Creating cell therapies for cancer is a complex process. The business case for them has proven tricky, too.
Biotech veterans Tom Farrell and Peter Flynn have teamed up to start a new San Diego company that aims to develop allogeneic, or off-the-shelf, cell-based immunotherapies using natural killer (NK) cells that can be manufactured at scale and delivered to cancer patients outside of the hospital.
Artiva Biotherapeutics (the name is a portmanteau of “art” and “viva”) emerged from stealth Thursday with $78 million in Series A financing, a partnership with a South Korean company for clinical manufacturing services, and plans to kick off its first human tests later this year.
The financing round was co-led by 5AM Ventures, venBio Partners, and RA Capital Management. Medivate Partners and Artiva’s seed investors and strategic partners, GC and its subsidiary GC LabCell, also invested.
Farrell, Artiva’s CEO, and Flynn, its chief operating officer, first started talking about launching a company to overcome some of the obstacles met at the 2018 annual meeting of the American Society of Hematology (ASH).
“We both knew the cell therapy space really well, we were both looking at next opportunities, and were particularly interested in off-the-shelf cell therapy—in particular addressing this challenge with cell therapy which is, there isn’t a good business model,” Farrell said in an interview.
Both have seen up close the difficulties of developing such therapies. Farrell previously headed Houston’s Bellicum Pharmaceuticals (NASDAQ: BLCM), which is developing cell therapies for cancer, and Flynn, while most recently an executive vice president at defunct anti-obesity company Orexigen Therapeutics, previously headed early program development at San Diego’s Fate Therapeutics (NASDAQ: FATE), which is advancing cell therapies for cancer and immune disorders.
Today’s cell therapies have led to curative results for some patients. But autologous treatments, which use the patient’s own cells, require removing and engineering them in a lab before reinfusion, and when administered can cause life-threatening side effects. That means these immunotherapies need to be delivered in a hospital setting that can provide intensive care if needed. The FDA’s approval of therapies that engineer T cells with chimeric antigen receptors, or CAR-T, against B-cell malignancies have drawn huge attention to immunotherapy’s promise for cancer patients, but logistical difficulties in their production have limited their reach.
“How do you take cell therapy and adapt it into more of a biologics business model?” Farrell said. “To do this you really need to be able to manufacture product at an affordable cost of goods, it needs to be safe enough to use on an outpatient basis, it needs to be off the shelf and accessible to any cancer patient who stands to benefit—and we need to be able to do that without sacrificing efficacy, which has really been the hallmark of the CD19 [-targeted] CAR-T cells.”
Prior to meeting Flynn at ASH, Farrell had visited a new facility opened by GC LabCell in Seoul dedicated to cell therapy research and production, which includes a 50,000-square-foot manufacturing site. GC was looking to partner with a US biotech, and in 2019 the company provided seed financing for Artiva. Farrell relocated to San Diego from Houston.
Farrell said investor interest, already piqued by the promise of NK cells for cancer therapy, rose in February when the MD Anderson Cancer Center published data from a study of a treatment that used NK cells modified to express an anti-CD19 CAR. Eight of 11 patients with relapsed or refractory CD19-positive cancers (non-Hodgkin’s lymphoma or chronic lymphocytic leukemia) in the study responded to the treatment without major toxic effects—and seven of those saw signs of cancer disappear entirely within 30 days of being dosed.
“We were in the right place at the right the time,” Farrell said. “I think it was a really attractive proposition for investors who were looking actively at off-the-shelf approaches to cell therapy, looking for a well-leveraged investment opportunity, which we have—we don’t have to spend money on manufacturing infrastructure, we don’t have to spend it on basic research or on product discovery, process development, etc.”
Artiva says it will use the Series A financing to establish clinical proof of concept for its investigational therapies, which are designed to deploy universal NK cell in combination with monoclonal antibody therapy and CAR-NK cells.
Its pipeline includes AB-101, a universal NK cell therapy which it plans to advance into clinical trials this year in combination with an anti-CD20 monoclonal antibody for the treatment of relapsed refractory B cell lymphoma; AB-201, a CAR-NK cell therapy targeting tumors that overexpress HER2; and AB-202, a CD19-specific CAR-NK cell therapy designed to CD19, which is broadly expressed in various B cell lymphomas.
Those therapies will use cord blood banked in the US then turned into treatments and cryopreserved by GC. Artiva anticipates the process developed by GC could make high and repeat dosing an option for patients.
“A single umbilical cord blood unit can generate enough pure NK cell product to treat hundreds to thousands of patients,” Flynn said. “It’s on a scale that we haven’t seen before.”
Brian Daniels, a partner at 5AM Ventures, in a prepared statement said technological barriers have stymied the “enormous therapeutic potential for cancer therapy” of natural killer cells.
“Artiva is systematically resolving the barriers to safe and effective NK cell therapies at a scale that enables broader access to potentially life-saving cancer treatments,” he said.