Onvansertib

Cardiff Oncology Secures Second Patent for Onvansertib in Bevacizumab-Naïve mCRC Patients

a month ago

• 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.

Robust Pipeline of 200+ Therapies Targets Colorectal Cancer Treatment Landscape

2 months ago

• DelveInsight's latest report reveals a robust pipeline with over 195 companies developing 200+ therapies for colorectal cancer, highlighting significant innovation in targeted treatments and immunotherapies. • Key drug candidates include XL092 (Exelixis), Adagrasib (Mirati Therapeutics), Olaparib (Merck/AstraZeneca), and novel approaches like LYL845, an autologous tumor-infiltrating lymphocyte therapy from Lyell Immunopharma. • The metastatic colorectal cancer segment shows particular promise with 150+ companies advancing 180+ pipeline therapies, including innovative treatments targeting specific mutations and immune pathways.

Elraglusib Plus Chemotherapy Shows Promise in Metastatic Pancreatic Cancer

5 months ago

• Actuate Therapeutics' elraglusib combined with gemcitabine/nab-paclitaxel (GnP) significantly improved survival rates in metastatic pancreatic cancer patients. • The Phase 2 trial showed a 43.6% one-year survival rate with elraglusib-GnP, compared to 22.5% with GnP alone, demonstrating a 37% reduction in death risk. • The combination therapy also increased median overall survival to 9.3 months versus 7.2 months with GnP alone, with a favorable safety profile. • Actuate plans to engage with the FDA in the first half of 2025 to discuss topline data and potential next steps for elraglusib's development.

Cardiff Oncology's Onvansertib Shows Promise in Metastatic Castration-Resistant Prostate Cancer

5 months ago

• 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 Shows Promising Results in RAS-Mutated Metastatic Colorectal Cancer Trial

5 months ago

• 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.

Onvansertib Plus FOLFIRI/Bevacizumab Demonstrates Efficacy in KRAS-Mutated Colorectal Cancer

6 months ago

• A phase 2 trial showed that onvansertib combined with FOLFIRI/bevacizumab significantly improved outcomes in KRAS-mutated metastatic colorectal cancer patients without prior bevacizumab exposure. • Patients naive to bevacizumab achieved a 76.9% overall response rate and a median progression-free survival of 14.9 months with the onvansertib combination therapy. • The study's findings suggest shifting onvansertib development to the frontline setting for colorectal cancer, where patients have not been previously exposed to bevacizumab. • Common adverse events included fatigue, neutropenia, nausea, and diarrhea, with manageable grade 3 or 4 events observed in a subset of patients.

KRAS Inhibitors Market Set for Growth with Novel Therapies Targeting Key Mutations in Cancer

8 months ago

• The KRAS inhibitors market is projected to grow significantly, driven by increasing cancer incidence and advancements in targeted therapies. • KRAZATI (adagrasib) is expected to lead in revenue among approved KRAS inhibitors, surpassing LUMAKRAS (sotorasib) during the forecast period. • Pan-KRAS drugs, targeting multiple KRAS mutations, hold substantial market potential due to their broader applicability across cancer types. • Emerging therapies like JDQ443 and avutometinib are poised to transform the treatment landscape, offering new options for patients with KRAS-mutated cancers.

Cardiff Oncology's Onvansertib Enters Phase 2 Trial for KRAS/NRAS-Mutated Metastatic Colorectal Cancer

9 months ago

• Cardiff Oncology has initiated a Phase 2 randomized trial (ONSEMBLE) of onvansertib in patients with KRAS/NRAS-mutated metastatic colorectal cancer (mCRC). • The company's Scientific Advisory Board (SAB) has been expanded with full membership, enhancing expertise for clinical development. • Fairooz Kabbinavar, MD, FACP, has been appointed as Chief Medical Officer, bringing extensive experience to guide clinical programs. • Cardiff Oncology's financial runway extends into 2025, supported by approximately $97 million in cash, cash equivalents, and short-term investments.

Drug Development Updates