The first cancer cell therapy employs the transformation of T cells into targeted tumor fighters. Nkarta Therapeutics sets out to show that a different type of cell could offer a new and possibly better twist on cancer immunotherapy. Now, the biotech’s early clinical data show that the use of natural killer (NK) cells is not only effective against two different types of blood cancers, but it is also potentially safe and effective compared to first-generation T-cell therapy sexual advantage.
this Preliminary results Monday’s report came from two Phase 1 dose-finding studies. Both companies have small patient samples, but the positive early data is an encouraging sign for both the company and the NK cell therapy development community. The South San Francisco-based stock closed Monday at $18.72, up nearly 141% from Friday’s close.
Natural killer cells are white blood cells that carry cancer-fighting enzymes. Nkarta develops its therapies by sourcing NK cells from healthy donors and engineering those cells to better track cancer targets and last longer in the body. The use of donor NK cells enables Nkarta to offer an “off-the-shelf” approach to cells, unlike CAR T therapy, a highly personalized first-generation cancer cell therapy made by engineering a patient’s own T cells.
Nkarta has two leading NK cell therapies. The first, NKX101, is in early clinical development for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). In both types of cancer, treatment evaluations are underway for patients who have relapsed or who have not responded to earlier cancer treatments. The Phase 1 trial of NKX101 enrolled 21 patients: 17 with AML and 4 with MDS. The results showed that the best responses came from the two highest doses, with three of the five AML patients having a complete response to treatment as well as hematologic recovery, meaning that blood cell types that were too low or too high had returned to normal levels. In three In two of the responders, no signs of disease were detected after treatment.
Nkarta’s second drug, NKX019, is being evaluated in relapsed or refractory B-cell cancer. As of last Thursday, 13 patients were enrolled and dosed in the Phase 1 study. Ten of these patients were diagnosed with non-Hodgkin lymphoma; five of these cases were described as aggressive large B-cell lymphoma. The company reported Monday that three of the six patients who received the higher dose level showed a complete response to the treatment. One of the patients had aggressive diffuse large B-cell lymphoma and the other had mantle cell lymphoma.
In both Phase 1 studies, Nkarta reported no dose limitation issues, nor any adverse events such as excessive autoimmune reactions and brain toxicity associated with CAR T therapy.
“We are delighted to see that our CAR NK, in combination with lead candidates NKX101 and NKX019, has shown such striking early single-agent activity in a heavily pretreated patient population with an excellent safety profile not associated with CAR T cell therapy side effects,” Nkarta President and CEO Paul Hastings said in a prepared statement. “These encouraging data spanning multiple indications further validate Nkarta’s best-in-class NK cell platform as we seek to transform cancer treatment by combining the safety advantages of NK cells with off-the-shelf modalities designed to benefit the cells.” Treatment is available in a community setting.”
Despite the small number of patients, Nkarta cell therapy passed the 30 percent complete response potency threshold set by non-engineered NK cell therapy, William Blair analyst Sami Corwin wrote in a research note. She added that early results from NKX019 showed efficacy comparable to a cord blood-derived NK cell therapy developed at MD Anderson Cancer Center.Partnership with Takeda Pharmaceuticals), Fate Therapeutics’ induced pluripotent stem cell-derived CAR-NK therapy and CAR T therapy. In addition, William Blair believes that CAR-NK cell therapy has better safety than CAR T.
Nkarta said it will continue to enroll patients in its two Phase 1 studies; study participants will receive a three-dose regimen of up to 1.5 billion NK cells. Data from these studies, including follow-up data and updates on the high-dose arm, will be presented at a future medical meeting.
in a Investor introduction, Nkarta said NKX101 has the potential to gain regulatory approval as a drug for relapsed or refractory AML with data from the single-arm expansion group. The company added that it is possible to move the therapy into earlier treatments. For NKX019, the higher 1.5 billion NK cell regimen offers the potential to improve and deepen response to therapy, Nkarta said. The company is planning to test the drug in an expansion cohort of patients who have previously received CAR T therapy, as well as patients with large B-cell lymphoma who have not previously received CAR T therapy. Nkarta expects to release the next data update for both projects in the second half of this year.
Nkarta has many companies looking for off-the-shelf NK cell therapies that are more effective than CAR T. NK cell therapy developers include Shoreline Bioscienceshas a partnership with Gilead Sciences and BeiGene; Bristol-Myers Squibb partners with Century Therapeutics; Wugen; and New startup Indapta Therapeutics.
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