Cardiff Oncology Presents Novel Preclinical Data at AACR Annual Meeting 2024 that Supports Ongoing First-line RAS-mutated mCRC Clinical Study

RAS-mutated mCRC

– In RAS-mutated mCRC, novel preclinical finding demonstrates onvansertib inhibits the tumor’s ability to adapt to hypoxia resulting in a significant decrease in both tumor vascularization and growth –

– Enhanced clinical efficacy signal in bev naïve patients in Phase 1b/2 trial is consistent with results of randomized ONSEMBLE trial providing two independent data sets in second-line mCRC validating our strategy to evaluate onvansertib in combination with chemo/bev in RAS-mutated first-line mCRC –

Therapeutic areas outside of RAS-mutated mCRC

– In RAS-wild type mCRC, onvansertib demonstrates antitumor activity in preclinical models as a single agent and in combination with cetuximab, highlighting that onvansertib activity in mCRC can be independent of RAS mutational status –

– In SCLC and ovarian cancer, robust preclinical data underscore onvansertib’s activity in combination treatments across multiple tumors –

SAN DIEGO, April 08, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced the presentation of five abstracts at the American Association for Cancer Research (AACR), taking place from April 5-10, 2024, in San Diego, California. In combination, the abstracts underscore the significant potential of the company’s lead molecule onvansertib in metastatic colorectal cancer (mCRC) and other cancers.

“Overall, the totality of our preclinical and clinical data we are presenting at AACR in mCRC is promising and provides scientific validation of our ongoing first-line RAS-mutated mCRC trial, where all patients have no prior exposure to bevacizumab, meaning they are bev naïve,” said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. “Furthermore, bev naïve patients in our Phase 1b/2 KRAS-mutated mCRC trial were approximately 4 times (73 % vs 19%) more likely to achieve a clinical response compared to bev exposed patients in the dataset presented at AACR. This is consistent with the data we later generated from our randomized ONSEMBLE trial in RAS-mutated mCRC, which serves as a second independent data set reproducing the robust efficacy signal for onvansertib plus standard of care in bev naïve patients. In addition, we are particularly encouraged by our RAS-mutated mCRC preclinical data highlighting onvansertib’s ability to inhibit activation of the hypoxia pathway via the regulation of HIF1α. We believe this mechanism acts complementary to bevacizumab, potentially providing an even greater reduction in tumor vascularization when the two agents are combined.”