Mirati Stock Sale Targets $200M as Lead Cancer Drug Starts Phase 3

Mirati公司计划公开募股融资2亿美元,推进开展非小细胞肺癌药物Ⅲ期试验

2019-06-28 16:08:00 Xconomy

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Mirati Therapeutics plans to raise more than $200 million this week in a public offering, funding that it plans to use to advance its lead cancer drug candidate, sitravatinib, into late-stage testing, and to continue developing its other targeted oncology programs. The San Diego company said Tuesday that it would sell 2.1 million shares of its common stock at $97 apiece, raising gross proceeds of $203.7 million. (Its underwriters have the right to buy another 315,000 shares in connect with the offering, which would tack on another $30 million or so.) On Wednesday, shares of Mirati (NASDAQ: MRTX) closed at $100.01. Mirati’s sitravatinib is an experimental treatment for patients with non-small-cell lung cancer (NSCLC). The company is testing the drug in combination with checkpoint inhibitors, a type of cancer immunotherapy, to target a class of proteins called tyrosine kinases. The combination will be compared to chemotherapy. The company plans to start its Phase 3 trial of the experimental combination in patients with NSCLC—a type of lung cancer that makes up about 80 percent to 85 percent of all such tumors—by month’s end. Lung cancer is the leading cause of cancer death for both men and women; about 228,150 new cases of the disease are anticipated this year, according to the American Cancer Society. Mirati’s Phase 3 study is enrolling patients whose cancer has progressed even after treatment with checkpoint inhibitors. According to the company’s prospectus, the study will include an interim analysis of the percentage of patients whose cancers respond to treatment. Analysis of this surrogate endpoint—an early look to see whether the treatment works—is expected to be completed by the end of 2020. The company says in the filing that this surrogate endpoint could be the basis for a submission for accelerated FDA approval. The main goal of the Phase 3 study is overall survival, the length of time that patient lives following the start of treatment. In addition to the sitravatinib program, Mirati is also developing another drug, MRTX849, which blocks a mutation in the KRAS gene that is associated with certain lung cancer cells. The experimental drug is in Phase 1/2 testing. Back in October, Mirati’s stock took a 15 percent hit after new data from its Phase 2 combination trial of sitravatinib in combination with nivolumab (Opdivo), an immunotherapy from Bristol-Myers Squibb (NYSE: BMY), disappointed investors. But it saw a 35 percent bump in the wake of January’s JP Morgan Healthcare Conference after the company updated investors about its pipeline. And Mirati stock jumped again more than 20 percent day-over-day early this month after Amgen (NASDAQ: AMGN), which is also developing a drug targeting KRAS in patients with advanced lung cancer, revealed promising Phase 1 data at the American Society of Clinical Oncology conference. The data reported were from the first-ever clinical trial of a KRAS inhibitor. While Amgen’s research is separate from Mirati’s, its results provided additional validation for drugs being developed to target the KRAS mutation. The money Mirati is raising will also go toward its preclinical programs, which include another KRAS inhibitor, and for working capital, the company said in a news release.
Mirati Therapeutics 计划本周通过公开募股筹集2亿多美元资金,用于推进其主要癌症候选药物 sitraatinib 进入后期测试,并继续开发其他有针对性的肿瘤项目。 这家圣地亚哥公司周二表示,将以每股97美元的价格出售210万股普通股,筹资总额为2.037亿美元。(其承销商有权再购买与本次发行相关的31.5万股,约合3000万美元)。周三, Mirati (纳斯达克: MRTX )的股价收于100.01美元。 Mirati 的 sitraatinib 是一种针对非小细胞肺癌( NSCLC )患者的实验性治疗方法。该公司正在与检查点抑制剂(一种癌症免疫疗法)联合测试该药物,以针对一类名为酪氨酸激酶的蛋白质。这种结合将与化疗相比较。 该公司计划在本月底开始对非小细胞肺癌(NSCLC)(一种肺癌,约占所有此类肿瘤的80%-85%)患者进行第三期临床试验。肺癌是男性和女性癌症死亡的主要原因;据美国癌症协会估计,今年将有大约228,150例新的癌症病例出现。 Mirati 的第三阶段研究是为那些即使在使用检查点抑制剂治疗后癌症仍在发展的患者进行登记。根据该公司的招股说明书,该研究将包括对癌症对治疗反应的患者比例的中期分析。对这一替代终点的分析——及早发现治疗是否有效——预计将在2020年底完成。该公司在文件中说,这个替代终点可能是提交加速 FDA 批准的基础。第三阶段研究的主要目标是总体生存,患者在开始治疗后的生存时间。 除了 sitraatinib 项目, Mirati 还在开发另一种药物 MRTX849,它阻断 KRAS 基因的突变,与某些肺癌细胞有关。实验药物正处于1/2期试验阶段。 早在去年10月, Mirati 的股价就下跌了15%,此前该公司第二阶段的 sitraatinib 与百时美施贵宝公司( NYSE : BMY )免疫疗法 nivolumab ( Opdivo )联合试验的新数据令投资者失望。但在1月份摩根大通( JPMorgan )医疗保健大会( JP Morgan Healthcare Conference )召开后,该公司股价大涨35%,此前该公司向投资者通报了其计划。 本月早些时候, Mirati 公司的股票再次上涨超过20%,此前安进(Amgen)公司( NASDAQ : AMGN )在美国临床肿瘤学会( AmericanSocietyofClinicalOncology )的会议上公布了有希望的第1阶段数据。 Amgen 公司也在开发一种针对晚期肺癌患者 KRAS 的药物。报道的数据来自 KRAS 抑制剂首次临床试验。虽然安进(Amgen)的研究与 Mirati 的研究是分开的,但其结果为针对 KRAS 突变开发的药物提供了额外的验证。 Mirati 筹集的资金也将用于其临床前项目,其中包括另一种 KRAS 抑制剂,并用于营运资金,该公司在新闻稿中说。

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