Oncology
Nkarta rethinks treatment with natural killer cells
Just over one year ago, Nkarta reported preliminary results from a clinical trial of NKX101, an off-the-shelf cancer treatment made from engineered natural killer cells: Three of five patients with acute myeloid leukemia, or AML, achieved complete remissions.
Today, Nkarta reported an update on the NKX101 study with less encouraging results. Two of the responding patients relapsed and died relatively quickly, and the third patient remains in remission but only after a curative stem-cell transplant. An additional 13 patients with advanced AML were treated with NKX101 but none achieved a complete remission.
The disappointing outcome has the company rethinking its dosing strategy. Nkarta is now using a more aggressive chemotherapy regimen to prepare patients for treatment. The process, called lymphodepletion, blunts a patient's immune system so that the natural killer cells in NKX101 can do their work. It also amplifies a specific molecule on leukemic cells that NKX101 relies on for a target.
Three of six patients with advanced AML offered the modified regimen have achieved complete remissions, Nkarta also reported Tuesday. All of the patients had AML that was particularly resistant to treatment, or with other characteristics that made complete remissions less likely, so the responses to the new lymphodepletion regimen and NKX101 are encouraging, said Nkarta Chief Medical Officer David Shook.
But the follow-up is still too short to determine if the responses will be durable, Shook acknowledged, which leaves the company in much the same position as it was last year. Nkarta expects to enroll another 12-20 patients and provide an update in the first half of next year.
Biotech
Biogen shareholders back Susan Langer
Biogen shareholders voted to add biotech executive Susan Langer, who is the romantic partner of departing director Alex Denner, to its board of directors yesterday, concluding a weekslong episode that led some investors to question the company's leadership.
Langer, 32, will join the eight-member board for a one-year term. Denner, who nominated her, did not stand for reelection. The results of Monday's shareholder vote remain preliminary, and Biogen said it will disclose the final tally within four business days.
Biogen did not disclose the relationship between Denner and Langer when it announced her candidacy June 12, a decision that rankled some investors and former employees of the company. Doron Junger, who leads the hedge fund Sanvia Capital, wrote on Twitter that Biogen's omission of the relationship "was ill-conceived, leaving us and others with the sense that the company attempted to conceal it."
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GLP-1
Not everyone's sold on Mounjaro
A U.K. agency that regulates the cost-effectiveness of medicines said it will not recommend Eli Lilly's rival to the in-demand diabetes drug Ozempic until the company provides more evidence of its long-term benefits.
As STAT's Andrew Joseph reports, the National Institute for Health and Care Excellence, or NICE, acknowledged that Lilly's Mounjaro demonstrated significant effects on blood sugar and body weight but took issue with "uncertainties in the clinical evidence" when it comes to diabetes-related complications and cardiovascular health. In a statement, Lilly said it would work with NICE to resolve those questions.
Lilly's treatment, approved in the U.S. for type 2 diabetes, appears to be more potent than Ozempic and Wegovy, made by Novo Nordisk, leading to multibillion-dollar estimates tied to its future as a medicine for obesity. In the U.K., NICE has recommended Novo Nordisk's drugs, but global demand has made them difficult to come by.
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