- Findings from the Phase 1b portion of company's Phase 1b/2 study in second-line KRAS-mutated mCRC
highlight the safety and promising efficacy of onvansertib in
combination with standard-of-care -
- These peer-reviewed published data are part
of the Phase 1b/2 data Cardiff
Oncology announced in August 2023 and
informed the shift to investigation in first-line in RAS-mutated
mCRC (CRDF-004)-
SAN
DIEGO, Jan. 17,
2024 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF),
a clinical-stage biotechnology company leveraging PLK1 inhibition
to develop novel therapies across a range of cancers, today
announced that the findings of the Phase 1b portion of the Phase 1b/2 study for the second-line treatment of
patients with KRAS-mutated metastatic colorectal cancer (mCRC)
disclosed by Cardiff Oncology in August
2023 have been published in the peer-reviewed journal
Clinical Cancer Research, a journal of the American
Association for Cancer Research.
The publication underscores the safety profile of onvansertib
when combined with the standard-of-care (SoC)
chemotherapy+bevacizumab. The results show that the combination has
a lasting response, indicating its tolerability and efficacy in
treating mCRC patients whose tumors harbor various KRAS
mutations.
Onvansertib is a highly specific Polo-like kinase 1 (PLK1)
inhibitor that has shown tolerability as a single agent and in
combination with multiple chemotherapies in various solid tumors.
Additional data from the full Phase 1b/2 study for the second-line treatment of
patients with KRAS-mutated mCRC will be presented at the upcoming
American Association for Cancer Research (AACR) Annual Meeting in
April 2024. These compelling
insights, along with the agreement from the US FDA, led to Cardiff
Oncology's decision to initiate a first-line trial (CRDF-004) in
RAS-mutated mCRC.
"Our groundbreaking Phase 1b study
targeted the KRAS-mutated mCRC patient population that has limited
effective treatment options, and for whom there has been no new
targeted therapy approved in decades. The Phase 1b study revealed the safety and enhanced
efficacy of integrating onvansertib, an oral PLK1 inhibitor, with
SoC FOLFIRI+bevacizumab in KRAS-mutated second-line mCRC patients,"
said Dr. Fairooz Kabbinavar MD, FACP, Chief Medical Officer of
Cardiff Oncology and one of the article's lead authors. "Our study
showed an improved objective response rate and median
progression-free survival compared to historical controls.
Encouragingly, the FOLFIRI+bevacizumab+onvansertib combination
demonstrated efficacy across multiple KRAS mutations. Our upcoming
presentation at AACR will showcase the full Phase 1b/2 data from all 68 patients in the study. The
data from this Phase 1b/2 study
serves as the foundation for our CRDF-004 first-line study in
RAS-mutated mCRC, which is now open for enrollment at multiple
centers."
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.
Forward-Looking Statements
Certain statements in this press release are forward-looking
within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements may be identified using words such as
"anticipate," "believe," "forecast," "estimated" and "intend" or
other similar terms or expressions that concern Cardiff Oncology's
expectations, strategy, plans or intentions. These forward-looking
statements are based on Cardiff Oncology's current expectations and
actual results could differ materially. There are several factors
that could cause actual events to differ materially from those
indicated by such forward-looking statements. These factors
include, but are not limited to, clinical trials involve a lengthy
and expensive process with an uncertain outcome, and results of
earlier studies and trials may not be predictive of future trial
results; our clinical trials may be suspended or discontinued due
to unexpected side effects or other safety risks that could
preclude approval of our product candidate; risks related to
business interruptions, including the outbreak of COVID-19
coronavirus, which could seriously harm our financial condition and
increase our costs and expenses; uncertainties of government or
third party payer reimbursement; dependence on key personnel;
limited experience in marketing and sales; substantial competition;
uncertainties of patent protection and litigation; dependence upon
third parties; and risks related to failure to obtain FDA
clearances or approvals and noncompliance with FDA regulations.
There are no guarantees that our product candidate will be utilized
or prove to be commercially successful. Additionally, there are no
guarantees that future clinical trials will be completed or
successful or that any precision medicine therapeutics will receive
regulatory approval for any indication or prove to be commercially
successful. Investors should read the risk factors set forth in
Cardiff Oncology's Form 10-K for the year ended December 31, 2022, and other periodic reports
filed with the Securities and Exchange Commission. While the list
of factors presented here is considered representative, no such
list should be considered to be a complete statement of all
potential risks and uncertainties. Unlisted factors may present
significant additional obstacles to the realization of
forward-looking statements. Forward-looking statements included
herein are made as of the date hereof, and Cardiff Oncology does
not undertake any obligation to update publicly such statements to
reflect subsequent events or circumstances.
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
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SOURCE Cardiff Oncology, Inc.