Cardiff Oncology, Inc. is an oncology therapeutics company, which engages in the development of drugs that target mitosis for the treatment of various types of cancer. It is focused on developing onvansertib, a first-in-class, third-generation Polo-like Kinase 1 (PLK1) inhibitor, in combination with standard-of-care chemotherapy and targeted therapeutics. The firm's clinical programs include KRAS-Mutated Metastatic Colorectal Cancer (mCRC), Resistant Metastatic Castration-Resistant Prostate Cancer (mCRPC) and relapsed or refractory Acute Myeloid Leukemia (AML). The company was founded by Gabriel M. Cerrone, L. David Tomei, Samuil Umansky, and Hovsep Melkonyan in 1999 and is headquartered in San Diego, CA.
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9
1 进行中
药物批准
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监管机构
0
监管机构数
成立时间
1999
进行中（未招募）
1
11.1%
已完成
5
55.6%
No Longer Available
1
11.1%
招募中
2
22.2%
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- DelveInsight's latest analysis reveals over 170 companies are developing more than 200 pipeline therapies for pancreatic cancer, marking significant expansion in the treatment landscape. - Advanced candidates include TQB2868, a PD-1/TGF-β bifunctional fusion protein in Phase III development, and Trabedersen, an antisense oligodeoxynucleotide in Phase II/III trials. - Recent regulatory milestones include FDA approval of OPTUNE Pax for locally advanced pancreatic cancer and Orphan Drug Designation for daraxonrasib from Revolution Medicines. - The pipeline emphasizes precision oncology approaches including dual-target immunotherapies, antibody-drug conjugates, and cell-based treatments targeting the tumor microenvironment.
- Cardiff Oncology's onvansertib demonstrated preliminary efficacy in approximately 40% of chronic myelomonocytic leukemia patients in a Phase 1 trial, with one patient achieving optimal marrow response at the 9 mg/m² dose. - The PLK1 inhibitor showed remarkable overall response rates of 77% and median progression-free survival of 14.9 months in bevacizumab-naïve metastatic colorectal cancer patients, compared to standard of care rates of 20% and 7 months respectively. - Cardiff is preparing for a registrational Phase III trial in metastatic colorectal cancer expected to begin in Q1 2026, with FDA Fast Track designation already awarded. - The company maintains a strong financial position with over $60 million in cash to support operations through 2027, while developing partnerships with Pfizer for clinical development infrastructure.
- DelveInsight's 2025 pipeline report reveals over 165 companies are developing 170+ investigational therapies for triple-negative breast cancer (TNBC), spanning from preclinical to Phase III trials. - Key emerging therapies include trilaciclib (G1 Therapeutics), olaparib (AstraZeneca), and patritumab deruxtecan (Daiichi Sankyo/Merck), with several receiving breakthrough therapy designations and showing promising clinical results. - Recent clinical milestones include Akeso's ivonescimab receiving breakthrough therapy designation from China's NMPA and Kazia Therapeutics reporting an immune-complete response in a stage IV TNBC patient treated with paxalisib combination therapy. - The TNBC therapeutics market is expected to experience substantial growth driven by rising incidence rates, improved diagnostics, increased awareness, and the anticipated introduction of novel treatment options.
- Cardiff Oncology's Phase 2 CRDF-004 trial showed a 19% improvement in confirmed objective response rate for onvansertib plus standard of care versus control in first-line RAS-mutated metastatic colorectal cancer. - The 30mg onvansertib dose demonstrated faster time to response, deeper tumor regression, and early signs of progression-free survival benefit with favorable tolerability. - The company maintains $60.6 million in cash resources with projected runway into Q1 2027, positioning for continued development of the PLK1 inhibitor. - An updated analysis from the ongoing Phase 2 trial is expected in Q1 2026 to provide more mature efficacy and safety data.
- DelveInsight's 2025 report reveals over 165 companies are developing 170+ pipeline therapies for triple-negative breast cancer, driven by rising disease prevalence and growing research investments. - Recent clinical milestones include Cardiff Oncology's positive Phase 1b data for onvansertib plus paclitaxel, Akeso's breakthrough therapy designation for ivonescimab combination, and multiple Phase III studies initiated by AstraZeneca and others. - Leading pipeline candidates include trilaciclib (G1 Therapeutics), olaparib (AstraZeneca), and patritumab deruxtecan (Daiichi Sankyo/Merck), representing diverse therapeutic approaches from CDK4/6 inhibitors to antibody-drug conjugates. - The TNBC therapeutics market is expected to undergo substantial growth due to improved diagnostics, increased awareness, higher healthcare spending, and anticipated launches of innovative treatments.
- DelveInsight's 2025 report reveals over 80 companies are actively developing more than 80 pipeline therapies for pancreatic ductal adenocarcinoma treatment. - Key pharmaceutical companies including Genentech, Revolution Medicines, and Merck Sharp & Dohme are conducting Phase 3 trials with promising novel therapeutic approaches. - Emerging therapies such as Onvansertib, Nadunolimab, and Zimberelimab represent diverse mechanisms of action targeting treatment resistance and immune suppression in pancreatic cancer. - Recent regulatory approvals include Anocca's VIDAR-1 Phase I/II trial targeting KRAS-positive advanced pancreatic cancer, demonstrating growing focus on precision medicine approaches.
- Cardiff Oncology has been granted a new patent (No. 12,263,173) covering the combination treatment of onvansertib with bevacizumab for all bevacizumab-naïve metastatic colorectal cancer patients through 2043. - The patent significantly expands treatment coverage to include both RAS-mutated and RAS wild-type mCRC patients across all therapy lines, potentially positioning onvansertib to redefine standard of care. - Onvansertib, a PLK1 inhibitor, is currently in Phase 2 trials in combination with standard chemotherapy regimens, with additional clinical data expected in the first half of 2025.
- DelveInsight's comprehensive analysis identifies over 80 pharmaceutical companies actively developing 85+ pipeline drugs for metastatic prostate cancer treatment. - Novel therapies in development include TAVT-45, a reformulated abiraterone acetate, and Onvansertib, a first-in-class PLK1 inhibitor, demonstrating innovation in treatment approaches. - Multiple clinical trials are underway, including Phase III studies by major players like Bayer, AstraZeneca, and Novartis, evaluating new treatment combinations and targeted therapies.
- Cardiff Oncology reports positive Phase 2 data for onvansertib in combination with Zytiga and prednisone for metastatic castration-resistant prostate cancer (mCRPC). - The trial demonstrated a 50% reduction in radiographic progression or death, with a median radiographic progression-free survival (rPFS) of 9.2 months. - Onvansertib plus Zytiga and prednisone was generally well-tolerated, with manageable side effects. - These findings support further investigation of onvansertib in mCRPC, potentially offering a new treatment option for patients.
- Cardiff Oncology's onvansertib, combined with standard-of-care, demonstrated a 64% objective response rate (ORR) in first-line RAS-mutated metastatic colorectal cancer (mCRC) patients. - The Phase II trial (CRDF-004) showed deeper tumor regression with the 30mg dose of onvansertib compared to the 20mg dose, with similar safety profiles. - Cardiff Oncology plans to initiate a Phase III registrational study (CRDF-005) and anticipates sharing further clinical data in the first half of 2025. - Following positive data, Cardiff Oncology announced a $40 million stock offering to fund clinical costs for onvansertib in mCRC.
