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Cardiff Oncology Announces Upcoming Presentations at the AACR Annual Meeting 2024

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Cardiff Oncology, Inc. announces the presentation of five abstracts at the AACR Annual Meeting, showcasing the potential of onvansertib in various cancer indications. Key highlights include improved outcomes in KRAS-mutant mCRC patients not exposed to bevacizumab, robust antitumor activity of onvansertib in RAS wild-type colorectal cancer, and promising synergies with paclitaxel in small cell lung cancer and carboplatin/gemcitabine in platinum-resistant ovarian carcinoma.
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The recent findings from Cardiff Oncology highlight the potential of onvansertib, a Polo-like kinase 1 (PLK1) inhibitor, in improving treatment outcomes for various cancers. PLK1 is a protein that plays a crucial role in cell division and its inhibition can lead to the disruption of cancer cell proliferation. In KRAS-mutant metastatic colorectal cancer (mCRC), the combination of onvansertib with FOLFIRI/bevacizumab has shown to not only inhibit tumor growth but also to modulate the hypoxia pathway, which is critical for tumor survival and angiogenesis. This dual mechanism of action suggests a significant therapeutic advancement, considering the limited options available for Bev-naïve mCRC patients.

Furthermore, the preclinical efficacy of onvansertib in combination with cetuximab for RAS wild-type colorectal cancer and with paclitaxel for small cell lung cancer (SCLC) indicates a broader clinical application. The robust antitumor activity in patient-derived xenograft models, including those resistant to standard therapies, is particularly promising. This could lead to new treatment paradigms in cancers that are notoriously difficult to treat, like SCLC.

Cardiff Oncology's strategic focus on PLK1 inhibition is validated by the compelling preclinical and early clinical data. The high objective response rates and progression-free survival observed in Bev-naïve patients suggest that onvansertib may address a significant unmet need in second-line treatment of KRAS-mutant mCRC. This has potential market implications, as the drug could become a preferred option in this setting, subject to further clinical validation and regulatory approval.

Additionally, the potential of onvansertib in platinum-resistant high-grade ovarian carcinoma represents a noteworthy development. Platinum resistance is a major hurdle in ovarian cancer treatment and the preclinical data indicating enhanced efficacy of standard chemotherapeutics when combined with onvansertib could translate into a new hope for patients with limited treatment options. The tolerability of the combination is also a critical aspect, as it could lead to better patient compliance and outcomes.

The oncology market is highly competitive and the success of new therapeutics depends on their efficacy, safety and ability to address gaps in existing treatment regimens. Cardiff Oncology's onvansertib represents a strategic entry into this market, targeting specific mutations and resistance mechanisms. The differentiation of onvansertib in terms of its dual action on tumor growth and the hypoxia pathway could position it favorably against competitors, especially if these preliminary findings translate into clinical success.

The anticipation of these study results could influence Cardiff Oncology's stock performance, as investors often react to potential breakthroughs in cancer therapy. The specificity of onvansertib's mechanism also aligns with the industry's shift towards personalized medicine, potentially opening additional avenues for growth and collaboration in the biotechnology sector.

SAN DIEGO, March 06, 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 publications of five abstracts that will be presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting, taking place from April 5-10, 2024, in San Diego, California.

“The posters we will be presenting at this year’s AACR meeting represent a broad view of the potential of onvansertib in several different cancer indications, including RAS-mutant mCRC, RAS-wild type mCRC, small cell lung cancer and ovarian cancer,” said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. “In RAS-mutated mCRC, we are showing the underlying mechanism through which the combination of onvansertib and bevacizumab targets the hypoxia response pathway. We believe this mechanism explains the strong clinical results we have seen in both our Phase 1b/2 and ONSEMBLE second-line RAS-mutated mCRC clinical trials. The additional posters provide new insights and rationale for future clinical trials in other cancer indications.”

Details on the posters and corresponding abstracts are shown below.

Poster Title: A phase 1b/2 clinical study of onvansertib in combination with FOLFIRI/bevacizumab revealed a new role of PLK1 in regulating the hypoxia pathway in KRAS-mutant colorectal cancer
Session Title: Microenvironment, Immunity, and DNA Repair in Therapeutic Response
Session Date and Time: Monday Apr 8, 2024: 9:00 AM - 12:30 PM PT
Location: Poster Section 27, Poster Board #14, Abstract Number #2031

This abstract presents updated clinical data and biomarker analysis from the Phase 1b/2 study evaluating onvansertib in combination with FOLFIRI/bevacizumab for second-line treatment of KRAS-mutant metastatic colorectal cancer (mCRC) patients. Analysis of patient baseline characteristics revealed superior clinical benefit in patients not exposed to bevacizumab in first-line treatment (Bev-naïve) compared to Bev-exposed patients. Bev-naive patients exhibited higher objective response rates (73.3% versus 15.7%) and longer median progression-free survival (14.9 versus 7.8 months) compared to Bev-exposed patients. Preclinical studies, using KRAS-mutant colorectal cancer mouse models revealed robust antitumor activity of onvansertib in combination with bevacizumab and a novel role of onvansertib in regulating tumor vascularization. Further preclinical investigations showed that PLK1 regulates the hypoxia pathway in KRAS-mutant CRC cells through the modulation of the hypoxia-inducible factor 1 alpha, HIF1α, emphasizing the potential crosstalk between PLK1 and angiogenesis. These findings reinforce the rationale for exploring onvansertib in combination with FOLFIRI/bevacizumab for Bev-naïve mCRC patients with KRAS mutation.

