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2022-12-06

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Cardiff Oncology falls 19% on plans to drop prostate cancer programs

The shares of clinical-stage biotech Cardiff Oncology (NASDAQ:CRDF) shed ~19% in pre-market trading

Cardiff Oncology falls 19% on plans to drop prostate cancer programs

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The trial designed to test onvansertib in combination with standard-of-care (SoC) FOLFIRI/bevacizumab is expected to generate topline data in 2H 2024.</p> <p>Highlighting initial data from the Phase 2 trial in second-line mPDAC, CRDF said that 4 out of 5 evaluable patients in the ongoing open-label study achieved disease control and remained on treatment as of the data cutoff date. The fifth evaluable patient has discontinued the study due to progressive disease.</p> <p>The study was designed to evaluate onvansertib in combination with nanoliposomal irinotecan and 5-FU in second-line metastatic PDAC. 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The decision followed a strategic review of clinical data and the current and projected therapeutic landscape for the indication, the company said, noting plans to reprioritize efforts on metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC). Given the unmet medical need and market opportunity in mCRC and mPDAC and the company’s results for the indications, “we will be focusing our resources on these programs and will not independently fund future clinical activities in prostate cancer,” Chief Executive Mark Erlander said. CRDF also announced plans to start a randomized Phase 2 trial for its lead asset Onvansertib in patients with KRAS-mutated mCRC in a second-line setup. The trial designed to test onvansertib in combination with standard-of-care (SoC) FOLFIRI/bevacizumab is expected to generate topline data in 2H 2024. Highlighting initial data from the Phase 2 trial in second-line mPDAC, CRDF said that 4 out of 5 evaluable patients in the ongoing open-label study achieved disease control and remained on treatment as of the data cutoff date. The fifth evaluable patient has discontinued the study due to progressive disease. The study was designed to evaluate onvansertib in combination with nanoliposomal irinotecan and 5-FU in second-line metastatic PDAC. More data from the study are expected in Q2 or Q3 2023. Updating on its liquidity level, CRDF said that its current cash resources would be adequate to fund operations into 2025. 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