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With new Fate data, same promise, questions surround natural killer cell therapy
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Bluebird, with little fanfare, is first to bring a second gene therapy to market
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Cathie Wood funds rally as gene editing edges closer to reality
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Dive Brief:
Iovance Biotherapeutics said it doesn t expect to seek U.S. approval of the experimental cancer cell therapy lifileucel until 2022 after failing to convince regulators that its potency testing is adequate.
The California biotech had once hoped to file its application with the Food and Drug Administration last year and made plans in 2019 to build a $75 million plant in Philadelphia to support production. After the FDA raised objections to Iovance s so-called potency assays lab tests meant to measure the strength of its treatment the company pushed back its target application date to 2021.
Iovance said it s working to develop and validate new assays that will meet the FDA s requirements and now expects to submit the therapy for approval in the first half of next year. The company s shares dropped by more than 10% at the start of Wednesday trading and then fell further after the company separately disclosed its CEO will be resigning.
Published May 14, 2021 National Institutes of Allergy and Infectious Diseases. (2016). Human natural killer cell [Micrograph]. Retrieved from Flickr.
Dive Brief:
Fate Therapeutics on Thursday reported new results from two early-stage studies testing two types of experimental leukemia treatments that use natural killer cells, an emerging form of cancer immunotherapy.
Four of nine patients who received one Fate NK cell therapy showed evidence of a response, as did one of three who got a different type of NK cell therapy. There were no instances of the neurological or immune-related side effects seen with other forms of cell therapy and there were also no side effects that would prevent testing of higher doses, according to the company.