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Cardiff Oncology Appoints Dr. Roger Sidhu as Chief Medical Officer and Announces Timing for the Next Update from the CRDF-004 Trial in First-Line RAS-mutated mCRC
Globenewswire· 2025-06-18 04:05
– Veteran executive with over 20 years of oncology leadership and clinical experience with proven track record of success in bringing development candidates through late-stage clinical development – – Company will hold a conference call on July 29 at 4:30 p.m. ET/1:30 p.m. PT to share additional clinical data from its randomized Phase 2 CRDF-004 trial evaluating onvansertib + standard of care for the treatment of first-line RAS-mutated metastatic colorectal cancer (“mCRC”) – SAN DIEGO, June 17, 2025 (GLOBE ...
Cardiff Oncology Announces Positive Data from Investigator-Initiated Trial of Onvansertib in Combination with Paclitaxel in Metastatic Triple-Negative Breast Cancer Presented at ASCO 2025
Globenewswire· 2025-06-03 04:05
文章核心观点 公司宣布评估onvansertib联合紫杉醇治疗转移性三阴性乳腺癌的1b期临床试验取得积极数据,该组合耐受性良好且毒性可控,最高剂量的onvansertib客观缓解率达40%,为开发onvansertib治疗多种癌症提供支持 [1][2][5] 公司概况 - 公司是临床阶段生物技术公司,利用PLK1抑制开发多种癌症新疗法,主要资产是onvansertib [4] - onvansertib正与标准疗法联用,针对RAS突变转移性结直肠癌等多种癌症开展临床试验 [4] 试验情况 - 试验由达纳 - 法伯癌症研究所的Antonio Giordano博士牵头,目的是评估onvansertib和紫杉醇组合的安全性、药代动力学和药效学 [5] - 研究主要终点是onvansertib加紫杉醇的安全性和剂量限制性毒性特征,确定推荐的2期剂量;次要终点包括药代动力学和药效学 [5] - 入组患者接受过中位数为3线的化疗 [5] 试验结果 - onvansertib联合紫杉醇在推荐2期剂量18mg/m(n = 10)时,根据RECIST 1.1标准客观缓解率达40%,有2例确认部分缓解和2例未确认部分缓解 [5] - 组合耐受性良好,毒性特征安全可控,最常见不良事件是骨髓抑制 [5] 公司观点 - 三阴性乳腺癌是最具侵袭性的乳腺癌亚型之一,开发新疗法满足患者需求十分紧迫 [2] - onvansertib加紫杉醇在患者中显示出强大疗效信号和可耐受的安全性,多数患者曾接受大量治疗,4例客观缓解中有3例患者曾使用过紫杉醇 [2] - 观察到剂量反应关系,最高剂量onvansertib客观缓解率达40%,研究结果验证了此前临床前数据中onvansertib和紫杉醇的协同作用 [2]
Cardiff Oncology: Buying The First-Line Onvansertib Strategy
Seeking Alpha· 2025-05-14 21:05
投资组合筛选 - 在医疗保健领域筛选投资标的较为容易 因该领域存在大量潜在目标 [2] - 需将候选名单进一步缩小至10个高优先级生物制剂公司作为重点观察对象 [2] 投资策略 - 重点关注开发突破性疗法和/或具有被收购潜力的创新型制药公司 [2] - 当前持有IBRX和PFE的多头仓位 包括股票、期权或其他衍生品 [3] - 考虑在未来72小时内建立CRDF的多头仓位 [3] 研究服务 - 提供Compounding Healthcare订阅服务 可免费试用 以了解更多投资方法 [1]
Cardiff Oncology Reports First Quarter 2025 Results and Provides Business Update
Globenewswire· 2025-05-09 04:05
- Completed enrollment in randomized Phase 2 CRDF-004 trial evaluating onvansertib + standard of care for the treatment of first-line RAS-mutated metastatic colorectal cancer (“mCRC”) - - Expanded intellectual property portfolio with second patent covering treatment of all bev-naïve patients, including RAS-mutated and RAS wild-type mCRC, across all lines of therapy - - Cash and investments of $79.9 million as of March 31, 2025, projected runway into Q1 2027 - SAN DIEGO, May 08, 2025 (GLOBE NEWSWIRE) -- Card ...
Cardiff Oncology Announces a Second Patent for the Treatment of mCRC for Bev-Naïve Patients
Globenewswire· 2025-04-24 04:05
文章核心观点 - 美国专利商标局授予Cardiff Oncology公司一项美国专利,扩大了onvansertib的知识产权组合,有望推动其在转移性结直肠癌治疗中的广泛应用和市场增长 [1][2] 专利信息 - 美国专利商标局授予Cardiff Oncology公司美国专利No. 12,263,173,预计不早于2043年到期 [1] - 该专利涵盖onvansertib与贝伐珠单抗联合用于治疗未接受过贝伐珠单抗治疗的转移性结直肠癌患者的方法,包括RAS突变和RAS野生型患者,适用于所有治疗线 [1] 公司观点 - 公司首席执行官认为知识产权组合的扩展为onvansertib带来更广泛市场机会和未来增长,其广泛适用性有望推动广泛采用、融入临床实践并重新定义转移性结直肠癌治疗标准 [2] 产品研发 - onvansertib是一种PLK1抑制剂,正与FOLFIRI和贝伐珠单抗或FOLFOX和贝伐珠单抗联合用于一线2期随机开放标签试验(CRDF - 004),治疗RAS突变的转移性结直肠癌患者 [2] - 公司于2024年12月公布CRDF - 004试验初始数据,预计2025年上半年公布更多临床数据 [2] 公司概况 - Cardiff Oncology是一家临床阶段生物技术公司,利用PLK1抑制开发多种癌症的新疗法 [3] - 公司主要资产onvansertib正与标准治疗药物联合用于临床项目,目标适应症包括RAS突变的转移性结直肠癌、转移性胰腺导管腺癌、小细胞肺癌和三阴性乳腺癌 [3]
Cardiff Oncology(CRDF) - 2024 Q4 - Earnings Call Transcript
2025-02-28 06:30
Cardiff Oncology (CRDF) Q4 2024 Earnings Call February 27, 2025 04:30 PM ET Company Participants Kiki Patel - PrincipalMark Erlander - CEOJames Levine - Chief Financial OfficerAlexander Kelly - Biotech Equity Research Associate Conference Call Participants Joseph Catanzaro - Director & Senior Equity AnalystAndy Hsieh - Research AnalystRobert Burns - MD & Senior Healthcare AnalystAlbert Lowe - Senior Research Analyst Operator Welcome to the Cardiff Oncology Fourth Quarter twenty twenty four Financial Results ...
Cardiff Oncology (CRDF) FY Conference Transcript
2023-01-19 03:30
Cardiff Oncology (CRDF) FY Conference January 18, 2023 01:30 PM ET Speaker0 All right. Good afternoon, everyone. Welcome to B. Riley Securities Oncology Conference and listening to our fireside chat. I'm Yuan Zhi, a healthcare equity research analyst at B. Riley Securities. Today, it's my great pleasure to have Mark Erlander, CEO of Cardiff Oncology. Thank you for joining us today. I want to focus today's discussion on your clinical trial of colorectal cancer and pancreatic cancer. But Mark, can you give us ...