi Hagen discussed the need, the company’s formation, and its first publicly-announced partnership with Kite Pharma.

Vineti was originally seeded within GE Ventures, the venture arm of GE Healthcare. It was a product of need, DuRoss said, as GE’s manufacturing customers often lamented about their struggles trying to bridge the technology gap between individualized cell therapies and large-scale production.

As Hagen noted, the sophistication of modern therapies has outpaced technology advances in manufacturing.

“It’s unrealistic to think that you could scale up the process without having that digitized information and transparency,” Hagen said, “However if you did, there’s a really big cost difference and these are already expensive therapies due to the fact that they’re personalized.”

GE didn’t have a solution but knew that one had to be built to service the next wave of complex therapies. Vineti was subsequently incubated and spun out to begin implementing a software platform that could coordinate all the moving parts.

Large companies like GE Healthcare typically engage promising new startups, they don’t cut them free. So why did Vineti leave home?

The answer is two-fold, DuRoss said. Firstly, the biomanufacturing process involves different technologies from different companies. So to truly standardize and simplify the individual steps, the team knew that Vineti would have to be brand-agnostic.

The second rationale has to do with agility and innovation. As a standalone startup, DuRoss and her team have created a unique and energetic culture, that’s not weighed down by the typical bureaucracy of a large organization. That allowed Vineti to attract the top talent.

“As everyone knows it’s very difficult to recruit and I think the focus we have, as opposed to being a subsidiary of GE, is pretty incredible,” Du Ross said, though she added that they deeply value having GE as a strategic partner.

Put into practice, Vineti’s cloud-based platform can handle complex steps, such as those required for CAR-T immunotherapies. To that end, its first biotech partner is Kite Pharma, one of the leaders in the space.

Broadly speaking, there are five steps involved in the process, which center around an autologous cell transplant. In most cases, there will be significant distances to cover, as the patient is treated in a local clinic and the cells are flown to a core facility for engineering.

Vineti positions itself as a single point of control throughout the process, with capabilities that can scale from hundreds of patients to thousands. It’s also thinking globally, in anticipation of the technology spreading overseas.

Importantly, DuRoss said Vineti is also committing resources towards making the process as user-friendly as possible. While they are in a partnership with Kite, the end-user is ultimately the doctor and the patient.

An approval for CAR-T therapies seems imminent. Novartis is reportedly expecting an FDA decision in mid-June and, in terms of filing for the BLA, Kite Pharma was just one week behind. Many observers are still wondering if the technologies can go mainstream. The answer may hinge on companies like Vineti.

Photo: shylendrahoode, Getty Images