Poster Title: The PLK1 inhibitor, onvansertib, is active as monotherapy and in combination with cetuximab in RAS wild-type colorectal cancer patient-derived xenografts
Session Title: Drug Resistance 2: Ras GTPase
Session Date and Time: Monday Apr 8, 2024: 9:00 AM - 12:30 PM PT
Location: Poster Section 24, Poster Board #12, Abstract Number #1934

This abstract focuses on the preclinical assessment of onvansertib’s antitumor activity in RAS wild-type colorectal cancer, as both a monotherapy and in combination with cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor (EGFR). Employing patient-derived xenograft (PDX) models, the study highlights the robust antitumor efficacy of onvansertib monotherapy, in cetuximab-sensitive and -resistant RAS wild-type colorectal cancer models. Furthermore, the combination of onvansertib and cetuximab was highly effective, resulting in tumor regression in 90% of the PDXs. These compelling data strongly support the clinical development of onvansertib as a potential treatment for RAS wild-type colorectal cancer.

Poster Title: A phase 2, randomized, open-label study of onvansertib in combination with standard-of-care (SoC) versus SoC alone for first-line treatment of RAS-mutant metastatic colorectal cancer(mCRC)
Session Title: Phase II and Phase III Clinical Trials in Progress
Session Date and Time: Tuesday, Apr 9, 2024: 1:30 PM - 5:00 PM PT
Location: Poster Section 50, Poster Board #5, Abstract Number #CT275

This abstract describes a clinical trial in progress.

Poster Title: The PLK1 inhibitor, onvansertib, synergizes with paclitaxel in small cell lung cancer
Session Title: Kinase and Phosphatase Inhibitors 1
Session Date and Time: Sunday Apr 7, 2024: 1:30 PM - 5:00 PM PT
Location: Poster Section 25, Poster Board #16, Abstract Number #606

This abstract outlines preclinical studies showing the promising potential of combining onvansertib with paclitaxel for small cell lung cancer (SCLC). The research reveals significant synergy of the combination in SCLC cell lines and demonstrates its robust antitumor activity in patient-derived xenograft models, including models resistant to the standard therapy cisplatin. Further insights into the combination's mechanism of action will be presented. These findings support that combining onvansertib with paclitaxel could emerge as a highly promising treatment strategy for SCLC.

Poster Title: In vivo anti-tumor activity of onvansertib, a PLK1 inhibitor, combined with gemcitabine or carboplatin in platinum-resistant ovarian carcinoma patient-derived xenograft models
Session Title: Application of Precision Medicine for Cancer Care
Session Date and Time: Sunday Apr 7, 2024: 1:30 PM - 5:00 PM PT
Location: Poster Section 39, Poster Board #13, Abstract Number #945

This abstract explores preclinically the potential of combining onvansertib with the chemotherapeutic agents carboplatin or gemcitabine for platinum-resistant high-grade ovarian carcinoma. Using patient-derived xenografts, we demonstrated robust efficacy for both combinations, coupled with favorable tolerability. These data underscore the potential of onvansertib to improve the efficacy of the standard-of-care carboplatin and gemcitabine for patients with platinum-resistant high-grade ovarian carcinoma.

The abstracts are available on the AACR Online Program and will be published in the online Proceedings of the AACR. Following presentation, the posters will be posted to the "Scientific Presentations" section of the Cardiff Oncology website.

About Cardiff Oncology, Inc.

Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard-of-care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC), as well as in investigator-initiated trials in small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. For more information, please visit https://www.cardiffoncology.com.

Cardiff Oncology Contact:
James Levine
Chief Financial Officer
858-952-7670
jlevine@cardiffoncology.com

Investor Contact:
Kiki Patel, PharmD 
Gilmartin Group
332-895-3225
Kiki@gilmartinir.com

Media Contact:
Richa Kumari
Taft Communications
551 344-5592 
richa@taftcommunications.com


The abstracts demonstrate the potential of onvansertib in various cancer indications, including KRAS-mutant mCRC, RAS wild-type colorectal cancer, small cell lung cancer, and platinum-resistant ovarian carcinoma.

The abstract showcased superior clinical benefit in Bev-naïve patients, with higher response rates and longer progression-free survival compared to Bev-exposed patients.

The study demonstrated the antitumor efficacy of onvansertib as a monotherapy and in combination with cetuximab, showing tumor regression in 90% of patient-derived xenograft models.

The research showed significant synergy between onvansertib and paclitaxel in SCLC cell lines, with robust antitumor activity in patient-derived xenograft models, including those resistant to cisplatin.

The abstract explored the potential of onvansertib in combination with carboplatin or gemcitabine for platinum-resistant high-grade ovarian carcinoma, demonstrating robust efficacy and favorable tolerability.
Cardiff Oncology Inc

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trovagene is a precision medicine biotechnology company developing oncology therapeutics for improved cancer care by leveraging its proprietary precision cancer monitoring® (pcm) technology in tumor genomics. trovagene has broad intellectual property and proprietary technology to measure circulating tumor dna (ctdna) in urine and blood to identify and quantify clinically actionable markers for predicting response to cancer therapies. trovagene offers its pcm technology at its clia/cap – accredited laboratory and plans to continue to vertically integrate its pcm technology with precision cancer therapeutics. trovagene's lead therapeutic asset is pcm-075, an oral, investigational drug and a highly-selective polo-like kinase 1 (plk1) inhibitor for the treatment of acute myeloid leukemia (aml). among the four members of the plk family, plk1 is recognized to be the fundamental component for cell division to take place correctly. most importantly, plk1 is only expressed in dividing cells, wh