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Mirati CEO Steps Down After Going Toe-to-Toe with Amgen in KRAS

2023-08-09

临床3期上市批准高管变更临床2期临床结果

Pictured: Man packing up his office things in a box/iStock, pcess609 Mirati Therapeutics on Tuesday announced that CEO David Meek has resigned from his post, with founder and president Charles Baum taking the company’s reins as it searches for a permanent replacement. As part of his “mutually agreed” decision to leave the company, Meek will also vacate his position on Mirati’s Board of Directors but will keep working with the biotech through Oct. 15 on a consultancy basis. “David has made a significant impact during his tenure at Mirati, most notably guiding the company through the successful launch of Krazati, the rapid advancement of our robust and innovative pipeline and the expansion of the Mirati team,” Chairman of the Board Faheem Hasnain said in a statement. In December 2022, the FDA awarded Mirati’s small molecule KRAS inhibitor Krazati KRAS inhibitor Krazati (adagrasib) accelerated approval, authorizing its use in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the G12C KRAS mutation. The regulatory win pitted Mirati against Amgen, whose own KRAS therapeutic Lumakras (sotorasib) was greenlit in May 2021 for the same indication. Also on Tuesday, Mirati released its second-quarter 2023 earnings results, reporting that Krazati scored a net revenue of $13.4 million. During the same period, Amgen posted net Lumakras sales of $77 million. Krazati’s figures may remain stunted in the near future after the European Medicine Agency's Committee for Medicinal Products for Human Use last month issued a negative opinion for its conditional marketing authorization. Mirati is continuing its development of Krazati including a Phase II study to push the monotherapy into the frontline setting in NSCLC and a Phase III trial testing its combination with Lilly’s EGFR blocker Erbitux (cetuximab) as a second-line treatment option for colorectal cancer. In its second-quarter update, Mirati also announced that by year-end it will initiate a Phase III study in first-line NSCLC to test the combination regimen of Krazati with Merck’s blockbuster Keytruda (pembrolizumab). Meek’s resignation also follows a late-stage blunder in May 2023, when the company announced that its investigational kinase inhibitor sitravatinib fell short of its primary efficacy bar in the Phase III SAPPHIRE study. The failure pushed Mirati to discontinue all development of sitravatinib, which in SAPPHIRE was being tested with Bristol Myers Squibb’s Opdivo (nivolumab) for non-squamous NSCLC. Following the leadership shake-up, Mirati announced it was putting $250 million worth of its common stock up for sale in an underwritten public offering. The company on Wednesday increased the aggregate gross proceeds from this offering to approximately $300 million. Mirati’s stock dipped 6% in after-hours trading. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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