公司概况 * Kairos Pharma是一家生物制药公司 专注于开发逆转癌症耐药性和免疫抑制的疗法[1] * 公司名称Kairos源自希腊语 意为"关键时刻" 旨在患者对标准护理药物产生耐药性且免疫系统受到抑制时进行干预[2] * 公司从Cedars-Sinai医疗中心分拆出来 该中心在美国新闻与世界报道中排名全美第二[15] 核心技术与产品管线 * **EMV-105**：一种治疗性抗体 通过阻断CD105来逆转癌症耐药性 CD105是一种在耐药性发展期间升高的细胞表面蛋白 它介导肿瘤细胞存活和治疗抵抗[3][4] * 在前列腺癌中 EMV-105可恢复对包括enzalutamide amiodarone apalutamide在内的整个激素疗法类别的敏感性[4] * 在肺癌中 针对使用osimertinib (Tagrisso) 或 gefitinib等EGFR靶向疗法产生耐药或不完全响应的患者[4][9] * 该药物也被证明与结肠癌 乳腺癌和头颈癌相关[3][4] * **Kairos 201**：一种针对胶质母细胞瘤的免疫疗法 已获得FDA的研究性新药(IND)批准 可产生靶向癌症干细胞的自体T细胞[3][11][14] * **Kairos 101**：一种GITR配体(葡萄糖诱导的肿瘤坏死受体样配体) 可增加能杀死癌细胞的T效应细胞 减少抑制免疫反应的T调节细胞 并可补充其他检查点抑制剂如pembrolizumab和nivolumab[11][12] * **Kairos 102**：一种GITR配体拮抗剂 可减少T细胞数量 是用于自身免疫性疾病和移植排斥的一类新药[12][13] * **Kairos 401**：一种小分子药物 可将肿瘤微环境中的促肿瘤巨噬细胞转化为杀癌巨噬细胞[12] 临床项目进展 * **EMV-105用于前列腺癌(随机多机构II期试验)**： * 由一项NIH拨款资助进行生物标志物研究 金额为320万美元[3][6] * 已发表的II期试验显示 在雄激素受体治疗失败后使用EMV-105 临床获益率(PSA反应和影像学反应)达到62% 而耐药后的预期反应为0% 且许多患者治疗时间超过一年[4][5] * 药物安全性良好 未出现3级或4级毒性[5] * 确定了一个三基因检测生物标志物 可在治疗前识别可能响应的患者 使用生物标志物可将关键III期试验的成功可能性从55%提高到76%[6] * 安全性先导部分10名患者的结果已于7月报告 疗效结果计划于9月18日与KOL讨论一起公布[7][8][16] * 试验主要终点是无进展生存期(PFS) 次要终点是生物标志物的验证[8] * **EMV-105用于非小细胞肺癌(NSCLC)(I期试验)**： * 针对EGFR驱动的NSCLC患者 约占NSCLC的20% 即约每年45,000名患者[9] * 针对对Tagrisso治疗失败或仅产生部分响应(80%患者)且存在循环肿瘤DNA的患者[9][10] * 临床前模型显示EMV-105可克服耐药性并缩小肿瘤[10] * 研究采用贝叶斯设计 主要确定EMV-105的安全性和有效剂量 次要终点是识别生物标志物[10] * 初步结果将在9月的世界肺癌大会上由主要研究者Karen Reckamp报告[10][16] * **免疫疗法项目**： * Kairos 201 (针对胶质母细胞瘤)已获IND批准 并在Cedars-Sinai医疗中心有经验的团队推动患者入组[3][14] * Kairos 101和102正在为小肿瘤和自身免疫性疾病快速开发IND[14] 市场机会与规模 * **前列腺癌市场**：110亿美元[14] * **EGFR依赖性肺癌市场**：140亿美元 其中Tagrisso alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone alone