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Freezing your T cells today for potential CAR-T therapies tomorrow

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Though it’s not clear how Big Pharma or regulators may respond to the proposal—it’s not exactly known how years of being frozen may affect the potency of a CAR-T product—Cell Vault hopes to explore whether starting with healthier cells could result in a stronger therapy down the line. (La Jolla Institute)

A company offering to freeze donors’ T cells and save them until the day they are needed—perhaps even years before the onset of cancer or disease—is getting off the ground with $1 million in funding and partnerships with some of the largest operators in blood sample management and cold chain logistics.

As a kind of T-cell insurance, Cell Vault is pitching a simple concept: Today’s cutting-edge chimeric antigen receptor T-cell (CAR-T) therapies require a starting point of donated T cells, which are genetically modified to better recognize, target and destroy tumor cells before being readministered to the patient.

Treatments like Novartis’ Kymriah and Gilead Sciences and Kite Pharma’s Yescarta have shown promise and been approved in different blood cancers, but these cell therapies are only used after other lines of treatment have failed.

As a result, many otherwise-eligible patients may not be able to provide enough viable T cells to support a CAR-T therapy following multiple regimens of chemotherapy and immune system-depleting treatments or due to the progression of the disease itself.

Cell Vault aims to sequester vials of blood cells and keep them on ice before patients reach that point, using the same processes employed in banking cord blood or freezing eggs for in vitro fertilization. This could be done at the time of diagnosis before beginning treatment or at any other point in a person’s life. The company plans to offer T-cell banking services at different rates and packages, ranging from annual payments to an 80-year plan that costs $100 per year.

According to the startup’s founder, Kevin Kirk, Cell Vault itself will focus mainly on marketing and driving adoption of its idea while the cryopreservation and biobanking work will be handled in partnership with Brooks Life Sciences.

“They handle all of the NIH’s stem cells, and all of Ancestry.com’s kits, for example,” Kirk told FierceMedTech in an interview. “They will produce, distribute and receive the kits, and then process them down to the cellular level.”

Elsewhere, mobile blood draw and sample collections will be completed by ExamOne, a Quest Diagnostics company. Cell Vault is also gathering medical advice from CAR-T specialists at the Medical College of Wisconsin.

The company plans to start in two or three major markets including New York and San Francisco—”longevity is a big deal for a lot of folks in San Francisco,” Kirk said—and it is slated to begin shipping kits in September.

But at the moment, it’s not clear how pharma companies, manufacturers or regulators may respond to the proposal—it’s not exactly known how years of being frozen may affect T cells’ potency as a final CAR-T product. However, Cell Vault does hope to explore whether starting the process with healthier cells could result in a stronger or easier-to-produce therapy down the road.

“CAR-T has only ever been done with T cells from people who have had cancer—it’s never been done with healthy cells before,” Kirk said. “No one has collected them ahead of time, before someone’s health has become compromised.”

In addition, the pursuit of so-called “off-the-shelf,” allogeneic CAR-T therapies may eliminate the need for patients to donate their own T cells in some cases.

“That was probably the biggest red flag or cause for concern that I found, as I was doing my due diligence,” Kirk said, though that technology may still be years away. “In the meantime—for the next five, seven, 10 years, however it plays out—if I can save one person from passing away because they had access to their own cells, I’m happy.”

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